• Psychedelic Medicine

PTSD | +60 articles

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Alexander "Sasha" Shulgin

MDMA shows promise for post-traumatic stress treatment

Neuroscience News | May 30, 2019

An international study involving researchers from UBC Okanagan has shown that MDMA may be a valuable tool for treating post-traumatic stress disorder (PTSD).

Published recently in Psychopharmacology, the study demonstrated substantial improvements in individuals who had not responded to prior treatments, explains UBCO Associate Professor of psychology Zach Walsh. This is also, he adds, the most comprehensive evaluation of the safety and effectiveness of MDMA-assisted psychotherapy for PTSD.

“PTSD symptoms decreased after one session of MDMA together with psychotherapy,” says Walsh, study co-author. He adds that 54 per cent of participants no longer met PTSD criteria after two sessions and that there was also improvement in their symptoms of depression.

The response of participants to MDMA-assisted psychotherapy was compared to those who received small doses or non-drug psychotherapy.

“These findings are promising and indicate the needed for larger studies,” says Walsh.

"Too many people with PTSD struggle to find effective treatment, and use of MDMA in a supportive environment with trained mental health professionals could be an important addition to our treatment options.”

MDMA is a synthetic drug made from a combination of methylenedioxy-methamphetamine. It is a controlled, illegal drug in Canada classified as a stimulant with hallucinogenic properties.

Walsh, as well as researchers from the United States, Switzerland and Israel, examined the results from six clinical trials, involving 103 people. Trial participants included men and women with chronic, treatment-resistant PTSD from a wide variety of causes.

Based on these results, the US Food and Drug Administration granted breakthrough therapy designation to MDMA-assisted psychotherapy for PTSD, acknowledging that it “may demonstrate substantial improvement over existing therapies” and agreeing to expedite its development and review.

The first of two more in-depth clinical trials of MDMA-assisted psychotherapy for PTSD began enrolling participants in November 2018, and aims to have 100-150 volunteers across 15 sites in the US, Canada and Israel. The second trial will take place after an interim analysis of the data from the first trial, and will enrol an additional 100-150 participants. European trials are planned to start in the near future.

Nearly four per cent of all people worldwide will suffer from PTSD during their lifetime. PTSD can be a debilitating disorder, with symptoms including intrusive thoughts and memories, negative effects on thinking and mood, depression, hyperarousal and reactivity, and avoidance. People with PTSD can experience much lower quality of life and relationships, related mental health conditions and suicidal tendencies.

 
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Another clinical trial finds psychedelics can be used to treat PTSD

by Shamani Joshi | Vice | 21 Jan 2020

New research indicates that people who were given controlled doses of ecstasy and magic mushrooms during post-traumatic stress disorder treatment showed more signs of improvement than those who did not take any drugs.

Psychedelics like LSD, magic mushrooms and MDMA have always been mired in controversy. While some supporters say that they give you great happiness and sex, and take you on a spiritual journey of self-exploration, others advocate avoiding the substances completely, especially if your mind is fragile and easily susceptible.

However, while many studies talking about the usefulness of psychedelics have emerged in a time many are touting as a ‘psychedelic renaissance’, yet another study on the subject shows that they can do more than just make you feel more connected to nature or experience intense euphoria.

New research presented by the Medical University of South Carolina’s Dr Michael Mithoefer says that psychedelics like MDMA and psilocybin mushrooms can be used to treat Post Traumatic Stress Disorder (PTSD), a psychiatric disorder that can occur in people who have experienced or witnessed a traumatic event and whose symptoms include flashbacks, recurrent anxiety and nightmares.

Dr Mithoefer and his team conducted six Phase 2 clinical trials along with independent investigators in four countries. In these trials, one group of patients was given MDMA during their psychotherapy sessions, while the other was administered a placebo or low dose alternative with the same psychotherapy. The findings indicated that those who took MDMA showed more symptoms of improvement than those who did not, proving yet again that psychedelics do have therapeutic advantages.

While scientists have been fascinated with the mind-altering effects of naturally growing psychedelics since the 1950s, the US Food and Drug Administration’s (FDA) crackdown against these substances in the 1970s put a stop to further studies that could prove their therapeutic use. However, since the start of the century, there has been a shift and the FDA has even given MDMA and psilocybin (the active ingredient in magic mushrooms) “breakthrough therapy” designations for treating PTSD and depression respectively. Meanwhile a 2016 study conducted by the Johns Hopkins University in the US, administered high doses of psychedelics to end-stage cancer patients, and found that 80 percent of patients felt free of existential depression and anxiety. This new clinical trial is yet another addition to the list of studies conducted to show that using the thought-provoking, hallucination-inducing psychedelics could after all be the answer to treating trauma-related disorders and depression.

 
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PTSD and MDMA: Science and perception

by Eugene Rubin | Psychology Today | Oct 03, 2018

As part of the search for novel psychotherapeutic drugs, some investigators have started studying several categories of drugs that are commonly abused. Multiple research groups have shown that ketamine can lead to rapid improvement of symptoms in severely depressed individuals. This drug can also rapidly decrease thoughts of suicide. Drugs related to ketamine are in advanced stages of clinical trials, and it is likely that several medications derived from the work with ketamine will be approved within the next few years.

There are also ongoing trials involving psilocybin and LSD for treating anxiety, depression, and substance use disorders. Another recreational drug with possible therapeutic benefits is MDMA. Users report increased empathy and euphoria when using the drug, but it can also have adverse side effects, including elevating blood pressure and increasing cardiac arrhythmias.

In an article published in Lancet Psychiatry, Michael Mithoefer and colleagues reported that MDMA, when combined with psychotherapy in a controlled setting, was effective in reducing symptoms of chronic post-traumatic stress disorder (PTSD) in a small study of military personnel and emergency first responders. This phase 2 study, together with other phase 2 trials, has led the FDA to designate MDMA-assisted psychotherapy as a “breakthrough therapy,” potentially hastening its approval as a treatment. It should be noted that the Mithoefer et al. study was sponsored by MAPS. Although members of this group may have potential conflicts of interests, this study was reasonably well-designed and the evaluators and participants were “blinded” to the dose of MDMA administered. Large phase 3, multisite, double-blind, placebo-controlled trials could soon follow.

Chronic PTSD is a relatively common condition in military personnel returning from active duty. However, it can be a difficult illness to treat. Some individuals respond to antidepressants such as sertraline or paroxetine, and some respond to specific types of psychotherapies. Nevertheless, these treatments do not substantially help many individuals suffering from moderate to severe symptoms of PTSD.

Mithoefer’s group examined the effects of MDMA-assisted psychotherapy in a group of 26 military veterans and first responders who scored above a threshold score on a standardized assessment of PTSD and who had experienced symptoms of PTSD for at least 6 months. (In fact, the mean duration of PTSD in this group of people was 7 years.) Study participants were randomly assigned to receive one of three doses of MDMA —30 mg (7 participants), 75 mg (7 participants), or 125 mg (12 participants) —together with time-intensive therapy. The lowest dose (30 mg) was considered to be an active control. Each person received MDMA on two occasions separated by 3–5 weeks. Prior to the first MDMA session, each individual participated in three 90-minute psychotherapy sessions “to establish a therapeutic alliance and prepare participants for the MDMA experience.”

Administration of MDMA was accompanied by an 8-hour session of “non-directive or client-directed psychotherapy.” This was followed by a week of daily phone contact and two 90-minute sessions “aimed at integrating the experience.” By the end of the first phase of this study, each individual had received about 13 hours of therapy not associated with MDMA and 16 hours of therapy accompanying two MDMA treatments. Each participant was assessed with a standardized scale for PTSD, as well as other standardized assessment scales, one month after the last administration of MDMA. True “blinding” of the participants may have been compromised in that there were different behavioral effects of the 75 mg and 125 mg doses compared with the 30 mg dose.

PTSD symptoms were substantially diminished in those receiving 75 mg and 125 mg MDMA when compared to the group receiving 30 mg. Six of the 7 in the 75 mg group and 7 of the 12 in the 125 mg group no longer met criteria for a PTSD diagnosis; only 2 of 7 in the 30 mg group achieved this level of response. Also, global psychological function substantially improved in those receiving 75 mg and 125 mg in comparison to those receiving 30 mg. Results from 75 mg were at least as good as results from 125 mg.

Following the double-blind portion of the study, those who received the 30 mg and 75 mg doses participated in an open-label trial of three additional sessions consisting of 100–125 mg MDMA and accompanying therapy. Those who received the 125 mg dose in the original double-blind portion of the study received one further session. The substantial improvements that occurred one month after the double-blind phase of the study were maintained a year after the open-label phase of the study.

The MDMA treatments appeared to be well tolerated. One person had a serious side effect involving a temporary increase in a cardiac arrhythmia that was possibly related to the study drug. Few individuals dropped out of the study; 24 of the 26 participants remained in the trial for its entire duration.

The exact mechanisms underlying the possible therapeutic benefits of MDMA are unknown. MDMA has strong influences on various neurotransmitter systems including serotonergic functioning, but relating these effects to treatment of PTSD would be speculative. MDMA is thought to increase openness and trust, and the authors suggest that these properties may enhance the effectiveness of the therapy sessions.

The present results are intriguing but have substantial limitations, including the small sample size, lack of true controls, possibility that therapists and participants were not always blind to doses used, and use of sessions to prepare subjects for the MDMA exposure. The authors indicate that larger phase 3 studies are under development. If these studies confirm that MDMA together with psychotherapy over a period of several months can lead to substantial symptomatic and functional improvement in military personnel with chronic PTSD, it would be an exciting and remarkable finding. Going forward it will also be very important to define the risks associated with MDMA when used for therapeutic purposes.

Exploring the therapeutic potential of counterculture drugs is a fascinating story. A small group of individuals have dedicated their careers to this cause. If research by other disinterested, non-conflicted scientists can confirm their findings, then this group will deserve credit for their persistence despite marked political resistance.

https://www.psychologytoday.com/us/...01810/ptsd-and-ecstasy-science-and-perception
 
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Can psychedelic drugs treat PTSD?

by Matt Smith | WebMD

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


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

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

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

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

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

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

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


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

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

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

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

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

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

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

https://www.webmd.com/mental-health/news/20180918/psychedlic-drugs-to-treat-depression-ptsd
 
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Israel treating PTSD with MDMA

by Jonah Mandel | Medical Xpress | Aug 21 2019

Nachum Pachenick says he lived a nightmare for nearly two decades after being sexually abused and developing PTSD—until MDMA therapy came to his rescue.

"It's a life full of stress, pressure, nerves, anxiety, fatigue," the 46-year-old Israeli said from his home in Sde Boaz, a wildcat settlement in the occupied West Bank south of Jerusalem.

"You can't live like that."

Pachenick said relief came in 2014, when he took part in a clinical trial that included the use of MDMA, the active component in the drug known to nightclubbers as ecstasy.

The treatment's success on him and dozens of others has led Israel's health ministry to approve its own pilot for MDMA-assisted therapy for people with treatment-resistant PTSD.

Encouraged by trials so far, therapists involved hold out hope for its future treatment possibilities, though there have also been warnings that further investigation is needed.

Last year, a research team reported in the journal The Lancet Psychiatry that a trial in the United States showed positive results, but stressed such treatment should only be done hand-in-hand with psychotherapy under professional supervision.

During that trial, 85 "adverse events"—including anxiety, headaches, fatigue and insomnia—were reported by 20 participants. It was not clear however whether the MDMA or something else was responsible.

Pachenick had been part of the second phase of three trials conducted in a number of countries under the auspices of the Multidisciplinary Association for Psychedelic Studies.

MAPS hopes to receive approval from the US Food and Drug Administration for the process by 2021.

"The results of the trial's first two phases were extraordinary," said Dr Keren Tzarfaty, a psychologist in charge of training therapists for MAPS in Israel.

"When we look at these people a year after the end of their treatment, we see that 68 percent of the people who received MDMA-combined therapy don't have (PTSD) anymore or are not defined as having PTSD," she said.

"Recovery rates are especially impressive when taking into account the fact that the people who reach us have tried everything," Tzarfaty said from her spacious clinic in the Israeli town of Hod Hasharon.

"Their trauma is resistant to medication, to psychotherapy; they come to us as a last resort."

'Brought me home'

The third and final phase of the trials began in the second half of 2019, and demand far exceeded the mere 14 spots allotted for Israeli participants.

As a result, the Israeli medical establishment has decided to operate its own pilot programme and allow dozens more to receive the treatment, which is done in a controlled setting.

"The Israeli health ministry decided to take the humane and responsible measure to start a pilot of 50 people suffering from PTSD who are resistant to other forms of treatment," said Dr Bella Ben Gershon, in charge of trauma for the Israeli health ministry.

Tzarfaty has facilitated the training of 30 Israeli therapists to work with MDMA.

PTSD is triggered by experiencing an event so traumatic it cannot be fully processed, leaving parts of the brain in a state of hyperarousal and harming its elasticity.

"What MDMA has been found to do is "remove all the defences, but also create lots of compassion to others and oneself," Ben Gershon said.

"The drug can afford the joy and empathy those suffering from PTSD need to begin processing their trauma in the therapy sessions," Tzarfaty said.

The treatment includes 12-15 therapy sessions, all attended by both a male and female mental health professional.

Two or three of the sessions are under the influence of MDMA, administered in the form of a small pill.

While the PTSD of most Israelis taking part in the trial was caused by sexual assault, the country has also fought a series of conflicts, resulting in relatively high rates of the disorder, Ben Gershon said.

"Because of that, she believed the government had a moral duty to do what it could to help those suffering from it," Tzarfaty said.

Most Jewish Israelis must perform mandatory military service.

The current trials with MDMA, a substance created in a laboratory in 1912, are part of the "renaissance" in the research of psychedelic substances and their application in psychiatry over the past decade, Tzarfaty said.

Pachenick said the effects of the treatment on him were dramatic.

"The process put me back on track, but in a more profound way brought me home, to myself," he said.

"I'm a much calmer person today. I have a family that's very dear to me—all these things were very unstable beforehand."

 
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MDMA may reawaken ‘critical period’ to help treat PTSD

Neuroscience News | April 4, 2019

MDMA, a psychedelic drug, has successfully been used to reopen the ‘critical period’ of learning the reward values of social behaviors. Researchers report, in mature mice given MDMA, oxytocin triggers signaling in synapses that help encode social learning and memory, a process that does not usually occur in older animals. The findings could help in the development of treatments for PTSD and other disorders.

Johns Hopkins neuroscientists have found that the psychedelic drug MDMA reopens a kind of window, called a “critical period,” when the brain is sensitive to learning the reward value of social behaviors. The findings, reported April 3 in Nature, may explain why MDMA may be helpful in treating people with post-traumatic stress disorder (PTSD).

Critical periods were first described in the 1930s in snow geese. About 24 hours after a gosling hatches, if mother goose is nowhere to be found, the hatchling will bond with an object, including non-living ones. Yet, if mother goose disappears 48 hours after her gosling hatches, the critical period is over, and the hatchling won’t bond to an object.

There is evidence for critical periods that smooth the way for development of language, touch and vision.

For the current study, neuroscientist Gül Dölen says, “We wanted to know if there was a critical period for learning social reward behaviors, and if so could we reopen it using MDMA, since this drug is well-known to have prosocial effects.”

Dölen studied groups of mice in enclosures with different bedding. They put several mice together in one enclosure with one type of bedding for 24 hours and, in the next 24 hours, put the same mice by themselves in another enclosure with a different type of bedding. The mice began to associate certain types of bedding with isolation or companionship. Then, they let the mice wander between enclosures with the two types of bedding and tracked how long the mice spent in each enclosure. The more time the mice spent in the bedding linked to their companions indicated more social reward learning.

“It’s why people gather around the water cooler,” says Dölen, assistant professor of neuroscience at the Johns Hopkins University School of Medicine. "People are conditioned to know that the water cooler is an optimal place to chitchat with companions."

In their experiments, Dölen and her colleagues found that the critical period for social reward learning in mice is around puberty and wanes once they become mature adults. To determine if they could reopen the critical period, the scientists gave MDMA to mature mice, waited 48 hours for the drug to be washed out of their system, and observed how the mice explored their enclosure and behaved with other mice in the enclosure. Following the treatment with MDMA, most of the animals responded to social interactions the same way as juveniles, by forming a positive association between social interactions and the bedding. This effect lasted for at least two weeks after the MDMA treatment, and it was not observed in mice given saline injections.

“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,” says Dölen.

Dölen and her postdoctoral student and first author of the current study, Romain Nardou, also observed that MDMA works to reopen the critical period only if the drug is given to mice when they are with other mice, not if it is given to mice while they are alone. "This suggests that reopening the critical period using MDMA may depend on whether the animals are in a social setting," say the scientists.

The mice maintained their ability to learn the rewards of social behavior for up to two weeks from the time they were given MDMA. During this time, Dölen and her colleagues also found that the brains of the mice had corresponding responses to oxytocin, known as the “love hormone,” which is made in the hypothalamus and acts in the brain as a signal between neurons that encode information about social rewards. They found these responses by looking more closely at synapses, the spaces between brain cells called neurons. Their experiments showed that, in mature mice given MDMA, oxytocin triggers signaling in the synapses that encodes learning and memory, which does not typically happen in mature mice.

Dölen says that opening the critical window for social reward behavior may also have implications for treating psychiatric conditions. A strong bond between a psychotherapist and patient is well-known to be important for successful treatment. If MDMA reopens the critical period for social reward learning in humans in the same way it does for mice, then it could explain why the drug has been successful in treating people with PTSD, perhaps by strengthening the psychotherapist-patient bond.

MDMA has been designated by the U.S. Food and Drug Administration as a “breakthrough therapy” for PTSD, meaning that the agency will fast-track the development and review of clinical trials to test it. However, the researchers caution that MDMA may not work for every psychiatric condition linked to social behaviors.

“As we develop new therapies or determine when to give these therapies, it’s critical to know the biological mechanism on which they act,” says Dölen.

 
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MDMA healed a first responder’s PTSD

Reality Sandwich | Sep 19 2019

As a first responder, Nick Watchorn had seen many terrible things in the course of his career. But the massive shooting of April 28, 1986 in Tanzania, Australia, completely shook his handle on reality. Now Nick is part of the experimental studies on therapeutic MDMA for PTSD treatment.

The Port Arthur Massacre, which occurred at a popular tourist site, left 35 dead and wounded 23 others. In terms of dealing with their own trauma, first responders were taught to “stay strong.” Equipped only with this attitude, Watchorn did not have any tools to emotionally process the event, and suffered thereafter from Post Traumatic Stress Disorder (PTSD).

Twenty years with PTSD

It wasn’t just the horror of the event. And, it wasn’t just the memories that haunted him, and woke him in the middle of the night with sweats and a racing heart. It had reshaped his entire worldview. After experiencing the worst side of humanity, he said he lost trust in people, knowing what they were capable of. Likewise, the inability to release an experience so wholly wrapped in fear made him terrified to try anything new. He lived in that fear and mistrust for 20 years, just trying to get by with alcohol, antidepressants, and reckless behavior. He also went to therapy, but his PTSD symptoms persisted.

Nick finally experienced relief from his PTSD while partaking in a Phase III clinical trial conducted by The Multidisciplinary Association for Psychedelic Studies (MAPS). MAPS spearheads research to study the possibilities of MDMA for PTSD sufferers, like Nick. Nick had 3 trials sessions. Taking an MDMA pill at the beginning of each, he then received psychotherapy treatment from Stephen Eric Sienknecht, Psy.D. While the effects of regular therapy sessions had dissipated within hours, these MDMA-induced sessions had lasting effects. Namely, he no longer feels PTSD symptoms. After 20 years, Nick feels free.

Street MDMA vs medical MDMA

MDMA is currently classified by the Drug Enforcement Agency (DEA) as a “Schedule I drug.” The substances that fall into this category are considered to have no medical use, and a high potential for abuse. Because of its illegality, MDMA consumers must buy it on the so-called black market. Accordingly, it is almost impossible to find the substance in pure form. Ecstasy found on the street can contain a variety of other substances, usually meant to keep one awake longer–like pain killers, caffeine, ketamine, or even amphetamines. Some of the pills don’t even contain any MDMA in them at all.

The point is – don’t think you can just call up your local drug dealer, order some “E” and resolve all of your traumas. Rather, the FDA has allowed MAPS to conduct clinical trials to administer MDMA in its pure form, which as we established, is hard to come by out there. Also, the subjects are not just sent on their merry way after taking the drugs, as they often are with legal prescription opioids and antidepressants. They must take the pills in the presence of psychotherapists. They stay with the patients throughout their entire “trip,” which can last 6-8 hours, or even overnight. The psychotherapists then prompt the patients to process their traumatic experiences in a new way. But how does that all work? Hold on, we’ll get there.

What is PTSD?

When most people hear PTSD, they think war veterans. That’s one group that has historically suffered from PTSD, without much success in alleviating their pain. And it’s easy to imagine, at least, how utterly overwhelming such an experience as war must be. There are different kinds of experiences however, war being one of them, that can trigger the brain to go into survival mode; that “fight or flight” thing your bio teacher always talked about. Its focus is to keep you alive – first. Thus, it puts the emotions aside for later. The emotions are usually too intense for the brain to process at one time anyway.

But the traumas that PTSD patients experience are so potent that they are difficult to process later, even 20 years later, as in Nick’s case. Instead, an emotional attachment to the memory continues to evolve, as well as a reiteration of fear. It becomes nearly impossible to control one’s thoughts, emotions, or physical symptoms. According to Nick’s psychotherapist, Psy.D Sienknecht, PTSD can even be life-threatening, or at the very least, completely debilitating.

MDMA for PTSD, why does it work?

MDMA basically does two things to the brain. First, it increases activity in the prefrontal cortex, which is responsible for creativity, planning, and critical thinking. It also decreases activity in the amygdala, which is responsible for fear response. Sienknecht describes this dual effect as a “window of tolerance.” In other words, the brain can re-experience the memory of traumas, but in a different way. A way that doesn’t cause re-traumatization by a fired amygdala.

MAPS published the results of Phase II clinical trials in a medical journal. In the Phase II trials, PTSD-affected subjects took MDMA and thereafter received psychotherapy treatment, just as Nick did. They revisited their traumatic memories, experiencing intense pain and anxiety, but with one key difference. They were able to remain emotionally engaged because of the MDMA. The study showed that 58% of participants no longer had PTSD after the trial, and 68% no longer had it a year later. This proof of effectiveness allowed the study to pass to Phase III, which Nick was a part of.

MAPS aims to prove that MDMA has medical and therapeutic benefits for patients with PTSD, like Nick. If they do, it may become the first Schedule I drug that the DEA reclassifies. There are other anxiety disorders, and medical conditions that psychedelics such as MDMA can potentially treat. MAPS, and other institutions around the world, recognize their power to heal trauma–in general. We await to see what other revelations MAPS, and organizations like them, will bring us, as they discover new ways of treating some of the biggest issues plaguing human beings today.

 
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Is Ketamine a breakthrough medicine for PTSD?*

Doctors know ketamine as an intravenous anesthetic used most often on children and animals and abused as the party drug sometimes referred to as “Special K.” In the early 1990s, it became clear that slow infusions of ketamine at very low doses gave quick but brief relief to patients with severe depression.

Dr. Krystal noted evidence that ketamine may work especially quickly in people with bipolar depression and offers hope for others in need of new options: people who fail to respond to electroconvulsive therapy, people with a psychotic depression, people with severe anxiety or agitation as well as those with severe pain.

PTSD patients badly need a new solution, he explained: they only see about a 10% reduction beyond placebo with current anti-depressants. Combat-related symptoms are especially tough. The Department of Veteran Affairs funded two large trials of promising drugs, Prasozin and Risperidone, but they proved ineffective. "Moving forward," Dr. Krystal explains, "requires turning to 'a deeper understanding of the biology' underlying depression and PTSD."

Is glutamate the important neurotransmitter in depression and PTSD?

Current anti-depressants boost the availability of serotonin or serotonin and norepinephrine, two neurotransmitters that enable neurons in the brain to communicate. It has been proposed that depression involves a paucity of those neurotransmitters. Dr. Krystal, with his colleague Dennis Charney, M.D., also a member of the BBRF Scientific Council and Dean of the Icahn School of Medicine at Mount Sinai in New York, found evidence otherwise.

“He led a series of studies showing that depleting the body of serotonin, or depleting the body of norepinephrine, or [both], did not produce depression in people,” Dr. Krystal explains. “This suggested to us that maybe the biology of depression and stress-related disorders didn't primarily live in the primitive parts of the brain that use serotonin or norepinephrine to communicate, but rather in the higher centers of the brain, the cerebral cortex, where glutamate is the predominant neurotransmitter.”

Both PTSD and depression can be caused by stress. Releasing cortisol is part of the stress response, our reaction to danger. "Cortisol can be harmful if it's too much for too long, but it may also be harmful if it's too little for too brief a period,” Dr. Krystal said. "In unipolar depression, we get a continual bath of cortisol, which is abnormal. In people with PTSD, not enough cortisol may have been released at moments of extreme stress."

The result may be a loss of connection-points between neurons, called synapses. Dr. Krystal found evidence of this loss in a pioneering MRI brain scan study of PTSD patients published in 1995. “Nowadays, using functional MRI, we can show that functional connections in the brain are reduced in PTSD in relation to or correlated with the overall severity of PTSD, and symptoms such as numbing and hyper arousal,” he said.

In both PTSD and depression, the brain evidently fails to remodel the lost connections. But over months of treatment with anti-depressants, brain scans show regrowth of dendritic spines—connection terminals and key players in the metabolism of glutamate.

Ketamine is thought by some to block the N-methyl-D-aspartate (NMDA) receptor, which binds glutamate. The temporary block may jolt the brain to release glutamate, prompting a cascade of regrowth and reorganization. For some people, a single dose of ketamine can make depression disappear for several days, or for as long as two weeks.

“There's no ketamine in the body at the time when people are reporting the greatest clinical benefit,” Dr. Krystal points out. "The benefit is an after-effect, not yet understood scientifically."

"Dissociation—feeling detached from one’s own body—and occasional nausea, two side-effects of ketamine, are easily managed in a clinic, and we have not had cases of drug abuse,”
Dr. Krystal said, referring to carefully controlled experimental use of ketamine in clinical settings. A many as three-quarters of severe depression patients who have tried ketamine infusions have found some relief. Over time, many need less frequent infusions: 40 percent of Yale’s patients come for infusions once a month or less often. The long-term effectiveness and impact of ketamine remain unproven.

“This new neurobiology of PTSD and depression suggests that there may be other mechanisms for treatment that may come from this line of research,” Dr. Krystal concluded. He hopes to have results from the PTSD trial by early 2020.

 
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How to use psychedelic mushrooms as a tool to heal C-PTSD

by Ashley Michaud | Sociedelic | Sep 13 2019

People exposed to severe and continuing violence, abuse, neglect, and suffering may develop complex PTSD, a condition that surpasses conventional PTSD.

I am Ashley, I have a Masters in Health Coaching and attuned as a Reiki Master / Teacher, I am also certified in Integrative Nutrition, Hormone Health and a published Author. I don’t mention this to give myself authority but instead show you what is possible when you use psychedelics as a tool for Elemental Growth.

I started my life off a mess – using sex, ecstasy, alcohol and cocaine to cover up pain rooted in childhood abuse. I was taught to hold things in and that the stuff I wanted to talk about didn’t matter. I was shown that drinking, putting on a mask and SAD (Standard American Diet) foods were my only options in life and then I had my first dose of psychedelic mushrooms. I realized just how f***ed up and oppressed every culture is, I saw the big picture. I moved out of my moms at 14 years old, was kicked out of high school shortly after and had a rough few years learning about the world and who I am.

At 20 I began experiencing hormonal issues but continued to party, at this time I also decided to get an education. Because I liked to party and travel, I enrolled into College as a Hospitality and Tourism student. Wise at the time but I am still paying student loans off for this party phase of my life. After a few semesters I began to travel Canada accumulating new life experiences along the way. One day as I looked out at the Pacific Ocean, I heard a voice tell me “it’s time to get sober, and to do this you have to go home to the roots of where your trauma started.”

I did get sober shortly after my return. I cleaned up my diet too and truly did start healing my roots. I created a timeline of my life, I said goodbye to friends, family, items and thoughts that did nothing good for me. I also threw myself into 2 hours of Kundalini Yoga DVD’s by Maya Fiennes everyday and a weekend dose of psychedelic mushrooms.

I was doing the meditation thing, the clean eating thing but it was mushrooms that truly made the connections and guided me back to purpose and passion for life. It was the mushrooms that told me to start looking at my food in a new light – to think about life force energy and what I consume psychically, mentally and spiritually – even more why I am consuming it. For a year I tested every food in my local grocery store and bulk bin to see if it would grow. That’s how I got into Fluoride, GMO’s and our solutions “Permaculture” and Integrative Nutrition.

It was mushrooms that introduced me and ultimately the reason I became obsessed with Joe Rogan, Duncan Trussell and the McKenna Brothers. It was mushrooms that supported my sacred journey to sobriety, backpacking 3 countries in South America with no map or clue what I was doing and it was mushrooms that has helped me clear out my C-PTSD so I can fill my life up with laughter and good times with my son who gets the best of me everyday.

What is a biohacking?

Biohacking is all about self-improvement and human optimization. As Tony Robins explains it “biohacking is essentially the practice of changing our chemistry and physiology through science and self-experimentation to energize and enhance the body.” Now I don’t know if Tony practices with entheogens, but I know that they have helped me make the process of biohacking more focused and enjoyable.

Here’s my prescription or C-PTSD

My biohacking specialty is Moon Cycles, Circadian Rhythm, Seasonal Alignment, Positive Psychology & personized Alchemy. Most recently I have been microdosing psilocybin, written about in my book Be The Change: Your Guide to Elemental Growth Through Nature, Love, Food & Movement.

Top 3 elemental tips:

- Write an ongoing list of all the things you hate and title it “Things I Will No Longer Tolerate”
- Take action by recognizing your feelings as they come up and then eliminating the things that make you feel like sh**
- Reward yourself with new habits that align with who and where you want to be. Your dreams are only possible when you believe “it’s all happening”.

I am Ashley, and this is my blog on how I biohacked C-PTSD and my destructive behaviors using psychedelic mushrooms. I am the girl that has cleaned up her life, broken through family karma and tapped into her natural flow. Like me you have everything you need to heal yourself and reach each dream you put forth but you don’t have to do it alone. Having your own guide on the side lines can help you breakthrough roadblocks and unleash your true potential.

As a health coach I don’t fix my clients, they do that, my job is to ask the questions that will spark transformation – so here it is: What resonated with you most? How do you think this bio-hack will be of service to you rising to become the hero of your own story? Sending you good vibes & positivity on your Elemental Growth journey, it’s all happening!!

 
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How MDMA is changing the treatment of PTSD*

by Rachael Beairsto | Psychiatry Advisor | October 7, 2019

Rick Doblin, PhD, founder of MAPS, anticipates that MDMA will be approved for PTSD by 2021. During his presentation at the 2019 Psych Congress, held October 3 to 6 in San Diego, California, Dr Doblin discussed results of recent research and future directions for treatment of PTSD.

Millions of Americans are affected by PTSD. Among veterans, it is the third most prevalent military service-related disability, which costs the Veterans Affairs disability payments service billions of dollars each year. Furthermore, treatment for PTSD can be challenging given the high number of nonresponders.

MDMA, a known psychoactive drug that is most often used recreationally, has been identified as potential therapeutic modality for this challenging condition. MDMA counters the neurologic effects of PTSD, which manifest as hypoactivity in both the hippocampus and prefrontal cortex and hyperactivity in the amygdala.

MDMA is not the entire therapy for PTSD; instead, it is MDMA-assisted psychotherapy — optimized with thorough preparation and integration of therapeutic outcomes — that has had early success in PTSD in multiple phase 2 trials and has now moved on to phase 3 studies.

In a series of 6 international phase 2 MAPS-sponsored studies, an active dose of MDMA (75-125 mg) was compared with a nonactive lower dose (0-40 mg; placebo group) in MDMA-assisted psychotherapy for chronic, treatment-resistant PTSD over multiple integrative sessions.

At 2-month follow-up, more than half of patients who received the active MDMA dose no longer met the diagnostic criteria for PTSD (56 percent, vs 23 percent in the placebo group). This improvement in PTSD with an active dose of MDMA was even greater at 12-month follow-up: two-thirds of patients (68 percent) were categorized as no longer having PTSD, indicating prolonged healing after MDMA-assisted therapy.

On the day of administration, rates of anxiety, jaw clenching/tight jaw, lack of appetite, and nausea were higher in patients who received the active dose of MDMA, while fatigue and headache were more common in the comparator group. Despite concerns about longer-term neurotoxicity with MDMA, the investigators noted no neurocognitive changes after treatment.

On the basis of these data, the United States Food and Drug Administration (FDA) approved the trial to move to phase 3 and granted breakthrough designation for MDMA-assisted psychotherapy for PTSD in 2017. The European Medicines Agency also approved the study to move to phase 3, with the condition that migrants and refugees be included. An interim analysis of the first of the phase 3 studies is expected around March 2020.

Though costs for MDMA drug development are high — an estimated $34 million before FDA approval and $11 million related to European Medicines Agency approval — MAPS, a nonprofit organization, is refusing investment from pharmaceutical companies in an effort to avoid competing interests. Representatives from MAPS are in conversations with the FDA to discuss expanded access through compassionate use, given that there are millions of patients with PTSD and only hundreds currently being enrolled in clinical trials.

As for next steps, Dr Doblin explained that patients with PTSD have a desperate need for this therapy. While MDMA-assisted treatment will never be a take-home, self-administered cure, he envisions a future with highly trained therapists at thousands of accessible psychedelic treatment centers across the world.

*From the article here :
 
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To unravel PTSD, she took MDMA*

by Will Stone | Apr 22 2019

Lori Tipton had recounted the details of her mother’s death many times, always with the same detachment as that first 911 call.

“I was the one who discovered their bodies in her home,” Tipton says of that night in 2005. “I completely just disassociated. … I couldn’t believe what I was seeing.”

A murder-suicide, her mother had killed a lover and a close family friend.

It wasn’t Tipton’s first encounter with trauma.

When Tipton was 20 years old, her brother came to visit her in New Orleans for his 21st birthday. He died of an overdose that night in her home.

“In the wake of that experience, I didn’t really allow myself to process any of that, because I immediately began to take care of my mother,” Tipton, now 39 years old, remembered.

Her mother had struggled with mental illness for many years and took a sharp decline after her son’s death.

But Tipton’s diagnosis of post-traumatic stress disorder didn’t come until later, and only by accident when Hurricane Katrina hit.

She was displaced and spent weeks in and out of hotels. Her life felt like a steady stream of loss — the tragedy only compounded by the devastation of the storm and its aftermath.

“Nearly everybody returning to New Orleans was being diagnosed with PTSD,” Tipton said. “I think that partly led me to believe that, maybe, I didn’t have this affliction.”

He describes the years that followed as “seeing the world through dirty goggles.”

“Imagine your brain, you go down a road and to the left is like happiness and joy, and to the right — anxiety,”
she said. “No matter what the circumstances were in my life, my brain would always go right, every single time.”

What happened to Tipton the following year cemented the sense that she was somehow broken, “unable to be saved,” as she describes it.

A close friend of Tipton’s, someone she trusted, raped her.

“I ended up pregnant from that rape and had an abortion,” she said.

Tipton avoided talking about the assault. She says she tried to mask her fear and isolation.

Heart-pounding panic attacks and unexplained dread became a daily part of her life. A specific word or touch, even from someone she loved, could overwhelm her with fear.

“When you have PTSD, you are living in this constantly triggered environment,” she said. “My disorder had become so much a part of who I was.”

She felt as if the universe was punishing her.

“Anytime I felt I could trust myself, I was proven wrong,” she said.

For more than a decade, Tipton searched for a remedy.

She tried everything offered — or that she could think of — to mitigate the symptoms of PTSD: antidepressants, psychotherapy, acupuncture, meditation and hypnotherapy.

She became a yoga teacher, tried Rolfing (a type of deep-tissue massage) and even saw a witch doctor.

Nothing really worked.

Amid a renaissance in psychedelic research, new treatments emerge

In 2017, Tipton came across an online ad for something different: researchers from the Multidisciplinary Association for Psychedelic Studies, also called “MAPS,” were looking for people with chronic, treatment-resistant PTSD.

It was an opportunity to participate in Phase 2 clinical trials for an experimental, yet promising model of treatment: MDMA-assisted psychotherapy.

Tipton was unsure at first.

“I went in there being as open as possible, but with a great deal of skepticism,” she said.

First synthesized in the early 1900s, MDMA is a psychoactive drug that boosts neurotransmitters like serotonin and also dials down activity in the amygdala, a part of the brain that processes fear. It can increase empathy and social connection.

The therapeutic benefits were explored throughout the 1970s, including in contexts like couples therapy. But those efforts stalled when the federal government — alarmed by the rise of the club drug “Ecstasy,” which can contain MDMA — classified it as a Schedule 1 drug in 1985.

Now research into psychedelics has picked up again in the U.S and that is offering hope for treating a variety of mental illnesses — from substance use disorder to depression.

MDMA is on the front line of these emerging treatments. A new drug hasn’t come onto the market to treat PTSD in more than a decade.

In 2017, the U.S. Food and Drug Administration granted Breakthrough Therapy designation to MDMA-assisted psychotherapy, developed by MAPS.

According to the FDA, the designation is reserved for a drug with preliminary clinical evidence indicating that it “may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.”

Phase 3 trials are taking place across the country, as well as in Canada and Israel.

“Seeing what was possible, you can’t go back,” said psychotherapist Saj Razvi of sessions aided by MDMA. “Things that may take months or even years to accomplish, or may never get accomplished, we see people are able to work into that territory.”

Razvi is director of medical education at Innate Path, a clinic based in Colorado. He was also clinical investigator in the Phase 2 trials for treatment-resistant PTSD.

“MDMA allows you to contact feelings and sensations in a much more direct way,” Razvi said.

The MAPS protocol typically consists of two to three sessions when MDMA is administered, each eight hours long. Those are bookended by sessions of therapy to integrate what the person has discovered while under the influence of MDMA.

Razvi, who has observed hundreds of hours of these sessions, says only by returning to the origin of the trauma can you “unpack this material, feel your way through it and get to the other side.”

“These are fundamentally powerful experiences that are corrective in nature, going back to these places where we were crushed,” he said.

It can look painful, he says — what some might call “a bad trip” — but only through this process can the quality of these traumatic experiences change.

“When we are being traumatized, we are fundamentally alone,” he said. “One of the things that MDMA does is, really, lets you know that you are not alone.”

Trauma revisited in the embrace of MDMA

Lori Tipton knew the story of her mother’s death well, but it always felt like it was happening to someone else.

That changed while on MDMA.

“I was able to remember all of those things, like truly able to remember these little pieces that were missing before,” she said.

She could stay present in the most terrifying moment of her life, safe in the “loving embrace of MDMA.”

As those memories emerged, they formed something new — forgiveness.

“I was able to find such empathy for myself. I realized how much I was thinking this was my fault and I should have done something,” she said.

Then she told herself to let it go.

“This is a terrible thing that happened, but you carrying the fear and shame over this, it’s worthless.”

Tipton unearthed other memories, too, feelings of joy and peace that had been sealed away. She was playing in the snow with her brother when they were children.

“I could remember exactly how I felt, that excitement of the first snow,” she said.

But as her last session was coming to an end, one moment still remained out of reach: her rape.

When she spoke of it, the heaviness would return. There was no catharsis.

Her therapists, a male-female duo, suggested something.

“How would you feel about potentially going into one of these poses and seeing what happens?”

Years of practicing yoga, even teaching it, and certain poses Tipton could never do; it took her back to the assault.

She lay on the floor and took the pose, her legs draped over her shoulders.

As the panic surfaced, they offered her a simple question.

“Can you ask what that feeling needs?”

“It needs to be heard,”
Tipton replied without thinking. “I had felt so silenced for so many years, people didn’t believe me … that, I needed that moment for them to understand me.”

They stayed with her, crouched on the floor, and let her know they did believe her.

“It was the first time I had told that story and that had been the response,” she said.

That was the end of Tipton’s treatment with MDMA.

More than a year later, she no longer fits the diagnostic criteria for PTSD. That was the case for nearly 70 percent of those who were given MDMA in the Phase 2 trials. It was a small group, fewer than 100.

Still, the potential of achieving durable remission could be a paradigm shift for millions with PTSD.

Tipton says it saved her life.

“Everything is at my fingertips for me in a way that it never was before,” she said. “I want that for everybody.”

*From the article here:

 
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MDMA-assisted psychotherapy for PTSD

CMHD

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

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

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

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

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

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

http://www.mentalhealthdisparities.org/mdma-trauma-study.php
 
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Bob Walker has suffered from PTSD for over 30 years. He's not alone in this struggle,
but he claims to have found a way out, through MDMA therapy. A group of specialists
across the country are using it to heal trauma victims in ways previously unimaginable.


Ecstatic states

by Lessley Anderson

Can an illegal drug heal crushing trauma?

In the Vietnam War, Bob Walker was a helicopter mechanic who saw his best friend decapitated by an incoming helicopter’s propeller blade. Ever since then the 69-year-old Paradise, CA vet has struggled with PTSD — a psychological condition that afflicts 7–8 percent of the population. It hits people who have been exposed to highly stressful situations in which their “fight or flight” response has been activated. Rape survivors. War veterans. Policemen.

People with PTSD can be highly irritable and suffer from insomnia, nightmares, and the inability to sustain deep relationships. Or, like Walker, they can walk through life feeling eternally numb. “Over the years, I tried everything from prescription drugs to biofeedback,” says Walker. “But nothing really worked. I knew something just wasn’t right.”

Then one day three years ago, Walker saw a segment on CNN about an experimental drug trial going on in South Carolina to treat people suffering from PTSD. In the study, patients took MDMA, more commonly known by its street name ecstasy, in the company of psychotherapists. The drug’s famous warm-and-fuzzy ability to enhance a person’s well-being and create a surplus of empathy allowed many of the participants to revisit painful memories without their usual fear. In neurochemical terms, MDMA decreases the fear response in the amygdala. It also stimulates the release of the feel-good neurotransmitter serotonin, as well as oxytocin and prolactin, which cause feelings of love and bonding. After taking the drug, many patients could look at their lives in a new way, reprocess trauma, and rewire their own brains.

"I got it, right away," says Walker, about watching the segment detailing the experiments. He figured, living right next to a college town, he could ostensibly score drugs easily. Why not try it himself?

"Finding MDMA was harder than I expected," he said. Asking around and attending a psychedelics event got him connected to some people doing sweat lodge and peyote ceremonies, but no ecstasy. But he finally tracked down ecstasy through a friend of a friend’s son and contacted a former therapist, who agreed to work with him while he was high. Jennifer*, who asked that her real name not be used because she feared she could lose her license, was a self-described "conservative" single mom who was typically scared of drugs. But she felt a warmth for Walker and trusted him. "For some reason, it didn’t feel wrong," she said. "He had really done his research." The first time was a therapy session like no other. "He didn’t seem high, he just seemed ‘real,’" she said. "We were able to carry on an intimate conversation for the first time."

"You lose your sense of connection,"
says Walker, describing the feeling of having PTSD. But on MDMA, Walker felt deeply connected, not just to his therapist, but also to himself, something he’d long struggled with.

The drug trials that inspired Walker were the work of MAPS. It’s one of a small handful of organizations worldwide trying to establish scientific evidence that psychedelic drugs have therapeutic value.

In the study looking at how MDMA could treat PTSD, the drug was given in conjunction with talk therapy. Patients lay down in a therapist's office and listened to soothing music with headphones, wearing eyeshades. They had the option of talking about what they were experiencing, and received counseling before and afterwards to integrate what happened to them while on the drug into their everyday lives. According to MAPS, 83 percent of the 19 people treated in a recent group had breakthroughs in this MDMA-assisted therapy and showed significant improvement in their PTSD symptoms.

"The MDMA allowed me to be my very, very, very best self, and I got to take care of my most broken self with my best self," says Rachel Hope, a sexual-abuse survivor who participated in the study. MAPS’ results from this study were encouraging enough to the FDA that it was able to expand its efforts into what’s known in drug-trial parlance as "Phase 2 studies." It’s now doing the same study with four new groups of patients in South Carolina, Colorado, Israel, and Vancouver.

In addition to the MDMA-to-treat-PTSD study, MAPS has also studied how LSD can help soothe anxiety in people with terminal illnesses, and in March received approval to study the effects of marijuana to alleviate PTSD. The latter study will be one of only two government-approved medical marijuana trials ever conducted.

Similarly to MAPS, the Santa Fe-based scientific research group the Heffter Research Institute has been collaborating with scientists at UCLA, Johns Hopkins, and NYU to study the therapeutic applications for psilocybin, the active ingredient in hallucinogenic mushrooms. In one study, published in 2011, it investigated how the drug might be used to make terminally ill cancer patients feel less anxious and depressed, and reported that of 11 patients given the drug, 30 percent reported an elevated mood that lasted long after the drug wore off. Now, Heffter scientists are looking at how psilocybin might help cure alcoholism and get people to quit smoking.

In many ways, this research isn’t new. Besides the thousands of years of indigenous peoples’ ritual use of mind-altering plants like ayahuasca and peyote, there was some modern scientific exploration of these kinds of substances, too. Before it was criminalized in 1968, LSD was being used by some doctors as an experimental method for treating alcoholism and anxiety. MDMA, prior to being outlawed in 1985, was used by hundreds of psychotherapists in the United States to treat a variety of phobias, addiction, trauma, and even relationship problems. In an interview with psychiatrist Julie Holland, author of the book Ecstasy: The Complete Guide, one of these therapists recalled: "When it came to, for instance, couples therapy, it was a remarkable catalyst."

Hopes for relief

MAPS and the Heffter Research Institute were founded with the mission of reintroducing these types of investigations and documenting their results in peer-reviewed journals. MAPS opened in 1986 and Heffter in 1993, after LSD, MDMA, and psilocybin became illegal. But until the 2000s this type of research would have been virtually impossible. The National Institute on Drug Abuse and negative media coverage throughout the ’80s and most of the ’90s depicted drugs like ecstasy, pot, and acid as a scourge without any therapeutic value. But personnel changes in the FDA and a softening of attitudes within the DEA and Institutional Review Boards, both of which greenlight drug trials, have opened up the field of psychedelic research like never before.

"A lot of the demonization of drugs as evil in all walks of American life has really calmed down," says Jeffrey A. Fagan, professor of law at Columbia University. "And that’s a great thing. There’s no reason why we can’t think in careful and responsible steps about the therapeutic value of controlled substances." As scientific evidence begins to mount, psychedelic researchers are looking towards a day when drugs like ecstasy, pot, LSD, and psilocybin will be categorized as "Schedule 2" drugs — that is, drugs that have risks associated with them, like Ritalin or Oxycontin, but can be prescribed by a doctor.

Rick Doblin, the founder of MAPS, says he envisions a future when hospice centers for the terminally ill sit next to psychedelic therapy centers, and licensed doctors can prescribe MDMA in clinics similar to the way methadone is handled. "Things are lining up in our culture and we have the opportunity to reintegrate psychedelics," says Doblin. "They’ll have an honored place rather than a suppressed place."

Harsh realities

But it may be too early for Doblin and his colleagues to get too excited. By the FDA’s own reporting, only 5 percent of all investigational new drugs actually make it through the testing and approval process. If any of the drugs that MAPS and the Heffter Research Institute are studying ultimately get approved for therapeutic use, the organizations’ research will have to show positive results among hundreds of participants.

Conducting these larger "Phase 3" studies will cost millions of dollars. Unlike commercial pharmaceutical companies with deep pockets, MAPS and the Heffter Research Institute are privately funded, acting, essentially, as nonprofit pharmaceutical companies. The drugs they’re studying have patents that have expired, making them of little interest to Big Pharma. Anybody could ostensibly make generic versions of them, driving down price and potential earnings.

Raising millions more from the public to continue this research won’t be easy, particularly because at least in the case of the Heffter Institute, psychedelic research operated under the radar for years. Dr. David E. Nichols, president and co-founder of the Heffter Research Institute says that his organization tried to keep its work on the down-low because it was widely considered controversial. Take the research around psilocybin and people with terminal illnesses, for example: "There are a lot of taboos about how people die," says Nichols. But when Nichols describes the effects the drug can have on people dying of cancer, he presents a moving case that would be hard for anybody to ignore.

"We had one woman say, ‘I realized how precious the people are around me — and I want to enjoy them while I still have time here,’" says Nichols, referring to a cancer patient who took psilocybin in his study and is now deceased. "She said that it changed her completely, and she was able to embrace the life she had left, and it should be there as an option for people to do if they want."

Nichols believes that, culturally, we’re getting closer to that reality. "Young people are more accepting of things formerly viewed as social ills, like same-sex marriage and certain illegal drugs," he says.

"The people who thought psychedelics were dangerous drugs are getting old and dying off," says Nichols. "It may be that when future generations approach that time of life, they’ll do so with an open mind, and regulations may follow."

 
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This war zone anthropologist used ayahuasca to heal his PTSD

by Ocean Malandra | reset.me

“What lives in my head is an abnormally long horror film about the monstrosities of the human race,” says anthropologist Riccardo Vitale, Ph.D. After two decades of working in some of the most violent and war torn regions of the world, as an advisor and researcher for large international aid and development agencies, he found himself struggling with a serious case of post-traumatic stress disorder (PTSD).

PTSD is a condition that develops after exposure to a traumatic event. Although it is closely associated with war veterans who witness and experience horrific and violent acts on the battlefield, it is also common among women who have been physically or sexually assaulted and those who go through terrifying and life threatening events, like Riccardo.

“In Mexico I did participant/observation research and worked with human rights organizations documenting abuses against indigenous peasants,” Riccardo tells Reset. “Most of this time I lived with indigenous Tzeltal, Chol, Tojolabal and Tzotzil communities."

“In 1996, after receiving some death threats, I was told to leave the country for my own security,”
he continues. “And I did, but I came back two months later.”

A year after he was warned to leave Mexico, Riccardo was abducted in broad daylight.

“As I walked near the Zocalo, in the middle of the day, someone approached me and said my name,” he tells us. “An car appeared and I was pushed in as the vehicle drove away. I was kept for about a day inside an old, beaten, unmarked car in the middle of a field in a rural area near Tuxla Gutierrez, the capital of the State of Chiapas.”

Although Riccardo was released the next day and forced to fly out of the country, his kidnapping and deportation coincided with a massacre of forty-five indigenous Tzotzil as they celebrated mass in a small chapel.

“As a young, enthusiastic, budding anthropologist I identified strongly with the indigenous people of Chiapas. The massacre and the deportation devastated me emotionally,” Riccardo explains.

“Because of Acteal (the village where the massacre took place) I stopped celebrating Christmas and New Year’s for more than seven consecutive years. I actively avoided family, people, and festive gatherings. I spent many Christmases and New Year’s locked in hotel rooms or alone in Cambridge working on my PhD.”

According to the Sidran Institute, an international non-profit that helps people understand and treat PTSD, sufferers may feel emotionally detached, withdraw from friends and family, and lose interest in everyday activities. They can also become very irritable and prone to anger.

“I became very uncompromising with myself and with others. Rigorous in my work, but also inflexible, belligerent, and temperamental,” Riccardo says. “Anger and poor mental hygiene were issues.”

Numerous studies have shown that the trauma and extreme stress that triggers PTSD actually causes brain changes and even brain damage, meaning that the emotional symptoms of the disorder have physical dimensions and it is not simply something that people can snap out of. In fact, most people with PTSD suffer for years as psychologists still struggle to manage the disease.

For Riccardo, however, the experience in Mexico was just the beginning. After the deportation and massacre in Mexico, he soon found himself right back in the hot zone again.

“Towards the end of my Ph.D. I did some work with refugees along the Iraqi borders,” he tells us. “In two different trips I had to witness some atrocious episodes and scenes. I can’t talk about these experiences out of decency, out of respect for the victims, and out of pain. The images are just too horrible and sad to convey.”

These events only served to worsen Riccardo’s PTSD symptoms.

“The relationship with my family deteriorated. I couldn’t relate to anyone anymore,” he says. “I was only interested in human rights and social causes. I stopped all hobbies. The concept of vacation was foreign to me. My life-long passions for skying, sailing, and scuba diving went to sleep."

“When my grandfather and then my grandmother died, I felt so estranged from family that I didn’t even think about catching a short flight to attend their funerals. This is something I will always regret.”


For the next ten years Riccardo worked for various human rights organizations in Colombia, often on the front lines of conflict, advocating for the victims of the half century of violence that has rocked this incredibly bio-diverse but tragic land. During a break between consulting jobs, Ricardo was traveling along the southern Putumayo River, when he encountered the Amazonian medicine known as yage or ayahuasca.

“I had traveled several hours south in the Putumayo River — this is a definite no-go area of Colombia,” he tells us. “Whilst in navigation, I spotted some Red Cross boats flashing their huge identifying flags. Great, I thought, I’m freelancing in a war zone without any assignment. I got that familiar, stomach churning, alert, alert, adrenaline boosting feeling."

“A couple of days later, at the old man’s wooden hut, in a remote area on the Ecuadorian side of the river, I was served a large chalice filled with a large portion of yage. A few small candles dimly lit the room. The old man and I were the only two people present."

"Just as I gulped down a first portion of the brew, a mortar went off in the distance, the sky lit up for a short moment. Then for a few seconds we heard gunfire. ‘It’s far away in Colombia,’ muttered the old man as he smiled compassionately."

“As the loud concert of the tropical forest reclaimed the night, I thought: ‘There is a reason why I am here and closed my eyes to wait for yage to start its work.’”


A highly hallucinogenic tea made from mixing N,N-Dimethyltryptamine (DMT) containing leaves with a particular rainforest vine, yage has been used since time immemorial by a large number of different indigenous societies across the Amazon. They consider it to be a sacred medicine that heals at a deep spiritual level. But the process is often quite intense.

“The famous ayahuasca purges, the diarrhea and vomiting, were just minor nuisances — a relief in fact — compared to other physical, spiritual, and mental hurdles that these experiences posed,” Riccardo recalls. “I felt so miserable that I wished I would die. I saw a huge red octopus-like creature convulsing inside my body. It was terrifying.”

But that ‘red octopus’ experience was a turning point for Riccardo, as the darkest ayahuasca ceremonies often turn out to be the most cathartic.

“I feel that yage continues to work in the weeks and months following the ceremonies,” Riccardo tells us. “The integration period is quite long. Only about six or seven months after my last ritual in 2015, I became aware of substantial and profound changes in my personality."

“At the end of 2015, after almost two decades of conflictive relations, I told each member of my family how much I loved them. I also said that I had forgiven myself for all of my mistakes and forgiven the mistakes of anyone else in my family.”


The profound healing power of ayahuasca, which often takes the participant into deep emotional places and forces them to re-live memories, is something that is creating a momentum of advocacy for its use to deal with modern day health crisis’s — like addiction and PTSD.

“The numerous anecdotal accounts of people reporting that ayahuasca experiences helped them overcome their PTSD justify a scientific study,” Rick Doblin, the founder and executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS), tells Reset.

MAPS has initiated several important studies that prove that psychedelics are perhaps the most powerful treatment options available for certain disorders, including the first North American observational study of the safety and long-term effectiveness of ayahuasca treatment for addiction and dependence.

They also recently published a bulletin on how PTSD affects the memory functioning of the human brain, and how ayahuasca can be used as treatment for the disorder.

“In the psychotherapy of the future, it’s possible that people with PTSD will be treated with a several month process of psychotherapy including a series of psychedelic-assisted psychotherapy sessions, some with MDMA and others with more classic psychedelics like ayahuasca, LSD, ibogaine, mescaline, or psilocybin, along with the option of marijuana,” says Doblin. “The long-term goal would be to enable people to function without symptoms of PTSD and without the need for any further medications.”

For Riccardo, working with ayahuasca over the last two years has continued to pay off. He feels that the PTSD has been resolved and that dramatic change and real healing have taken place in his life.

“In 2016, the ceremonies brought me some very different experiences,” he says. “The utter agony was gone. There was some pain, but eventually that also changed. I realized that I’m on a learning path. Yage is showing me a way. It’s an interesting, significant, yet difficult and slow learning process. The ceremonies of 2016 focused on the equilibrium between matter and spirit; self control and the power of the mind over matter."

“I have learned to process adversities and obstacles, even daily minor ones, as learning opportunities that you can resolve with clarity and grace.”


Riccardo now makes his home in Colombia, and has developed deep relationships with several indigenous communities in the Putumayo area.

“An Inga friend, an experienced yage drinker, told me that the medicine dismembers your defenses and your ego. It takes you apart. Until you are a nothing but pieces of disconnected raw material. Everything is there though, all the hurt, the pain, the joy. At this point your task is to reassemble everything. To rebuild yourself,” Ricardo explains.

And rebuilding his life is now what occupies Riccardo’s time. Although he continues to do advocacy and research work on human rights issues here in Colombia, he has also teamed up with a handful of anthropologists and human rights professionals to create an anthropology-based organization in partnership with local Inga communities and the Union of Traditional Indigenous Yage Medics of the Colombian Amazon (UMIYAC). Together they aim to assist indigenous communities that are experimenting with alternative development models based on cultural exchanges, small scale farming, and traditional healing practices.

“Now we are marketing, raising more necessary funds and organizing a crowd-funding campaign for an Amazonian Center for Ancestral and Spiritual Plant Knowledge and Education,” Riccardo tells us. “This is a community-based initiative. It’s an educational hub were youth from the Amazonian basin can learn and practice ancestral medicine from elderly healers. This is a key issue, because every year that goes by we are losing a huge patrimony of autochthonous knowledge about plants and healing.”

This indigenous knowledge may be the key to not just preserving traditional ayahuasca practices, but the very world we live in as well.

“We have adopted a development model that is unsustainable,” says Riccardo. “We are stressing the ecosystem. Indigenous people are on the front line of extractive economy. They see their forests and rivers dying because of unscrupulous, aggressive mining, logging, oil perforations, flooding, droughts, cattle ranching or mono-crop cultivations of eucalyptus, soya, and African palm."

“Concerned about these environmental catastrophes, indigenous spokespeople are proposing an alternative development model based on their millenarian experience, their philosophy, their cosmology, and their spirituality. We should listen and incorporate this vision into all development models.”


In the end, this is the same message that ayahausca is delivering to us. The damage that we are wreaking on the earth is also the same damage we are inflicting on ourselves as manifested in war and ensuing mental illnesses like PTSD. The incredible medicinal power of ayahuasca is not that it is a magic cure-all, but a teacher that points us towards another way of being.

“I don’t believe in panaceas,” says Riccardo. “If the world is experiencing a psychological fallout, we need to work on structural changes. Happiness is not about finding the perfect medicine; it’s about resetting our value system and the implementation of social and environmental reforms."

“Love and compassion should replace profit as the driving force of development. This however is not going to occur as long as our quintessential spirituality is kept dormant.”


In other words, in order to save the world, to save ourselves, maybe we should all go native.

http://reset.me/story/this-war-zone-...heal-his-ptsd/
 
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Study finds 'frozen' fear response may underlie PTSD

by Bill Snyder | Medical Xpress | Dec 4 2019

Learned fear responses enable animals—including humans—to flee or freeze in the face of a perceived threat. But if these behaviors persist after the danger lifts, they can become paralyzing and disabling. That's a key element of posttraumatic stress disorder (PTSD).

To explore how fear becomes entrenched, researchers at Vanderbilt University Medical Center have traveled down the precise neuronal pathways in the brains of mice that trigger fear responses, and which normally extinguish the behaviors once the danger has passed.

This scientific journey, detailed recently in Nature Neuroscience, challenges conventional wisdom about how the brain is "remodeled" in response to the intrusion—and subsequent removal—of fear-inducing stimuli.

It's widely assumed that the brain's advanced seat of cognition, the cerebral cortex, decides how to respond to a threat and its order "filters down" to a more primitive part of the brain, the central amygdala, where the flee-or-freeze response is executed and terminated.

But the Vanderbilt scientists found something unexpected: initiation and termination of learned freezing responses occur in cortical parts of the amygdala via a flexible remodeling of excitation onto two distinct subtypes of central amygdala "output channels."

It is here that the animal learns to fear certain stimuli through one neuronal channel and "unlearns" the fear through the other channel once the threat is gone.

"You don't want too much thinking going on" in the face of danger, explained Sachin Patel, MD, Ph.D., the paper's corresponding author and director of the Division of General Psychiatry at Vanderbilt.

"You want very distinct outputs to happen independently so the animal can choose very quickly—should I freeze, run or just go about my business? That's part of the novelty here."

"There's a lot of learning-related plasticity and remodeling in the brain that's occurring at some of these more 'primitive' central amygdala synapses rather than just within the cortical-like areas,"
he said.

How might this knowledge apply to the human condition?

People who have been exposed to stress or trauma can form associations between environmental cues and the fear that their lives are in danger. If the association persists after the threat is gone and the environmental cues continue to trigger anxiety and fear, that can lead to PTSD.

"It's like they're stuck on the freezing channel and can't flip back to the … normal behavior channel," said Patel, also the James G. Blakemore Professor of Psychiatry and professor of Molecular Physiology and Biophysics and Pharmacology. "That's a theory (but) it might be related to some sort of deficit in this synaptic flexibility mechanism we've discovered."

Currently PTSD is treated by gradually exposing patients to the environmental cues that trigger their fear responses to help their brains "re-learn" to extinguish the behaviors. But exposure therapy is intense. Some patients can't tolerate the anxiety it can cause.

The next step for the researchers is to look for receptors or proteins expressed by cells in one channel but not in the other. "That would provide opportunities to pharmacologically manipulate the dynamic switching between those channels," Patel said.

"It's not so far-fetched and people are doing it" he added. "If we knew that they had a different molecular composition, maybe there's a way that we could inhibit the 'freezing' channel, the fear channel, and promote the other channel."

Patel said the knowledge gained about the fear response may advance understanding of other brain disorders including drug and alcohol abuse.

"Addiction in part is driven by aberrant learning … cues triggering drug seeking and relapse," he said. "We know the amygdala is important in both fear-learning as well as making associations between rewarding effects of drugs and environmental cues. A lot of the same mechanisms might be at play."

 
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How ibogaine is helping former Special Op soldiers with TBI and PTSD

by Wesley Thoricatha | psychedelic Times | 28 Jan 2020

In this continuation of our first conversation with Marcus and Amber Capone of VETS, we discuss ways that traumatic brain injury (TBI) can overlap and complicate post-traumatic stress disorder (PTSD), and how the psychedelic root bark iboga and it’s derivative ibogaine can treat both disorders. Marcus is a former SEAL Team operator who exhausted every conventional treatment for depression, PTSD and TBI before finding lasting healing with ibogaine and 5-MeO-DMT. You can read the first part of our interview with Marcus and Amber here.

Marcus and Amber, thank you again so much for speaking with us. One of the things I love about your story is that it’s the story of both of you. The majority of the time when you hear about veterans healing from PTSD, it’s all about the veteran themselves, but of course behind every vet there are families and loved ones who also carry incredible burdens.

One thing I’m curious about is how your community is responding to the work you are doing with VETS and helping people find psychedelic treatments. How do the veterans and Special Forces guys react? And Amber, how do the wives and families react?


Amber: There is an unprecedented level of trust in the SEAL community, so this has taken on a life of its own due to the growing number of guys who’ve had profoundly positive results.

That being said, at first some people can be skeptical and may say, “Oh that’s not for me.” I say to those who are hesitant, “I hope you’re never at a point where you are so desperate that you will consider anything, but if you find yourself there, we can help.” That’s where I eventually found myself… willing to consider anything to save my marriage, my husband and my family – which required me to think outside the box.

Marcus: Former Special Operations veterans I’ve worked with are all across the board when they hear about this kind of treatment. Some guys are scared to death; others are extremely excited because they’ve found out how many individuals are actually having positive outcomes. They say, “Wait there’s something out there that really works? Sign me up!” Others give it careful thought over a long period of time and try many other things before deciding to pursue this path. These treatments are not risk free, so careful consideration is necessary before making a final decision.

There are around 16 million people in the US with major depression, and close to a hundred million people worldwide. Individuals with brain injuries are spending millions of dollars on these brain clinics, and yes, a lot of people have successful results from them, but also a lot don’t get better—and it’s those individuals that are seeking out this treatment.

At the end of the day, if psychedelic-assisted therapy allows you to be a better person, be a better husband, and have a better relationship with your kids, then who’s going to argue that? Whether you have a brain injury, post-traumatic stress, or you’re depressed, or just an angry individual, these treatments work.

Amber: Marcus spent weeks at brain clinics which was so monotonous and, for him, ineffective. We were at a point where I felt like Marcus was a dead man walking. I told my parents that I believed he would be dead within two years if I left him because our family was the only stabilizing force in his life. Removing his last piece of identity and stability (us) would almost certainly push him over the edge. Whether he drank himself to death, committed suicide, or wrapped his truck around a pole from driving drunk, it just was bound to end badly. We were willing to try anything at that point because we felt that we were out of options.

Many other wives are in a similar position and don’t know what to do. It’s agonizing because you feel that you’re going to lose no matter what. I never wanted to leave Marcus, but at some point, I felt I had no other choice. There is a lot of pressure with that.

These women have already endured so much throughout their husband’s time in service. It’s unbelievably difficult… but they are also incredibly tough. I’ve tried to encourage spouses to have an open mind that these treatments could work—to give it a shot and be supportive, realizing that many of their husband’s struggles may currently be beyond his control due to TBI. If he is willing to commit to seeking treatment, clearly he wants to be better too, so this could be the beginning of something very positive!

Yeah, I’d love to hone in on the TBI element of all this, because the sound bite that most people hear is that vets come back suffering from PTSD, which then gets healed in this emotional release kind of way, particularly with MDMA-assisted psychotherapy. You guys talk a lot about TBI and how significant it was in your equation, so I’m curious if you can speak more on that.

Marcus: When we talk about head injuries, there is still a lot to be learned, especially with blast injury. I don’t believe that even the medical community fully understands how or why the various levels of severity and suffering exist. We do know, however, that TBI is the “signature injury” from OIF and OEF. We also know that other communities, particularly professional contact sports, are experiencing their own TBI epidemic. The coming years will be pivotal in understanding and addressing these increasing concerns.

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Around 2008 I was getting really bad headaches and taking handfuls of ibuprofen, but I was still operating at the time. Later in 2011 or 2012, I realized something was not right. I started to get very impulsive and angry, and things were not lining up correctly. I remember talking to one of my colleagues and they strongly recommended that I seek out the SEAL psychologist; maybe he could provide me with some medicines that may help with whatever I was struggling with. So I tried this, and went through eight years of consistent SSRI use, and all kinds of other medications. Some worked for a short amount of time, some didn’t work at all, and others made me want to climb up a wall. They were just terrible. Later I went through multiple brain clinics, and the scans showed many signs of TBIs. What’s more concerning, however, is what can’t be seen on traditional imaging; the microscopic damage that isn’t yet detectable in the living.

Amber: One of the things I remember was that you went to a clinic and came back and said, “Today they found that I had trouble with memory and recollection, and balance and coordination.” And I’m like, what? You’re 38! You know, memory recollection, okay, I’ve seen that… But balance and coordination? To me, Marcus has always been this stellar athlete, the most capable human being I know… how can this be that he’s lacking balance and coordination? It wasn’t until Marcus’ friend’s brain autopsy came back showing blast injury that everything started to make sense. The other symptoms correlated, as well…

Before ibogaine, Marcus had gotten lost driving, he couldn’t remember people’s names, he would repeat things over and over, and he had horrible headaches, insomnia, rage, impulsivity, depression, vision changes, confusion, suicidality, you name it…. And his go-to coping mechanism was alcohol, which was like pouring gasoline on a fire. The ibogaine treatment worked on some deep psychological traumas, but it also it also really did a number on his brain. I’m no scientist, but I can tell you that something physiologically changed in his brain. For me, the most exciting thing that came out of Marcus’ ibogaine treatment was the return of his cognitive functioning. Obviously much more research needs to be done to support our observation of this, which we hope to raise funding for in the future. The other significant benefit was the cessation of his drinking, which has lasted for over two years now.

Marcus, you mentioned in our first interview that you had never done cannabis or any psychedelic before your ibogaine treatment. Ibogaine is a “big daddy” of a drug, and is known for sometimes being an extremely intense ordeal of a journey. What was your experience like under the effects of this entheogen?

Marcus: I’ve never had an ayahuasca treatment, but I’ve heard from others about how it can comfort you, and provide you with an easier journey to whatever you’re seeking. Ibogaine just backhands you. It’s a Mack truck running you over again and again; it’s like going to hell and back. Everyone’s experience is different, but for the majority of people, the deeper the hurt you’re dealing with, the harder the experience is going to be. It’s laughable that as a Schedule 1 drug in the US, Ibogaine is considered to have a “high likelihood for abuse.” Ibogaine is the most non-recreational medicine, and I can’t think of anyone in their right mind would ever want to use Ibogaine recreationally. I’d rather do just about anything than have another Ibogaine treatment.

When you have deep-rooted trauma and throw in some mild traumatic brain injury on top of it with a bunch of other war trauma and bad shit that’s happening in your life, it’s a recipe for an excruciating journey. I dealt with some shit that I really didn’t want to deal with again. Past emotions hanging out in my subconscious that were affecting my relationships with my wife, my kids, my friends and my parents. I dealt with them during this ibogaine experience because that’s exactly what the medicine does. During the Ibogaine experience, a psychotherapist sits at your side throughout the journey. Their job is to help create space and bring those deep-rooted traumas and hurts to the surface so they can be dealt with once and for all.

Regardless of the type or extent of these traumatic experiences, you’re probably going to deal with them on ibogaine for eight or ten or twelve hours. I mean, how bad does it suck that you have to relive these experiences again? But it’s a critical component to the healing.

Ibogaine is one of the hardest experiences I’ve ever been through. Many psychedelic-assisted therapy experiences are similarly described this way; but I feel they are likely some of the best therapies for veterans, and especially my teammates, because in order to truly deal the bad, dark trauma, you have to face the darkness that is impeding your livelihood head on. You need to go deep, and ibogaine takes you down. I mean, it takes you all the way down and then it brings you back. You come out of the experience feeling like, “Wow, there’s hope, and you know what? Life is not that bad.”

Think of an Ibogaine experience as a heavy backpack weighted down with rocks, and as your journey plays out in front of you literally like a movie, you face these demons; the backpack gets lighter because the rocks are being dumped out. It truly sets you free. Sometimes you’re crying, sometimes you’re screaming, but at the end you’re like, “Holy shit, I’m good! I feel great!” When Amber walked in after my experience was over, she just said this glow was around me, and it was like, “Oh wow, Marcus is back!”

Amber: It was crazy! When I walked into the room, I felt like it was as if we were in college again. His countenance was different, his eyes were different, his whole energy was different. I was in complete shock!

Marcus: I don’t want to confuse people and make everyone think that by taking a pill, one time, will cure them forever, though for many, including myself, Ibogaine and the 5-MEO combination can be the most profound experience of their lives. My coach/therapist reiterates to me on a regular basis, “Marcus, you’re going to have to deal with this deep-rooted crap, and put in the daily work to continue to get better." She’s says, “Your job is to now go help ten thousand others, or a hundred thousand, or a million other people. You’ve been cursed with the darkness, but you are now blessed with the light, and you have the ability to help save many others.” And I think what Amber and I are doing with VETS is right on par with that; it’s the coolest and most humbling thing imaginable.

Amber: This is a bigger movement than just Marcus and me; there’s something very special happening in the veteran community, and quite honestly, in our world. It’s exciting that there’s so much momentum behind psychedelic research, and that much of it is focused on treating and helping veterans. It also doesn’t end with the veteran… this impacts marriages, families, and generations to come.

Healing is happening on physiological, psychological, and spiritual levels… bondages are being broken, lives are being saved, and families are being reunited. It’s absolutely the most incredible thing we’ve ever been a part of; giving back to this amazing community that has given us so much is humbling beyond words, and is proving to be worth every day of struggle we endured.

 
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War, morality, and MDMA: A conversation with an anonymous military psychologist

by Wesley Thoricatha | Psychedelic Times | 23 Apr 2019

In a continuation of our first interview with an anonymous military psychologist and MDMA therapy recipient, we look to the future implications of MDMA therapy in the military, and discuss the broader moral questions and imperatives raised by this kind of treatment for war veterans.

As we were discussing before, MDMA-assisted psychotherapy changed your life and cured your PTSD, and as a psychologist who works in suicide prevention and PTSD treatment, you are very excited about it becoming more widely available for therapeutic work. How would you like to see this treatment adopted by the military? Would it just be for people being discharged from the military, or for active duty service members as well?

One thing to clarify: the military does not actually discharge troops who have PTSD. You can be in the military and have a diagnosed mental health condition as long as it does not impair your ability to deploy and function on military deployment. I have quite a few troops who have a diagnosis of PTSD and remained in the military, and they are good at their jobs.

This may surprise you, but a lot of troops with PTSD from combat actually want to go back. They volunteer to go back to Iraq or Afghanistan in part because when you are deployed, everything makes more sense. For example, if you are aggressive and quick to react with violence in Afghanistan, they give you medals for that. But when you come home to the States, if you are aggressive and quick to react with violence they put you in jail. Being deployed actually makes more sense in this case, because in that role we tend to be prone to aggression and preemptively acting on concerns for threats.

One of the things about PTSD is the constant belief “I am not safe, I need to be able to protect myself at all times” and so we are constantly scanning crowds and surroundings for potential signs of danger or threat. Going downrange is actually something we want to do. I volunteered to go back because it made more sense. So a lot of my troops want to deploy, and they can do fine downrange— it’s just home station where they can’t do well. They struggle with their marriage, with civilians, with their job, and with the civilian world.

MDMA-assisted psychotherapy could be an option in the military, because the protocol that MAPS is using is only 90 days, and they are getting astounding results. We could do that in the military— we just remove you from being deployable for 90 days while we treat you, then most likely they would want to see you 90 days after that to see that you are stable. So we’re talking about 6 months total. That would be doable under the current system— you could get treatment, get better, and stay in.

This therapy could save the military a lot of money in terms of needing to recruit new people, because when we train people, particularly for certain jobs like special forces, you’re spending a lot of money. With some special ops positions it takes half a million dollars to recruit and train somebody, so if they get discharged or they leave the service because of PTSD, that’s money that we’ve invested in a soldier that we can’t get back. We have to recruit and train another person at half a million dollar cost, so this is something that could save our troops’ careers, and save taxpayers a lot of money, while increasing military readiness. This is something I’m really excited about from a readiness perspective, as well as doing the right thing for our troops and getting them treatment that will work.

This is also something that I’m convinced would restore a lot of our troops to being deployable and qualified worldwide. Currently, the goldline medication recommendation for PTSD is Sertraline which is an SSRI. It’s well tolerated and relatively effective with few side effects, but the problem is that you can’t deploy to certain locations on Sertraline without them really closely scrutinizing your record. If you are on Sertraline and you deploy to Africa for example, we don’t have a medical infrastructure there like we have in the Middle East. Even if you have a supply of medication for months, let’s say you run out or lose it— we don’t know if you’re going to remain stable if you discontinue it. MDMA therapy could be a game changer because we know you’re stable and not reliant on a medication you are taking indefinitely. I think this would make things easier from a military readiness and deployability perspective because we don’t have to take you off medication and see if you are stable.

Interesting points. Do you think that after going through this kind of treatment soldiers could be reluctant to deploy again, or perhaps be less inclined to violence?

I know after I came back from Afghanistan and before my treatment, I didn’t kill anything for years. I didn’t fish, I didn’t hunt, I didn’t even kill bugs. A lot of times people come back from war with a renewed reverence and respect for life because they see how quickly and easily it can be extinguished, and how valuable it is.

I could definitely see how being under the influence of MDMA seems to foster a sense of oneness and connectedness with others as well as with all beings—animals, the earth, the connectedness of all life. I could see how MDMA could influence people in that direction, but at the same time, I pretty much became anti-war after I returned from Afghanistan, yet stayed in the military. My rationalization is that I’m a medic, and medics will treat anybody, be they our soldiers, or Taliban, ANA (Afghanistan National Army) troops, and so on. So I’m rationalizing staying in because I’m here to help people. A lot of our military people rationalize that war itself is evil, killing is evil, but doing it to serve their country is a necessary sacrifice that someone has to make.

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I recently had two different soldiers come through my office, and both had over 10 years in service. Usually if you are over 10 years in, you want to stay until 20 because then you can retire with a check. Both said they were done and were on their way out—they didn’t believe in war anymore, didn’t believe in killing. One said, “If my country was attacked I would go to war, but this war is not a moral war; there’s no reason for it.” The other one had become very much a pacifist and thought war was illegitimate under any circumstances. Neither one of them had used MDMA or anything else, but their experience of war had led them to that conclusion.

So I could see how drugs in this class could influence people in that direction, but I think that most of our military people have already rationalized their role and how it sometimes includes violence, and the people who are becoming reluctant to continue are arriving at that conclusion on their own without MDMA.

That’s fascinating. I wonder if a soldier gets PTSD and is treated with MDMA, is it a good thing if they have more reverence for life, or would it get in the way of the operational necessities of following orders? It seems like you can’t have everyone trying to make a moral judgement all the time, you just have to follow what your superiors are saying.

The oath that we take is that we will obey all lawful orders, and part of our training is to instantly obey those orders unless you don’t think they are lawful. You’re right— I went through a 2-year period where I asked myself if I could stay in the military because of my concerns about the morality of killing. After I came back from Afghanistan, I was no longer enlisted or in combat arms, I was in medical, so I was actually helping people. So that’s how I was able to rationalize it.

I had a soldier a few months ago who was able to rationalize it because he was in communications. He was no longer in a killing position, so he could continue on. A lot of times when people are no longer comfortable doing one job, they simply transfer and retrain into a different job. So that could be an option for some people if that were to happen. I think that would be a small percentage of people, but I could be wrong— because you’re right, it does really give you a renewed perspective on life and on the act of killing. Until you brought it up, I hadn’t really thought about it. That would be an interesting research question.

I would wonder what the top brass thinks about this issue.

I think our first ethical responsibility is to treat our wounded service members, because we put them in harm’s way. Our first obligation should always be to do what’s right for our troops. And then if it were to become a problem that they no longer felt right with violence and couldn’t serve in the military, then you know what? They served honorably, they went downrange, they did what we asked them to do and got hurt, we treated them, and now we’re going to release them in a good state back into the civilian world instead of in a damaged state where they could be a liability to others. When we harm people, we have a moral obligation to restore them before they reenter society, in whatever way possible. This is how we do right by our troops. So worst case, we would have at least restored them and made them whole before releasing them on the public again.

I completely agree. This is a vast moral question, but the one thing that I feel is rock solid is that these soldiers absolutely deserve help. And I’m curious too, out of those who are reluctant to go back to Afghanistan specifically, how many would still be willing to protect the country in a war that was more understandable and not morally vague.

I think there’s a difference when your country has been attacked or threatened versus a preemptive war. A preemptive war by definition violates the Christian doctrine of just war theory which is widely taught in the military as a moral perspective. When a military action is taken which doesn’t seem like self defense, I think that in the future you’re probably going to see more people questioning it, because it has happened so often.

We’ve been almost continuously at war for decades, and we’ve only been attacked once. I used to think the US was a peaceful country, but I think now we’re pretty militaristic and violent. It’s hard to argue that we’re a peaceful country when we’re always attacking countries that never attacked us. I could see how wider use of medications such as MDMA or other similar ones could increase respect for life and awareness of the value of life, and cause some to question the use of military force around the world.

Right, and maybe that’s a good thing. Of course there has to be a balance— we can’t just naively give up all security and readiness, because then someone else would exploit us. But in my opinion, if we seek a peaceful world and want to retain legitimacy at home and abroad, we should be more discerning and reluctant to use force unless absolutely necessary.

Today I still believe that war is sometimes necessary. I don’t like war, I hate war, but I think it’s sometimes necessary. I think it’s possible that we have sometimes been too quick to use the military and go to war.

Right, and as you were saying, many people are already having these second doubts, so the military has to deal with this issue whether MDMA becomes legal or not. It’s just that this therapy might somewhat accelerate that process.

For some people, maybe. As powerful as the MDMA experience is, the realities of war and killing already force people to face this moral issue, so I doubt it will be disruptive.

Do you think that once MDMA therapy is legalized, the military will instantly adopt it? Will there be a lag time?

I don’t think there will be much of a wait, because it addresses so many problems. One of the things about the military is that a lot of people don’t report and don’t seek mental health treatment because they are afraid to be kicked out. But if they know they can get treatment and get better and stay in their jobs, they will be more likely to seek help. And for those on their way out, we can get them the help they need so they can reenter society without a debilitating condition. With MDMA, we are not treating the symptoms or relying on an ongoing prescription, we are actually treating the trauma itself—and that’s one of the most remarkable things about this medication.

 
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First responders report lasting personal benefits after MDMA-assisted psychotherapy

by Christian Rigg | PsyPost | 23 Mar 2020

While a number of pharmaco- and psychotherapies exist to treat post-traumatic stress disorder (PTSD), a large group of individuals, including military veterans and first responders, have demonstrated resistance to classical approaches. As a result, less traditional treatments have been explored, including the use of MDMA.

A long-term follow-up qualitative study, published in the Journal of Psychoactive Drugs, found that many veterans, police officers, and firefighters described experiencing lasting personal benefits and enhanced quality of life after receiving MDMA-assisted psychotherapy.

The goal of the study, and what sets it apart from previous research, is a focus on MDMA-assisted psychotherapy in a long-term context. The results of this novel intervention were encouraging. One year after an MDMA-assisted clinical trial for treatment-resistant PTSD, 15 of 19 participants showed significant (> 30 percent) reduction in symptoms.

However, researchers wanted to delve deeper into the results of the therapy. To this end, a supplementary questionnaire was given to the participants, to better understand real-life benefits of the intervention beyond symptom reduction. Among the most significant improvements reported were increased self-awareness, improvements in relationships and social skills, and reduced substance abuse, and openness to continued therapy.

“The reemergence of psychedelic-assisted psychotherapy has allowed for more research to present evidence of safety and efficacy for these treatments. Based on the quantitative outcomes, the FDA designated MDMA-assisted psychotherapy for PTSD as a ‘Breakthrough Therapy.’ Findings from this retrospective qualitative analysis of a phase 2 MDMA-assisted psychotherapy trial illuminate a range of outcomes from the treatment that are not fully covered in quantitative explorations,” the researchers wrote in their study.

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A number of limitations apply to the current study, well enumerated by the researchers. First and foremost, this was a qualitative study conducted after the start of a clinical trial. As a result, it was necessary to adapt the study’s method to pre-existing protocols. This included, for example, having one of the original trial therapists for the clinical trial conduct the interviews for this study, which may have influenced participants’ responses. Additionally, not only is the population size quite small in general, but it was almost exclusively male and White/Caucasian.

The use of psychedelic drugs in therapeutic interventions is not without controversy, given their potential for abuse, presence in the media, and colorful legal status. Much more data is needed to understand exactly how and why MDMA-assisted treatment was able to improve the quality of life of these individuals. Nonetheless, studies like this have already demonstrated their efficacy in treating psychopathologies, especially those which fail to improve through traditional interventions.

The study, Perceived Benefits of MDMA-Assisted Psychotherapy beyond Symptom Reduction: Qualitative Follow-Up Study of a Clinical Trial for Individuals with Treatment-Resistant PTSD, was authored by William Barone, Jerome Beck, Michiko Mitsunaga-Whitten, and Phillip Perl.

 
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Michael Mithoefer, MD

MAPS reports significant difference in PTSD symptoms after MDMA-assisted psychotherapy

MAPS | 12 May 2020

Today, the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) announced the results of an interim analysis of the data from the first of its two Phase 3 clinical trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). This is the best-case scenario for an interim analysis, and suggests that MAPS’ research program is on track for approval by the U.S. Food and Drug Administration (FDA).

The analysis was conducted by an independent Data Monitoring Committee, which reviewed the results from the first 60 out of 100 participants. The analysis revealed a 90% or greater probability that the trial will detect statistically significant results when all participants have been treated, and that the trial will not require additional participants beyond the first 100. The interim analysis was approved by the FDA as part of MAPS’ Statistical Analysis Plan approved by the FDA.

The results strongly suggest that the FDA made the right decision in granting MAPS both (1) Breakthrough Therapy Designation for MDMA-assisted psychotherapy for PTSD, which accelerates the clinical trial process and acknowledges MDMA-assisted psychotherapy as a potentially significant advance over currently available treatments for PTSD, and (2) Expanded Access, which will allow some patients early access to MDMA-assisted psychotherapy for PTSD prior to approval.

Not all interim analyses are successful. For example, in February 2020, Tonix Pharmaceuticals’ Tonmya®, the only other drug granted Breakthrough Therapy Designation by the FDA for PTSD, failed its interim analysis.

“In the pharmaceutical drug development community, this is what you dream about,” says Rick Doblin, Ph.D., MAPS Founder and Executive Director. “The results of the interim analysis of MAPS’ pivotal first Phase 3 trial are the most powerful evidence yet that MDMA-assisted psychotherapy could help transform the lives of people suffering from PTSD. We have trained approximately 70 new therapists to work on Phase 3, so these results also show that the treatment is scalable, eventually to tens of thousands of therapists worldwide.”

To complete this research and make MDMA a legal medicine, MAPS, in collaboration with the Psychedelic Science Funders Collaborative (PSFC), has launched the $30 million Capstone Fund. The Capstone Fund has already secured the first $12 million, and has brought together a diverse array of supporters committed to healing PTSD globally.

“Psychedelic medicines show incredible promise for treating a range of mental health conditions, but psychedelic research has been underfunded for decades,” says Joe Green, Co-Founder and President of PSFC. “This first look at data from the first-ever Phase 3 trial of a psychedelic-assisted therapy only makes us more confident that we’re standing on the cusp of a breakthrough. The approval of MDMA-assisted psychotherapy would be a catalytic event that brings psychedelic medicine into the mainstream. That’s why we are excited to partner with MAPS in creating the Capstone Fund to bring this research across the finish line.”

MAPS is continuing its Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD at 15 sites in the U.S., Canada, and Israel. The Phase 3 trials are expected to be completed in 2021, meaning that the FDA could approve the treatment as early as 2022. MAPS is also in the process of obtaining regulatory approvals for Phase 2 trials in the UK, Germany, Czech Republic, and the Netherlands.

PTSD affects millions—and soon to be millions more—due to the global trauma of the COVID-19 pandemic. This includes victims of the disease and their families, health care and emergency service professionals, as well as front-line workers who are risking their lives to provide essential services.

As a non-profit organization focused on mental health services, MAPS is committed to protecting the safety of its study staff and clinical trial participants. MAPS is taking active measures to minimize the risk of exposure to the COVID-19 virus and adhere to physical distancing. As a result of this initiative, new enrollment of participants in MAPS-sponsored trials is temporarily postponed, with treatments continuing for some participants as evaluated on a case-by-case basis.

“I believe this medication-assisted treatment will be a breakthrough in treating trauma,” says Amy Emerson, Executive Director of MAPS Public Benefit Corporation (MAPS PBC). “I would like to thank the investigators leading the studies, study volunteers for their time and participation, the independent Data Review Committee for their careful analysis, and the amazing research team at MAPS PBC who helped us achieve this milestone in non-profit pharmaceutical development.”

About MDMA-assisted psychotherapy for PTSD

MDMA-assisted psychotherapy uses MDMA to improve the effectiveness of psychotherapy for PTSD. The treatment involves up to three administrations of MDMA in conjunction with psychotherapy in a controlled clinical setting as part of a course of psychotherapy. Once approved, patients will not be able to take the MDMA home—patients won’t be filling their prescriptions at their local pharmacy. Instead, MDMA-assisted psychotherapy treatment will only be available through a doctor and only in supervised therapeutic settings from certified clinicians.

 
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Promising outcomes for PTSD patients in MAPS phase 3 trials

by Barb Bauer | Psychedelic Science Review | 19 May 2020

On May 12, 2020, MAPS announced the results of an interim analysis of the data from their Phase 3 clinical trials using MDMA (3,4-methylenedioxymethamphetamine) to treat post-traumatic stress disorder (PTSD).

A third-party data monitoring committee (DMC) analyzed the data from the first 60 (out of 100) participants. They found “…a 90% or greater probability that the trial will detect statistically significant results when all participants have been treated, and that the trial will not require additional participants beyond the first 100.” The DMC conducted the analysis during Phase 5 in agreement with the FDA, who oversees clinical trials.

In the MAPS press release, Founder and Executive Director Dr. Rick Doblin said,

"In the pharmaceutical drug development community, this is what you dream about."

In August 2017, MAPS received breakthrough therapy designation from the US Food and Drug Administration (FDA) for using MDMA to treat PTSD. This means that the therapy was showing such promise in early trials that the FDA allowed MAPS to accelerate the entire clinical trial process. The designation also permitted access to MDMA-assisted psychotherapy before FDA approval for some patients who were not part of the clinical trials.

According to the MAPS press release, “The Phase 3 trials are expected to be completed in 2021, meaning that the FDA could approve the treatment as early as 2022. MAPS is also in the process of obtaining regulatory approvals for Phase 2 trials in the UK, Germany, Czech Republic, and the Netherlands.”

In an interview with David Carpenter of Forbes, Doblin summarized the impact of the DMC findings.

"The great results from the interim analysis has changed everything in that we are now actively preparing for FDA approval and commercialization based not on hopes and dreams but on actual data from Phase 3."

 
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