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Medicine PTSD

mr peabody

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Welcome! Following is a DIGEST of articles and reports that is constantly updated. Jump in!




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.

How might MDMA therapy work?

No one goes home with a bottle of Ecstasy.

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.

"The MDMA alone or the therapy alone don't appear to be as effective," Dr. Mithoefer said. "The 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?

That's an open question.

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?

Not big pharma. 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. 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.

Does this mean people can just self medicate with MDMA?

People already are. The National Survey on Drug Use and Health found that in 2014 more than 17 million Americans reported using MDMA. While many are likely doing it purely for recreation, word of the therapeutic uses has spread, and combat veterans are trying it illegally at home.

But street Ecstasy is dangerous. Doses of the street drug can be an unknown mix of other stimulants and hallucinogens, and an overdose can be fatal. High frequency use of MDMA can also damage the brain.

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.

Is MDMA therapy new?

Yes and no. MDMA is an illegal drug and has never been approved for any use by the F.D.A. But for about a decade before it was outlawed in 1985, it was used as an aid in psychotherapy, especially on the West Coast.

At the time, academics were beginning to argue that it and other psychedelic drugs could be a useful ally in psychotherapy. The idea failed to gain traction then, but now a number of prestigious researchers are studying the potential therapeutic uses of LSD, psilocybin and MDMA.

https://www.nytimes.com/2018/05/01/us/ecstasy-molly-ptsd-mdma.html
 
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mr peabody

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FDA designates MDMA as "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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mr peabody

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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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mr peabody

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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 memories. 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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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

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-and-medicine/mdmaassisted-therapy-for-ptsd-edges-closer-to-fda-approval-after-largestever-trial/page-2/
 
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mr peabody

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Is psychiatry ready for medical MDMA?

Within five years, science will likely have answered a controversial question: can methylenedioxymethamphetamine (MDMA) treat psychiatric disorders?

After some studies showing a positive effect, MDMA-assisted psychotherapy is entering final clinical trials as a treatment for post-traumatic stress disorder (PTSD). If these trials show positive results, MDMA will go from an illegal drug to a prescription medicine in the United States by 2021, potentially prompting movement in this space in Australia and Europe.

MDMA would move from the fringes to mainstream psychiatry, becoming recognised as a mainstream treatment option. What remains less clear is how psychiatry will deal with questions arising from this new treatment approach.

MDMA in medicine: a brief history

German pharmaceutical company Merck patented MDMA in 1912. However, it appears not to have been used in humans until later that century.

Better known as a street drug in the rave scene of the 1980s and ’90s, MDMA was used in the 1970s by a small band of US psychiatrists and therapists. This group believed it enhanced the therapeutic bond and improved treatment for ailments ranging from marital distress to, potentially, schizophrenia.

Following rebranding as “ecstasy”, large-scale recreational use of MDMA led to its 1985 listing as an illegal drug in the USA (Australia followed in 1986). The MDMA-therapy community unsuccessfully protested against this designation.

Advocates for MDMA-assisted psychotherapy have been playing the long game ever since, undertaking a painstaking process of research and advocacy, which has culminated in the upcoming trials.

MDMA versus ecstasy

Advocates for MDMA-assisted psychotherapy have been at pains to distinguish the street drug ecstasy from MDMA the medicine. Ecstasy can contain a range of substances as well as varying doses of MDMA.

This is unsurprising given early evidence that high repeated MDMA doses – more relevant for recreational than therapeutic use – damage serotonergic neurons in animals.

Catastrophic predictions of a lost generation of ecstasy users, however, failed to materialise. Indeed, numerous people have received MDMA doses similar to those proposed for therapy in laboratory studies. This shows that MDMA can be safely administered under controlled conditions to well-screened healthy adults.

It remains unknown whether the same is true of groups excluded from most studies. This includes children and older people, and those with psychiatric or physical illnesses. Studies to date do, however, suggest acceptable safety in adults with PTSD.

Pharmacologically enhanced treatment

One aspect of MDMA therapy attracting less attention is that it involves a fundamental shift in psychiatric medication. All currently approved psychiatric medications treat symptoms rather than the disease itself. Relapse is common after stopping treatment.

MDMA-assisted psychotherapy, by comparison, involves limited MDMA doses over two or three sessions of eight to ten hours. The aim is to “fast-track” psychotherapy to produce long-lasting changes.

Possible mechanisms of such an effect are unclear. One suggestion is that the effects of MDMA, such as feelings of empathy, openness and reduced fear, might allow people to reprocess traumatic memories during psychotherapy.

Other medications are also being considered as adjuncts for psychotherapy. These include potent psychoactives like LSD and psilocybin, or drugs thought to enhance psychotherapy via mechanisms other than psychoactive effects (e.g. d-cycloserine).

It is possible, however, that a broader range of pharmaceuticals could be used in this way. Thus, a potential benefit of MDMA’s approval could be to spur further research in this area.

The challenges of regulation

The potential approval of MDMA for prescription gives rise to pressing questions about regulation. For instance, should prescribing be limited to physicians with specific qualifications? What training should be required for those conducting the psychotherapy? How should the drug be handled and stored by pharmacists?

The combination of a drug-affected patient with non-drug-affected therapists could make patients vulnerable during psychotherapy. This suggests a need for stringent training and oversight of MDMA-assisted therapy.

Approval of MDMA will also lead to off-label prescribing, with doctors prescribing the drug for conditions other than PTSD. This could include a range of conditions, such as depression and substance use disorders, and various patient groups.

A particular issue is prescribing to children/adolescents. To date no controlled studies have assessed the safety of MDMA in young people. Planned studies in adolescents with PTSD will thus be important.

Is anything ‘penicillin for the soul’?

The slow progression of MDMA-assisted psychotherapy from the subcultural margins towards approval has been driven by the belief of those advocating for it.

Without this motivated community, MDMA would likely not have been developed as a medication, as it is off patent. The downside of this robust advocacy base is that it can lead to rather extreme claims (e.g. “penicillin for the soul”) and experimenter bias.

In addition to well-designed studies that control for experimenter bias, there is a need for researchers and clinicians outside the MDMA-advocacy community to be involved in the ongoing development of this research direction.

If MDMA is to become a part of mainstream psychiatry’s armamentarium, many questions will need to be answered. The next few years will be critical to see if MDMA joins the ranks of failed psychiatric treatments, or offers new hope to people suffering from PTSD.

https://theconversation.com/is-psychiatry-ready-for-medical-mdma-94105
 
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mr peabody

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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-the-push-to-legalize-magic-mushrooms-for-depression-and-ptsd/#comments
 
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mr peabody

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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/lifestyle/magic-mushrooms-show-promising-results-for-treating-ptsd-and-depression/
 
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mr peabody

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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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Captain.Heroin

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MDMA therapy achieves astounding 76% success rate for treating PTSD
The other 24% of us need something better, and I would prefer 2c-I, DO_, or something of that nature, long lasting and visually intense. Methamphetamine "substitutes" to some degree or another. MDMA does not for me, personally.

I know this from enough experimentation over the course of my lifetime.
 

mr peabody

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MDMA could revolutionize care for trauma, a social worker’s perspective

by Courtney Hutchison | Feb 19, 2019

In my role as a social worker and psychotherapist, I see so many clients suffering from the repercussions of trauma—experiences of abuse, neglect, and discrimination—that have left them struggling to feel safe on a fundamental level.

Healing from these traumas invariably focuses on helping these clients overcome feelings of disempowerment and disconnection, rebuilding interpersonal trust and intimacy in the context of the therapeutic relationship.

At the same time, there is growing recognition in the mental health field that we must address trauma across multiple levels: not only interpersonally or psychologically, but physiologically. We must also heal the way trauma inscribes itself on the brain and body, leaving survivors hijacked by nervous systems that vault into fight, flight, or freeze at a moment’s notice.

That is why it is imperative that social workers, and all mental health professionals, take notice when a new promising treatment comes along that seems to treat trauma across these multiple levels: the limited, adjunctive use of MDMA (3,4-methylenedioxymethamphetamine) in psychotherapeutic treatment for posttraumatic stress disorder (PTSD) presents just such a treatment.

MDMA-assisted therapy as a breakthrough treatment

Research on MDMA-assisted psychotherapy for PTSD has been growing over the past 15 years, showing remarkable success in clinical trials. The FDA granted it “breakthrough therapy” status in 2017 based on these strong results.

For example, a 2011 study found that 83% of those receiving a combination of supportive psychotherapy and two MDMA-assisted psychotherapy sessions no longer met criteria for a PTSD diagnosis after treatment, compared to only 25% of those who received the same supportive psychotherapy and a placebo.

Moreover, these studies were working with the hardest-to-treat cases—clients whose PTSD had failed to respond to other treatments, such as prolonged exposure therapy, other cognitive behavioral therapies, or pharmaceutical medications. Follow-up studies have shown that the majority of those helped are still PTSD-free nearly four years later.

These striking findings led me and my colleague, Dr. Sara Bressi, to explore the potential of this treatment, especially given the stigma often attached to MDMA as being the primary ingredient in the recreational drug “molly” or “ecstasy” (though substances found in recreational settings are rarely observed to be pure MDMA).

This article is a summary of the findings from our recent paper on this topic, including: why mental health professionals are in dire need of better treatment for PTSD, how MDMA-assisted psychotherapy works, and how important a treatment like this could be for addressing the immense burden of trauma in vulnerable communities, especially communities of color and low-income communities.

Treating PTSD is an uphill battle

For those with PTSD, past traumatic events intrude upon their daily life through flashbacks, nightmares, and pervasive anxiety and hyper-vigilance that makes it difficult for them to engage in day-to-day life, and can make it especially difficulty to talk about or reflect on their traumatic experiences.

In an attempt to minimize their symptoms, individuals with PTSD often avoid anything that could trigger them, and begin to isolate themselves from the world and others—consequences that tragically cut them off from the potentially healing effects of relationships, both within their personal lives and within the context of therapy.

Existing PTSD treatments try to reduce these symptoms in a few different ways: psychiatric medications try to change brain chemistry to reduce anxiety; exposure therapies try to de-link trauma triggers from the strong fear response; skills-focused therapies target areas such as emotional coping and interpersonal skills; other trauma-informed approaches try to create a sense of safety in session that rebuilds trust over time and extends outside of the therapy room.

Unfortunately, these treatments often have mixed results and do not meet the needs of all people with PTSD: studies in veterans, for example, show that more than 70% of those engaging in PTSD treatment do not see significant improvement.

How does MDMA-assisted psychotherapy work?

In MDMA-assisted psychotherapy, the MDMA acts as a catalyst for the therapeutic process, working synergistically with regular psychotherapy sessions. Biochemically, MDMA releases chemicals that increase a sense of well-being, enhance empathy and feelings of closeness to others, and dramatically reduce fear and anxiety.

A potentially key ingredient in this process is oxytocin, sometimes called the “love hormone” because we release it when we bond socially, when we are with people we care about, and even when we cuddle with our pets.

In a course of MDMA-assisted psychotherapy, traditional talk therapy is interspersed with two or three medicated sessions. These medicated sessions occur over 6-8 hours (the drug’s duration plus a few hours), under medical supervision, and consist of periods of quiet introspection and client-led discussion of traumatic material, facilitated by two therapists.

Non-drug psychotherapy sessions then help process and understand what came up for client while on the drug. After treatment, which generally occurs over 8-15 weeks, the majority of participants are not only PTSD-free, they report an “increased self-awareness,” “increased ability to feel emotions,” and “improved relationships in general.”

Though research on why MDMA is such a powerful catalyst is still new, in our paper we hypothesize that MDMA’s fear-reducing and pro-social affects work together to help clients tap into their capacity to heal, allowing them to engage in therapy faster and more profoundly than they could otherwise.

The fear-reducing effects help clients think and talk about their trauma without being as hijacked by flashbacks or panic symptoms, allowing them to gain perspective on what happened to them and integrate it into a larger narrative of their lives.

The pro-social effects help clients trust and bond with their therapists and “take in” the support and empathic attunement they provide—a task that is especially difficult for those who have had their trust violated through interpersonal trauma and abuse.

Moving forward: How this treatment could be a game-changer

That MDMA-assisted psychotherapy has worked so rapidly, and so effectively, in many people who have not responded to existing treatments is a powerful testament to its potential—especially for low-income communities and communities of color who disproportionately experience trauma.

At the same time, it is unclear what access to this treatment will be like for these populations. Given that people of color and low-income individuals already face the dual hurdle of being more likely to experience trauma, and less likely to have reliable access to health care, it will be essential that social workers be attuned to these potential barriers and be fierce advocates for access to this breakthrough treatment.

First and foremost, trauma survivors have experienced ruptures in trust—trust in others, in the safety of the world, and in their own inherent value. Too often, these ruptures are then tragically re-experienced in relationships with loved ones, clinicians, and institutions.

If MDMA-assisted psychotherapy, in helping clients move toward spaces of empathy and trust, can facilitate and accelerate repair of these ruptures, its use will have repercussions far beyond the treatment of PTSD symptoms.

It could enable clinicians to more readily, more consistently, and more profoundly tap into what psychotherapy at its best offers: a pathway toward more fully, authentically, and lovingly engaging with themselves and their lives.

https://psychedelic.support/resources/mdma-assisted-psychotherapy-trauma/
 
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mr peabody

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How MDMA helps patients with trauma

by Janna Lawrence | 15 OCT 2018

When combined with intensive psychotherapy sessions, MDMA — commonly known as ecstasy — has elicited impressive results in phase II trials and a global phase III study is just beginning.

On 4 July 2014, the people of South Carolina were celebrating Independence Day. But Jonathan Lubecky, a veteran of the Iraq War, was unable to join in with his neighbours because he was suffering from severe post-traumatic stress disorder (PTSD). “Where I live, they love fireworks, so my whole neighbourhood turns into Baghdad,” he says. That particular night, his now wife walked into the closet in their bedroom to find Lubecky wearing his body armour, with his service dog, having flashbacks.

In the eight years since returning from Iraq, Lubecky had tried to commit suicide five times and was taking 42 pills per day to control his depression, suicidal ideation and symptoms of PTSD. But by the following year’s Independence Day, despite the booming of fireworks, Lubecky was out on his porch. This time, he was “annoyed and … a little bit triggered” but more angry, rather than in the non-functional state he had been in the year before.

The “miracle” that changed his life is MDMA. Lubecky participated in a study using MDMA-assisted psychotherapy sessions to treat PTSD. After the trial his suicidal ideation was “eliminated,” his depression subsided by 40% and is now 70% gone, and his PTSD symptoms were reduced by 50%.

Lubecky is one of 26 veterans, police officers and firefighters who received MDMA for their moderate-to-severe PTSD in a 2018 study run by Michael Mithoefer, a psychotherapist and clinical researcher at the Medical University of South Carolina, and his wife Ann, a nurse. One month after the final MDMA session, 68% of the patients who received an active dose no longer met the criteria for PTSD.

This was the second trial conducted by the Mithoefers and overall the sixth phase II trial to use MDMA to treat PTSD — the others being conducted in the United States, Canada, Israel and Switzerland. After the success of the Mithoefers’s second trial, the US Food and Drug Administration (FDA) gave the drug breakthrough status and a phase III trial has just started. “The phase II trials have been very encouraging,” says Michael Mithoefer. This has buoyed other psychiatrists too, who are now investigating MDMA-assisted psychotherapy to treat different illnesses, such as alcohol addiction and social anxiety in adults with autism. Alicia Danforth, a clinical psychologist at the University of California, San Francisco, says “knowing what we know about MDMA, there could be tremendous implications for psychotherapy.”

Early research

MDMA was first synthesised in 1912 by a German chemist working for the pharmaceutical company Merck. The company patented it in 1914 but never investigated the compound. Decades later, psychologists and therapists began to take an interest in MDMA for its ‘feeling enhancing and non-hallucinatory properties’ and, between 1977 and 1985, several case studies were published using the drug to facilitate psychotherapy sessions.

MDMA is loosely categorised as a psychedelic, although many of its features are unique. Chemically, it has structural similarities to both the psychedelic mescaline and the stimulant amphetamine. Charles Grob, a psychiatrist at Harbor-UCLA Medical Centre in Los Angeles, California, who has completed two studies with MDMA, became acquainted with psychedelic research in the 1970s and says it persuaded him that this class of drug should be of great interest to mental health professionals.But MDMA was banned in the UK in 1977 and in 1985 in the United States. It was given Schedule 1 status in both countries, meaning that it is classified as a drug of abuse with no medical applications, which made researching it difficult and costly. “Because of the political and cultural turmoil … for a couple of decades all research into psychedelics was halted." As the years went by, Grob, along with Mithoefer, saw an opening in the regulatory landscape and started to apply for permission to work with MDMA. It seemed like an ideal candidate to use for psychotherapy, “particularly this notion that patients remain alert, oriented, tapped into their feelings and able to articulate and achieve insight,” says Grob. In 1998, he published the first phase I study administering MDMA to healthy volunteers, which established “good safety parameters.”

Shortly after, in 2001, Mithoefer applied for permission to use MDMA for the first time to treat PTSD caused by sexual assault, abuse or violence in a phase II trial. He had spent many years treating patients with PTSD and recognised that there was a “large percentage of people we just couldn’t help with existing therapies.”

Current treatment for PTSD entails psychotherapy alongside taking an antidepressant — commonly a selective serotonin reuptake inhibitor, an anxiolytic and a sedative. Mithoefer explains: “We realised a long time ago that although some medications could be useful for treating PTSD symptoms, the definitive treatment is psychotherapy. This treatment path is recommended in international guidelines, including those from the National Institute for Health and Clinical Excellence. But even with gold-standard treatment, between 25% and 50% of people do not respond was shut down,” says Grob.

For these people, it seems that psychotherapy does not work because they are too traumatised to fully participate. “As soon as they’re asked to reflect on the traumatic memory, they are so overwhelmed with negative affect that they dissociate and they can’t do the trauma process work,” explains Ben Sessa, a psychiatrist working in Bristol, UK. Lubecky, who had psychotherapy for eight years before taking part in the MDMA trial, says that “when I was doing regular therapy I wouldn’t talk about the trauma because … I felt like I was back there again, my body would react like it did when the trauma first occurred.”

Mithoefer explains the theory was that MDMA would stop people from being overwhelmed and help “overcome the obstacles to successful therapy.” But there was a delay in beginning this first phase II trial, which was only published in 2010, because of what turned out to be false claims about MDMA’s toxicity in primates.

Phase II trials

When the results from the study were eventually published, they showed that, of the 12 people given MDMA, 10 no longer met the criteria for PTSD at the end of the study compared with 2 out of 8 patients in the placebo group. As an additional benefit, all three subjects who were unable to work on account of PTSD returned to employment.

Mithoefer says that, since these data have been published, there has been a “very striking change” in attitude towards MDMA and the public seem to be more educated now. It was the strength of the first phase II results that prompted the other five studies, including the 2018 one, which have all returned “strong results”, says Mithoefer. While his first trial involved survivors of sexual assault and violence, research suggested war-related PTSD is harder to treat and so his 2018 study recruited veterans and emergency workers, including Lubecky.

Patients came to the trial through word of mouth or referral from a mental health professional. Lubecky says that he only found out about it when his psychiatrist’s intern told him to google “MDMA PTSD”. At this point he had tried to commit suicide so many times that he says he had nothing to lose, so he called the Mithoefers. Like all participants he was required to undergo a physical examination and baseline assessment before enrolling in the study. This is primarily to exclude patients with prior cardiovascular disease because MDMA can elevate blood pressure, explains Mithoefer. Participants are also required to taper off their normal medicines owing to concerns about drug interactions.

Each participant is carefully prepared for the trial with three psychotherapy sessions, each 90 minutes long, before they take any MDMA. On the day that patients take the drug, they attend the Mithoefers’ medical practice, which is in a converted house. Despite being hooked up to a blood pressure and temperature monitor, Lubecky says the environment is “comfortable”, with a real bed to relax on.

Mithoefer stresses that “we don’t believe [MDMA is] something you should be able to pick up at the pharmacy and take home,” it should only be given through licensed clinics. The study also confirmed that the potential for abuse of MDMA following clinical use is low. Of 26 participants, 6 had previously taken MDMA between two and five times. In the 12 months following treatment, two participants who had previously taken MDMA took it again, but none of those who were new to the drug did so.

He says he was “in such a safe place with the MDMA. I was able to just talk about things I had never talked about before without having a physical response to it,” he adds. He refers to the experience as “doing therapy and feeling like you’re being hugged by everyone on the planet who loves you, and a load of puppies are licking your face.”

Pharmacology

Lubecky is describing the myriad effects that MDMA has on the brain caused by its action at multiple receptor sites. It exerts an effect through the 5HT1A and 1B receptors, therefore stimulating the release of serotonin, which reduces anxiety and depression and causes mood-elevating effects. In addition, it has a mild psychedelic effect; nothing like as intense as classical hallucinogens, such as LSD, says Sessa, but enough to provide for an “extra level of creativity so that you can see things in a new light."

Crucially, it also dampens the activity of the almond-size region of the brain called the amygdala which, says Sessa, “selectively impairs the fear response which allows the patient to work in that mental state where they can safely recall and reflect upon painful trauma." Hormones such as oxytocin, the bonding chemical, are also released, as well as dopamine, which can help people to focus.

While this is happening in the brain, the participants in the PTSD trial complete an eight-hour psychotherapy session. This is repeated one month later.

Going into the study, all participants had moderate-to-severe PTSD. One month after the second blinded dose of MDMA, 6 out of 7 patients in the 75mg group and 7 out of 12 patients in the 125mg group no longer met the criteria for PTSD, compared with only 2 out of 7 patients in the active placebo group. Symptoms of depression, global psychological function and sleep quality also significantly improved in the active treatment groups compared with the 30mg placebo group. A third, open-label MDMA dose was given to all patients after this point and the active placebo group were given the option of having two or three full-dose sessions. Following these sessions, PTSD symptoms dropped by at least a further 30% for four out of six placebo patients.

For the active-dose groups there was a continued trend towards improvement in symptoms, but a third MDMA session did not have a significant benefit. However, the improvements that patients did experience were sustained. A year later, 67% of the 24 patients who completed follow-up no longer met the criteria for PTSD and, on average, symptoms of depression had reduced from severe to minimal.

However, MDMA is not without side effects. There were 85 adverse events reported during the trial. Four occurred before drug administration and another four were serious. Of the four serious events, only one of these was deemed to be related to MDMA; a patient who had premature ventricular contraction at baseline developed an acute increase during the third session, but later fully recovered. The most frequent adverse reactions were anxiety, headache, fatigue, muscle tension and insomnia, occurring in the seven days following administration, but these symptoms did not last. Mithoefer says that the risk benefit ratio of taking MDMA in a clinical setting, where the patient is screened and monitored, is very different to the risk profile of recreational use when patients can overheat, dehydrate or take too much.

The reported side effects have not been enough to dissuade researchers. Sessa calls MDMA a “remarkable compound” with its use signifying “a paradigm shift in how we can deal with chronic mental health conditions.” He has just embarked on a phase II trial using MDMA to treat alcohol addiction, in collaboration with Imperial College London and based in Bristol, UK.

Since the end of the 2018 PTSD study, Mithoefer has been supervising preparations for the much larger phase III trial, which began officially in September 2018. Fifteen locations in the United States, Canada and Israel are participating and he has reviewed how all of the researchers administer MDMA to ensure “consistency across sites”. The EU is not currently involved but Mithoefer says that the research team is talking to the European Medicines Agency to try and understand the needs of the regulatory agency. “It’s likely to be second or third line in Europe but we don’t want this to be a requirement … we think the clinician should decide,” he says. This is partly because he hopes that when veterans come back from war they could potentially have the treatment very early, before PTSD becomes chronic.

Concerns

But widespread use in countries with government-funded healthcare could be hindered because of the amount of psychotherapy needed. The PTSD and social anxiety trials follow the same therapy protocol — after the first three preparatory sessions and the first dose of MDMA, there are a series of integration sessions to help people “identify those insights … and remember that state of mind”, says Danforth. This process is repeated after each MDMA session. But this amount of therapy raises some concerns with Alain Brunet, a clinical psychologist at McGill University, Montreal, Canada, who is not involved in MDMA research. He says that he is “pretty impressed with the results” because the treatment effect size is large and the participants had failed previous treatments, but that the method is labour intensive and hard to teach.

In total, the psychotherapists spend 16–24 hours during the two or three MDMA sessions and roughly another 10 hours in the additional therapy. “As a therapist, if you’re ready to invest 30 plus hours of treatment with a patient, you’re likely to get good results,” he says. His concern is that “from a service provision point of view you’re always looking for the smallest dose of treatment that will deliver the largest bang for the buck.”

Mithoefer says that the time involved is a “valid concern” and is going to be a challenge. But he points out that although patients improved with psychotherapy alone, it was not nearly as much as with MDMA. He adds that the researchers are already thinking about ways to reduce costs, such as through group therapy sessions. He argues, however, that despite the high upfront cost of therapy, in the long run it may save money if patients who were previously untreatable are able to come off medication and even return to work.

To illustrate this point, in the 2018 PTSD trial, 86% of patients were taking an anxiolytic and an antidepressant and 71% were taking an antipsychotic, such as quetiapine, which Mithoefer points out comes with a host of costly side effects. Lubecky’s pill count has gone from 42 down to 2; he now only takes Concerta for the traumatic brain injury he sustained in Iraq and occasionally Ambien to help him sleep.

The changes in Lubecky’s personal life have been even more profound. He says he is now a better father to his stepson and a better husband to his wife. He has also been able to go back to work doing something he loves, as the veterans and governmental affairs liaison at the Multidisciplinary Association for Psychedelic Studies (MAPS), which has funded the MDMA research into PTSD and social anxiety in adults with autism. This was something he could not do before because it involved being around crowds. His goal is that “everyone with PTSD knows that this treatment is coming and has hope and does not get to the point that I got to and want to take their life."

https://www.pharmaceutical-journal.com/news-and-analysis/features/like-a-hug-from-everyone-who-loves-you-how-mdma-could-help-patients-with-trauma/20205586.article?firstPass=false
 
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mr peabody

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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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mr peabody

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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 3,4-methylenedioxymethamphetamine or 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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mr peabody

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PTSD: An overlooked consequence of cancer

by Nathaniel Scharping | Nov 21, 2017

Roughly one in five cancer patients struggle with post traumatic stress disorder (PTSD) in the aftermath of diagnosis and treatment.

A recent study from Malaysia indicates that PTSD is a fairly common result of the long and difficult process of living with and treating cancer. Though most commonly associated with soldiers returning from war, PTSD can result from many different forms of trauma. The disorder can sometimes go unnoticed, or be misdiagnosed, causing those suffering to endure psychological distress that can lead to suicide in some situations.
Hidden Pain

Researchers from the National University of Malaysia followed 469 cancer patients starting one month after their diagnosis to four years later. Roughly 20 percent showed some symptoms of PTSD six months after their diagnosis, as researchers detail in a paper published Monday in the journal Cancer. By the fourth year, that percentage had dropped to just over six percent, though a third of those initially diagnosed actually saw their symptoms worsen after four years. It’s a reminder that cancer can have detrimental effects even long after remission, and evidence that counseling services and pharmacological interventions could be warranted for some cancer patients.

PTSD is characterized by frequent flashbacks to a traumatic event, as well as painful and intrusive memories and nightmares. Those suffering from the disorder are often frequently on edge and can experience depression and anxiety as a result of the trauma, as well as be susceptible to violent or emotional outbursts and have trouble connecting with those closest to them.

For cancer patients, this can translate to a hesitation to return for follow-up appointments for fear of bringing up stressful memories, as well as anxiety caused by even minor aches, pains and sicknesses, which spark fears of remission. In addition, some patients may not seek help during the course of their treatment for fear of appearing weak, according to lead author Caryn Mei Hsien Chan.

“Many cancer patients believe they need to adopt a ‘warrior mentality’, and remain positive and optimistic from diagnosis through treatment to stand a better chance of beating their cancer. To these patients, seeking help for the emotional issues they face is akin to admitting weakness,” Chan says in a statement. “There needs to be greater awareness that there is nothing wrong with getting help to manage the emotional upheaval — particularly depression, anxiety, and PTSD — post-cancer.”

Getting Treatment

There are some indications that interventions like cognitive behavioral therapy can help cancer patients deal with the stress of the disease, and various drugs targeting stress hormones may also provide some relief. Indeed, among breast cancer patients, who received special care and therapy at the hospital the study was conducted at, rates of PTSD were over three times lower. That’s promising, though, as a 2016 review study of PTSD care for cancer patients found, much of the hard evidence for the benefits of therapy so far is slim and further study is needed.

Therapeutic benefits could also come from an unlikely place: psychedelics. Two studies published last year looked at how giving psilocybin, the active ingredient in “magic mushrooms” to terminally-ill cancer patients affected their levels of anxiety and depression. Both studies found a significant improvement in the patients’ outlook, and indicated that it helped them come to terms with the disease and with their own mortality. The same effect could hold for those coping with cancer’s lingering pall. Other studies, both of PTSD and depression using psychedelics, have also returned positive results, and anther psychoactive drug, MDMA, just received a “breakthrough therapy” designation from the FDA, clearing the way for further trials.

 
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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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Aeon Psyche

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Everyday use of mdma is rediculous which makes it impossible as a medicine for PTSD. I suffer from it and it helps in the greatest way while on it but mdma can't be used so very often or you will hit depression and possible other negative side-effects.
 

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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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