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Is MDMA the key to treating women with PTSD?

by Kelley McMillan

Some say yes—and that the prescription could come as early as 2021.

On a bright, sunny morning in June 2012, 36-year-old massage therapist Roxxann Murphy and her husband, David, 34, were driving to Oklahoma City's Myriad Botanical Gardens with their 18-month-old daughter, Romy. Almost as soon as David—blond and handsome, with light-blue eyes—turned their Honda Fit onto the highway, they saw a man waving wildly for assistance on the right side of the road. Eager to help, David slowed down and parked the car. It turned out to be a domestic disturbance between the man and his female companion; after making sure the couple was OK, David began walking back toward Murphy, the flat plains framing his athletic build.

Suddenly, a car swerved from the highway at 70 miles per hour, striking David and another man who had stopped to help. Murphy recalls watching the stranger fly through the air upside down. He's not going to survive, she thought. Then she saw David's body roll to a stop in the grass that lined the highway. "David! David!" she screamed, before grabbing Romy from her car seat and running to his side. He was unconscious by the time she reached him, with blood seeping from a deep gash in his forehead and nose. She knelt beside him, gently stroking his head and body with one arm while breast-feeding Romy in the other, the only thing that would soothe her crying daughter. Sunlight streamed down and small crickets hopped over David's body as Murphy begged him not to leave her. An hour later, they were still waiting for an ambulance to arrive. "I felt him dying," Murphy says. Soon, he was gone.

Immediately after the accident, Murphy began having flashbacks. She jumped at noises. She hallucinated that shadowy, hulking men stood by her bed. She lost 25 pounds and rarely slept; when she did, she dreamed of blood, gore, and body parts. Her waking hours were spent in a zombie-like state. Mostly, she fantasized about bashing her brain with a hammer; but she had to stick around for Romy, which made her resentful.

So a few weeks after David's death, she began seeing a cognitive behavioral therapist at the University of Oklahoma. He diagnosed her with post-traumatic stress disorder, or PTSD, a condition characterized by flashbacks, feelings of hopelessness, and emotional numbing that affects 8 million U.S. adults (81 percent of them women) and can occur when someone experiences a traumatic event like military combat or sexual assault. But even with weekly therapy, Murphy was still suicidal two years after the accident. Desperate for something that would keep her alive for her daughter, she sought out alternative PTSD treatments online, and finally, as a last-ditch effort, took a weeklong trip to Boulder, Colorado, to join a progressive clinical trial that would eventually save her life: a psychotherapy session catalyzed by the hallucinogen MDMA.

Better known by its street names, Molly or Ecstasy, and long viewed as a party drug, 3,4-methylenedioxy- methamphetamine, or MDMA, is currently being studied as a treatment for chronic, treatment-resistant PTSD in four FDA-approved, phase-two clinical studies: in Boulder; Charleston, South Carolina; Vancouver, British Columbia; and Beer Yaakov, Israel (international studies can be used in the FDA-approval process). Over the course of about five months, the trials' 98 subjects, including 54 women, ingest between 75 and 188 milligrams of MDMA during three- to five-day psychotherapy sessions (comparable to a street dose), supplemented by about 20 hours of non-drug-enhanced talk therapy with mental-health professionals. Lauded for its ability to break down emotional barriers, enhance communication skills, and promote deep introspection, the drug acts not as a medication, but as a catalyst to psychotherapy, many times achieving in a few sessions what might take years in traditional therapeutic settings.

Results from an earlier phase-two study in Charleston completed in 2008 (there are three stages for a medication to get FDA approval) showed great promise: After just two sessions of MDMA- assisted psychotherapy, 83 percent of participants no longer qualified for a PTSD diagnosis, compared with only 25 percent who were cured from talk therapy alone. If these current trials are successful, MDMA-assisted psychotherapy may become a prescription treatment for PTSD and radically change how we treat a wide range of psychiatric illnesses, like autism, anxiety, and anorexia.

Though it's frequently associated with war veterans, PTSD is common in civilian women; one in 10 women will experience it in their lifetime, owing, in part, to the fact that women are more likely to suffer sexual trauma, the type of incident that most frequently leads to the disorder. Standard treatments for PTSD include antidepressants and talk therapy, but their efficacy is mediocre at best: In clinical trials, these therapies were ineffective for about 25 to 50 percent of patients.

About two years after David's death, Murphy sat in the bright, airy office of therapist Marcela Ot'alora, the Boulder study's lead investigator, preparing to embark on her first MDMA-assisted psychotherapy session. She was nervous to take the hallucinogen in front of a therapist, especially one she didn't know. Rhythmic drumming played on the stereo in the background. Lit candles adorned a table where Murphy placed a photo of her and David kissing in a field of goldenrod.

Twenty minutes after Murphy swallowed her capsule of MDMA, the drug took hold. Murphy envisioned herself rocketing through the earth's atmosphere toward space, where she came upon David, illuminated like a zodiac drawing among the stars. They spoke about the mundane—her travel hiccups getting from Oklahoma to Boulder—and the profound. She updated him on his family, shared her worries about Romy's future, and expressed anger with him for leaving her to raise their daughter alone. He nodded knowingly and assured her with his big Aw, shucks smile. Then Murphy asked him a question: "How big are you?" David threw open his arms, which unfurled into wings that stretched across the entirety of the universe. After two years of terror and grief, Murphy finally felt peace.

MDMA-assisted psychotherapy may seem like a novel treatment born of the medical-marijuana age. But this new round of research is, in fact, revisiting old ground. Before it was co-opted by club-goers, MDMA was used by therapists during similar intensive, daylong therapy sessions in the late 1970s and early '80s. California therapist and pioneer of the psychedelic psychotherapy movement Leo Zeff coined it "penicillin for the soul." In 1985, the Drug Enforcement Administration (DEA) classified it as a schedule I substance, along with heroin and LSD—a designation given to "drugs with no currently accepted medical use and a high potential for abuse."

That kicked off years of bad publicity for MDMA, including inaccurate claims that MDMA causes Parkinson's disease and holes in the brain, and permanently damages serotonin reserves. In reality, no studies have shown that clinical usage—that is, taking pure MDMA in moderate doses under medical supervision a limited number of times—leads to long- term cognitive damage, according to Matthew Johnson, associate professor of psychiatry and behavioral sciences at Johns Hopkins Medicine. MDMA has been administered in various studies to more than 1,113 subjects, with only one report of a serious, drug-related adverse event, which ended once the drug wore off. (A subject was admitted to the hospital with an irregular heartbeat and was released the next day.)

Recreational and pharmaceutical MDMA barely resemble each other, however. While the terms MDMA, Ecstasy, and Molly are used interchangeably, Molly or Ecstasy bought on the street is often misrepresented or cut with dangerous adulterants, like methamphetamine, and rarely contains actual MDMA. (Only 9 percent of the Molly the DEA collected in New York state in 2013 contained the pure form of the drug.) And using even pure MDMA in a nonmedical setting, like a club, can be risky: The drug increases blood pressure and heart rate and can cause hyperthermia, or overheating, which can lead to liver, kidney, muscle, and heart failure.

Ranging in age from 23 to 66, the 54 women in the six phase-two studies are mothers, teachers, professional athletes, military veterans, police officers, psychotherapists, and office managers. They have survived combat, rape, physical and sexual torture, and more. Each has taken the DSM-IV Clinician- Administered PTSD scale, or CAPS test, the standard for diagnosing the disorder. (The maximum score is 136; anything above 60 is considered severe PTSD. The average score among the studies' participants is 82.) For these women, participation is oftentimes their final attempt to reclaim their lives.

Rachel Hope, a 43-year-old writer from Los Angeles, endured a troubled childhood: At 4 years old, she was physically and sexually abused, then hit by a truck at age 11, which left her partially paralyzed for a year and requiring four surgeries and years of physical therapy. As a result of the various traumas, Hope suffered from debilitating, treatment-resistant PTSD, which manifested as extreme irritable bowel syndrome (IBS), acute anxiety, night terrors, panic attacks, and insomnia, among other symptoms, and left her malnourished and unable to maintain romantic relationships or to work outside the home. "It was a monstrous existence," she says. At one point, she was on 15 medications before enrolling in the Charleston study in 2005. "I was dying," she says of her choice to join the study. "I had nothing to lose."

Brenda, a 38-year-old teacher from the Denver area, who was physically and sexually tortured by her father from ages 3 to 12, was so clinically depressed from PTSD that she was left suicidal and unable to teach her elementary school classes. She tried 11 medications and was in weekly therapy for 15 years before enrolling in a study. "I entered the Boulder study with a CAPS score of 87, on meds," she says. "That's bullshit. That's me doing everything I'm supposed to do, everything that these therapists are taught to do in school, and it's not helping." She was wary of using a so-called party drug to treat her condition, but she was was desperate. "I was really in a fight for my life," Brenda says. "The fear of the stigma associated with using MDMA was far less than the fear of continuing to feel the PTSD symptoms for the rest of my life."

The sessions are not high-flying, blissed-out psychedelic drug trips, but intense feelings of "connection," or love for oneself and others, do pervade the experience. "My husband and I have been married 17 years, and it was the first time I understood how much he must love me and how I deserve that love," explains Brenda, who says MDMA opened up a world of new emotions for her. "I was able to feel. I think that's the biggest takeaway. While on the MDMA, I had access to feelings that I hadn't ever had access to before." The drug, which lasts three to six hours, produces an objective state in which one is able to revisit difficult emotions and experiences, and able to do so without being overwhelmed by them. "I was terrified a lot of the time. I was reliving it," says Murphy, who regularly went back to the scene of the trauma. "I actually saw all of the accident, but it didn't overwhelm me because I was outside of it somehow."

This sense of peace is typical of the MDMA sessions. "Instead of feeling hyperaroused or overstimulated, I felt a tremendous calm and had reduced anxiety," says Hope. Despite the enhanced sensory perception that is a hallmark of the psychedelic experience (things like light appearing more crystalline, the sensation of air currents wafting over skin), participants are extremely focused on the task at hand: healing. "Even though MDMA is a psychedelic, I didn't feel like I was tripping," says Hope. "I didn't feel fucked up. I felt really empowered, like I could direct my mind where I needed to."

There's a chemical explanation for all of this. MDMA triggers a massive release of serotonin, a neurotransmitter critical to mood regulation; dopamine, which modulates emotional response; and oxytocin, the hormone of bonding, trust, and intimacy. "Patients are awake, alert, connected. They want to talk. They want to explore. They feel calm enough and their fear is extinguished enough that they can actually process the trauma," says psychiatrist Dr. Julie Holland, author of Ecstasy: The Complete Guide: A Comprehensive Look at the Risks and Benefits of MDMA. "You basically couldn't design a molecule that is better for therapy than MDMA."

MRI brain scans suggest that one way MDMA works is by decreasing activity in the amygdala, the brain's fear center, while increasing activity in the prefrontal cortex, regions associated with memory and higher functioning. In the PTSD brain, activities in these areas are out of balance. Researchers believe MDMA's effects on the amygdala and prefrontal cortex allow people to understand a trauma without being overwhelmed by negative emotions. "It's almost like anesthesia for surgery," says Holland. "It allows you to dig and get to the malignant thing that needs to be pulled out and examined. It takes years in psychotherapy to dig around the trauma and start to get to it. This is a way for people to process the core issue in order to move forward."

Accessing traumatic memories allows patients to re-remember them, a process called memory reconsolidation, in which memories can be changed if they are reactivated and updated with new information. "You're actually manipulating that memory, and when it gets stored again, what's stored again is a little different than what you pulled out," says Johnson. This is key for people with PTSD, whose brains haven't properly worked through trauma. "I felt as if I was literally reprogramming my brain and confronting all of the fixed thought patterns and belief structures that were keeping the PTSD in place, that were making me relive the past over and over again. I was able to file those memories in the past," says Hope.

From June through October 2014, Murphy underwent three 8-hour MDMA treatments. After her first session, her sleep improved. After her second, she stopped wanting to kill herself; her flashbacks began to subside. "It felt like burdens were lifted off my shoulders," Murphy says. By the end of her participation in the study, her CAPS score had fallen from 114 to 37, meaning she no longer qualified for a PTSD diagnosis. "It saved me," she says of the treatment. "It delivered me back to my good life and delivered my daughter her mother."

Brenda also credits MDMA-assisted psychotherapy with saving her life. "I spent 35 years suicidal, and I'm not anymore, because of the MDMA and two really skilled therapists," she says. She is now off all her medications and teaching full-time again for the first time in seven years. "I'm the healthiest I've ever been, because I have so much clarity." And more than 10 years after enrolling in the first study in Charleston, Hope says she is still cured of PTSD and has not suffered IBS, flashbacks, or night terrors since her first MDMA session.

Whereas psychiatric medications such as Zoloft try to address so-called biological imbalances, they act as a temporary Band-Aid to suffering, say researchers. MDMA may heal it altogether. And MDMA may be safer than psychiatric medications, in part because you don't have to take it every day. "If used carefully, it could be safer simply because your side effects are time-limited," says Johnson. Zoloft and Paxil, traditional treatments for PTSD, can cause weight gain, sexual dysfunction, and suicidal thoughts, whereas a single dose of medical-grade MDMA may only cause increases in heart rate and blood pressure during the session, and fatigue, loss of appetite, and low mood for a day or so afterward. For people like Murphy, Brenda, and Hope, the insights and emotional shifts gleaned from their MDMA sessions have profoundly changed their lives. Brenda says, "It's really like stepping outside into a whole new world and breathing fresh air."

MDMA research has helped pave the way for psychiatry's current psychedelic resurgence. Scientists at Johns Hopkins, Imperial College London, and the University of New Mexico are studying LSD and psilocybin, the psychoactive compound in magic mushrooms, as antidotes to addiction, anxiety, depression, and more. In the future, MDMA researchers hope to see the no-longer-experimental treatment administered by specially trained and licensed therapists in mental health clinics around the globe.

But Bertha Madras, Ph.D., a professor of psychobiology at Harvard Medical School, fears that legalizing MDMA for medical use is just the first step in decriminalizing serious drugs in the United States. "The illicit hallucinogens MDMA, LSD, and psilocybin are the next wave of drugs being promoted as 'medicines,' with the long-term view of normalizing their use for psychoactive purposes," she says. "At present, there is insufficient evidence to support the use of MDMA for therapeutic purposes." Dr. Joseph Lee, medical director of Hazelden Betty Ford Foundation Youth Continuum, a rehab facility in Minnesota, believes MDMA may have therapeutic properties but worries about the greater ramifications of legalizing MDMA-assisted psychotherapy. "My concern is that somehow this conversation about researching MDMA for PTSD will bleed into people justifying recreational use or minimizing misuse. We've seen that happen with prescription drugs," says Lee. He also cautions against overuse of MDMA. "We routinely see kids every year who used too much MDMA or for whatever reason had a side effect from the MDMA and needed to be psychiatrically hospitalized before coming to treatment," he says, touching on another concern of MDMA— that it may trigger latent psychiatric issues. (Prospective participants for the MDMA-assisted psychotherapy trials are screened for any psychological issues—like bipolar disorder and schizophrenia—that may be of concern.)

One of the biggest obstacles standing in the way of developing MDMA into an FDA-approved medication is funding. The process is a $20 million endeavor and one that relies completely on the fundraising efforts of MAPS, the Multidisciplinary Association for Psychedelic Studies, a nonprofit research and educational organization that studies and develops therapeutic applications for psychedelic drugs—partly because pharmaceutical companies have little interest in developing a drug administered only a few times. In 2016, MAPS will move MDMA-assisted psychotherapy one step closer to legalization when it begins phase-three clinical trials, which will involve more than 400 participants and last five years. If those trials are successful, psychiatrists may be prescribing the treatment by 2021.

In the meantime, MDMA has caught the attention of those at the highest levels of the military; 22 veterans per day commit suicide. The National Center for PTSD, in the Department of Veterans Affairs, has been consulting with MAPS concerning an upcoming study, which will look at MDMA-assisted couples therapy involving veterans and top VA-affiliated psychologists, and will begin at the end of this year. Based on the results, Rick Doblin, MAPS founder and executive director, is hopeful the Department of Defense may fund further studies and allow MAPS to work with active-duty soldiers.

Today, Murphy lives with Romy on a quiet street in Norman, Oklahoma, and is thriving. In June, she traveled to Northern California, where she lived with David for two years, to scatter his ashes at Muir Woods, a stretch of lush redwood forest near the Pacific that they frequented and loved. She brought along her new boyfriend, who, coincidentally, is also named David; they met after Murphy's second MDMA-assisted psychotherapy session. They are talking about a life together, something she never could have imagined before the experimental treatment. For the first time in years, she is hopeful about what lies ahead. "I'm able to make a life for us now, and he's right here with me," she says of her late husband. "I feel blessed that I ever got to be with him in the first place." Some days, when she's out in her yard with Romy, a bird will fly by and Murphy will reach up to the sky and say, "Daddy's birds." Her daughter smiles, knowing her father is close by, and, at long last, so does Murphy. "It's still sad," she says. "But I can access those memories, and see him in my daughter, and I rejoice in it."

https://www.marieclaire.com/health-fitness/news/a15553/mdma-ecstasy-drug-ptsd-treatment/
 
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FDA designates MDMA a "breakthrough therapy" for PTSD

by Ashley Welch - August 31, 2017

After years of lobbying and experimental research, the FDA has granted "breakthrough therapy" status for the drug MDMA as a potential treatment for post-traumatic stress disorder. The designation does not mean the drug is FDA-approved, but it does ease the way for clinical trials to test its safety and effectiveness in patients with PTSD.

The non-profit Multidisciplinary Association for Psychedelic Studies (MAPS), which has been advocating and fundraising for MDMA research for three decades, announced the FDA's designation late last week. (The FDA told CBS News it does not publicly disclose information about which drugs qualify for breakthrough status, citing confidentiality, but said researchers or drug companies are free to do so.)

More commonly known as its street names ecstasy or Molly, MDMA (methylenedioxymethamphetamine) is a psychoactive drug that produces feelings of energy and euphoria, often followed by an emotional crash. In recent years, some in the scientific community have suggested it could have medical benefits, as well.

In previous phases of clinical trials, the drug was shown to offer significant relief to sufferers of PTSD, a mental health disorder characterized by nightmares or flashbacks and heightened anxiety or depression after experiencing or witnessing a terrifying event. It affects an estimated 8 percent of Americans, with certain populations, including those who served in the military, more vulnerable.

According to the FDA's website, a designation of "breakthrough therapy" simply means the agency will expedite the review of the drug and potential approval. The status is granted when "preliminary clinical evidence indicates that the drug may demonstrate substantial improvement" over other available therapies.

In a press release, MAPS said the designation means "the FDA has agreed that this treatment may have a meaningful advantage and greater compliance over available medications for PTSD."

MAPS, founded in 1986, has also been a long-time advocate for the medical use of drugs like psychedelics and marijuana. Its mission statement reads: "We envision a world where psychedelics and marijuana are safely and legally available for beneficial uses, and where research is governed by rigorous scientific evaluation of their risks and benefits."

In phase 2 clinical trials sponsored by MAPS, 61 percent of the 107 participants with chronic, treatment-resistant PTSD no longer had the disorder after two months of MDMA-assisted psychotherapy treatment. At a 12-month follow up, 68 percent no longer had PTSD.

The organization expects to begin phase 3 trials with a larger group of participants next year.

"For the first time ever, psychedelic-assisted psychotherapy will be evaluated in Phase 3 trials for possible prescription use, with MDMA-assisted psychotherapy for PTSD leading the way," Rick Doblin, founder and executive director of MAPS, said in a statement.

Amy Emerson, executive director of the MAPS Public Benefit Corporation (MPBC), adds, "our Phase 2 data was extremely promising with a large effect size, and we are ready to move forward quickly."

However, not everyone in the scientific community is enthusiastic about the prospect of a psychedelic drug being used as a medical treatment.

While advocates point out that a key difference between pure MDMA used in a medical setting and street versions of ecstasy or Molly is that street versions are often mixed with other harmful drugs, MDMA itself is not without side effects.

In its purest form, MDMA can lead to nausea, chills, sweating, muscle cramping, and blurred vision. Overdose can also occur with symptoms including high blood pressure, faintness, panic attacks and in severe cases, loss of consciousness and seizures.

"I think it's a dangerous substance," Andrew Parrott, a psychology professor at Swansea University in Wales who spent years researching the drug's harmful effects, told the Washington Post.

He told the newspaper that he worries approval for treatment of PTSD could lead the public to believe MDMA is safe for recreational use.

MAPS notes that serious adverse events have been uncommon and non-life threatening in their studies.

https://www.cbsnews.com/news/fda-designates-mdma-as-breakthrough-therapy-for-ptsd/
 
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In 2007, Rudy Gonsior joined the Army Special Forces, where he served as a sniper on a team trained to deploy abroad on short notice.
The fast tempo of missions left him feeling that he had joined a “cult of death,” he said.


Psychedelic therapy draws veterans to jungle retreats

by Ernesto Londoño | New York Times | 30 Aug 2020

GIGANTE, Costa Rica — There was a ghostlike quality to Rudy Gonsior, an American former Special Forces sniper, on the morning he arrived at a jungle retreat to see if a vomit-inducing psychedelic brew could undo the damage years of combat had done to his mind.

Glassy-eyed and withdrawn, he barely spoke above a whisper and was much quieter than the six other veterans who had come to dredge up painful memories of comrades fallen in battle, thoughts of suicide and the scar that taking a life leaves on the psyche.

“I have traveled across continents to come to the jungle to do psychedelics,” marveled Mr. Gonsior, who had steered clear from drugs his whole life. “I guess this is what might be considered a Hail Mary.”

They had come to western Costa Rica to try ayahuasca, a substance people in the Amazon rainforest have imbibed for centuries. Some Indigenous communities regard the brew, which contains the psychedelic DMT, as a powerful medicine that keeps them spiritually resilient and in harmony with the natural world.

The lodge the Americans visited late last year was a far cry from that, with a gleaming swimming pool and a sprawling deck that anchors well-appointed cabanas featuring splendid ocean views. Charging from $3,050 to $7,075 per person for weeklong retreats, the lodge is among the newest and priciest additions to a booming alternative healing sector.

Until relatively recently, only a few botanists, hippies and spiritual seekers gained access to the world of Amazon shamanism, which missionaries drove underground during colonization in much of the Amazon basin as they sought to convert Indigenous groups to Christianity.

But now, thousands of people from around the world make pilgrimages each year to the more than 140 ayahuasca retreat centers in Latin American countries where the substance’s use in ceremonial settings is legal or, as in Costa Rica, not explicitly outlawed.

Besides psychedelic ceremonies, which are often physically and emotionally draining, retreat organizers offer group therapy sessions, yoga classes, art therapy, meditation circles and warm floral baths.

Collectively, these centers have become an unlicensed and unregulated mental health marketplace for people searching for an alternative to antidepressants and other widely prescribed pharmaceuticals.

The draw of psychedelics has surged amid a growing body of scientific research that builds on promising studies in the United States and Europe from the 1960s and 1970s. Much of that earlier research was shut down after psychoactive substances were outlawed during the Vietnam War era — a response to concerns over widespread drug use on college campuses.

But in the last few years, the Food and Drug Administration designated psilocybin, the psychedelic component in what are commonly called magic mushrooms, and MDMA, the drug known as ecstasy, as “breakthrough therapies.” That rare designation allows scientists to fast-track larger studies that could pave the way to administering psychedelics as medicine.

Drinking ayahuasca can be dangerous, especially while taking certain pharmaceuticals, including antidepressants and hypertension drugs. It can also set off psychotic episodes for people with serious mental health conditions, like schizophrenia.

And while some retreats have strict rules and protocols that have been developed in consultation with medical professionals, the ayahuasca boom has sometimes been exploited by scammers and charlatans, and it has come under scrutiny for instances of sexual assault on vulnerable or impaired participants, including cases in Peru.

“You have to recognize that there’s a Wild West element” to ayahuasca retreats, said Dr. Matthew Johnson, a professor of psychiatry and behavioral sciences at Johns Hopkins University who has studied psychedelics since 2004.

"In a controlled setting," he said, "unleashing the brain can help patients revisit repressed trauma and generate new insights. So the medical establishment, once deeply skeptical of the therapeutic potential of psychedelics, is embracing “what is essentially a new area of medicine,” he added.

But Dr. Johnson worried that psychedelic retreats in general may be ill equipped to screen people for whom trips can be dangerous. In extreme cases, people have tried to commit suicide while high on psychedelics or experienced psychotic episodes that required hospitalization.

“These are powerful, powerful tools and they can put people in a very vulnerable place,” Dr. Johnson said. “That is not to be underestimated.”

Still, the growing buzz around psychedelic-assisted healing, which has been amplified by authors, celebrities and influential podcast hosts, has put places like the Soltara Healing Center, where the veterans went, at the forefront of a push to challenge conventional mental health care.

Melissa Stangl, a co-founder of Soltara, argued that responsibly run ayahuasca centers could be the seeds of a transformation.

“We are on the cusp of bringing psychoactive medicines into the mainstream health care system,” she said. “Once science really catches up to just how effective that is for people who aren’t being served by the current medical system, we can become allies.”

Before their first ayahuasca ceremony, the veterans met individually with two Peruvian “maestros,” or healers, from the Shipibo community in Peru.

“Their hearts are hardened,” said Teobaldo Ochavano, who helps run the nighttime ceremonies alongside his wife, Marina Sinti. “They seemed unable to experience love or joy.”

Ms. Sinti said years of interacting with foreigners on retreats had made it painfully clear why these rituals are in such high demand.

“People in the United States and Europe are very disconnected,” she said. “From each other and from the Earth.”

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‘A cult of death’

Like many service members of his generation, Mr. Gonsior said he enlisted in the Marine Corps to avenge the attacks of Sept. 11, which happened when he was in high school.

In 2006, he said he deployed to western Iraq for the first of multiple combat tours. He and his men were constantly ambushed with powerful roadside bombs and shot at by snipers, he said, and 17 service members he deployed with returned home in body bags.

The experience, Mr. Gonsior said, turned him into a ruthless warrior.

As a Marine, Mr. Gonsior was deployed five times — to Iraq, the Philippines, Nepal, South Korea and Afghanistan.

“My sole goal was to survive,” he said. “I did a lot of things that I am not particularly proud of.”

Instead of relief for surviving, he felt a crushing sense of shame.

“It was just by dumb luck that I wasn’t shot and wasn’t blown up,” he said. “Like to the point where, statistically, I should be dead by now or at least seriously injured.”

In 2007, Mr. Gonsior said he joined the Army Special Forces, where he served as a sniper. It left him feeling that he had joined a “cult of death,” he said.

“The last 17 years of my life, my job in one way or another has revolved around death,” he said. “As I get older, it weighs heavy.”

Killing became mundane. But one life he took in Afghanistan in 2012 haunted him for years.

During a routine operation, Mr. Gonsior opened fire on a man on a motorcycle, believing he was an insurgent. Soon after, Mr. Gonsior learned he had killed an Afghan intelligence source working with his unit.

Mr. Gonsior said he didn’t allow himself to grieve that death properly or process the guilt until years later, when he was gripped by depression and bouts of rage that were sometimes set off by inconsequential things his children did.

Abstract thoughts about suicide eventually turned chillingly specific, he said. At the Veterans Affairs hospital where he sought help, Mr. Gonsior, 35, said he was urged to take antidepressants. He said he refused, based on the side effects he had seen fellow soldiers suffer.

Last year, after listening to a story about ayahuasca and trauma on the radio, he became fascinated by the idea that healing deep wounds requires grappling with their roots.

“There’s a lot of emotional wreckage, shipwrecks that are kind of down there,” he said.

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By the time he and the other veterans filed into the darkened ceremony room, with its netted windows and cone-shaped roof, they had signed a lengthy hold-harmless agreement.

It warned of the “unlikely event of a psychotic episode,” the danger of drinking ayahuasca while taking antidepressants, and that psychedelic trips leave some people feeling worse “mentally, physically and emotionally.”

Dressed in traditional outfits, the Peruvian maestros blew tobacco smoke into the candlelit room, known as a maloca. Participants sitting on cots arranged in a circle stepped up to gulp a shot glass of the dark brown, sludgy ayahuasca brew.

Chris Sutherland, a 36-year-old Canadian soldier who said he recently retired on full disability for post-traumatic stress disorder, had come after years of panic attacks, binge drinking and periods of taking antidepressants that left him feeling that “I was no longer human.”

Chris Sutherland, a Canadian military veteran, did three military tours — one in Bosnia in 2002 and two in Afghanistan.

David Radband, a British former special forces soldier, said he came to the jungle hoping to drown out the rage that had consumed his life after he left the army. He said it had cost him custody of his children, landed him in prison for assault and pushed him to try to kill himself twice, once by hanging and once by stabbing himself in the gut.

“I was blocking emotions with anger,” said Mr. Radband, 34. “I was putting up a wall all the time.”

Juliana Mercer, 38, a Marine veteran, said she developed a condition called caregiver fatigue after spending four years looking after wounded service members in San Diego. When she deployed to Afghanistan in 2010, she said she experienced crippling fear every time she saw young, healthy Marines drive off the base.

“I was just so desperate to keep everybody safe,” she said.

It was quiet in the room when the maestros blew out the candles, save for the gentle lapping of waves from the nearby beach. But the silence was short-lived.

As the ayahuasca began taking hold, the Peruvians began pacing across the room slowly as they sang Icaros, high-pitched songs that the Shipibo regard as the crux of the healing process.

At times, their rhythm and cadence can be soothing and hypnotic, lullaby-like. But higher notes and fast-pace sequences can feel taunting or exasperating.

When ceremonies reach a crescendo, the room often feels like a state of controlled pandemonium. Bouts of loud vomiting pierce the singing. There is sometimes audible weeping in one corner and ecstatic laughter from across the room.

As dawn approaches and the ayahuasca starts wearing off, participants emerge from the room looking gaunt and dazed as the rational mind struggles to regain control.

Juliana Mercer was a Marine who deployed to Afghanistan.

“These experiences have a way of completely blasting people out of the mental ruts they’re stuck in and to look at a broader set of possibilities,” said Dr. Johnson at Johns Hopkins, one of several universities conducting clinical trials.

Unlike antidepressants, which numb symptoms of distress when effective, psychedelics appear to turbocharge the kind of healing process that results from psychotherapy, he added.

But he and other experts who cite the psychiatric promise of psychedelics worry about their use in retreats or other settings without adequate controls.

“The room for error is not having adequate medical support” in the rare instances when people have serious adverse effects, said Collin Reiff, a psychiatrist at New York University.

Still, Jesse Gould, a former Army Ranger who brought the veterans to Soltara, says the benefits of the jungle retreat experience outweigh the risks.

Mr. Gould said he created the Heroic Hearts Project, a nonprofit group that raises money to send veterans to psychedelic retreats, after stumbling into one at a low point in his life.

After leaving the Army and traveling a bit, he said he landed a comfortable job in finance that drove him to drink heavily and left him with “a feeling of dread about everything.”

Jesse Gould, a former Army Ranger, created the Heroic Hearts Project, a nonprofit that raises money to send veterans to psychedelic retreats.

When he sought help at the Department of Veterans Affairs in Tampa, where he lived, Mr. Gould said he was encouraged to take antidepressants, which held no appeal to him. In 2016, he quit his job and booked a retreat at a center in Peru.

The decision was radically out of character for Mr. Gould, 33, a strait-laced veteran who said he had avoided drugs his whole life.

“I definitely grew up in the D.A.R.E. generation,” he said, referring to the antidrug advertising campaign that began in the 1980s. “I was very much into ‘Just say no.’”

His first few ceremonies were brutal, Mr. Gould said, calling them “an all-out war” in which he vomited as many as 20 times in one night and felt like he was pushed “to the edge of sanity.”

But in the months that followed, he said his depression mellowed, his crippling social anxiety melted away and his mood swings, which had felt like a “tug of war in my brain,” ceased.

“It seemed to almost rewire my brain,” Mr. Gould said.

Since then, Mr. Gould and his team have raised more than $250,000 to pay for psychedelic retreat “scholarships” for dozens of veterans. And they have infused the movement to decriminalize psychedelics with testimonies that belie the stereotype of New Age stoners.

“People instantly have the image of a hippie,” he said. “But because of my service, a lot of people that are in a completely different demographic tend to listen.”

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‘Another layer of understanding’

As their weeklong retreat came to an end, Mr. Radband, the British soldier, said the ceremonies had reignited his desire to live.

“You know, I tried to kill myself twice, but I’m not ready to die,” he said. “I have so much more to give.”

David Radband, a British former special forces soldier, came to the jungle hoping to drown out the rage that had consumed his life after he left the army.

Mr. Sutherland, the Canadian, said one of the ceremonies had been “the most terrifying night of my life, more terrifying than any combat I have ever been in.” But collectively, he said, the trips helped him overcome a longstanding fear: “I am not a sociopath,” he said.

“I was always worried that I was evil, but I was shown where my compassion lies,” he said.

Mr. Gonsior, the American sniper, likened the experience to a “final surrender” that was grueling but restorative.

“You have so many experiences that run the gamut from absolute terror to pure joy,” he said. “You realize there’s another layer of understanding there.”

On the last day, as Mr. Gonsior was waxing poetic about the universe and how all living beings are connected, Mr. Gould couldn’t resist getting in a little jab.

“There’s a hippie inside every veteran,” he said.

 
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MDMA therapy achieves astounding 76% success rate for treating PTSD

by Rich Haridy | NEW ATLAS | 1 Nov 2018

Newly published results from a Phase 2 clinical trial into the efficacy of MDMA-assisted psychotherapy in treating post-traumatic stress disorder (PTSD) have revealed striking success, with 76 percent of subjects not meeting the standard clinical criteria for PTSD 12 months after receiving the treatment.

This latest study is one of six key Phase 2 clinical trials that were used to last year convince the FDA to grant the landmark MDMA-assisted treatment a Breakthrough Therapy Designation. This particular trial, sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), was conducted in Boulder, Colorado and led by psychotherapist Marcela Ot'alora.

The trial comprised 28 subjects, all with clinically diagnosed PTSD that had persisted for an average of almost 30 years, despite attempts with other conventional treatments, including drugs and psychotherapy. The structure of the treatment resembled the model established by MAPS in other trials: two day-long MDMA treatment sessions followed by integrative therapy sessions. A third MDMA session was also offered to evaluate whether that improved long-term responses compared to two sessions.

Responses to the treatment were evaluated using the Clinician Administered PTSD Scale (CAPS-IV), the current best standard for PTSD assessment. Here the results were nothing less than spectacular. On enrolment the average CAPS-IV score of each participant was 92, and at a follow-up 12 months after the final MDMA session, the average CAPS-IV score was just 31. A remarkable 76 percent of participants, after 12 months, did not meet the clinical diagnostic criteria for PTSD.

These impressive results bode well for the long-term staying power of the treatment, with the average CAPS-IV score dropping an additional 9.6 points from the point the treatment finished to the 12-month follow-up.

The final stage before MDMA for PTSD can become an FDA-approved treatment is expansive Phase 3 trials. These trials kicked off in September 2018, after a slight delay in producing and encapsulating the MDMA needed to conduct the experiments. Encompassing between 200 and 300 subjects across 16 different sites in the US, Canada and Israel, it should take up to two years to complete this final stage, with ultimate FDA approval on track for sometime in 2021 if all goes well.

https://newatlas.com/mdma-ptsd-successful-trial-results/57074/
 
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We’re excited about MDMA’s potential for treating PTSD

by Kevin Franciotti - Oct 16, 2018

By the 1970s, the cultural zeitgeist around LSD was such that, despite nearly three decades of serious research touting the drug’s medical potential and its integral involvement in the discovery of serotonin’s function in the brain, further development was squashed under the full weight of an oppressive, authoritarian crackdown. Now, another drug that researchers started examining from a similar lens in the ’80s and ’90s may become a prescription medicine: MDMA. Known to the public as ecstasy (and more recently as molly), it has quietly been used in a clinical setting by a small community of therapists since the late ’70s (and is often still used in “underground treatment” settings). It has also been slowly gaining steam toward full-on medical approval: The Food and Drug Administration, as part of its assessment of whether MDMA warrants the agency’s approval, recently approved large-scale testing in humans. If it goes well, what has been a painstaking effort of nearly four decades of drug development research may soon culminate in MDMA being in therapy rooms as a legally available medicine for the treatment of post-traumatic stress disorder.

The question is whether we’re approaching this potentially game-changing expansion in the right way. It’s understandable that many proponents of MDMA therapy have grandiose expectations—the current treatment options for PTSD are largely inadequate. Just two medications are approved for PTSD and are meant to simply manage some of the symptoms, but they’ve been shown to be only somewhat effective at that. MDMA seems like a promising alternative: It has an unconventional history and novel therapeutic efficacy, with dramatic results from the initial clinical trials boasting an 83 percent reduction in symptoms among the majority of trial participants, and over two-thirds of participants no longer meeting DSM criteria for PTSD diagnosis following treatment. But significant questions about just how much of an impact this treatment could have might be a buzzkill to MDMA’s promise as a medicine.

In simple terms, PTSD develops in someone when one or more traumatic events are experienced, and the subsequent anxiety related to the trauma significantly interferes with quality of life, ability to hold a job, and interpersonal relationships. It’s a condition that is fundamentally resistant to treatment, because often the necessary criteria for successful psychotherapy—such as trust in one’s therapist and empathy towards oneself—are often critically lacking in someone who’s been traumatized.

MDMA affects the brain almost as if it were specially designed to treat the symptoms that prevent someone with PTSD from succeeding in psychotherapy. Synapses are primarily flooded with serotonin, which provides a pleasant euphoria allowing someone to face their painful thoughts and feelings. At the same time the release of dopamine, norepinephrine, oxytocin—sometimes referred to as the “empathy chemical”—cortisol, and prolactin reinforce the mood lift while attenuating anxiety and the fear response, acting in concert to amplify the therapeutic bond.

Of course, bringing a drug through the FDA approval process is no small task, let alone one currently listed in Schedule I of the Controlled Substance Act, the most restrictive class of drugs deemed to have no medical use and a high potential for abuse. Though no federal agency has funded a single study looking for potential benefits from MDMA, the government’s own efforts to corroborate some of the outlandish claims of its danger to users—including its potential to eat away at brain tissue—failed, and some of that same research was actually later used to convince the FDA that MDMA was safe enough to test in humans. Since 1986 (the same year the Drug Enforcement Administration permanently designated MDMA as a Schedule I substance), a small nonprofit known as the Multidisciplinary Association for Psychedelic Studies (MAPS) has been hoping to be the first to break such ground. In a handful of small-scale clinical trials, researchers showed that using MDMA in combination with psychotherapy can effectively treat people with PTSD. MAPS must now replicate the results on a larger scale involving hundreds of participants recruited by over a dozen research sites—a stage in the process known as phase 3.

The irony in pharmaceutical drug development is that the FDA doesn’t recommend prescription approval based on how an experimental drug works: It makes that assessment based simply on whether it’s more effective than placebo, and whether any side effects are tolerated reasonably well in the majority of people it’s studied in. The FDA functions merely as a regulatory agency that provides guidelines on how to conduct drug development research and approves experimental protocols but ultimately, when it comes to the science itself, that focus is left to the study’s sponsor—in this case, MAPS. MAPS is somewhat unique compared to other pharmaceutical companies because, in addition to their MDMA development efforts, they are also funding basic science research to show what mechanisms are involved in successful treatment.

This line of research remains preliminary, as most of the findings are from animal studies and only a few human participants (including MAPS Executive Director Rick Doblin). Results suggest MDMA’s facilitation of processes known as fear extinction and memory reconsolidation may be part of the therapy’s beneficial outcomes for people with PTSD. Based on the current evidence, if I were a careful scientist, I’d say that we don’t yet know whether MDMA therapy does actually work because it’s all still very preliminary, but it’s worth continued investigation.

The need for the treatment, however, is enormous and pressing. According to the National Institutes of Health, nearly 8 million American adults are affected by PTSD. Only around 100 people have participated in the first two phases of clinical development of MDMA-assisted psychotherapy for PTSD. This is not an unusually low number of people at this stage of experimental drug research, but the fact that it’s taken over a quarter-century to reach that number is. By comparison, the pharma giant Eli Lilly took only seven years to earn FDA approval for Prozac, the first in the class of antidepressants known as “selective serotonin reuptake inhibitors” (SSRIs).

The waiting list for participants hoping to enroll in the phase 3 trials is in the tens of thousands (most of the discretion around recruitment is left up to the teams at each of the individual research sites). Recruitment for clinical trials is challenging—the FDA’s guidelines are strict, so participants are often screened out for inability to come off contraindicated medication, past suicide attempts, personal or family history of psychosis, or failure to meet minimum scores on objective symptom measures. There are also logistical barriers, like being unable to afford to take time off work to make the appointments, securing child care, and travel costs. These requirements tend to result in socioeconomic bias in who makes the cut.

This issue isn’t trivial: A recently published review of the demographics from 18 studies involving psychedelics showed that a substantial majority of participants were non-Hispanic whites, and were not a demographically balanced socioeconomic representation of the geographic regions participants were recruited from. The authors of the review paper are attempting to directly address this inequity as part of a MAPS-sponsored MDMA therapy team studying treatment of racial trauma at the University of Connecticut. They are also consultants to ensure the phase 3 protocols are more sensitive to ethnocultural dynamics. (The National Institutes of Health mandate that NIH-funded research include diverse participant samples, but the FDA’s regulations do not require this, and MAPS receives no NIH funding.)

Last year, MAPS’ MDMA research was granted a “Breakthrough Therapy” designation that the FDA uses to streamline the regulatory process. Next year, MAPS is expecting to apply for another FDA program called “Expanded Access” wherein an unapproved drug can be given special exemptions allowing for use on a case-by-case basis (and not just for PTSD). This is promising but also likely to reinforce some of these structural problems—case-by-case exemptions are not likely to be covered by insurance. And it remains unclear how many people with PTSD will be able to access MDMA therapy even if it becomes medicine—there are some troubling indicators that it will stay limited. Insurance coverage remains an open question, and though Medicaid and Medicare are generally required to cover all FDA-approved drugs, private insurers have slightly more room to argue denials of coverage. If insurance does not cover it, it’s likely that the only people able to afford MDMA therapy will be the few privileged by a wealth of resources, able to pay out of pocket and commit to the time-intensive therapy that must accompany the medication in order for it to be effective.

As a nonprofit that’s also the sole owner of its own subsidiary, the MAPS Public Benefit Corporation, the company won’t be allowed to advertise treatment during the trials using patient testimonials, but once it receives full FDA approval, it can advertise like any other drug, according to Doblin. Again provided that the FDA approves, it will also serve as a licensing body and training institution that will yield the only therapists permitted to administer MDMA therapy (it will also sell prescription MDMA). Those able to provide the therapy will likely be relying on a business model dependent on maximizing cash-ready patients seeking treatment.* Venture capitalist–backed for-profit pharmaceutical companies are already becoming involved in similar areas of psychedelic medicine development. We’ve seen how aggressive marketing of opiate painkillers wrought havoc, and with the continuing practice of direct-to-consumer advertising, it doesn’t require too big an imagination to think of what might go wrong in that market.

As a cynical harbinger of the harms inherent in a capitalist society, particularly toward the already under-resourced, I fear MDMA’s arrival as a prescription medicine for PTSD will simply be as the most glowing product in the growing cottage industry for trauma treatment that only the rich and comfortable can access. I worry that we have no real plan of ensuring that it is available and accessible to the people that in many ways, need it the most. In this way, the story of prescription MDMA might mirror the unmet promises of the antidepressant boom, and that fate is just marginally better than if it went the way of LSD. When antidepressants first came to the market, we leapt on their easy potential and failed to address the factors driving depression rates, resulting in medications that are now barely as effective as placebo.

Even a seemingly powerful unique treatment like MDMA therapy won’t reach its potential if we don’t ensure that all people who need it can access it, along with the entire recommended process of care. Essentially, it’s never enough to just approve the treatment—you also have to assess the process. The FDA is tasked with assessing the efficacy. It’s unclear who’s tasked with assessing access.

https://slate.com/technology/2018/10/mdma-ptsd-treatment-access.html
 
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The use of MDMA for PTSD

by Prof. David Nutt - November 9, 2018

PTSD is becoming one of the great problems of our time. We know that in the United States Military the incidence of PTSD in people returning from Iraq was as high as 18%. And in fact, more soldiers returning from Iraq and Afghanistan have committed suicide from untreated PTSD than actually died in the conflict.

The first pointer to MDMA being useful in the treatment of PTSD came from the work of Mithoefer or the two Mithoefers. And the slide here shows that when MDMA was used in a two-session psychotherapeutic treatment regime, almost all of the people who had previously treatment resistant PTSD recovered. Whereas, in the placebo group, only one recovered. And not only did the MDMA produce a profound improvement in the symptoms of PTSD but the effects lasted and people stayed well for at least a year. Many are now well three or four years after the treatment,

The efficacy of this particular study and the long-term value encouraged us to write a paper about this on Psychiatry. And you can see the front page of that journal. There you can see – the man there is Alexander Shulgin and there’s his wife. And he was the guy that re-synthesized MDMA. MDMA was first made back in the 1900s. But he re-synthesized it for the Drug Enforcement Agency in the States and realized it was very, very different to other drugs he tested. And he tested more drugs than anyone in the world probably. His wife who was a therapist took it as well. And she said this drug has a particularly beneficial effect in that it helps break down the barriers that build up between couples. It makes people love each other again. And of course, that’s why MDMA when it’s used as ecstasy produces a state which people called loved up. But by breaking down those hostilities that build up over the years, MDMA proved to be a very powerful tool for couple counseling, couple psychotherapy. And it was widely used. And then it was called empathy. No one had any worries about it.

What is interesting about it is it produces decreased activity in the brain, not increase. So in these images, blue means less brain activity or less brain blood flow. This is what we call arterial spin labeling image of brain blood flow. The effects of MDMA to reduce blood flow are largely in lower brain regions, particularly the amygdala and the hippocampus . And we believe this explains why MDMA can be a useful treatment for people with PTSD because the problem with PTSD is actually to overcome it you have to remember the trauma and then get emotional. You got to get then cognitive control over the emotional memories which can be very disruptive and many people can’t try to remember the trauma because they emotions overwhelm them and they hate it and they’re terrified of it. With MDMA, we believe that can dampen down the emotions enough so that people can engage with them and then get control over them.

So the key points for MDMA in the treatment of PTSD. The first one is MDMA is a powerful empathogen. It makes people more sympathetic to each other and it works through releasing 5-HT. Although it was first made in the early 1900s, it was re-discovered in the 1970s and found to be a useful drug to break down anger and hostility in couple counseling. However, when it started to be used in the rave scene, its name was changed to ecstasy and it was made illegal. In recent years, several trials have shown it to have a special efficacy in the treatment of PTSD and PTSD that has proven resistant to conventional treatments. In the PTSD therapy, it’s used on two occasions usually two weeks apart in a strong psychotherapeutic setting usually with two co-therapists. And then it can produce very long-lasting improvement in symptoms. Separate brain imaging studies have shown it to reduce activity in amygdala and hippocampus which may explain how it helps patients overcome the emotional reliving of traumatic memories.

https://psychopharmacologyinstitute.com/clinical-psychiatry/ptsd/the-use-of-mdma-for-ptsd/
 
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'Ecstasy' study results promising for PTSD

by Matt Smith - Oct. 30, 2018

The long-banned “club drug” MDMA showed strong results as a treatment against posttraumatic stress disorder in its largest and longest study to date, researchers reported Monday.

The phase II clinical trial followed 28 patients with chronic PTSD, including military veterans and crime victims, who took the drug during three daylong psychotherapy sessions over 3 months. After two sessions, 43% of the group that received active doses of MDMA no longer met the definition of PTSD, compared to 33% who got a low dose of the drug as a placebo. And a year after the first session, 76% of the active-dose group no longer had PTSD, according to results published in the Journal of Psychopharmacology.

"The long-term results are better than those seen in previous MDMA studies," says Brad Burge, a spokesman for the Multidisciplinary Association for Psychedelic Studies, which funded the research.

“That efficacy actually increases the more time passes,” Burge says. “That’s absolutely remarkable, especially when compared to traditional treatments where people have to take drugs for months or years, or for the rest of their lives, to see any benefit at all.”

Doctors diagnose posttraumatic stress disorder in people who’ve experienced a life-threatening event by looking at a battery of symptoms, including nightmares, flashbacks, or feelings of depression. These new results don’t mean that all the problems associated with participants’ PTSD have gone away, “but they don’t qualify for a diagnosis of PTSD anymore,” Burge says.

MDMA is the active ingredient in what’s commonly known as “ecstasy” or “Molly.” It was invented in 1912 as a way to help produce drugs that controlled bleeding. But starting in the 1970s, psychiatrists found it enhanced communication with patients. By the mid-1980s, it was becoming widely abused, and the U.S. government banned it in 1985.

The latest MDMA study, conducted at a private clinic in Boulder, CO, produced no serious adverse events related to the drug. MDMA can cause the heart to race and blood pressure to jump, but the participants handled the drug well, the researchers report.

Researchers have been giving MDMA and other hallucinogenic drugs a second look for a variety of hard-to-treat mental health issues in recent years. The shift in thinking is significant as not only did the federal government classify these drugs as having no acceptable medical uses and a high potential for abuse, but many researchers believed they were too powerful to use therapeutically. But many officials and researchers now believe the mental health field is facing “a moment of great need” that’s prompted some rethinking.

The FDA last week granted “breakthrough therapy” status to another long-banned drug, psilocybin -- the active ingredient in psychedelic mushrooms -- as a potential therapy for treatment-resistant depression.

COMPASS Pathways, the U.S.-U.K. consortium behind the psilocybin research, says it plans to conduct the first large-scale psilocybin therapy trial over the next year.

“The breakthrough therapy designation is a strong endorsement for the potential of psilocybin therapy,” Robin Carhart-Harris, MD, head of the Psychedelic Research Group at Imperial College London, says in a statement announcing the move. “We look forward to learning more as further clinical studies are carried out, by our team at Imperial College as well as in COMPASS's multi-center trial."

Breakthrough designation is granted to drugs that show “substantial improvement” in clinical studies over existing treatments for serious conditions, such as depression. Earlier research led by Johns Hopkins University concluded that psilocybin showed promise in fighting anxiety and depression in patients with life-threatening cancer, raising the prospect that it could help relieve those conditions where conventional antidepressants have had little effect.

“For the second time in a year, we have the FDA determining that a psychedelic-assisted therapy could be a significant advance over what’s currently available for mental health treatment,” Burge says. “That’s very different from the last 40 years of regulatory, political and cultural attitudes around these drugs.”

Regulators named MDMA a breakthrough therapy in 2017, which could put it on the fast track to approval if an upcoming phase III trial produces positive results.

“It’s been decades since psychiatry has had a new set of tools available to it,” Burge says. “And here we have psychedelics entering as a whole new class of pharmaceuticals that when used in combination with psychotherapy, could actually be better than conventional treatments.”

https://www.webmd.com/mental-health/news/20181030/ecstasy-study-results-promising-for-ptsd
 
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MDMA-assisted therapy for PTSD edges closer to FDA approval after largest-ever trial

by Aliyah Kovner | IFL SCIENCE | 30 Oct 2018

Exciting results from the largest-ever trial assessing MDMA-assisted psychotherapy for the treatment of post-traumatic stress disorder (PTSD) have provided even more evidence that the highly regulated party drug – also known as ecstasy or "molly" – has the potential to revolutionize mental health interventions.

The phase 2 investigation, now published in the Journal of Psychopharmacology, is the latest in a spate of promising MDMA for PTSD studies sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit organization dedicated to advancing the use of psychedelic compounds for improving human health and well-being through research, education, and advocacy. Based on the high success rate and low risk seen thus far, phase 3 MDMA trials were initiated in September 2018.

The FDA-sanctioned assessment included 28 adults with PTSD who did not respond to at least one pharmacotherapy and/or psychotherapy regimen. After three 90-minute preparatory sessions with trial therapists grouped into eight different teams, each participant was randomized to take either a high active dose of 100 or 125 mg MDMA or a low, 40-mg dose at the beginning of two eight-hour psychotherapy sessions spaced one month apart. Neither the participant nor the therapists present were aware of what dose was administered. Using a similar set-up as the pioneering psilocybin- and LSD-assisted psychotherapy experiments of the 1950s-1970s, the sessions were unstructured and experience-based, rather than discussion-based.

“Therapists presented neither agendas nor solutions, and remained curious, open, and attentive to the participant’s developing experience. As much as possible, they followed the participant’s process and respected their pace, creating a sense of safety and communicating trust in the participant’s innate capacity for healing,” the authors wrote. (If you want to know more about this emerging form of therapy, we recommend reading this incredible new book).

At a check-in appointment one month after the second session, 42.9 percent of those given the active dose no longer qualified for a diagnosis of PTSD, compared to 33.3 percent in the low-dose MDMA group. At this point in the study, the study’s "blinding" was broken, and participants and their therapy teams were informed of the doses they had been assigned. Moving forward, the subjects who had been given low doses completed three active-dose MDMA sessions, each one month apart, while those who had already done two active dose sessions completed one more 100 mg to 125 mg MDMA-assisted session.

One year after their third active dose session, a whopping 76 percent of participants no longer met the diagnostic criteria for PTSD – a remarkable finding that tidily demonstrates how efficient and long-lasting MDMA’s psychotherapeutic effects appear to be.

"The results of the study indicate that this treatment has the potential to greatly improve the lives of people suffering from PTSD, regardless of the source of their trauma,” principal investigator Marcela Ot’alora said in a statement. “After treatment, a great majority of our participants have reported feeling more connected to themselves and to others, more joy, more compassion, and with new skills for facing life’s challenges.”

Last summer, the FDA granted "breakthrough therapy" designation to MDMA-assisted psychotherapy for PTSD, meaning that the approval review process will be expedited based on evidence that the treatment offers significant benefits over the currently available options. Breakthrough designations are only given to treatments for serious or life-threatening conditions.

https://www.iflscience.com/health-a...-fda-approval-after-largestever-trial/page-2/
 
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Psychedelic drugs could help treat PTSD

Neuroscience News | Jan 17 2020

Backing up previous research, a new study reveals psychedelics can have beneficial effects for treating PTSD when combined with traditional trauma-focused psychotherapy. Findings suggest MDMA assisted therapy is significantly more effective at treating patients with persistent PTSD than psychotherapy alone.

Clinical trials suggest treatment that involves psychedelics can be more effective than psychotherapy alone.

More than three million people in the United States are diagnosed each year with post-traumatic stress disorder, whose symptoms include nightmares or unwanted memories of trauma, heightened reactions, anxieties, and depression–and can last months, or even years.

People with PTSD–difficulty recovering from experiencing or witnessing a traumatic event–have traditionally been treated with a combination of trauma-focused psychotherapy and a regimen of medications. Many sufferers have not responded well to that treatment, but new research to be presented by the Medical University of South Carolina’s Dr. Michael Mithoefer and colleagues, at the annual meeting of the American College of Neuropsychopharmacology, suggests that the combination of some psychedelic drugs and traditional psychotherapy holds promise.

Psychedelic substances are often found in nature and have been used in various cultures over thousands of years. Formal medical research into their medicinal uses starting in the 1950s produced promising results published in major journals but was largely halted in the 1970s for political rather than medical or scientific reasons. More recent studies argue that, when administered in a controlled clinical setting, MDMA (more commonly known as ecstasy) and psilocybin (the active ingredient in “magic mushrooms”) have acceptable risk profiles –and patients who experienced temporary adverse reactions did not require additional medical intervention.

In the past few years the FDA has granted both MDMA and psilocybin Breakthrough Therapy Designations for PTSD and depression respectively, acknowledging they may improve upon existing therapies, and agreeing to expedite their development and review.

The research by Dr. Mithoefer and his team includes six Phase 2 clinical trials conducted by independent investigators in four countries. In the trials, one group of patients was administered MDMA during their psychotherapy sessions, while the other group was administered a placebo or low dose comparator in conjunction with the same psychotherapy. The overall conclusion from these studies was that MDMA-assisted psychotherapy was significantly more effective at treating patients with persistent PTSD than unassisted psychotherapy.

In the past few years the FDA has granted both MDMA and psilocybin Breakthrough Therapy Designations for PTSD and depression respectively, acknowledging they may improve upon existing therapies, and agreeing to expedite their development and review.

The researchers aim to both review the successes that have been seen in the use of psychedelic drugs to treat trauma-related disorders and depression, as well as address several of the outstanding questions the medical community may still have concerning the safety, efficacy, and neurobiological functions of these novel treatment options.

 
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Inside the push to legalize magic mushrooms for depression and PTSD

by Troy Farah | 02.07.19

When Todd’s psychiatrist suggested he start taking psychedelics, he figured it was a joke.

It wasn’t. The former corporate executive from Colorado retired in 2006 after an MRI revealed his spine was riddled with a dozen tumors called hemangiomas, which later spread to his brain. Todd was told he would die before the end of 2008.

Somehow, Todd has survived—he credits medical marijuana, which he now uses daily—but he is still considered terminal. “It could be tomorrow. It could be five years from now,” he says in a call.

However, the 54-year-old spent the past decade plagued by a host of mental health problems, including PTSD and treatment-resistant depression. He was suicidal and tormented by violent night terrors. Nothing, not even massive doses of Xanax or Valium, could temper his panic attacks or end-of-life anxiety.

“My mental condition was deteriorating rapidly, and I was on [antidepressant] medication No. 14 and it wasn’t working,” Todd says. “My psychiatrist said, ‘I honestly think you're a big candidate for psychedelics.’”

That was about a year ago. Todd began taking homegrown psilocybin, the highly illegal alkaloid in so-called magic mushrooms. Known for prompting profound hallucinations, psilocybin was placed in the restrictive Schedule I category in 1970, meaning the US government recognizes no medical use for the drug and says that it carries a high risk of abuse.

Todd says there have been clear benefits from psilocybin with few side effects. He hasn’t had a single PTSD episode since he began taking it. His depression evaporated. The mushrooms even help ease the pain—agony that feels like being “shot in the back”—from the nerve-crushing tumors in his spine and skull.

“It’s knocked that out, it’s wiped that slate clean,” Todd says. The day before we talked, he’d eaten eight grams of fungus. A heavy dose is considered five grams, so this was no psychedelic snack—but Todd ingests this much about every week.

The experience is positively hypnagogic, allowing trippers to enter a dreamlike conscious state where time is distorted, color is amplified, and depth perception is warped. Euphoric, unbridled laughter is common, as are oddly introspective thoughts about existence and reality, and even synesthetic sensations, such as being able to “see” sounds. A trip can last four to six hours.

There can be negative effects as well, such as nausea, dizziness, paranoia, or panic attacks, but Todd doesn’t experience those. He still takes 10 milligrams of escitalopram, an antidepressant, and when the mushrooms wear off, 30 milligrams of the opioid oxycodone, but otherwise his prescription drug intake has drastically decreased.

That was about a year ago. Todd began taking homegrown psilocybin, the highly illegal alkaloid in so-called magic mushrooms. Known for prompting profound hallucinations, psilocybin was placed in the restrictive Schedule I category in 1970, meaning the US government recognizes no medical use for the drug and says that it carries a high risk of abuse.

There can be negative effects as well, such as nausea, dizziness, paranoia, or panic attacks, but Todd doesn’t experience those. He still takes 10 milligrams of escitalopram, an antidepressant, and when the mushrooms wear off, 30 milligrams of the opioid oxycodone, but otherwise his prescription drug intake has drastically decreased.

The Swiss chemical company Sandoz began in 1886 as a dye manufacturer, later pivoting to pharmaceuticals. But in 1947, with the help of one of their lead scientists, Albert Hofmann, the business began producing a psychiatric drug they called Delysid. Most people know it as LSD.

The psychedelic showed promise for treating mental health problems, but an LSD trip can last eight to 12 hours, so Sandoz sought a shorter-acting alternative. In 1958 Hofmann became the first to isolate psilocybin from mushrooms, subsequently developing a synthetic version called Indocybin. He first tried it on himself. Indocybin was safely marketed from 1961 until a rising cultural backlash against psychedelics led Sandoz to discontinue sales in 1966.

Now, more than 50 years later, a company is looking to pick up where Sandoz left off. Compass Pathways was founded in 2016 by George Goldsmith and Ekaterina Malievskaia, a married couple from London with little experience in the pharmaceutical industry. When their son developed treatment-resistant depression and OCD, they were desperate for help.

“The more they were treating him, the worse he was getting,” Malievskaia says in a call. So they took matters into their own hands. They began looking into scientific reports that psilocybin can rapidly reverse symptoms of depression for patients who have tried other approaches without results. And unlike Todd, these patients took only a single dose, not one per week.

Compass, which has reaped about $31.5 million in Series A investment, is conducting two studies to see how viable psilocybin is for psychotherapy. The first, due to finish in early 2019, is a double-blind placebo-controlled trial planned with 90 healthy volunteers to evaluate cognitive and emotional function. The study is also helping to train Compass’ therapists.

The Food and Drug Administration recently granted the company “breakthrough” therapy status for its second study, giving Compass priority review, following approval in August of a phase IIB clinical trial, designed to establish proper dosing.

The study is recruiting 216 participants across North America and Europe, making it the largest clinical psilocybin trial to date. Patients meet with a therapist to prepare, then are later given synthetic psilocybin, which can cost upward of $7,000 per gram, while being monitored for the duration of the trip. Afterward, the therapist helps patients process the experience. If successful, these trials could lead to psilocybin therapy becoming legal in the US by 2021.

Compass began as a nonprofit, but after realizing this research could cost an estimated $300 million, the company shifted to a for-profit model. That transition and other moves have drawn sharp criticism from some in the psychedelic community. A Quartz article published in November aired the concerns of numerous critics of Compass, who claimed that the company was backed by dubious investors and was attempting to monopolize magic mushrooms.

About a quarter of Compass is owned by Atai Life Sciences, a biopharmaceutical startup founded in 2018 by entrepreneur Christian Angermayer. One of Atai’s backers is PayPal cofounder and tech mogul Peter Thiel, who has come under fire for helping bankrupt Gawker via a lawsuit, donating money to President Trump, and selling surveillance tech to various governments for countering terrorism and policing migrants.

Malievskaia dismisses the criticism of Thiel. He has no say in Compass’ business operations, she says. “Peter is not one of the major investors. Personally, I think it's an excellent use of his money,” she says. “We don't screen investors based on their political convictions or what skeletons they have in their closets … It’s an equal-opportunity investment, and we are in charge of our mission, vision, execution.”

Because it occurs in nature, it’s not possible to patent psilocybin, but it is legal to patent a synthetic manufacturing process, which Compass has done. To manufacture psilocybin in large quantities, they solved about 60 different technical problems, a project that cost about $750,000, according to Malievskaia. Switching to a for-profit strategy was a “very logical development,” she says. But some have interpreted this as Compass trying to corner the psilocybin market or prevent others from researching it.

“It doesn't mean that we patented psilocybin as a molecule,” Malievskaia says. “Anyone can make it in many different ways: 3D printing, growing on yeast, genetic engineering … This is not blocking anyone. Investigators who want to use our product, we share it free of charge in exchange of providing safety data.”

While the US federal government has long held that psilocybin is dangerous, scientific evidence says otherwise. In the November issue of Neuropharmacology, a team of Johns Hopkins University School of Medicine researchers argued that under the Controlled Substances Act’s own criteria, psilocybin should not be Schedule I but the much less restrictive Schedule IV.

The grassroots movements in Oregon and Denver are citing this and other research in the hopes of removing local penalties for using or growing mushrooms.

The first to appear was the Oregon Psilocybin Society, founded by married therapist couple Tom and Sheri Eckert of Beaverton, who were inspired by—what else?—a personal mushroom experience. Their initiative would not only drastically reduce penalties for using or possessing psilocybin, it would create a state framework for therapists to become licensed psilocybin administrators, not too unlike Compass.

In other words, you wouldn’t be able to walk into an Oregon Circle K and get an eighth of shrooms. But if you believed that psilocybin, synthetic or from mushrooms, could help your mental health—or heck, even if you were just curious about what the experience is like—there’d be options. Getting insurance to cover it would be another issue entirely, of course.

The state attorney general recently approved OPS’s ballot title, so they now have until July 2020 to gather about 117k signatures. Then, during the next presidential election, Oregon voters will decide if this program is right for them. OPS hired a marketing research firm to test the waters and found that 47 percent of voters were in favor of their campaign with 46 percent opposed. That number rose to 64 percent when pollsters explained details about the initiative, with 54 percent in support of decriminalization.

So far, OPS has experienced no opposition, they say, but anticipate some backlash once the question is on the ballot.

“We suspect that Big Pharma is not gonna like this idea,” Sheri says in a call. “If you can treat an individual and it actually heals them and they no longer need to be daily dosing psych meds—that definitely impacts their budget.” She and others note that psilocybin could help ease the enormous financial cost of mental health disorders, which make up about 10 percent of the global burden of disease. (The market for depression medicine alone is expected to be worth $16.8 billion worldwide next year.)

The Eckerts are wary, but not completely distrustful, of bigger players like Compass. “We don't want to see it locked up in hospitals, costing impossible amounts of money,” Tom says. “The market has to play out in some way, but we are doing everything we can to make this a community-based framework.”

The ordinance proposed by Decriminalize Denver, the pro-psilocybin movement in Colorado, wouldn’t provide a system for public sales or psilocybin therapy, but for anyone 21 and over, personal use and possession of psilocybin would carry the lowest law-enforcement priority. The group’s ballot initiative would also prevent the city from spending any money to impose criminal penalties. (Despite living in Colorado, Todd, the psilocybin patient, would not be affected because the law would apply only to Denver.)

After the local elections division approved their ballot initiative in October, Decriminalize Denver gathered and submitted more than 8,500 signatures, almost double the required number. About 5,500 were accepted, meaning on May 7, 2019, city voters may decide whether to decriminalize personal possession and use of mushrooms.

The mile-high town is historically progressive on drug use: It was the first US city to legalize marijuana, in 2005, and in 2018 the city council voted in favor of overdose prevention sites for drug users to use narcotics like heroin under medical supervision. That law is pending state approval. Denver mayor Michael Hancock has walked back his support for supervised drug use and also does not support the psilocybin proposal.

Denver would not be the first North American locale to decriminalize mushrooms. In 2005, a New Mexico Court of Appeals ruled that growing mushrooms for personal use doesn’t technically count as drug manufacture, so even sprouting psilocybin in your dorm room isn’t illegal. Louisiana also exempts the cultivation of psychoactive plants and fungi “strictly for aesthetic, landscaping, or decorative purposes.” Nonetheless, Denver’s precedent on other drug issues has made folks like Kevin Matthews, the DD campaign director, optimistic that voters will reward his efforts.

“We talk to people all the time who say ‘Mushrooms have saved my life, mushrooms saved my marriage, mushrooms have broken me out of my depression, mushrooms are the only thing that works for my cluster headaches,’” Matthews says in a call. “I had a gentleman who signed the petition the other day who said it's the only thing that works for his wife's polycystic kidney disease. I had never even heard that one before.”

Meanwhile, in British Columbia, a team of seven health care professionals are gearing up for a legal fight in the hopes of legalizing psilocybin for terminal patients with end-of-life distress. About eight years ago, Bruce Tobin, a psychotherapist with 35 years of experience practicing in Victoria, British Columbia, was approached by one of his patients who desperately requested psilocybin therapy. She had survived cancer, but couldn’t shake the debilitating psychological suffering she had experienced with her diagnosis.

“She had tried everything: medicines, therapists, $1,000-per-day residential treatment programs. Nothing had worked,” Tobin says in an email. But what she was asking was still very illegal. Rather than break the law, Tobin decided to change it.

“I discovered,” Tobin explains, “I could apply for a so-called Section 56(1) exemption that would excuse me from the provisions of the Canadian Controlled Drugs and Substances Act, allowing me to legally use psilocybin in cases where it was ‘necessary for a medical purpose.’”

Thus, TheraPsil was born. The organization is petitioning the Canadian health authority to make psilocybin available medicinally, but only for people with dire need, similar to a trial planned in Melbourne, Australia this April. Tobin filed his application with Health Canada in January 2017, and it has been a slow road ever since, he says. Six other psychotherapists and medical professionals have since joined his efforts.

“If they decline to approve our application, our path forward is clear,” Tobin says. “Our legal counsel will file for a judicial review of Health Canada’s decision. If that is unsuccessful, we plan to go to the Federal Court of Appeals using the same arguments based on the Canadian Charter of Rights and Freedoms that were successful in compelling the government to change federal law to allow for patients’ access to medical cannabis. We are feeling confident.”

“There have been few, if any, real breakthroughs in the last quarter century in the development of psychiatric medicines,”
Tobin adds. “Psilocybin promises to be a real game-changer.”

Indeed, it may not be long before psilocybin is legally available, one way or another, in various parts of the globe. As Robin Carhart-Harris, a leading psilocybin researcher, recently put it at the most recent World Economic Forum meeting, “The climate’s looking good.”

Like an underground hyphal knot, these efforts could form into fat, juicy mushrooms—the fungal fruits from decades of combined political, scientific, and social justice campaigns to bring psilocybin into the light.

https://www.wired.com/story/inside-...c-mushrooms-for-depression-and-ptsd/#comments
 
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Psilocybin shows promising results for treating PTSD and depression

by Austin Schoonmaker | Feb 10, 2019

Psilocybin has been shown to be highly effective in treating PTSD and depression. It has long been utilized for spiritual revelation, but scientists are beginning to explore the unique relationship it has with our brains, and how it can be used as an effective treatment for mental health patients.

According to a 2013 study conducted at the University of South Florida, psilocybin has a profound effect in stimulating what is known as neurogenesis. This phenomena results in the growth and repair of brain cells in the hippocampus, which is said the be the center of emotion in memory in our brains.

In the study, researchers strived to understand the effect psilocybin has on the brain. To do this, researchers trained lab mice to be afraid of an auditory tone, followed by an electric shock using conditioning. Over time, the mice developed a fear of the tone, as they understood that it would be followed with an electric shock. The mice’s exhibited level of fear was documented by researchers, with some mice remaining immobile for prolonged periods of time, essentially stuck in a fear response. These responses were much like how veterans with PTSD would react to certain stimulus that trigger traumatic memories.

Once the groups of mice were conditioned to fear this auditory tone, researchers split the mice into three groups. One group was injected with low doses of psilocybin, another with a high dose, while the third group was injected with an inert saline solution. The three groups of mice were then reintroduced to the auditory tone to see how well they could relinquish their fear. Of the three groups, the one which received a low-dose of psilocybin were most successful in overcoming their fears.

This study provides compelling evidence in the effectiveness of psilocybin being used for alternative forms of therapy for those who suffer from PTSD. About 11-20 out of 100 veterans suffer from PTSD. Non-veterans in the U.S. also suffer from PTSD, often stemming from a life experience involving serious accidents, life-threatening illness, physical or sexual abuse, or natural disasters. PTSD can be easily triggered with a memory or stimulus, causing intense fear and anxiety, and can be extremely debilitating.

Already, there are several trials taking place across the country utilizing psilocybin for treating PTSD and depression. Organizations like the Multidisciplinary Association for Psychedelic Studies are championing the study and use of psychedelic compounds like psilocybin in treating psychiatric disorders. The time of prohibition for the use of psychedelic compounds for medical treatment is nearing the end, and the potential it shows for treating patients gives us a glimpse of a promising future.

https://www.sdentertainer.com/lifes...ing-results-for-treating-ptsd-and-depression/
 
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How psychedelics saved my life: My experience with anxiety and PTSD

I was drawn to journalism at a young age by the desire to provide a voice for the ‘little guy’. For nearly a decade working as a CNN investigative correspondent and independent journalist, I became a mouthpiece for the oppressed, the victimized, the marginalized. My path of submersion journalism brought me closest to the plight of my sources, by re-living the story to get a true understanding of what was happening.

After several years of reporting, I realized an unfortunate consequence of my style - I had immersed myself too deeply in the trauma and suffering of the people I’d interviewed. I began to have trouble sleeping as their faces appeared in my darkest dreams. I spent too long absorbed in a world of despair and my inability to deflect it allowed the trauma of others to settle inside my mind and being. Combine that with several violent experiences while working in the field and I was at my worst. A life spent reporting on the edge had led me to the brink of my own sanity.

Because I could not find a way to process my anguish, it grew into a monster, manifesting itself in a constant state of anxiety, short-term memory loss and sleeplessness. Heart palpitations made me feel like I was knocking on death’s door.

Why I chose psychedelic medicines

Prescription medications and antidepressants serve a purpose, but I knew they weren't for me. I first heard of the healing powers of psychedelics as a guest on the Joe Rogan Experience podcast. Joe told me that psychedelic mushrooms transformed his life and had the potential to change the course of humanity for the better. My initial reaction was one of amusement and somewhat disbelief, but the seed was planted.

Psychedelics were an odd choice for someone like me. I grew up in the Midwest and was fed 30 years of propaganda about how bad these substances were. You can imagine my surprise when, after the Rogan podcast, I found so many articles and studies on the prodigious medicinal effects of these substances… and the examples of how we’ve been misled by authorities who classify psychedelics as Schedule 1 narcotics with ‘no medicinal value’ despite dozens of scientific studies proving otherwise.

Tripping around the world

Having only ever smoked the odd marijuana joint in college, in March 2013 I found myself boarding a plane to Iquitos, Peru to try one of the most powerful psychedelics on earth. I ditched my car at the airport, packed my belongings in a backpack and headed down to the Amazon jungle placing my blind faith in a substance that a week earlier I could hardly pronounce: Ayahuasca.

Ayahuasca is a medicinal tea that contains the psychedelic compound dimethyltryptamine, or DMT. The brew is rapidly spreading around the world after numerous anecdotes have shown the brew has the power to cure anxiety, PTSD,depression, unexplained pain, and numerous physical and mental health ailments. Studies of long-term ayahuasca drinkers show they are less likely to face addictions and have elevated levels of serotonin, the neurotransmitter responsible for happiness.

If I had any reservations, doubts, or disbeliefs, they were quickly expelled shortly after my first ayahuasca experience. The foul-tasting tea vibrated through my veins and into my brain as the medicine scanned my body. My field of vision became engulfed with colors and geometric patterns. Then I saw a vision of a brick wall. The word ‘anxiety’ was spray painted in large letters on the wall. “You must heal your anxiety,” the medicine whispered. I entered a dream-like state where traumatic memories were finally dislodged from my subconscious.

It was as if I was viewing a film of my entire life, not as the emotional me, but as an objective observer. The vividly introspective movie played in my mind as I relived my most painful scenes - my parents divorce when I was just 4 years-old, past relationships, being shot at by police while photographing a protest in Anaheim, and crushed underneath a crowd while photographing a protest in Chicago. Ayahuasca enabled me to reprocess these events, detaching the fear and emotion from the memories. The experience was akin to ten years of therapy in one eight-hour ayahuasca session.

But the experience was terrifying at times. Ayahuasca is not for everyone - you have to be willing to revisit some very dark places and surrender to the uncontrollable, fierce flow of the medicine. Ayahuasca also causes violent vomiting and diarrhea, which shamans call “getting well” because you are purging trauma from your body.

After seven ayahuasca sessions in the jungles of Peru, the fog that engulfed my mind lifted. I was able to sleep again and noticed improvements in my memory and less anxiety. I yearned to absorb as much knowledge as possible about these medicines and spent the next year traveling the world in search of more healers, teachers and experiences through submersion journalism.

I was drawn to try psilocybin mushrooms after reading how they reduced anxiety in terminal cancer patients. The ayahuasca showed me my main ailment was anxiety, and I knew I still had work to do to fix it. Psilocybin mushrooms are not neurotoxic, nonaddictive, and studies show they reduce anxiety, depression, and even lead to neurogenesis, or the regrowth of brain cells. Why would governments worldwide keep such a profound fungi out of the reach of their people?

After Peru, I visited curanderas, or healers, in Oaxaca, Mexico. The Mazatecs have used psilocybin mushrooms as a sacrament and medicinally for hundreds of years. Curandera Dona Augustine served me a leaf full of mushrooms during a beautiful ceremony before a Catholic alter. As she sang thousand year-old songs, I watched the sunset over the mountainous landscape in Oaxaca and a deep sense of connectivity washed over my whole being. The innate beauty had me at a loss for words; a sudden outpouring of emotion had me in tears. I cried through the night and with each tear a small part of my trauma trickled down my cheek and dissolved onto the forest floor, freeing me from its toxic energy.

Perhaps most astounding, the mushrooms silenced the self-critical part of my mind long enough for me to reprocess memories without fear or emotion. The mushrooms enabled me to remember one of the most terrifying moments of my career: when I was detained at gunpoint in Bahrain while filming a documentary for CNN. I had lost any detailed recollection of the day when masked men pointed guns at our heads and forced my crew and I onto the ground. For a good half an hour, I did not know whether we were going to survive.

I spent many sleepless nights desperately searching for memories of that day, but they were locked in my subconscious. I knew the memories still haunted me because anytime I would see PTSD ‘triggers’, such as loud noises, helicopters, soldiers, or guns, a rush of anxiety and panic would flood my body.

The psilocybin was the key to unlock the trauma, enabling me to relive the detainment moment to moment, from outside of my body, as an emotionless, objective observer. I peered into the CNN van and saw my former self sitting in the backseat, loud helicopters overhead. My producer Taryn was sitting to the right of me frantically trying to close the van door as we tried to make an escape. I heard Taryn scream “guns!” as armed masked men jumped out of security vehicles surrounding the van. I frantically dug through a backpack on the floor, grabbing my CNN ID card and jumping out of the van. I saw myself land on the ground in child’s pose, and I watched as I threw my hand with the CNN badge in the air above my head yelling “CNN, CNN, don’t shoot!!”

I saw the pain in my face as security forces threw human rights activist and dear friend Nabeel Rajab against a security car and began to harass him. I saw the terror in my face as I glanced down at my shirt, arms in the air, praying the video cards concealed on my body wouldn’t fall onto the ground.

As I relived each moment of the detainment, I re-processed each memory, moving it from the “fear” folder to its new permanent home, the “safe” folder in my brain’s hard drive. Five ceremonies with psilocybin mushrooms cured me of my anxiety and PTSD symptoms. The butterflies that had a constant home in my stomach have flown away.

Psychedelics are not the be-all and end-all. For me, they were the key that opened the door to healing. I still have to work to maintain the healing with the use of floatation tanks, meditation, and yoga. For psychedelics to be effective, it’s essential they are taken with the right mindset in a quiet, relaxed setting conducive to healing, and that all potential prescription drug interactions are carefully researched. Ayahuasca can be fatal if mixed with prescription antidepressants.

I am blessed with an inquisitive nature and a stubbornness to always question authority. Had I opted for the doctor’s script and resigned myself in the hope that things would just get better, I never would have discovered the outer reaches of my mind and heart, and I might still be in the midst of my battle with PTSD.

https://www.sociedelic.com/how-psych...saved-my-life/
 
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Can psychedelic drugs treat depression and PTSD?

by Matt Smith | Sep 18, 2018

Jon Lubecky was running out of options when he checked into a small house-turned-clinic outside Charleston, SC.

The onetime Army artillery sergeant had been struggling with post-traumatic stress since he got home from Iraq, where his post had been shelled so often it was nicknamed “Mortaritaville.” In 2006, near the height of the insurgency and religious violence that followed the U.S. invasion, one of those shells sent shrapnel tearing through the outhouse where he was sitting in the middle of the night.

The shrapnel missed, but the shock of the blast knocked Lubecky out and left him with a traumatic brain injury. When he came home that fall, he found his wife had left him. He made the first of what would be five suicide attempts that Christmas.

“My life was a country song,” Lubecky says.

By the time he got to the clinic door in November 2014, doctors at a Veterans Affairs hospital had him taking half a dozen medications to treat his PTSD, and it wasn’t working. So Lubecky signed up for an experimental treatment he hoped would help: MDMA, a psychedelic drug commonly known as ecstasy or Molly -- a compound that’s been banned for decades.

“And that’s when everything went weird,” he says. “Good, but weird.”

After years underground, psychedelic drugs are getting attention as a potential treatment for depression and post traumatic stress disorder (PTSD).

MDMA, also known as ecstasy, has shown promise in studies of combat veterans. Psilocybin, the compound in “magic mushrooms” that gets you high, has been tested as a potential boost for people struggling to quit smoking. Researchers in Europe are conducting a survey of how “microdoses” of LSD or other drugs affect mental activity without altering perception. And the American Psychological Association held a symposium in early August on the potential uses of psychedelics.

“This is a very interesting, intriguing moment in psychiatric drug development,” says John Krystal, MD, chairman of the psychiatry department at the Yale University School of Medicine.

Lubecky was part of a trial conducted with the government’s blessing. He went to the house-turned-clinic three times, taking a dose of MDMA in combination with an extensive psychotherapy session. The drug is a form of amphetamine known for producing a sense of openness and emotional warmth, and Lubecky said it helped him discuss his experiences without producing the kind of intense physical responses of PTSD.

“The adrenaline kick didn’t happen. The hair didn’t stand up on my neck,” he says. “It’s like doing therapy while being hugged by everyone who loves you in a bathtub full of puppies licking your face.” The therapy sessions lasted up to six hours, “but it’s not traumatic at all.”

“There was no ‘A-ha’ moment,”
he says. “It was an incremental change over time, with jumps after each therapy session.”

Doctors have been reluctant to explore the potential uses of psychedelics since the 1960s, Krystal says. Not only did the federal government classify them as having no acceptable medical uses and a high potential for abuse, but many researchers believed they were too powerful to use therapeutically. "But the mental health field is facing “a moment of great need” that’s prompted some rethinking," he says.

“Our appreciation of the seriousness of psychiatric disorders is much more mature than it was then,” Krystal says. “We have a much better understanding about how common, how disabling -- and in some cases, with the rising suicide rate, how lethal these disorders are.”

Over the last 50 years, researchers have made “transformative” advances in understanding how the brain works. "But there haven’t been corresponding breakthroughs in psychiatric drugs," he says. And there have been some promising results so far.

A phase III clinical trial of the use of MDMA to treat PTSD is moving ahead after it won FDA designation as a potential “breakthrough therapy” last summer. That status holds out the prospect of speedy review by the agency and “catapulted” fundraising for the trial’s backers, says Brad Burge, spokesman for the California-based Multidisciplinary Association for Psychedelic Studies (MAPS).

“That breakthrough therapy designation communicates to funders and to the rest of the world that this is a very serious treatment and the FDA is taking it very seriously. That’s huge,” Burge says.

The new study is a follow-up to the one involving Lubecky and another 25 veterans, police and firefighters who took MDMA combined with psychotherapy. "After three doses in controlled settings, nearly all participants saw some improvement in their symptoms -- and about two-thirds “simply didn’t have PTSD anymore,” Burge said.

The results were published in May. Researchers checked in with participants 2 months after treatment, then a year later. "On average, those results actually kept getting better,” Burge says.

In Lubecky’s case, he says his PTSD symptoms are diminished by about 50% on the scale doctors use to assess the condition. Depressive symptoms are down 70%, and he no longer has suicidal thoughts. He’s now an advocate for MDMA therapy and works on veterans issues for MAPS, which he said “saved my life.”

“I was in such a place where I figured my stepson was going to be handed a folded flag off my casket at the age of 14,” he says.

“I know what an impact it’s had on my life,” he adds. “I have close friends of mine who are suffering right now. Anything I can do to grease the skids on that and the get the guys I served with, my guys, the help they need, I’ll do.”

“And now, I get to watch him grow up, drop him off at high school, watch him fall in love, watch him get his heart broke, watch him go to prom and go off to college … then when he’s old, and I’m really old, he’ll get the flag off my casket. And that’s the way it should be.”


There were no serious side effects, but the researchers did find one surprising result: Lower doses of MDMA were less helpful than not being given the drug.

“What we think might be happening there is it could be bringing up emotions or memories in people with PTSD without giving them the additional resources to deal with it in a productive way in therapy,” Burge says.

The FDA last month approved a study testing psilocybin to treat depression. British company COMPASS Pathways plans to begin the phase II trial immediately.

“Depression is the leading cause of ill-health and disability worldwide, and treatment-resistant depression affects more than 100 million people,” George Goldsmith, chairman of COMPASS Pathways, says in a statement. “It is a huge unmet need, and the trial will teach us more about how this new approach might address it."

Meanwhile, researchers at Johns Hopkins University have been studying the use of psilocybin to help people quit smoking. In follow-up interviews, 15 participants reported “a number of persisting positive effects beyond smoking cessation,” says Matthew Johnson, PhD, associate professor of psychiatry at Johns Hopkins.

“We found generally people claimed vivid insights into their self-identity in psilocybin sessions -- insights into the reasons they smoked,” he says. For most participants, withdrawal symptoms “really took a back seat to their fascination with their unfolding contemplation of these psychedelic sessions."

“I had one pilot participant who said, ‘It’s kind of like I’m in The Matrix and everything’s in slow motion. Here’s a craving that’s coming … instead of that sort of automatic response where my hand goes into my pocket, grabbing a cigarette and it ends up in my mouth, it’s more of a slow, deliberative mindful response.’”


Other participants described increased appreciation or a re-emergence of interest in music and art or poetry.

"Earlier research by Johnson and others at Johns Hopkins found psilocybin can produce 'clinically significant' improvements in depression and anxiety in patients with life-threatening cancer. The drug may be able to provide hope where conventional antidepressant drugs have had little effect," he says.

"But though imaging technology has given researchers the ability to view your brain on drugs, how psychedelic drugs work is still something of a mystery," Burge says.

“Even with MDMA, we have some strong theories about how it might be working to reduce PTSD symptoms in the long run, but we don’t know exactly why,” he says.

"More brain-imaging studies might help to determine the mechanism of action of these drugs," Burge says, "but they’re not needed to get federal approval of a treatment. The FDA only wants to know whether a drug is effective and that the benefits outweigh the risks."

Krystal, who also leads the clinical neuroscience division at the National Center for PTSD at the Department of Veterans Affairs, has warned that the lack of effective drugs to treat posttraumatic stress disorder is a “crisis.” Recent advances in neuroscience may provide a way to reopen the door for psychedelics or drugs like ketamine, which is also being tested as a treatment for depression, but he says that door should be pushed open cautiously.

“I think the central question at the moment is to determine exactly how much of the excitement over the potential therapeutic value of psychedelic drugs is hype and how much of it is real benefit,” Krystal says. “I’m afraid our current research base is so shallow that we have to approach these drugs in a very cautious and exploratory manner.”

https://www.webmd.com/mental-health/news/20180918/psychedlic-drugs-to-treat-depression-ptsd
 
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MDMA as a remedy for PTSD

by Dave Philipps | May 1, 2018

Research published Tuesday in the British journal The Lancet Psychiatry found that after two sessions of psychotherapy with the party drug, officially known as MDMA, a majority of 26 combat veterans and first responders with chronic PTSD who had not been helped by traditional methods saw dramatic decreases in symptoms.

The improvements were so dramatic that 68 percent of the patients no longer met the clinical criteria for PTSD. Patients taking the drug also experienced “drastic” improvements in sleep and became more conscientious, according to the study.

The results, which mirror those of similar, small-scale studies of the illegal drug in recent years, come as MDMA is about to enter larger, Phase 3 trials this summer. Based on previous results, the Food and Drug Administration has given MDMA breakthrough therapy status, which could speed approval. If large-scale trials can replicate safety and efficacy results, the drug could be approved for legal use by 2021.

“I was finally able to process all the dark stuff that happened,” Nicholas Blackston, 32, a study participant who had been a Marine machine-gunner in Iraq, said in an interview. “I was able to forgive myself. It was like a clean sweep.”

But the possible legalization of a widely abused party drug raises a lot of questions.

If approved by the F.D.A., MDMA would only be administered by a licensed therapist. First, a patient goes through three sessions of psychotherapy. In the fourth session, the patient takes a pill.

After taking the drug, the patient lies on a futon amid candles and fresh flowers, listening to music. Two therapists — one female, one male — sit at the patient’s side as guides. That session lasts eight hours.

“We encourage them to set aside all expectation and agenda and be open. Experiences tend to be very individual,” said Dr. Michael Mithoefer, one of the principal researchers.

The drug floods the brain with hormones and neurotransmitters that evoke feelings of trust and well-being, users report. Researchers say this allows patients to re-examine traumatic memories.

In follow-up psychotherapy, patients process emotions and insights brought up during the MDMA session. The current protocol calls for patients to take MDMA two or three times, each a month apart, interspersed with psychotherapy.

“MDMA alone or the therapy alone don’t appear to be as effective,” Dr. Mithoefer said. “MDMA seems to act as a catalyst that allows the healing to happen.”

What do patients say about it?

“I was actually able to forgive myself,” said Nigel McCourry, 36 a Marine veteran who was deployed in 2004 to Falluja, Iraq, whose experiences mirrored those of three other patients interviewed.

Mr. McCourry came home from war unable to escape scenes of an explosion that nearly killed him, and haunted by the memory of two young girls he accidentally killed in a fire fight. He struggled to sleep. He drank to forget. Rage eroded most of his relationships.

He tried help at a Veterans Affairs hospital, but couldn’t let his guard down enough to benefit from standard psychotherapy. A handful of medications meant to help left him feeling like a zombie, and he gave them up. He was contemplating suicide when he tried MDMA.

“When it kicked in, it was like an epiphany,” he said. “I could see all these things from combat I was afraid to look at before, and I had a totally new perspective. I relived the parts of me I had lost. I realized I had viewed myself as a monster, and I was able to start to have some compassion for myself. It was a turning point, and for the next year I continued to get better.”

“There are also still some challenges I have to face from time to time related to the PTSD,” he added. “But now I am able to work through them without getting stuck.”


But does it actually work?

Large-scale trials, which will include up to 300 participants at 14 sites, may not be able to replicate the success of previous trials, which were limited to a few dozen patients. But so far, results are encouraging. Nearly all patients saw clinically significant reductions in symptoms, and a majority saw such drastic reductions that they no longer met the criteria for a PTSD diagnosis. In the 12 months after MDMA therapy, PTSD symptoms generally continued to decrease.

Side effects, including anxiety, headache, fatigue, muscle tension and insomnia, were generally minor and limited to the days following the MDMA sessions.

Other researchers, intrigued by the results, are starting their own studies of MDMA therapy, including the Department of Veterans Affairs.

Seems risky. Isn’t there something better?

Not really, said Dr. John Krystal, who heads the Neurosciences Division at the Department of Veterans Affairs National Center for PTSD. He described the current lack of effective therapy as “a crisis.”

“The problem is that we don’t have many treatments, and what we have doesn’t work that well,” he said.

Only about one in three combat veterans with PTSD are effectively treated, he said.

Doctors often use a combination of off-label drugs to try to manage patients’ nightmares, flashbacks and depression, but the drugs do nothing to treat the underlying condition, and can have negative side effects.

Psychotherapy also has limitations. Though many patients find it helpful, others find it too traumatizing or ineffective and quit therapy. In some studies, dropout rates were as high as 40 percent.

Who is behind these studies?

The research is organized by a small nonprofit called the Multidisciplinary Association for Psychedelic Studies, or M.A.P.S., which was created in 1986 shortly after MDMA was outlawed.

“No one else would touch this, so we had to do it,” said the founder of M.A.P.S., Rick Doblin, who has a doctorate in public policy from Harvard and has made legalizing MDMA his life’s work.

The Phase 3 trials are expected to cost $27 million.

Where does the money come from?

It’s all donations. And they have come from an odd array of sources. David Bronner, the vegan C.E.O. — that’s Cosmic Engagement Officer — of Dr. Bronner’s Magic Soaps and an unapologetic evangelist for psychedelics has given $5 million.

But also in the mix are the archconservative Mercer family, who typically fund right-leaning institutions including Cambridge Analytica and Breitbart News; the late Richard Rockefeller, a champion of public health; and an anonymous donor known only as Pine, who transferred $5 million in Bitcoin.

Who cashes in if MDMA becomes legal?

M.A.P.S. would at first. MDMA was originally patented by pharmaceutical giant Merck in 1912, but it was never marketed and the patent lapsed. The F.D.A. grants temporary “data exclusivity” to groups that show new uses for drugs with expired patents. That would give M.A.P.S. a five-year monopoly in the U.S. After that, other companies could make it.

M.A.P.S. plans to spin off sales to a for-profit benefit corporation, which would then funnel the money back into clinical research on the use of MDMA with other disorders.

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I have suffered from a lifetime of isolation and self-loathing from childhood traumas. My experiences with MDMA served as the catalyst that helped me to learn compassion for myself, and ultimately forgive those against whom I harbored a lifetime of hatred and mistrust. With he help of MDMA and some very compassionate friends, I was able to contextualize everything that happened to me without being so overwhelmed by the immediate and negative emotionally overpowering responses that I had typically experienced when engaging with those truamatic memoreis. MDMA made it possible for me to live a life filled greater empathy for and more vulnerable connections with other human beings.

-James

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MDMA works where conventional psychotherapy fails to help those who suffer from PTSD. As a rape survivor who suffered from PTSD I am speaking from personal experience. 2 years of therapy and years of anti anxiety medication did nothing to help me with flashbacks, panic attacks and debilitating nightmares. A close helpful friend and a the use of MDMA finally helped me to work through the PTSD that had haunted me for 10 years. MDMA is not a magic pill. Talk therapy is still needed but it somehow helps you to see things in a different frame of mind; something that conventional therapy alone and other medications cannot achieve.

-Andrea

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I never saw combat, nor do I claim to have had PTSD, but I did experience some truly emotionally damaging things in my early childhood that left me full of self-loathing and filled with rage all through my 20's. I realize this is completely anecdotal, but in my early 30's a girlfriend and I did MDMA (she called it "Adam") five or six times together and, well, I was finally able to process all the dark stuff that happened. It was... transformative.

-James

https://www.nytimes.com/2018/05/01/us/ecstasy-molly-ptsd-mdma.html#commentsContainer
 
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MDMA-assisted psychotherapy for PTSD

Posttraumatic stress disorder (PTSD) is a disorder that describes the issues faced by many people after they experience or witness a traumatic event. Anyone who has been exposed to traumatic events that causes a serious fear for their life or the lives of others is at risk to develop PTSD. People typically affected include: survivors of violent acts and disasters, emergency responders to traumatic events, people who experience the sudden death of a loved one, anyone who has been abused, neglected children, and combat veterans. However, many other events can be traumatic as well, particularly to people of color, including police harassment, distressing childbirth experiences, and incarceration.

The Multidisciplinary Association for Psychedelic Studies (MAPS) is a non-profit research and educational organization that is currently sponsoring Phase 3 clinical trials of MDMA as a tool to assist psychotherapy for severe PTSD. Importantly, MDMA used in these trials is not the same as the street substances known as "ecstasy" or "molly," since these drugs frequently also contain unknown and/or dangerous adulterants. In MDMA-assisted psychotherapy, MDMA is only administered a few times, unlike most medications for mental illnesses which are often taken daily for several years. More information on MDMA can be found in the MAPS Investigator Brochure, which is available online here.

Preliminary studies suggest that MDMA can catalyze powerful psychotherapeutic work in helping people overcome PTSD by reducing fear of traumatic memories and increasing feelings of trust and compassion towards others without causing sensory distortions or inhibiting access to difficult emotions. As such, MDMA could increase the effectiveness of psychotherapy by strengthening the alliance between therapist and patient.

In our site at the University of Connecticut, we are participating in a MAPS-sponsored, FDA reviewed Phase 2 open-label study and then moving on to Phase 3 randomized clinical trials in Spring 2018. We are focusing on the recruitment of ethnoracial minority participants who meet criteria for PTSD. Our team’s work is focused on culturally-sensitive and respectful treatment approaches for people of diverse backgrounds.

We recognize that doing things the way they have always been done will not be sufficient to open the doors of these therapies to people of color. A culturally-informed approach must be used. Here are some of the efforts that have been made to date to ensure the ongoing MDMA research is culturally inclusive:

- Addition of a study site focused on the ethnic minority trauma experience
- Revision of informed consent documents for all sites to improve understanding and acceptability to people of color
- Diversification of the UConn treatment team at every level
- Ongoing cultural training for all UConn team members, with an emphasis on cultural humility
- Re-examination and revision of the setting and music used during MDMA sessions for cultural congruence
- Recognition and validation of experiences of racial oppression at a cultural and individual level
- Integration and specialized training for independent rater pool, with ongoing supervision for cultural differences

http://www.mentalhealthdisparities.org/mdma-trauma-study.php
 
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MDMA may help treat PTSD

by Rubi Valdez | 9 April 2019

MDMA, an active ingredient of the drug ecstasy, could help treat patients with post-traumatic stress disorder. A mice trial showed that MDMA reopened the brain’s critical period responsible for memory and learning social behaviors.

An experiment on mice shows that MDMA, commonly known as ecstasy, may rewire the brain to help treat post-traumatic stress disorder (PTSD).

Recovery from PTSD would require that the brain is still malleable to accommodate the so-called critical periods. This is when the brain can still learn social behaviors. During a critical period, the brain should feel good when adapting to a new social behavior.

The window of critical period

Researchers at the Johns Hopkins University did a study on mice to determine the reopening of the critical period. The experiment called conditioned place preference aimed to condition the mice into associating a location with a thing.

The mice were put with a certain bedding together with several other mice for 24 hours. They then transferred the mice individually to a different bedding in another enclosure.

Eventually, the mice started associating a particular bedding with isolation or companionship.

What the researchers found is that the critical period heightened around the adolescent period and then declined through adulthood. The adolescent stage is when the mice felt that being sociable is a rewarding behavior.

"It's why people gather around the water cooler," said Gül Dölen, an assistant professor in the Department of Neuroscience and Brain Science Institute at Johns Hopkins University. "This suggests that we've reopened a critical period in mice, giving them the ability to learn social reward behaviors at a time when they are less inclined to engage in these behaviors."

Oxytocin and learning social behavior

Dölen's team gave the mature mice MDMA and waited 48 hours for the drug to be washed out of their system. They observed how the mice would behave toward the other mice in the enclosure following the MDMA treatment.

Most of the animals interacted with each other the same way as the younger mice did. This social behavior lasted for at least two weeks after giving the MDMA. The mice who were given saline injections did not show the same kind of behavior.

The researchers also found that MDMA triggered the oxytocin, or the so-called love hormone. Oxytocin is responsible for encoding learning and memory, which gradually diminishes as an individual matures.

Dölen said the reopening of the critical window may have positive effects in treating psychiatric illnesses. The team proposed that MDMA can help treat PTSD patients by strengthening the psychotherapist-patient relationship.

"In disease states, closure of critical periods limits the ability of the brain to adapt even when optimal conditions are restored," the authors reported in the study published in the journal Nature.

 
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Ibogaine and PTSD: My experience

by Tim Williams

I suffer from PTSD, and quite a severe level. I have severe depression with suicidal ideation, short term memory issues, anticipative anhedonia, and aversion to interacting with other members of the public. There ARE some things you can look at that may be of considerable help. I have extensive, personal experience with each, and they've all helped me to great degrees.

The curative abilities of psychedelics are well-documented and have been noted since the 1960s. Specifically, low-dose psilocybin provokes neurogenesis (neuron birth) in the hippocampus. This is significant since the hippocampus shrinks in profoundly depressed and anxious people. Short term low-dose psilocybin has been shown to cause fear extinguishment, i.e. cessation of the nervous response when exposed to a trauma trigger. I can vouch for this being of considerable benefit for me right now. MDMA and LSD also have effects, though slightly different. LSD is known to weaken depression and addictive/compulsive behaviours, and MDMA was one of the most effective tools in psychoanalysis until it was banned as a party drug. Single or intermittent use of DMT is also known to be of benefit - this one, personally, completely cured fear of dying on my first go.

Ibogaine is a psychedelic but a very unusual and interesting one. It has a number of effects on a number of receptors, with stunning and profound results. One of its uses is in drug addiction, where it is up to 20x more effective than traditional detox programs. The OTHER use, which is intertwined with the anti-addictive effects, is in non-psychotic depressive disorders.

Its multi-pronged action simultaneously resets opiate receptor tolerance; floods the brain with dopamine, leading to re-regulation of disturbed dopaminergic effects such as anhedonia; has profound NMDA inhibitory effect (which is a whole new area of anti-depressive research right now, and also allows you to re-process traumatic memories); is a stimulant (cures brain fog and lethargy); is an SSRI (cures depressive behaviours); and last but not least, it up-regulates production of BDNF. BDNF is a growth factor which causes neurons to re-sprout and repair - think a bare tree growing new leaves. Further, taking the full flood dose of 25mg/kg gives you a fascinating 20 hour trip in which you have unparalleled access to all your memories (thanks, NMDA inhibition) and can literally re-visit and gain insight into any part of your life. This has been called "2 years of intensive therapy in a single day."

Ibogaine can be dosed as the psychedelic flood dose, but that requires medical preparation, a minder, and is quite rough as a trip - expect nausea and ataxia. However it's rewarding enough that many people do it once a year just for the incredible insight into one's self that it brings.

The way I tend to use it is microdose. This is a 50mg dose per day, in a 7 days on, 3 days off pattern. The dose is not psychedelic at this point. You don't notice it affecting you at all, but it IS there doing its work... and by the second week you will definitely start to notice significant improvements in many areas.​
 
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MDMA therapy achieves an astounding 76% success rate for treating PTSD

by Rich Haridy - November 1st, 2018

Newly published results from a Phase 2 clinical trial into the efficacy of MDMA-assisted psychotherapy in treating post-traumatic stress disorder (PTSD) have revealed striking success, with 76 percent of subjects not meeting the standard clinical criteria for PTSD 12 months after receiving the treatment.

This latest study is one of six key Phase 2 clinical trials that were used to last year convince the FDA to grant the landmark MDMA-assisted treatment a Breakthrough Therapy Designation. This particular trial, sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), was conducted in Boulder, Colorado and led by psychotherapist Marcela Ot'alora.

The trial comprised 28 subjects, all with clinically diagnosed PTSD that had persisted for an average of almost 30 years, despite attempts with other conventional treatments, including drugs and psychotherapy. The structure of the treatment resembled the model established by MAPS in other trials: two day-long MDMA treatment sessions followed by integrative therapy sessions. A third MDMA session was also offered to evaluate whether that improved long-term responses compared to two sessions.

Responses to the treatment were evaluated using the Clinician Administered PTSD Scale (CAPS-IV), the current best standard for PTSD assessment. Here the results were nothing less than spectacular. On enrolment the average CAPS-IV score of each participant was 92, and at a follow-up 12 months after the final MDMA session, the average CAPS-IV score was just 31. A remarkable 76 percent of participants, after 12 months, did not meet the clinical diagnostic criteria for PTSD.

These impressive results bode well for the long-term staying power of the treatment, with the average CAPS-IV score dropping an additional 9.6 points from the point the treatment finished to the 12-month follow-up.

The final stage before MDMA for PTSD can become an FDA-approved treatment is expansive Phase 3 trials. These trials kicked off in September 2018, after a slight delay in producing and encapsulating the MDMA needed to conduct the experiments. Encompassing between 200 and 300 subjects across 16 different sites in the US, Canada and Israel, it should take up to two years to complete this final stage, with ultimate FDA approval on track for sometime in 2021 if all goes well.

https://newatlas.com/mdma-ptsd-successful-trial-results/57074/
 
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MDMA-assisted psychotherapy for PTSD may have benefits beyond reduction in clinical symptoms

by Eric Dolan | psypost.org | May 7, 2019

New research suggests that MDMA-assisted psychotherapy for post-traumatic stress disorder is associated with several beneficial side effects. In addition to reductions in PTSD symptoms, the treatment may be associated with lasting personal benefits and enhanced quality of life, according to research published in the Journal of Psychoactive Drugs.

“Through my work as a clinical psychologist, I have often witnessed the distress, difficulty functioning, and depleted quality of life associated with severe PTSD for many individuals. Additionally, I have seen the difficulty with which many individuals with PTSD have going through traditional treatments for PTSD,” said William Barone, a clinical psychologist and the senior qualitative researcher on the study.

“I had also been interested in the potential of psychedelic and psychoactive compounds to aid in the therapy process, and the first few phase 2 clinical trials confirmed that MDMA-assisted psychotherapy can have a profound effect on PTSD symptoms beyond anything seen in traditional pharmacotherapy or psychotherapy.”

“I took to develop qualitative research in this field for a number of reasons. There had not been any published qualitative studies in MDMA-assisted psychotherapy for PTSD, and it seemed to be a great opportunity to explore the qualitative perspective that I believe is very important in such a study.”

“While quantitative measures are important for showing that a treatment works and that it is safe, in treatments as nuanced as MDMA-assisted psychotherapy, they can have difficulty picking up key details to understanding how and why the treatment may be effective,”
Barone told PsyPost.

“In addition to gaining that nuanced picture, qualitative studies give the participants a voice, and provide insights into how people are affected in very real ways through their participation in the treatment.”

A clinical trial recently tested the safety and effectiveness of MDMA-assisted psychotherapy in 26 military veterans and first responders with PTSD. For the new study, the researchers interviewed 19 of the participants one year after the end of the trial.

“The Phase 2 clinical trials of MDMA-assisted psychotherapy for treatment-resistant PTSD have shown strong reductions in PTSD symptoms over the year following treatment. Based on our study, there appear to be additional benefits to this treatment beyond reduction of PTSD symptoms,” Barone told PsyPost.

Besides reductions in their PTSD symptoms, many of the participants said that the therapy had led to improvement in their self-awareness and social functioning. The therapy also motivated the participants to try new things and reduced the use of both prescription medication and illicit substances.

The participants also expressed being more open to exploring other treatment options following MDMA-assisted psychotherapy. Prior to the clinical trial, many participants expressed very little motivation to continue any treatments for PTSD or other ailments (as is common in individuals with treatment-resistant PTSD).

“Importantly, even the one participant in our sample who was seen to have not benefited from the treatment, displaying less than a 10% reduction in PTSD symptom scores at one year post-treatment, noted that ‘there is improvement from every one of my problems I had when I first came here. Definitely improvement,'” Barone explained.

“The other major take-away from our article is the importance of qualitative investigations in clinical trials, but especially in the psychedelic sciences. Human experience is generally far too nuanced to be captured by t-scores. Especially when the treatment involves ineffable altered states.”

But the study — like all research — includes some limitations.

“The major caveat with most qualitative studies is that they tend to be based on small samples, and even as such are very time and resource intensive. This means it can be difficult to generalize the results,” Barone explained.

“Furthering the difficulty in generalization, the sample included limited diversity, focusing mainly on War Veterans, but also police and firefighters with trauma in the line of duty.”

“However, qualitative studies do not seek generalizability, but rather seek knowledge on an individual level to understand the experience of a phenomena. In recognizing that these experiences took place we have a better understanding of what to look for in future studies,”
Barone said.

Last year, the Multidisciplinary Association for Psychedelic Studies (MAPS) began efforts to recruit volunteers with severe PTSD for Phase 3 clinical trials of MDMA-assisted psychotherapy.

The recent surge in scientific studies on psychedelics has led to a new interest in qualitative research as well.

“Following this publication there has been an increased interest and focus on developing qualitative research in the psychedelic sciences,” Barone said. “We are especially interested in finding graduate students looking to complete theses and dissertations on similar studies, and will be training researchers to do this work on a range of studies in the coming months.”

 
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Could MDMA help with PTSD, depression and anxiety?

by Jesse Noakes | The Guardian | Apr 13, 2019

As Australia’s first trial for psychedelic therapy for terminally ill patients gets under way, a growing movement says it could also help other conditions,

In August 2016 I went to New York for the first time. On the second evening, I was sitting on a long couch on the top floor of an old church. All around me instruments were scattered on the floor – singing bowls, tuning forks, rainsticks, Tibetan bells. At the foot of a wall, carpeted completely in moss, was a large bronze gong.

On the table in front of me two small ceramic bowls contained a capsule of 125mg of pure MDMA and a chilli guacamole with three grams of powdered magic mushrooms stirred through it. I eyed them nervously. I was terrified that I was going to lose my mind but I was more scared that nothing would happen at all, that I was too broken for even this radical treatment.

I’d left Australia to take psychedelics with a therapist. Almost a decade of regular talk therapies for depression had done little to explain why I still felt so numb, trapped and terrified. A few months earlier I’d tracked down a guy online who said that, while it wasn’t a magic bullet, he might have something that would help. I can’t name him because it’s still completely illegal.

He was sitting across from me and after I’d swallowed the contents of both bowls he handed me a padded eye mask and suggested I lie back on the couch. I heard him move across the room in the steamy darkness as I tried to relax and focus on my breathing. Moments later I heard the first strange notes from the gong.

2016 was a breakthrough year for psychedelic therapy, not just for me. In May, a study from the Beckley Foundation in partnership with Imperial College London found that two-thirds of their participants with treatment-resistant depression were in remission a week after a therapy session with psilocybin, the active chemical in magic mushrooms. One participant said: “I found I felt more connected, to myself, other people, nature, life in general. I felt alive, rather than distant and isolated and cut off.”

In November 2016 two US university studies jointly published their findings: 80% of the terminally ill patients who had similar psilocybin sessions experienced significant reductions in depression and anxiety.

The following week the US Food and Drug Administration announced that it was approving the final phase of trials of psychotherapy for post-traumatic stress disorder (PTSD) using MDMA.

Meanwhile, in Australia – nothing. At the end of 2015 Psychedelic Research in Science and Medicine (Prism), a non-profit research association formed in 2011, had its second application for a study of MDMA-assisted psychotherapy knocked back by Deakin University. The email from the deputy vice chancellor for research said: “The university will not engage in research that has the potential to damage its reputation as an ethical organisation.”

Dr Martin Williams, president of Prism and a medicinal chemistry researcher at Monash University, got the message loud and clear. “We realised then that it was going to be a hearts and minds operation on our behalf, that we were going to have to be an advocacy organisation and play the long game,” he says.

The momentum has been building for decades overseas. In 1986 Rick Doblin, a trainee therapist with a PhD from the Harvard Kennedy school, founded the Multidisciplinary Association for Psychedelic Studies (Maps) to overturn the decision by the US Drug Enforcement Agency (DEA) to criminalise MDMA use. Initially a drug used in the 1970s by American therapists to enhance their clients’ feelings of trust and openness during sessions, MDMA’s effects had become too popular to contain and, like LSD a couple of decades before, it broke through into wider culture leading to a blanket ban on recreation and research.

Doblin, a shambling sun-bear of a man with a perpetual smile, initially launched an appeal against the DEA decision through its own legal channels, and won. However, the DEA disregarded the ruling so Maps opted for medicalisation – taking MDMA through several phases of clinical trials to establish its safety and therapeutic efficacy. “I just knew from personal experience, from working with patients, that MDMA was so different, that eventually the truth would come out,” says Doblin. “Did I think it would take 32 years? No.”

It was only last year that the full results of six phase-two trials of MDMA-assisted psychotherapy were published, in Lancet and the Journal of Psychopharmacology. Of 107 patients with treatment-resistant PTSD who were administered the drug in two or three seven-hour sessions, with therapists, eye mask and music, 68% were in remission at the 12-month follow-up. It’s about twice the success rate for the gold-standard treatment for PTSD: prolonged exposure therapy.

MDMA’s therapeutic properties emerge from a combination of factors. Its most acute effect is to significantly dampen the activity of the amygdala, the part of our brain that regulates fear response. While it relieves anxiety and stress, MDMA also sharply increases the brain’s supply of serotonin and oxytocin, the neurotransmitters primarily responsible for mood regulation and social bonding.

A recent study in Nature suggested that MDMA can temporarily return the brain to an early development state of “exuberant brain plasticity” that fosters renewed social reward learning. The American psychiatrist Julie Holland says: “You basically couldn’t design a molecule that is better for therapy than MDMA.”

A former firefighter, Ed Thompson, was overdosing nightly on a combination of booze and benzos when he entered a Maps trial in Charleston, South Carolina, in 2015. The trauma of losing nine colleagues as they fought a warehouse fire beside him, the worst firefighting loss in the US since 9/11, was compounded by a chronic illness afflicting his twin baby daughters.

“My body felt like it was going to explode from the inside out ... I was underwater and drowning,” he told me last year. After three all-day MDMA sessions with two therapists beside him, he no longer met the criteria for PTSD. “It was just an incredible time of healing.”

In 2017 the US Food and Drug Administration declared MDMA a “breakthrough therapy”, and Doblin expects it to be a legal medicine in the US again by 2021. Phase-three trials have begun at 15 sites in the US, Canada and Israel and will roll out across Europe this year after agreement with the European Medicines Agency.

In Australia a proposal for an MDMA trial with just four participants is slowly moving through the approvals process, this time at Edith Cowan University in Perth. Stephen Bright, senior lecturer in addiction studies at the university and vice president of Prism, says it supports the trial, and the wider community is increasingly open to the idea. “The public are generally receptive,” he says. “All the stuff I’m talking about – depression, trauma, addiction – they have been touched by in some way. At the end of the day, the evidence says that psychedelic therapy is effective at treating a range of conditions.”

Nigel Strauss, a Melbourne psychiatrist and trauma specialist who worked with Prism on its failed proposal, says the way psychedelic therapy works is a challenge to prevailing medical assumptions. “Psychedelic drugs are a whole change of perspective,” he says. “These are ‘meaning’ drugs, and the whole concept of meaning eludes people and they think it’s hocus-pocus. These are concepts that don’t fit easily into medical science at the moment … particularly in this country.”

But something has shifted. In January St Vincent’s hospital in Melbourne announced that Australia’s first trial of psilocybin-assisted therapy for 30 people with terminal illnesses will start in coming months. It is believed the mind-expanding and mystical properties of the psychedelic experience might be especially effective at relieving the existential angst and hopelessness that often accompanies a terminal diagnosis. “When you’re working with psychedelics you can reliably expect these deeply embodied transformational moments,” says Rosalind Watts, a clinical psychologist working on the Beckley/Imperial trial.

Williams, who is co-investigator on the St Vincent’s study, which Prism has helped organise, says what has been called the “psychedelic renaissance” overseas is more like the dawning of a new age in Australia, where there is no history of psychedelic research. “It’s definitely a major step forward because … as long as we achieve positive results from the research, then we expect to move that into therapeutic practice in a period of time … perhaps five to 10 years,” he says.

Gillinder Bedi, a senior research fellow at the University of Melbourne who has previously run US studies of the pharmacology of MDMA, says of some advocates: “They are the true believers. Scientists are a little bit uncomfortable with the language that gets used. I don’t think that organisations like Maps coming from the counterculture on the people outside it.”

For Bedi their findings are almost too good to be true: “The results I’ve seen are unique – the effects are really clear. It’s just that they’ve been in small studies and they’ve been conducted by people who have massively vested interests in the whole thing … There’s a part of me that goes, ‘Why did your data end up so neat and nice?’ I’m not sceptical about the rigour of the science, I’m just confused more than anything.”

But Bedi insists that contrary to its reputation MDMA is safe to use therapeutically: “It’s pretty clear now that we can administer it in a controlled environment with appropriate supervision pretty safely.” Psychedelics studies exclude people with a history of psychosis or mania, as well as those with certain medical conditions that the drug effects could exacerbate. “If it’s given to people who are well screened beforehand, those risks can be controlled.”

The Prism team was cagey about the St Vincent’s study until the moment it was announced, but Williams has noticeably relaxed his attitude discussing psychedelics in the Australian context. “I think there’s been a broad shift in the public discourse, which has been this ongoing process, probably since the results of the clinical trials in the US and Europe were first communicated,” he says. “ … It’s thanks to the great groundwork of Maps and others overseas that we’re at the point we are now at all.”

A new non-profit called Mind Medicines Australia launches next month to coordinate training more therapists to meet the potential demand. Williams and Strauss are planning a study of psilocybin for treatment-resistant depression, modeled on UK research.

For more than a decade, the Beckley Foundation has developed groundbreaking psychedelic research in partnership with Imperial College London. They produced the first brain scans of the LSD and psilocybin experience which suggest that, rather than amplifying neural activity as expected, psychedelics appear to selectively inhibit the “default mode network”, which regulates executive brain function like a disciplinarian teacher. When psychedelics take it out of the picture for a period, a whole bunch of new connections and neural activity fires up like exuberant children, allowing a wider range of phenomena to reach conscious awareness. Brain scans of long-term meditators have shown the same pattern.

The novel neural connections facilitated in the psychedelic state can lead to lasting changes. A 2018 Beckley/Imperial study using data from their previous depression trial measured significant increases in the personality domain of “openness”’ three months after the single high dose of psilocybin.

It replicates similar findings from Johns Hopkins University in the US. Albert Garcia-Romeu, who is leading another Hopkins psilocybin study, told me that openness goes hand-in-hand with reductions in symptoms such as rigid negative thinking. “It has shown association with overall happiness and quality of life, so in that regard I think it can be an important piece of the puzzle in terms of psychedelics’ therapeutic potentials,” he says.

Ian Roullier, a participant in the Beckley study of treatment-resistant depression, described how he experienced it: “Depression is a very narrow, restricted state and taking psilocybin really helps you to zoom out a lot more … I felt a lightness within myself and more of a freedom.” Like MDMA for PTSD, psilocybin has just been given “breakthrough therapy” status for treatment-resistant depression and large-scale trials are being rushed through across Europe.

For me, about an hour and a half after I lay down in New York, I took off the eye mask and sat up to a world transformed. For as long as I could remember there had been a wall of glass between the world and me, trapping me in a numb limbo that a litany of talk therapy and medications couldn’t touch.

Like magic, the wall was gone. Everything I looked at had a new clarity and immediacy as I drank it in. It was as though an iron knot of tension in my forehead, which contracted my whole body in its clenching grip, had suddenly dissolved. I felt calm, confident and connected. I didn’t feel like I was tripping – I felt like myself for the first time in years. It was the purest relief I’d ever known.

Almost three years later I’m back living in Fremantle but it’s all changed. I had spent past Western Australian summers in bed, staring at the wall with the blinds down. This year I’m up at five most mornings making the most of the rising sun: gym, swim, long walk on the beach, and in the studio by eight this morning to finish off my edits before uni. I’d always wanted to write but the words wouldn’t come, and while I still have to work bloody hard to keep the show on the road, it’s all flowing now.

 
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