• Psychedelic Medicine

PTSD | +60 articles

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Impressive long-term benefits of MDMA for treating PTSD, study reports

(underlying paper: Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials)

A new study published in the journal Psychopharmacology is presenting a comprehensive look at the long-term efficacy of MDMA-assisted psychotherapy for the treatment of post-traumatic stress disorder (PTSD). The study finds not only do the substantial beneficial effects of the therapy hold strong for well over a year after completing the treatment, but patients continue to improve as time passes following the few MDMA sessions.

After decades of prohibition and stigma, MDMA is finally on the precipice of becoming a clinically approved medicine. Currently deep in Phase 3 human trials for severe treatment-resistant PTSD, the therapy has proved so effective the U.S. Food and Drug Administration (FDA) recently approved it for Expanded Access, a program allowing certain patients access to the therapy before full market approval is granted.

While several studies have been published outlining positive Phase 2 trial results, this new paper investigates long-term outcomes from the treatment, compiling follow-up data from six prior trials. Around 100 subjects were included in the study.

At the original end-point of the trials, 56 percent of the cohort no longer met the clinical criteria for PTSD. The long-term follow-up data revealed continued improvements in most subjects for well over a year, with 67 percent of the cohort subsequently no longer meeting the PTSD criteria. Other long-term results noted in the cohort include reductions in suicidal thoughts and clinically significant symptom improvements.

"These long-term follow-up findings show that once people with PTSD learn that they can productively process traumatic memories instead of suppressing them, they can continue to heal themselves even after they have stopped receiving MDMA-assisted psychotherapy,” notes Rick Doblin, co-author on the new study.

It is important to note the MDMA-assisted psychotherapy treatments involve more than just a simple dose or two of the drug. The entire treatment process takes between eight and 12 weeks, encompassing two to three day-long MDMA psychotherapy sessions, each spaced around a month apart. Extensive preparatory therapy sessions are conducted before the MDMA treatments, and follow-up integrative therapy sessions are conducted in the days and weeks after the active drug sessions.

The new study also suggests the long-term follow-up data finds the treatment does not lead to MDMA abuse, or any other substance abuse, and no significant adverse effects are detected from the therapy. At the 12-month follow-up point it is noted around 94 percent of subjects did want to engage in additional MDMA-assisted psychotherapy sessions. While the researchers do acknowledge this desire may be underpinned by some subjects wanting to experience the pleasurable effects of MDMA, the study suggests the urge to complete additional treatments is more likely a result of the positive outcomes of the treatment.

“Although our Phase 3 trials are not yet completed, these long-term data support the hypothesis that MDMA-assisted psychotherapy may provide significant advantages in treatment outcomes, safety, and durability over available PTSD treatments,” says Berra Yazar-Klosinski, co-author on the new study. “This is the breakthrough that the world needs right now.”

Phase 3 clinical trials are currently underway at a number of sites in the United States, Canada and Israel. These trials are expected to run for 12 to 18 months, and FDA approval for the treatment should come sometime in 2022.

https://newatlas.com/health-wellbeing/long-term-benefits-mdma-ptsd-trials-maps-study/
 
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Psychiatrist explores possible benefits of treating PTSD with MDMA*

36-Minute Listen: Download Transcript

Dr. Julie Holland, author of the new book, Good Chemistry, says that when patients taking antidepressants have stopped experiencing relief, psychedelic drugs might be used in conjunction with talk therapy to help some work through past traumas.

People who have been taking antidepressants for several years sometimes hit a wall, a point when that treatment no longer seems to ease their symptoms. Psychiatrist Julie Holland says that's where psychedelic drugs could help.

Holland was in charge of Bellevue Hospital's psychiatric emergency room on the weekends from 1996 until 2005, and currently has a private psychotherapy practice in Manhattan. She's a medical monitor on the MAPS studies, which involve, in part, developing psychedelics into prescription medication. Her new book, Good Chemistry, explores how she thinks psychedelic drugs, including LSD, psilocybin, MDMA and marijuana, might be used more widely in psychiatry to make treatment more efficient and effective.

"There are certain plant medicines in particular — things like psilocybin or ayahuasca — that really help people not only explore their personal trauma," she says, but also "this feeling of unity and connection. People really come away from these experiences having a new perspective."

Holland acknowledges that the use of psychedelic drugs in psychiatry is controversial — but she says the practice is slowly gaining acceptance.

"Good psychotherapy takes years and there are a lot of fits and starts," she says, "and people run away when things get too heavy. But it's changing more and more. ... The data is so compelling that in my opinion, people in my profession have no excuse for not knowing what's going on."

Interview Highlights

On the limits of antidepressants

We haven't had a lot of innovation in antidepressants in a long time. People got on these medicines and then they never got off. And a lot of people are taking antidepressants for decades and they really weren't designed to be used that way. So that's sort of a No. 1 issue. But things are absolutely changing where people are having a better understanding that it's not as simple as just altered chemistry or altered genetics. That your childhood experiences and trauma and things like income inequality — there are all sorts of things that have an impact on what your mental health is going to be. And a big part of it is processing trauma. So the daily doses of antidepressants, anti-anxiety medicine, sleeping pills, antipsychotics, they are really not there to help the primary problem. They're there to sort of seal up the cracks and act as Band-Aids, whereas psychedelic-assisted psychotherapy is really trying to get to the root cause of the symptoms instead of just sort of papering over the symptoms. ...

My main job is that I prescribe antidepressants and anti-anxiety medicines and sleeping pills and sometimes mood stabilizers, antipsychotics. There are medicines that work very well. My patients are doing very well and they're taking these medicines. So I don't want to completely disparage it. It's just, for some people, it's not really what they need. It's not appropriate.

But for other people, they need to stay on their meds. And it's very dangerous to go off their medicines. So I don't mean to imply that everybody should throw their pills away at all. But I do think for people who have been on just antidepressants for decades, that it is worth exploring whether there are other ways that maybe you could treat some of the symptoms, and maybe get at some of the underlying causes of the symptoms.

On treating post-traumatic stress disorder with cannabis

This is sort of a new paradigm, a revolutionary way to treat trauma. When people are traumatized, they get very anxious. They get sort of hyper-aroused. They can't sleep well. They can't eat well. You can give medicines to decrease anxiety or ... to help with sleep. But you're not really getting to the root cause, which is that they've been traumatized and they need to further process the trauma and work through the trauma. ... And what CBD does and cannabis does and some psychedelics do and MDMA does is it puts you over into the other side of the nervous system, which is the parasympathetic nervous system, which is not about fight or flight — it is about staying and being open.

On treating PTSD with MDMA

MDMA is just an exquisitely perfect chemical for augmenting the process of psychotherapy, so that's really why it has been chosen. MDMA helps people to feel more relaxed and more open and trusting and more trusting of the therapist, which is important. ... It helps people be awake, alert, verbal, want to talk, want to explore. But also, because it increases serotonin, there is very little anxiety and also a feeling of satiety — like you don't really need anything, like you have everything you need. So this high-dopamine, high-serotonin and also high-oxytocin state makes it really great for being open, being trusting, being able to explore traumas comfortably and trusting your therapist that they're going to help you to explore these traumas safely. And this feeling of safety is actually very important. MDMA, because it increases oxytocin, there is a quieting of the amygdala — the fear response. Exploring trauma is scary, and often if people become afraid, they close down and they don't want to talk and they don't want to explore.

On the effectiveness of MDMA-assisted psychotherapy

Pretty much everybody that I've spoken to who has had an MDMA-assisted psychotherapy session has come away from it feeling like they have processed a good deal of their trauma — maybe not all of their trauma, but they certainly have a better, sort of, lay of the land of what it looks like. ... I have a patient who, her spouse committed suicide. And she had a very hard time sort of forgiving him or processing that and [with MDMA] she was able to do that in one session and to just leave some of that weight and heaviness there in the therapy room.

I've had patients who have stopped self-harming or picking at themselves. I have had patients who are no longer feeling compulsively suicidal. Lots of patients who have changed their behaviors around alcohol or eating compulsively or drug abuse.

On why MDMA doesn't work if a patient is on antidepressants

Eighty percent of these antidepressants are prescribed by people who aren't psychiatrists and they just get renewed over and over. Antidepressants that work on serotonin are called the SSRIs — where they sit is exactly where MDMA needs to go to do the work. So they absolutely block the site. So if you're taking an SSRI, you basically won't feel MDMA if you take it. And then you have something like ayahuasca, which is very popular — a psychedelic tea — and there are a bunch of medicines that you cannot take if you're going to have an ayahuasca experience.

There needs to be some sort of medical monitoring sometimes in these situations, because I don't want people to do things that are potentially deadly when they could have a positive growth experience if they just weren't taking certain medicines.

On how these psychoactive medicines might facilitate brain rewiring

A lot of these medicines we're talking about, like ayahuasca and psilocybin, MDMA, cannabis, they all facilitate what's called neuroplasticity, which is the brain sort of growing and changing and rewiring. And there are things called synaptogenesis, which is like new synapses forming. And then there's neurogenesis, which is new brain cells forming.

Anyone who grew up in the '80s has this idea that these drugs kill brain cells, but it's actually the exact opposite — that a lot of these plant medicines and psychedelic medicines, they engender brain cell growth and what's called neuroplasticity, which is sort of new connections being formed and potentially the brain being somewhat rewired, which really helps. That's what's fostering the growth and the change in behavior. And you don't necessarily see a lot of growth and change in behavior when people are taking antidepressants or even maybe going to therapy for years. With really good therapy [that] you go [to] for years, you do have behavioral changes. But to see them after one session is really remarkable. And it's hard to just go back to the daily dose after you see this kind of tremendous behavioral change.

On how the pandemic has made many people more anxious

Even before the pandemic and the sort of political unrest, I had patients who were extremely anxious just by the current political situation or some people are upset about the environment and what's happening. So our anxiety levels were already pretty high before all of this happened in the spring. Basically since the '90s, the numbers have just been going up and up on prescription anti-anxiety medicines being used. And we saw a big spike around 9/11, and we're going to see a big spike now as well. So it's pervasive. It's an ongoing problem. Anxiety has sort of overtaken depression as the No. 1 complaint, not only with psychiatrists, but just sort of general medical practitioners. ...

At the beginning of the pandemic, there was anxiety about contracting the virus. But what's happened over the last several months is, besides the sort of a pervading sense of anxiety and doom, is that the people who have been isolated, the people who are living alone, my patients haven't had any human touch for three months. And being that isolated and that disconnected will make you more anxious. It will make it harder to sleep. ... So it feeds on itself. That's the thing I'm really worried about now, is that the isolation and the disconnection affects the physiology, makes people more anxious, and then they don't sleep well, they don't eat well. They're trying to soothe themselves with all these unhealthy behaviors, and it all cycles on itself.

*From the article here :
https://www.npr.org/sections/health...fits-of-treating-ptsd-with-ecstasy-or-cannabi
 
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Will MDMA-assisted psychotherapy be covered by health insurance?

by Russell Hausfeld | Psymposia | Jan 24 2019

This series explores MAPS' ongoing FDA phase 3 clinical trials, rescheduling, health insurance, and the FDA program known as expanded access.

If MDMA-assisted psychotherapy gets approved by the Food and Drug Administration (FDA) for post-traumatic stress disorder (PTSD) treatment, the next big question will be whether or not it will be covered by health insurance.

Up until now, insurance companies have covered drugs, and insurance companies have covered therapy. But, MDMA-assisted psychotherapy involves therapy while on a drug.

“There are no mechanisms in place in mental health care to ensure the coverage of a drug-therapy combination,” said Ekaterina Malievskaia, the co-founder of Compass Pathways, a for-profit European psilocybin startup working to medicalize psilocybin-assisted psychotherapy. “We will have to be innovative in how we develop these [mechanisms], working with all stakeholders, including insurers.”

One glaring issue that psychedelic-assisted psychotherapy providers will have to address with insurance companies is the initial high costs and amount of labor involved with their treatment. The current protocols being developed for MDMA treatment involve a two-person co-therapy team and about 42 hours of therapy. This entails three day-long, eight-hour MDMA sessions and twelve 90-minute non-drug psychotherapy sessions for preparation and integration. While estimates for the MDMA itself are about $150 per session, estimates for full treatment are nearly $15,000.

Rick Doblin, the founder and Executive Director of the Multidisciplinary Association for Psychedelic Studies (MAPS), added that it is important to keep in mind that some PTSD patients will not need all three MDMA sessions, and others may need more than three sessions.

But, he says that MDMA treatment could save both patients and insurers a lot of money down the line. While the cost of medicine like an SSRI, without therapy, is much lower on a monthly basis, many find that traditional antidepressants don’t work well for them and need to be taken for months, years, or even decades — costs that will add up over a period of time. A worst-case-scenario PTSD sufferer could spend about $10,000 on treatment every four years according to the Congressional Budget Office. Couple that with lost productivity at work, higher rates of divorce (a process which can cost thousands), and the fact that many sufferers of PTSD also deal with depression, anxiety, and substance abuse (treatment which can also cost thousands).

Moving forward, both Doblin and Malievskaia stressed the importance of following the well-being of patients from their studies. Getting approval from insurance companies, they say, will likely require post-approval studies and long-term follow-up.

“Our negotiations [with insurance companies] involve adding various measures of health care utilization and functionality to our Phase 3 designs including long-term follow-up,” Doblin said. “The purpose of these measures is to try to demonstrate in our research subjects that helping reduce PTSD symptoms also reduces other health care due to high levels of stress, emergency room visits, heart attacks, strokes, etc.”

PTSD patients have higher than average health care utilization. But, the challenge is that reduced health care utilization shows up over many years, not just immediately or in a one-year follow-up. So, there is much more observation and documentation to be done among PTSD sufferers receiving MDMA-assisted psychotherapy.

Until this treatment is proven without a doubt to reduce long-term costs, many insurance companies do not have an incentive to cover MDMA-assisted psychotherapy. This brings us to one of the main reasons MAPS is working so closely with the United States Department of Veteran Affairs (VA) to bring this treatment to PTSD-suffering veterans. In a two-year period, from 2010 to 2012, the Department of Defense spent $789.1 million and the VA spent $8.5 billion on PTSD treatment.

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“While successful treatment of PTSD can reduce the number of patients who become disabled from their PTSD, the insurance companies that cover disability payments are usually different than those that cover medical treatments,” Doblin said. “The one major exception is the VA which both pays for treatment and also pays for disability for a lifetime. That means that the VA has more incentive than any other insurance company to cover the costs of treatments that are initially more expensive, but can reduce disability payments in the long-run.”

Another consideration that Malievskaia said insurance companies will consider is the availability of trained and qualified therapists who can deliver the treatment. She said that these therapists will have to be credentialed in a way that is accepted by insurers. Compass Pathways currently requires therapists participating in their treatment-resistant depression trials to undergo a five-part training program, along with supporting at least six participants in a psilocybin research setting under the supervision of an experienced therapist.

In conversations about insurance, MAPS has also run into issues about therapist costs. Doblin told me that their two-person therapy team — which is very important to MAPS’ protocol — adds costs, but probably doesn’t make treatment twice as effective.

“For our research, we’ve focused on maximizing therapeutic benefit, not on providing the lowest-cost treatment for results that are just good enough to obtain FDA approval,” Doblin said.

In Europe, where there is national health care, cost is even more of an issue than in the US. One solution that MAPS has been grappling with is having only one licensed therapist and one student working for free or minimal costs. But, even this, he said, could cause an issue with insurers who may have trouble paying for an unlicensed therapist. So, MAPS is working to develop a new specialty for psychedelic psychotherapy which will provide people who are otherwise unlicensed with credentials.

“I am OK with making the overnight stays after each MDMA session — [a current part of MAPS’ protocol] — optional as a potential cost savings,” Doblin said. “But, I am much less comfortable going to a one-therapist model due to the safety and support provided by a two-therapist team.”

Nothing is completely set in stone. And, we won’t know if MDMA will be covered under insurance until we know if it is even approved for legal prescription use. Doblin said the priority for Phase 3 trials, regarding insurance, is to be able to present the insurance companies with significant results.

“Our challenge is to get such compelling results from MDMA and psychotherapy that insurance companies are willing to pay for both elements of our treatment,” Doblin said.

*From the article here:

 
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Military invests $27M to develop new class of psychedelic-inspired drugs

by Ben Adlin | 24 Jun 2020

The successful use of controlled substances such as ketamine and psilocybin mushrooms to treat mental health issues like depression and anxiety has ushered in a new era of interest in psychedelic drugs. But for researchers and clinicians eager to expand such therapies, an obvious question remains: Does treatment with psychedelics necessarily require a psychedelic experience?

An international research team hopes to answer that question by researching and developing a new class of drugs that offers the same fast-acting mental health benefits as traditional psychedelics without the disorienting, sometimes uncomfortable effects of a full-blown trip. Funded by $26.9 million from the U.S. Department of Defense’s Defense Advanced Research Projects Agency (DARPA), a new project announced this month “aims to create new medications to effectively and rapidly treat depression, anxiety, and substance abuse without major side effects,” according to a University of North Carolina (UNC) School of Medicine press release.

“Although drugs like ketamine and potentially psilocybin have rapid antidepressant actions, their psychedelic and disorienting side effects make their clinical use limited,” said Bryan L. Roth, a professor of pharmacology at UNC School of Medicine and the research project’s leader. “Our team has developed innovative methods and technologies to overcome these limitations with the goal of creating better medications to treat these neuropsychiatric conditions.”

Research into the possible therapeutic effects of currently illicit drugs such as ketamine, psilocybin, MDMA and others has expanded tremendously during the past decade. Nonprofit groups such as MAPS have led the way, with university researchers and drugmakers entering the mix more recently.

In September of last year, Johns Hopkins University announced the launch of the nation’s first-ever psychedelic research center, a $17-million project to study the use of psychedelics to treat conditions such as opioid use disorder, Alzheimer’s disease, depression, anxiety and PTSD.

Government interest in psychedelic drugs has also grown. Also in September, DARPA, a federal agency that exists to support the development of emerging technologies for use by the U.S. military, announced its Focused Pharma program, meant to develop drugs “that work quickly and deliver lasting remedies for conditions such as chronic depression and post-traumatic stress.”

While that DARPA announcement didn’t mention specific substances or even use the word “psychedelics,” it referred to “certain Schedule 1 controlled drugs that engage serotonin receptors” and that have significant side effects.

The press release for the new DARPA-funded project, lead by Roth at UNC, mentions ketamine and psilocybin specifically. The team will use both biological modeling and sophisticated computational approaches in an effort to design fast-acting drugs inspired by psychedelics but free from what researchers call “disabling side effects.”

“Depression, anxiety, and substance abuse affect large segments of the population,” Roth said. “Rapidly acting drugs with antidepressant, anti-anxiety, and anti-addictive potential devoid of disabling side effects do not exist, not even as experimental compounds for use in animals. Creating such compounds would change the way we treat millions of people around the world suffering from these serious and life-threatening conditions.”

At DARPA, Dr. Tristan McClure-Begley, Focused Pharma’s program manager, said last fall that the agency’s interest in developing such drugs is due to the country’s large number of veterans with PTSD and other mental health conditions.

“It is research we need to undertake given the scale of the mental health crisis our veterans face,” he said in September, “and if it works, the payoff is a completely new, safe, and effective therapeutic option that transforms complex and previously intractable mental conditions into something more acutely treatable.”

 
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Leiden University Medical Center of The Netherlands

First-of-its-kind clinical trial to study psychedelic treatments for PTSD in veterans

by Javier Hasse | Forbes | 12 Aug 2020

Psychedelics-based treatments developer NeuroPharm Inc., a subsidiary of publicly traded Mydecine Innovations Group Inc., recently announced it would be collaborating with the Leiden University Medical Center of The Netherlands (LUMC) on clinical trials for the treatment of PTSD in veterans.

The project involves the preparation of an IRB-ready protocol that will later be utilized in the LUMC-based clinical trial. The ARQ National Psychotrauma Centre will also be involved in the trial.

The first compound to be studied will be psilocybin, a psychedelic prodrug compound that can be produced by more than 200 species of mushrooms. The initial protocol will involve three doses in a study spread over 12 weeks.

It is believed this is the first trial of its kind.

When prompted about the trial, Dr. Jetly explained that, while PTSD occurs throughout society, it impacts military and veteran populations at a higher rate.

Currently, PTSD is most commonly treated using a combination of exposure therapies and medication.

“Unfortunately, in a significant proportion of veterans suffering from PTSD these treatments are either ineffective or only partially effective. Hence, efforts continue throughout the world to find safe and effective treatments for PTSD,” he said.

But, where do psychedelics come in?

As Dr. Jetly explained, psychedelic medications have been used for years, most frequently to address issues related with the mind.

“In fact, there are many well-designed and executed studies that have been published in peer-reviewed journals. Prestigious universities and academics are heavily involved in the studies,” he voiced, bringing up examples of studies evaluating MDMA for the treatment of PTSD, and psilocybin, for the treatment of depression.

“These preliminary trials have been so impressive that they have led to the FDA to designate MDMA and psilocybin ‘breakthrough therapies’ for PTSD and treatment-resistant depression, respectively,” he added.

There are, however, no published, peer-reviewed studies looking at psilocybin for the treatment of PTSD in veteran populations so far.

“There is evidence that veterans are particularly hard to treat with conventional evidence-based therapies, which increases the need for novel therapies that are safe and effective,” Dr. Jetly said.

This is what NeuroPharm and LUMC will be doing.

‘Medication-assisted psychotherapy’

It’s important for readers to understand that these trials are not “drug trials.”

NeuroPharm and LUMC will be administering psilocybin in a safe and controlled environment, facilitating healing through psychotherapy.

“As such, these are ‘medication-assisted psychotherapy’ trials. We are interested in the safety and efficacy of our approach,” the Dr. said.

“Many people are ‘defended’ psychologically. This blocks them from accessing their deepest feelings, such as guilt, shame or fear, and it is felt that the hallucinogens help lower this resistance or defense to allow the individual and therapist access to these core feelings.”

Ultimately, the researchers hope the results of this trial will help veterans suffering from PTSD and struggling with the reincorporation into civilian life.

“My hope is that through a relatively short course of medication assisted psychotherapy we can help lift depression and lessen the acuity of these haunting memories. We can hopefully integrate these traumatic memories and give them a place to rest ‘in the past,’” Dr. Jetly commented, adding "the trial will also explore medication-assisted psychotherapy for the treatment of Moral Injury, a type of feeling often experienced by veterans suffering from PTSD."

The timeline

Responsible clinical research takes time, and NeuroPharm and LUMC intend to do things the right way.

The trials will start in LUMC under the supervision of Prof. Eric Vermetten, and then spread throughout Europe, North America and the Caribbean. Some of these trials are already being prepared.

But, before the first iteration kicks off, a clinical protocol needs to be finalized, submitted to a university Research Ethics Board (REB), and subsequently approved by this REB.

The team anticipates the trial will commence some time this year.

The processing North America also involves approvals from regulatory bodies such as Health Canada and the FDA as well. The company says it’s already working on these.

“I feel that there were likely also some refinement of the compounds perhaps developing a psilocybin with a shorter duration of action (or half-life) or indeed we may identify clinical benefit with a lesser psychedelic experience. In time it is my belief that safe and effective compounds and approaches will make it into mainstream medicine and reduce the overall burden caused by mental illness,” Dr. Jetly concluded.

Dr. Rakesh Jetly, OMM, CD, MD, FRCPC, currently serves as the Head of the Centre of Excellence on Mental Health in Ottawa, Ontario. He is also an associate professor of psychiatry at Dalhousie University (Halifax), and the University of Ottawa, as well as a scientific advisor for NeuroPharm.​
 
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MDMA, PTSD, and potentially overlooked positive outcomes

by Sabrina Eisenberg, MS | Psychedelic Science Review | 21 sep 2020

Measuring and increasing post-traumatic growth may lead to more rewarding interpersonal relationships, self-esteem, and a more optimistic outlook on life.

MAPS recently reported a promising interim analysis of their Phase 3 clinical trials researching MDMA for post-traumatic stress disorder (PTSD). In light of this, one may ask, is there anything about these trials that is not receiving attention? Post-traumatic growth (PTG) is one such under-reported outcome that may hold insight into increasing positive gain from MDMA-assisted psychotherapy.

What is PTG?

PTSD symptomology includes reexperiencing the event, avoidance, numbing behavior, and hyperarousal. Those with PTSD experience these symptoms in a way that impairs daily functioning and relationships. PTG, on the other hand, involves the positive changes in self-perception, interpersonal relationships, or philosophy of life that are influenced by challenging adversarial experiences.

The PTG construct is measured along five factors: relating to others, new possibilities, personal strength, spiritual change, and appreciation of life. Focusing on PTG involves highlighting what an individual can gain from MDMA-assisted treatment, in contrast to the usual concentration on how the therapy has reduced symptomatology.

The data from the MAPS sponsored trials provide a distinctive opportunity to study the relationship between PTG and PTSD when treated with psychotropic medication-assisted therapy. This relationship has never been studied before.

Analyzing pooled data

In an April 2020 study published in the Journal of Traumatic Stress, Gorman et al. pooled the data from three of MAPSs’ six completed Phase 2 trials that tested MDMA for PTSD treatment. All six trials found a significant reduction in symptom severity but failed to independently analyze or report the possibility of positive life changes produced from the treatment.

To remedy this gap, the pooled data were analyzed for possible increases in PTG. Gorman and colleagues chose the only three studies (designated MP-4, MP-8, and MP-12) that included PTG measures in their data collection. The studies used the Post-Traumatic Growth Inventory (PTGI) to measure the five factors of PTG at baseline and compare them with measurements at the primary endpoint, treatment exit, and a 12-month follow-up.

Not only did this analysis confirm the initial findings that 67.2% of participants no longer met PTSD criteria at the 12-month follow up, but it also found significantly more PTG in the active treatment group compared to the control group. The impact of treatment was supported by the correlation of symptom improvement with PTG only for the active treatment group. This suggests that MDMA-assisted psychotherapy results in both long-term, sustainable symptom reduction, and positive gains that influence appreciation and quality of life, interpersonal relationships, and personal growth.

When interpreting these data, connections can be made to the non-directive nature of the therapy, the use of MDMA, or a combination of the two. According to Gorman et al., MDMA-assisted psychotherapy specifically focuses on self-growth of the subject and emphasizes a loosely guided self-exploration, which is particularly well-suited for increasing PTG. Increases in the “personal strength” component of the PTGI may reflect the independence nurtured in this approach. Increases in the “appreciation of life” and “new possibilities” components of the PTGI may reflect empirical evidence of long-term personality change along the dimensions of openness and neuroticism following MDMA use. Increases in the “relating to others” component of the PTGI may reflect the release of oxytocin and serotonin prompted by MDMA use, connecting the subject to their therapist and increasing their sociability.

Limitations in reporting PTG data

Despite the significant findings, Gorman et al. identified some limitations that qualify the validity of the study. The PTGI measures were self-reports, which carry the risk of exaggeration and bias. The pooled studies also included a relatively small sample size, with an under-representation of minority subjects, which is common in psychedelic studies but serves as a barrier to extrapolating or generalizing the results.

Summary

The significant results from this study are grounds for including measures of PTG to be analyzed in future clinical trials of the same nature. Understanding PTG and the possibility that MDMA-assisted treatment could lead to positive secondary outcomes may result in reconfiguring therapy to bolster PTG in synchrony with the existing ventures to reduce symptom severity. Efforts to increase PTG may lead to more rewarding interpersonal relationships, self-esteem, and a more optimistic outlook on life.

 
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Magic mushrooms could help ex-soldiers to overcome trauma

by Jamie Doward | The Guardian | 4 Jul 2020

As more troops self-medicate with psychedelic drugs to help with PTSD, a group of experts lobby for proper clinical trials.

A growing number of soldiers suffering from post-traumatic stress disorder are turning to “magic mushrooms” and LSD to treat their condition. But drug laws make it almost impossible to establish whether they work.

Now a new body, the Medical Psychedelics Working Group, a consortium of experts, academics, researchers, policy specialists and industry partners, is to begin lobbying for a change in the law so that scientists can conduct clinical trials.

“This is something that’s been developed by veterans,” said Professor David Nutt from Drug Science, an independent scientific body which calls for an evidence-based approach to the legislation and is part of the group.

“Three years ago if I was asked the question would psilocybin work for veterans, I would have said it would be quite dangerous to relive the trauma when tripping. But so many vets are doing it now that I’m convinced it can work.”

It is estimated that 17% of people who have seen active military service report symptoms such as flashbacks, nightmares, anxiety, depression, grief and anger.

Earlier this year a team at the Medical University of South Carolina reported on clinical trials which found that PTSD sufferers who used magic mushrooms as part of their therapy showed greater levels of improvement compared with patients who did not receive the drug.

But such clinical trials are difficult in the UK because LSD and magic mushrooms, which were legal until 2005, are classed as Schedule 1 drugs.

The classification means it costs around £3,500 for a licence from the Home Office to conduct tests using the drugs, and the application process can take a year. Scientists face prison sentences if the drugs fall into the wrong hands.

“But when ex-servicemen and women in the UK are reporting how their own use of psychedelics is having a marked effect on PTSD symptoms, we need to restart our studies,” Nutt said. “It could be that these substances can improve the lives of countless people who are suffering with debilitating and life-diminishing mental health conditions.”

Guy Murray, an infantryman with the 4th Battalion The Rifles, served on a long tour of Helmand Province, Afghanistan where his best friend and many other colleagues were killed by the Taliban. He was diagnosed with PTSD in 2017, after suffering from suicidal thoughts, anxiety and severe depression for several years.

After watching a Ted Talk about psilocybin and depression, he began experimenting with magic mushrooms, and then, under specialist supervision, was given LSD.

“It allowed me to address things which I was not open to addressing and it has honestly changed my life,” Murray said. “I believe I left my PTSD behind in those sessions. I am no longer destructive or closed off. I have my life back.”

Crispin Blunt, Conservative MP for Reigate, who served with the 13th/18th Royal Hussars, said that Murray’s experiences were common among the armed forces.

“About a third of veterans with PTSD from recent conflicts, estimated by some to be 2,400 individuals, have the condition so seriously as to be beyond recovery from current treatment practice,” Blunt said.

“We need to provide a safe, professional and lawful route of access to novel treatments such as psilocybin, collecting evidence and calling for our drug laws to be evidence based so our servicemen and women are not forced to travel to other countries, go underground or break the law to obtain treatment that works.”

 
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Psychedelic treatment for trauma-related impairment*

Alan Davis, Lynnette Averill, Nathan Sepeda

Special Operations Forces (SOF) personnel constitute the most elite members of the military; they were selected based upon indicators of superior physical and psychological resilience and trained to endure the challenges of combat. The group cohesion among elite SOF members is a protective factor against posttraumatic stress disorder (PTSD) and other mental health issues. Despite inherent resiliencies and specialized training, SOF personnel are often exposed to a greater number of deployments and intense combat which are associated with increased prevalence of PTSD. Although SOF Veterans exhibit PTSD symptoms at rates comparable to conventional forces Veterans, they may be more reluctant to seek mental health treatment. There is growing concern of a mental health crisis and an alarming increase in the incidence of suicides in SOF members highlighting limited effective treatment methods for this unique population.

Combat Veterans with PTSD frequently demonstrate a complex spectrum of co-morbid psychological and neuropsychiatric symptoms. One of the signature injuries of the recent conflicts in Iraq and Afghanistan is traumatic brain injury (TBI)—largely attributed to exposure to improvised explosive devices and increased survival from life-threatening injuries. Veterans who have sustained a TBI are more likely to have comorbid psychological and neuropsychiatric issues including PTSD, depression, anxiety, cognitive impairment, and suicidal behaviors.

Currently available treatments demonstrate limited efficacy in addressing the unique and complex spectrum of psychiatric symptoms in SOF members and Veterans. Currently approved psychotherapies aim to address troubling memories (e.g., cognitive processing therapy, prolonged exposure, eye movement desensitization, and reprocessing), and although these therapies are the most effective treatments currently available, they do not work for all Veterans. Pharmacotherapies are prescribed to reduce persistent physiological arousal, mood symptoms, or mitigate cognitive deficits. However, current pharmacotherapies also have limited efficacy for many individuals with PTSD, have unwanted side effects, and require long-term use. Therefore, it is essential that novel and potentially curative treatment approaches are developed that can address the underlying etiology and spectrum of symptoms in the Veteran population. Given the comorbid presentations associated with PTSD (depression, anxiety, etc.), there is need to develop transdiagnostic treatments that can simultaneously address PTSD and its common overlapping comorbities.

Psychedelic drugs demonstrate potential as transdiagnostic treatment approaches for the Veteran population. Psilocybin, LSD, and MDMA are the most widely researched psychedelic-assisted therapies. These substances exhibit preliminary efficacy as transdiagnostic treatments in numerous psychiatric conditions including depression and anxiety associated with life-threatening diseases, treatment-resistant depression, substance use disorders, and in Veterans with PTSD. Although none of these treatments are as yet approved by the Food and Drug Administration, the therapeutic efficacy of these substances is broadly hypothesized to occur in part through pharmacological action on serotonergic functioning, stimulation of neurotrophic growth factors and neuroplastic changes, and through psychological mechanisms such as reprocessing of traumatic content, emotional breakthroughs, mystical-type experiences, and fostering adaptive changes in personality. Ibogaine and 5-MeO-DMT are lesser researched psychedelic substances which may be of particular relevance for addressing the symptom clusters experienced by SOF Veterans.

Ibogaine

Ibogaine is a psychoactive indole alkaloid which is extracted from the Tabernanthe iboga rainforest shrub and has been used for centuries in Central Africa for initiatory rituals. Ibogaine was used in France for over 30 years as an anti-depressant and a stimulant until the mid-1960s. Ibogaine treatment is reported to alleviate a spectrum of mood and anxiety symptoms and is associated with self-reported improvements in cognitive functioning in individuals with substance use disorders. During treatment, ibogaine allows the evocation and reprocessing of traumatic memories and occasions therapeutic and meaningful visions of spiritual and autobiographical content,26,29,30,32 which are of central relevance in addressing PTSD-related psychological content. The benefits of ibogaine may be associated with its effects on serotonin and dopamine transporters, sigma, N-methyl-d-aspartate, nicotinic acetylcholine, and opioid receptors, and the production of glial-derived neurotrophic factors and brain-derived neurotropic factor36 which are identified sites of interest in the treatment of cognitive impairment in neuropsychiatric disorders. The primary adverse effects of ibogaine include cardiovascular effects, ataxia, nausea, and vomiting, and psychological effects (e.g., auditory and visual hallucinations, re-experiencing traumatic memories, acute fear, distress, or guilt).

5-MeO-DMT

5-MeO-DMT is a psychedelic tryptamine found in plant species46 and notably in the venomous secretions of the Sonoran Desert/Colorado River toad. In observational studies, 5-MeO-DMT demonstrates therapeutic potential across a variety of psychiatric symptoms that correspond with common sequelae in Veteran populations. For example, in individuals who received vaporized 5-MeO-DMT in a group naturalistic setting, approximately 80 percent of those who reported a diagnosis of depression or anxiety endorsed improvements in these conditions following 5-MeO-DMT use. In an epidemiological survey of 515 individuals, participants who endorsed having psychiatric diagnoses indicated that their symptoms improved following 5-MeO-DMT use, including PTSD (79 percent) and depression (77 percent), and anxiety (69 percent). In a recent prospective study, a single administration of vaporized 5-MeO-DMT from toad secretion was associated with reductions in symptoms of depression, anxiety, and stress as well as increased life satisfaction and mindfulness-related capacities. The observed psychotherapeutic effects of 5-MeO-DMT may occur in part through occasioning mystical-type experiences or experiences of ego dissolution similar to other classical psychedelics such as psilocybin and LSD. 5-MeO-DMT also demonstrates neuroprotective, regenerative, and anti-inflammatory properties which may prove therapeutic in addressing the underlying etiology of cognitive impairment and PTSD. The primary adverse effects of 5-MeO-DMT include physical effects such as alterations in blood pressure and heart rate, heart palpitations, chest pressure, and physical shaking/trembling as well as psychological effects including feelings of acute fear, anxiety, sadness, grief, guilt, and near-death type experiences.

Discussion

A panel of experts have recently noted in a consensus statement that there is a “crisis” regarding the limited number of effective therapies available for those suffering from PTSD. Preliminary results from our study suggest that ibogaine and 5-MeO-DMT treatments may offer a novel, rapid-acting and potentially cost-effective treatment for people suffering from PTSD. Participants in this study received a single dose of ibogaine and three to five doses of 5-MeO-DMT over the course of three days. When surveyed about their symptoms after treatment, participants reported significant and large reductions in PTSD, depression, and anxiety symptoms, suicidal ideation, and cognitive impairment. Importantly, these improvements occurred over a short period of time and after a limited number of exposures to ibogaine and 5-MeO-DMT.

Another important finding from this study was that participants reported increased psychological flexibility following their ibogaine and 5-MeO-DMT treatment, and these increases were strongly associated with reductions in cognitive impairment, and symptoms of PTSD, depression, and anxiety. Interestingly, researchers have begun to examine the relationship between psychological flexibility and therapeutic outcomes after using psychedelics. Consistent with the current findings, a recent study showed significant increases in psychological flexibility after using a psychedelic substance in nonclinical settings, and these increases in psychological flexibility mediated the relationship between the acute effects of psychedelics and decreases in depression and anxiety. Furthermore, increased cognitive flexibility has been associated with decreased PTSD symptom severity as well as being a positive predictor of treatment outcomes. It is possible that psychedelic-assisted therapy may promote change by increasing psychological flexibility more rapidly than traditional psychotherapy.

Conclusions

This is the first study to report on the effects of ibogaine and 5-MeO-DMT used as a treatment for SOF Veterans suffering from psychological and cognitive impairment. Our preliminary results suggest that ibogaine and 5-MeO-DMT may offer a rapid and robust, and well-tolerated, treatment option for those suffering from a variety of psychiatric and cognitive symptoms. However, further research is needed to support this preliminary evidence. Our results suggest that randomized, double blind, placebo-controlled trials are warranted in order to determine the safety and efficacy of ibogaine and 5-MeO-DMT in treating Veterans with psychiatric and cognitive impairment. Our study did not assess adverse effects or side effects of ibogaine and 5-MeO-DMT which should be investigated in future research. Future research should also explore the unique effects of ibogaine and 5-MeO-DMT individually in the treatment of psychiatric disorders.

Given the significant number of Veterans suffering from PTSD and other psychiatric problems and the overwhelming rates of suicide among military and Veteran populations, investigation into novel pharmacotherapies such as ibogaine and 5-MeO-DMT are needed. Furthermore, because of the promising trial results of MDMA-assisted psychotherapy, it is also possible that these novel therapies could be paired with trauma-focused psychotherapy to increase adherence and outcomes. This would be an advantage, especially in light of the fact that a significant portion of Veterans consistently demonstrate high levels of non-response and dropout rates for conventional therapies as well as limited confidence in the perceived efficacy of VA mental health treatment. Despite the need for more research, results from this study provide a signal that ibogaine and 5-MeO-DMT may offer a robust and rapid acting treatment option for Veterans suffering from PTSD.

*From the article here :
 
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Veterans are using Ketamine-assisted psychotherapy to help with PTSD

by Justin Hampton | 18 Nov 2020

Canada leads the way in using psychedelics to treat mental health issues.

For many veterans of war, the battle continues even after they’ve returned home from combat. The Veterans Affairs Canada website estimates that up to 10 percent of their warzone veterans will suffer from PTSD or another mental health affliction, and are 14-19% more likely than the general Canadian population to commit suicide, according to their 2019 Veteran Sucide Report. While both medications and therapeutic interventions are available for this condition, they haven’t proven very effective.

To address this, the Canadian-based psychedelic mental health provider Field Trip Health Ltd. announced a partnership with Heroic Hearts, a nonprofit which pairs veterans with psychedelic therapy. Under the partnership, Heroic Hearts will educate veterans about the benefits of ketamine-assisted psychotherapy, and recommend them towards the ketamine treatments of Field Trip Basecamp, a Field Trip offshoot which delivers KAP+, or Ketamine-Assisted Psychotherapy-plus, to veterans and first responders.

Heroic Hearts founder and president Jessie Gould says "the nonprofit’s mission is to highlight the responsible players in this rapidly expanding field of psychedelic health and ensure all veterans are supported when they decide to participate in something like ketamine assisted therapy.” He praised Field Trip for having “made great efforts to work with us in supporting the veteran community in both Canada and the US.”

Much of the activity around psychedelic medicine and PTSD centers on MDMA, which is currently undergoing Phase III clinical trials in America through MAPS. However, Field Trip Basecamp Director Adam Wright points to off-label studies of Ketamine for PTSD as well as treatment-resistant depression and major depressive disorder, and maintains that it can be just as helpful.

“With the promising results in PTSD, as well as the highly comorbid nature of PTSD and depression, we have developed a treatment stream that will specifically target military veterans,” says Wright.


"People with PTSD often dissociate as a defense mechanism against dealing with overwhelming emotion or horrific memories," says Dr. Jessica Katzman, a psychologist and cofounder of Healing Realms, a ketamine-assisted psychotherapy practice in San Francisco.

“Ketamine can potentially reduce anxiety and hypervigilance, the driving forces behind dissociation, and may allow the individual to step back and explore what’s under the defensive layer,” says Katzman.

For now, Basecamp will offer this treatment exclusively to Canadian soldiers at their Field Trip Toronto facility, and assist in insurance and reimbursement options with participants.

"In spite of the ketamine derivative Spravato’s availability in the US, the partnership cannot offer treatment or reimbursement for KAP+ treatment through the Veteran/s Administration health program at this time," says Gould.


“For many veterans, ketamine therapy can be cost-prohibitive without some form of subsidy. Unfortunately, the US Veteran Affairs has faltered on its promise to increase veteran access to ketamine options,” Gould says. “Since the Canadian VA has been more willing, we hope to use the Canadian model to guide and put more pressure on the US to adopt similar practices.”

Field Trip has already expressed its intention to open up psilocybin treatment clinics in Oregon following the passage of Proposition 109, which legalized licensed psilocybin-assisted therapy in that state. Field Trip currently runs clinics in New York, Chicago and Santa Monica.

 
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Facilitating MDMA therapy as a treatment for PTSD

by Maria Mocerino | Chacruna | 20 Nov 2020

Originally from Colombia, Marcela Ot'alora G. was first introduced to MDMA in the 1980s. She was 23 years old and suffering from PTSD. Where other treatments failed her, MDMA changed her life.

Marcela has been facilitating MDMA for over 20 years and ketamine-assisted psychotherapy for three years. Originally from Colombia, Marcela was first introduced to MDMA in the 1980s. She was 23 years old and suffering from PTSD. Where other treatments failed her, MDMA changed her life. She decided to pursue psychology as a career in order to bring MDMA therapy to those suffering from PTSD and, more broadly, to underserved communities.

Since 1999, Marcela has worked for the Multidisciplinary Association for Psychedelic Studies (MAPS) as a co-therapist and a principal investigator in various studies concerning MDMA as a treatment for PTSD, and in a study for therapists in training. Furthermore, she has been a seminal force behind MAPS’ current efforts to get MDMA through the FDA approval process as a prescription for PTSD by 2023. As a respected and beloved figure in the psychedelic community, Marcela maintains a private practice in Boulder, Colorado and trains therapists to work with MDMA. Thus, she has played an integral role in building a Western healing modality based in empowerment, connection, and choice.

In this interview, Marcela Ot’alora G talks about the MAPS phase III MDMA clinical trials, PTSD as a condition, facilitating MDMA-assisted psychotherapy, and shares her thoughts on how to ensure access and accessibility to marginalized communities.

Maria Mocerino: What’s the update with the phase III MDMA clinical trials?

Marcela Ot’alora G:
We’ve just begun the screening process for the second half of phase III. We’ll be treating another 100 participants throughout the 15 MAPS-sponsored sites. We’ll still be assessing the efficacy and safety of MDMA, as we did in the first half of phase III. We’ll also be collecting more data on its physical effects. This is all in preparation for MDMA becoming a medicine, we hope, in 2023.

MM: Let’s say MDMA get approved by the FDA. What would this look like, initially?

MO:
It’s not like people will be able to just go and get MDMA. There will be certified clinics throughout the US, Canada, and Europe run by people that have gone through the MAPS training program to do this work. The treatment model will look similar to what we currently have. However, there will be more flexibility in terms of the treatment programs that we are able to offer.

For example, maybe we can spread someone’s treatment over a period of time that is longer than three months and be able to tailor the treatment to each participant. That might make it more accessible for some, in the beginning. At MAPS, we’re committed to finding ways to serve the underserved when MDMA-assisted psychotherapy becomes a legal treatment. We are doing this through initiatives and grants to help pay the costs.

MM: You’ve been working with MDMA in a clinical setting for over 20 years. From your perspective, how do we begin to address this issue of access?

MO:
We need to begin where it is the most needed. That includes marginalized communities. However, they aren’t just going to join a study, for example. They could have had traumatic experiences with Western doctors, or had exchanges with medical personnel who were not culturally informed. What has their experience been like? What has their family’s experience been like? What about people without access to transportation?
The commitment of therapists working with marginalized communities needs to go beyond the initial intake. We have to take that extra step to reach members of marginalized communities and make them feel like they are heard and seen because, often, unfortunately, their experience has not been that of feeling welcomed.

I used to be a consultant for therapists that worked with Latino populations. I told them that they couldn’t just give them the resources. They might have to call them, because they might not read English. They might not even have a phone. Maybe they are terrified of making that call to a therapist. The commitment of therapists working with marginalized communities needs to go beyond the initial intake. We have to take that extra step to reach members of marginalized communities and make them feel like they are heard and seen because, often, unfortunately, their experience has not been that of feeling welcomed.

We might not know why someone from a marginalized community distrusts the medical care system, but we can ask questions from a place of curiosity and find out. As therapists, we want to have a beginner’s mind and come from a place of curiosity and cultural humility so that we can actually help a person. We need to have an understanding of the person’s culture and who they are as a human being.

MM: What about training therapists of color to help introduce MDMA-assisted psychotherapy to their communities?

MO:
Training therapists from different communities is great. People will feel safer, and generally better understood, by doctors and therapists from the same culture. I don’t think we want to fall into a trap, however, of sending all Black people to Black therapists, for example. We can’t just do that and wipe our hands clean.

I used to be a therapist in schools in Boulder that had a high percentage of Latino students, mostly Mexican children. I am a Colombian woman. Every week, I had a teacher, coach, and even a janitor come up to me and say, “Your kids are doing something over there. You need to go and tell them to not do that.”

My kids go to a different school,” I clarified to them. “These are our kids, right?” There was a mentality that all the Latino children were my responsibility because I was the Latina at the school. I think we need to stop doing that.

MM: How do you see this treatment getting into marginalized communities?

MO:
We need to have clinics in marginalized communities. They can’t be in another town. That way, people will feel that they have access to it. For that purpose, it is advantageous to have therapists of color that can bring it into their communities. I hope we can. We can’t stop people from having different agendas in terms of how they want to see psychedelics in the mainstream, and I hope we can maintain the integrity of the modality and have people’s healing as the main priority.
If you think about it, if someone hasn’t been able to breathe for 20 years, if a person is holding tension in their body due to the hypervigilance that often accompanies PTSD, there are going to be physical issues.

MM: Have you noticed that people’s physical ailments start to subside when they start this healing process?

MO:
Absolutely. There are a lot of links between trauma, mental health, and physical conditions. If you think about it, if someone hasn’t been able to breathe for 20 years, if a person is holding tension in their body due to the hypervigilance that often accompanies PTSD, there are going to be physical issues. Maybe they can’t quite relate it to trauma. A doctor might not be able to either. That’s why having treatment that works for people with PTSD is important. It’s affecting their bodies every single day.

MM: Feelings and emotions are usually not factored as a probable cause for disturbances in one’s health in Western medicine.

MO:
Everything in the West is separated and compartmentalized into little boxes. No wonder we live in a patriarchal society (laughter).

I have one little story. After the MDMA sessions, we always follow up with the participants, not just for the purposes of the study, but because we want to know what’s changed for them in general. One person said that they went to a doctor and grew an inch. We all had a laugh about “MDMA making you grow.” Really, what she was doing was standing tall. She was no longer hunching over. Talk about a physical manifestation.

MM: How did you get into facilitating psychotherapy with MDMA?

MO:
I had MDMA-assisted psychotherapy for PTSD when I was 23 in 1984, the year before MDMA was criminalized. It was incredibly helpful for me. I had tried a lot of different treatments before and nothing worked, so I wanted more people to have access to this medicine. It was devastating that it was not a treatment with access to all who needed it and wanted it.

I went back to school, studied transpersonal psychology, and got myself ready to help people in their healing process. Finally, in 1999, a study was approved in Spain to treat women with MDMA who had PTSD from sexual abuse or assault. Unfortunately, the study was shut down after only six or seven women were seen.

MM: Why was the MDMA study shut down?

MO:
There was a lot of erroneous information going around about MDMA. It was said that MDMA could cause holes in the brain, so I think the government was scared. It was the first time that they were conducting this kind of study.
When I see over 400 people on the waiting list for 15 spots in the MDMA clinical trials, it’s a reality check. It shows how many people are suffering and want this treatment.

Changing the narrative around MDMA has been a slow process. It hasn’t been slow in the last few years. For 20–25 years, though, it was very, very slow. It hasn’t always been easy for me. When I see over 400 people on the waiting list for 15 spots in the MDMA clinical trials, it’s a reality check. It shows how many people are suffering and want this treatment. But I remember what I’m working towards: the possibility of bringing this modality to more people, especially in vulnerable populations. That keeps me going.

MM: How many people know they have PTSD? Do you think we even understand how many people are suffering from this?

MO:
A lot of people don’t know that they have PTSD. Meaning, they don’t call it that.However, I think that these people know that they are suffering a great deal. It’s incredibly challenging to be alive. Education and media have changed this somewhat, but oftentimes people think that PTSD is something that only happens to veterans of war. I’ve heard that in MDMA sessions. “I haven’t been to war, so I don’t have it as bad.” Some participants in the clinical trials even felt guilty that they had gotten into the study.

MM: You’ve talked about how choice is taken away from people with PTSD. Thus, it’s amazing that people are coming out of these MDMA-assisted psychotherapy sessions feeling like they have a choice. Can you go into a little more depth as to what you mean by that?

MO:
In most cases, trauma that results in PTSD is harm inflicted by another person. They did not have a choice about what was being done to them. As a result, they feel that choice is not available to them. They do not want to be affected by the trauma, and they do not have a choice about this. Healing brings back choice.

One of the ways that I describe PTSD, and of course, this doesn’t happen for everyone, is that shame and fear become one’s moral compass.[6] If our reference point is fear, shame, and hypervigilance, one is constantly on the lookout and can’t let our guard down. As a result, the world becomes small and contained as an attempt to have a semblance of control, which is impossible. We develop coping strategies that often make life very challenging, because it is the only way to survive. There is no choice in that.
The philosophy behind the MDMA training program is based on empowerment, because people with PTSD do not feel empowered.

MM: What is the philosophy behind the facilitation approach? How do you train people to work with MDMA?

MO:
The philosophy behind the MDMA training program is based on empowerment, because people with PTSD do not feel empowered. I always refer back to what a psychologist named Judith Herman said. As a therapist, “No matter what you do, even if you’re right, if any intervention takes away the power of the participant, then you’re not doing the right thing.” We are not the experts in the room, they are the expert in their own healing process. They know themselves better than we could ever know.
I think if given the opportunity, people naturally go towards healing, because there is an inherent drive in the human spirit to heal.

When I walk into a session, I come in with that attitude. They have what it takes to heal, and I am following them. I want to empower the person to trust their inner healing intelligence. In all the sessions I’ve done, I’ve never seen anyone who doesn’t have an empowered voice that knows what is best for them. I think if given the opportunity, people naturally go towards healing, because there is an inherent drive in the human spirit to heal.

MM: You said that you felt that MDMA had a spirit…

MO:
Oh, absolutely. The spirit of MDMA gives you the gift of your spirit. It allows the “inner healer” to speak in the most empowered way. So many participants already knew that this voice existed in them. Due to their trauma, however, that inner healing voice had gotten faint or lost. In MDMA sessions, that voice enters in the room, and it’s difficult to ignore. It’s there to bring equilibrium to the body as well as their attention to the present moment experience.
In the MDMA study, I’ve heard many people say, “I’m meeting myself for the first time.”

I’m not sure who said this, but “I am the one that I have been waiting for.” In the MDMA study, I’ve heard many people say, “I’m meeting myself for the first time.” The participant has the opportunity to look at the trauma from this empowered perspective, instead of one rooted in shame and fear.
Maybe, when we were children, we got really hurt. And we try to protect that little person by avoiding the painful feelings. But we are not only avoiding the trauma. We’re missing out on all the gifts that part of us has to share; wonderful things, like curiosity, humor, creativity, and joy.

MM: What do you think is an essential step in making that transition from one perspective to another?

MO:
I think that we avoid the parts of ourselves that are challenging for us. We do this to protect those parts, because we feel that they are too vulnerable. Maybe, when we were children, we got really hurt. And we try to protect that little person by avoiding the painful feelings. But we are not only avoiding the trauma. We’re missing out on all the gifts that part of us has to share; wonderful things, like curiosity, humor, creativity, and joy. We no longer have access to the richness of who we are as a whole person.

How do we make room for these parts of ourselves that we’ve been so afraid to explore because they hold so much pain and suffering? What else is behind there? How can we meet each other at a place of curiosity: therapist and client? How can we form a therapeutic alliance that allows the participant to discover their healing power?

 
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The Veterans Guide to Psychedelic Healing

by B.A. Wesler | Reality Sandwich | 11 Nov 2020

This is a field guide for veterans who are struggling with post-traumatic stress disorder (PTSD) and are interested in accessing the healing capacity of psychedelic plant medicine. It is assumed that the reader already understands the symptoms, impact, and challenges of living with PTSD. It is sufficient for the purpose of this article to acknowledge that you are different than you were before the traumatic experiences of warfare.

The challenges of the ordinary

The essence of the military experience is participation in a phenomenon much bigger than oneself. Combat operations are among the most visceral of human experiences. Day after day, a wide range of intense, brutal, and tragic events can occur, and it can all happen at hyper-speed. Your mind must recalibrate itself for moment-to-moment survival in this environment.

Then… you come home, but your mind is still calibrated for the combat environment. Returning to “normal” life is challenging, overwhelming, or even impossible. Your body may have come home, but your mind and spirit have not yet completed the journey. Psychedelics, when administered in a safe and guided setting, can help you recalibrate to the ordinary world and help you fully arrive home in mind, body, and spirit.

The nature of the psychedelic experience

The exact mechanism of how psychedelic substances heal the mind is still not understood. However, the consensus among researchers is that psychedelics allow us to recalibrate the mind. Traumatic experiences can cause the brain to get stuck in repetitive and negative thought patterns; psychedelics allow us to break those patterns.
Veterans with PTSD who have used psychedelics in a safe and guided setting have reported the following:
  • Significant reductions in PTSD symptoms.
  • Significant reductions in suicidal thoughts.
  • Improvement in mental, emotional, and physical well-being.
  • Drastic reduction in the use of prescription medications, alcohol, and other substances that “numb” the pain.
  • The ability to get back to living a normal and healthy life.
What exactly happens during the psychedelic experience that enables such results? The answer is: there is no exact experience you can expect to have. Every psychedelic experience is different, and the experience’s details are often difficult or impossible to describe. However, those who have undergone psychedelic healing often describe the following general characteristics:
  • A profound, mystical, and life-changing experience.
  • A connection with the Divine, with all beings, and with nature.
  • A sense that ancient wisdom has been “downloaded” into one’s mind.
  • An ability to view the entirety of one’s experiences with compassion and forgiveness.
  • A deep sense of peace about one’s existence.
There is a deep sense of knowing that the experience was real and that it means something. We are then inclined to bring that meaning into our daily lives. There is a desire to live more fully, love more fully, and just be a good human in service to others.

Integrating the psychedelic experience

Psychedelic healing is not just about ingesting a substance. After the psychedelic journey, it is essential to “integrate” the experience into everyday life. This requires work and is often best accomplished with a counselor or guide who understands the nature of psychedelic integration. Interestingly, the psychedelic journey seems to orient us toward healthier lifestyle choices. It is common to have an increased desire to exercise, meditate, eat healthier food, and cultivate healthy relationships. Correspondingly, toxic habits and relationships seem to fade away.

Psychedelics are NOT a silver bullet

Psychedelics are not a “quick fix”, but the overwhelming majority of veterans who have used them in a safe and guided environment have had positive results. Everyone responds differently to various substances, and no two experiences are the same. Sometimes a positive mental shift is felt right away, and sometimes the shift is spread out over time. Do not be discouraged if the experience did not have the impact you were expecting. Continue to educate yourself and explore the possibilities; the right medicine will find you.

Psychedelic resources

A well-established process for guiding veterans to psychedelic healing does not exist. However, the resources below will provide a good foundation for understanding psychedelics and how to access this type of healing.

Common psychedelics for alleviating PTSD

There are many psychedelic substances that have been used to treat PTSD. However, the following psychedelics are the most available, studied, and referenced in the realm of treating veterans with PTSD.
  • Psilocybin: The psychoactive substance found in Magic Mushrooms. This substance just gained legal status via Measure 109 for therapeutic use in the State of Oregon.
  • Ayahuasca: A powerful psychedelic substance that is native to the Amazon region, and should be administered under the care of a skilled Shaman.
  • MDMA: The psychoactive substance found in “Ecstasy” or “Molly”. This substance has been extensively studied, and will likely be legalized soon for therapeutic use in the United States.
  • Ketamine: This is a “dissociative anesthetic”. It is effective for alleviating severe PTSD and chronic pain. This substance is legal and available in the United States.
Visit the Reality Sandwich Substance Guides to learn more about the wide range of psychedelic substances.

Psychedelic healing in the mass media

There are an abundance of resources for learning about psychedelics. The selected materials below are a starting point for understanding how psychedelics have helped veterans who are struggling with PTSD.
  • From Shock to Awe: A documentary that follows two combat veterans suffering from severe PTSD as they abandon pharmaceuticals to seek relief through the use of Ayahuasca.
  • Psychedelic Soldiers: A short documentary that follows two combat veterans and their battle with PTSD. After having tried conventional treatment without success, they turned to MDMA-Assisted therapy.
  • Psilocybin, Love, the Meaning of Life: In this TEDx Talk, Mary Cosimano from John Hopkins University shares her experience in administering psilocybin to hundreds of patients. Although this talk is not focused on veterans, it emphasizes the potent healing capacity of psilocybin.
  • Psychedelics for PTSD: What a Long Strange Trip It’s Been: In this testimonial, military veteran Virgil Huston shares his experience receiving MDMA-assisted psychotherapy. He credits this therapy with saving his life.

Accessing psychedelic healing

We are entering a new era in psychedelic substance legalization in the United States. Although there are many ways to safely access psychedelics, the legal route within the United States is still limited. The following organizations can help guide veterans to safe and legal psychedelic healing.
  • Heroic Hearts Project: This organization was founded by Jesse Gould, an Army veteran who suffered from PTSD. Heroic Hearts connects veterans who are suffering from PTSD to psychedelic-assisted therapy programs and retreats worldwide.
  • MAPS: This organization has been studying psychedelic therapies for several decades. They are leading the effort to legalize the therapeutic use of MDMA. They have administered MDMA to veterans with PTSD, and have had positive and enduring results. At the time of this writing, MAPS is accepting applications for an MDMA-assisted therapy study for the treatment of PTSD; click here to view the application.
  • Johns Hopkins University, Center of Psychedelic and Consciousness Studies: This institution has been studying psilocybin-assisted therapy for two decades. They are continuously conducting new studies. Check the research tab of their website with regular frequency for PTSD-related studies.
In addition to the organizations above, safe and legal psychedelic retreat centers are accessible outside the United States. The Retreat Guru website is helpful for finding reputable psychedelic retreat centers. When seeking a psychedelic retreat center, mitigate the risk through education and diligence. Do not just read reviews; connect with people who have experience at different retreat centers. Ensure that any retreat center you select is reputable, safe, and is experienced in guiding veterans with PTSD.

Accessing Ketamine treatment

As mentioned above, Ketamine is legal and available in the United States, and is effective for alleviating PTSD symptoms. Given the wide availability, this is a good treatment choice if you are experiencing severe distress and suicidal thoughts. Ketamine treatment will bring a sense of relief and stability while you plan for a deeper psychedelic healing experience, if desired.

There are several dozen Ketamine clinics in the United States. Visit the Ketamine Directory to find a clinic near you. Also, Ketamine Wellness Centers have several clinics in the United States; they have guided veterans with PTSD through the treatment process, and they offer a military discount.

The sacred Fire

Some veterans with PTSD have expressed concern about psychedelics for a variety of valid reasons. The following addresses some of the common concerns, and offers some different ways of viewing the possibilities.

The warrior remains

One concern is that psychedelics will make you “soft” by taking away your heightened sense of vigilance, thus leaving you vulnerable. Psychedelics will NOT dull your edge and leave you vulnerable. You are a warrior, and the psychedelic experience will not take that from you. You will retain the ability to tap into your warrior ethos if needed. However, your sense of awareness and response will be appropriate for the situation. You will no longer see threats where there are none.

Your service continues

Another concern is that psychedelics will make you forget or “let go” of your experiences. This is not the case; there is no forgetting. Rather than letting go, psychedelics help you integrate those experiences into your life. Rather than your experiences defining the rest of your life, psychedelics help you see your experiences as just one part of you. Allow your experiences to become a unique and potent gift for enlightening others and improving the human condition. In the words of Zen Master Thich Nhat Hanh:
“Veterans are the light at the tip of the candle, illuminating the way for the whole nation. If veterans can achieve awareness, transformation, understanding, and peace, they can share with the rest of society the realities of war. And they can teach us how to make peace with ourselves and each other, so we never have to use violence to resolve conflicts again.” - Thich Nhat Hanh


You’ve got to feel it to heal it

Finally, many veterans are concerned about reliving the trauma during the psychedelic journey; thus having a “bad trip”. This is a valid concern. However, working your way through the trauma during the psychedelic journey might be necessary for true healing. This is why there is a strong emphasis on taking psychedelics in a safe setting with a trained guide. A guide helps you navigate, process, and heal the trauma. Without a guide, you risk coming to the edge of the traumatic experience, but not working through it, and therefore not healing the trauma.

You have been forged in many fires during your military service. You have been the Phoenix rising from the ashes many times over. The psychedelic journey is just another fire to walk through, but this one is a sacred, healing, and purifying fire that burns bright in the seat of your soul. You will emerge stronger, with a sense of wholeness, full of love, ready to live and to continue your service to the world around you.

 
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A preliminary trial has looked at the safety and feasibility of incorporating two MDMA sessions
into a treatment protocol for couples therapy, where one member is suffering from PTSD.


MDMA-assisted couples therapy investigated in landmark pilot trial for the treatment of PTSD

By Rich Haridy | NEW ATLAS | 8 Dec 2020

In the late 1970s and early 1980s MDMA was often utilized to help facilitate positive results in couples counseling. A few dozen pioneering psychotherapists in the United States explored the drug’s therapeutic uses until the US government declared MDMA a Schedule 1 controlled substance in 1985.

Richard Ingrasci, a psychiatrist who had for years been successfully using MDMA as an adjunct to marriage counseling, was one of several therapists who opposed the scheduling of the drug. Ingrasci, whose work became foundational for many modern psychedelic-assisted psychotherapy researchers, provided prominent testimony during the government's scheduling hearings in 1985.

“I have seen MDMA help many couples break through longstanding communication blocks because of the safety that emerges in the session as a result of the drug,” Ingrasci declared in his testimony from the scheduling hearings. “It is difficult to convey in words how deeply moving it is to watch couples heal in this way with the help of MDMA.”

Of course, we all know what happened next. MDMA was classified a Schedule 1 drug with no medical uses making it virtually impossible to clinically study anywhere in the world. Since the turn of century research into the therapeutic uses of MDMA has slowly but surely moved back into the realm of clinical credibility, largely due to the efforts of Rick Doblin and his non-profit organization, MAPS.

MAPS was founded in 1986, in the wake of MDMA’s Schedule 1 restriction. Its goal was to get MDMA clinical research going again, and over the years its primary framework to do that was through investigating the drug as an adjunct to psychotherapy for post-traumatic stress disorder (PTSD).

After years of work, and some truly extraordinary results, MDMA-assisted psychotherapy for PTSD is now on the cusp of being approved in the United States. And now some researchers are turning their attention to engaging in clinical studies investigating the benefits of the drug in couples therapy.

This latest study, published in the European Journal of Psychotraumatology, is the first to explore the effects of MDMA therapy in couples where one member is suffering from PTSD. Candice Monson, corresponding author on the new study, says this new proof-of-concept trial arose organically out of the prior MDMA for PTSD research.

“PTSD in one partner can cause distress in the relationship and barriers to understanding each other,” says Monson. “It seems that MDMA-assisted psychotherapy can engender empathy and connection, opening a pathway to remembering why came together in the first place and a desire to understand the other.”

This preliminary study investigated the feasibility of incorporating two MDMA sessions into a previously established PTSD therapeutic regime known as CBCT, or cognitive-behavioral conjoint therapy. As opposed to traditional PTSD therapies focusing on the individual, CBCT is designed to help improve relationship functioning for couples, while still improving PTSD symptoms in the individual patient.

The new trial recruited six couples, in which one member of the couple had a pre-existing PTSD diagnosis, and explored the feasibility of incorporating two MDMA sessions into the CBCT protocol, which traditionally involves around 15 therapy sessions conducted over several months.

“The literature that inspired this study suggests that MDMA may allow people to talk about painful experiences without experiencing the pain again,” explains Monson.

“The therapist can guide couples to talk about very difficult things that they’ve either experienced themselves or experienced together—against the other or with the other— with a greater sense of understanding, openness, connection, and empathy.”

The new study reports the addition of MDMA to the couples therapy protocol resulted in effects that were, “on par with, or greater than, those achieved with CBCT alone.”

Improvements were detected in both relationship outcomes and individual PTSD symptoms. The effects were most significant at the six-month follow up implying the MDMA therapy confers compelling long-term benefits.

It is important to note the study was uncontrolled, so any efficacy comparisons to CBCT alone can only be garnered by examining prior CBCT studies. However, this feasibility study does establish the addition of MDMA to the pre-existing therapeutic protocol is safe and it does not negatively interfere with other PTSD treatments.

A previously published case study in the Journal of Psychoactive Drugs outlined the experiences of one couple in this preliminary trial. The couple, Stuart and Josie, were suffering from relationship difficulties after Stuart’s trauma-related PTSD symptoms had returned.

“For Josie, the CBCT + MDMA experience allowed her the opportunity to no longer feel she had to 'walk on eggshells,' and to experience relief from anxiety and tension,” the case study reports. “Together, Stuart and Josie were able to share the experience of Stuart’s traumatic memories, and face them in a united and accepting manner.”

Interestingly, the improvements seen in PTSD symptoms in this pilot study were noted as greater than those seen in several individually delivered MDMA-assisted psychotherapy for PTSD trials. Of course, this is a tiny pilot study, so little can be concluded by comparing its efficacy results to these larger ongoing randomized trials. However, the interpersonal nature of PTSD and the way the condition impacts close relationships does suggest involving partners in a therapeutic protocol could hypothetically improve treatment outcomes.

A larger Phase 2 randomized controlled trial is currently being prepared by the research team. The next steps will be to better explore the safety and efficacy of MDMA-facilitated CBCT for PTSD in a diverse set of participants with a variety of relationship distresses.

The new study was published in the European Journal of Psychotraumatology.

 
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As more people turn to psychedelics, integration proves a crucial factor for breakthroughs

by David Carpenter

Nick Watchorn had suffered for most of his adult life from severe post-traumatic stress disorder (PTSD) before he sought psychedelic treatments to deal with his chronic condition. He credits those psychoactive sessions, and particularly the work he did afterwards in a process known as integration — a way of gleaning insights from the experience — with saving his life. “I thought I was too far gone,” he says of himself before receiving therapeutic treatments using MDMA-assisted therapy (aka ecstasy).

At 54 years old, Watchorn had suffered for 22 years from the terror of a mass shooting he experienced as a young cop. The year was 1996, in Port Arthur, Tasmania, after a gunman had gone on a deadly shooting spree that left 35 people killed and 23 wounded. It was, and still is to this day, the worst single gunman massacre in Australia’s history. For more than two decades after the terrible event, Watchorn was plagued by visions of the mass killing. His grief led to the classic PTSD symptoms of anxiety, depression, social isolation and destructive behavior. Repeatedly playing back the awful carnage of the crime scene in his mind, he continued to re-experience his trauma on an endless loop. In the years following Port Arthur, Watchorn would eventually quit the police force, saying in MDMA: From The Club To The Clinic, a book I wrote this year about his experience, “I couldn't make decisions anymore. I just didn't trust my own thoughts.”

Watchorn says he tamped down the brutal, recurring mental images for 22 long years, aided by alcohol, pain pills, and a revolving door of psychotherapists. Then one day he heard about a breakthrough clinical study being conducted to treat PTSD using MDMA. The trials, which combined the drug with psychotherapy sessions, were proving to be incredibly effective at treating the symptoms of emotional trauma. Trials were (and still are) steadily progressing through important phases with the U.S. Food and Drug Administration (FDA) to potentially become a legal, prescriptive medicine. Watchorn would eventually qualify to take part in the trials in 2018 through the MAPS, having experienced symptoms of treatment-resistant PTSD for over two decades. Before his trials with MDMA, he had never in his life experienced a psychoactive drug. Not so much as a puff of marijuana, he laughs. He was making a brave choice to face his demons through a relatively new scientific experiment.

While under the influence of MDMA, which took place in three 8-hour clinical sessions with trained therapists, Watchorn assumed he would first confront memories of the horrible scenes he faced at Port Arthur. All the gore of dozens of people killed and wounded by a madman with a high-powered rifle. He was bracing himself to experience those raw emotions up close and personal, to finally deal with the sad and terrible memories. Instead, he would be surprised by what first appeared in his mind’s eye: a vision of himself at eight years old shivering alone by a poolside. Before tackling the events that he believed would be foremost in his wounded psyche — the death and destruction he witnessed in 1996 — he would first reel through a series of early, relatively benign childhood encounters. A place where he felt rejected, abandoned and at the mercy of his parents’ needs. Watchorn was starting at the beginning, where his trauma first rooted — an uncomfortable place many people avoid.

The place where he received the initial injuries of his life that later affected his ability to cope through the aftermath of the killings. He would not fully understand the meaning of all those buried mental images that came flooding back from his childhood until after his experience under the influence of MDMA. During integration therapy sessions, he would reflect on what emerged during his time on the drug and slowly patch together the meaning of it all. Only then would he have the true tools to begin healing himself of his PTSD.

Integration is an often-overlooked aspect of the psychedelic experience, yet it is one of the most important factors for success. Generally speaking, it is the wild and mystical moments that take center stage. Once a person returns to ordinary states of consciousness, the psychedelic trip — whether perceived as positive or negative — is often left in the rearview mirror to fade like a dream. One of the key points of integration is to not let significant parts of the experience fade out, but to examine the mental deep dive and mine it for valuable insights. This can also have the effect of reducing subsequent harm in the event of a challenging experience.

Because the majority of people who use psychedelics will not use them in controlled clinical settings like Watchorn — his case and condition were so extreme that he qualified for the FDA trial over roughly 900 applicants who applied in his area — a group of researchers and clinicians have recently laid out a framework defining integration and its importance in patient care. It is the first peer-reviewed paper of its kind, published in Frontiers in Psychology, and outlines how mental health providers may benefit from understanding the unique motivations, experiences and needs of people who use psychedelics. Still largely illegal in the U.S. and much of the world, psychedelic drugs can be a tricky topic for mental health professionals to come together and agree on standards and practices.

Dr. Ingmar Gorman, co-author of the paper on harm reduction and integration and co-founder of Fluence — an organization focusing on psychedelic education and training mental health providers in psychedelic treatments — saw the necessity to begin a dialogue around offering healthcare providers clinical skills and knowledge to provide effective, compassionate, evidence-based psychedelic therapy and integration services to patients. “Many psychotherapists and other providers have encountered clients who use psychedelics already, but there hasn’t been a consistent approach to working with these individuals,” says Gorman. “We’re hoping that this publication will start a conversation that’s been missing in the field, so that we can be most helpful to those who need us.”

Gorman is in a unique position to discuss concepts around psychedelic integration and harm reduction, having served on Phase 3 clinical trial teams that employ MDMA for PTSD (the same FDA trials participated in by Watchorn), as well as serving as a therapist on FDA-approved clinical trials using psilocybin-assisted treatment for alcohol use disorder and treatment-resistant depression.

Co-author Dr. Elizabeth Nielson, who is also a co-founder of Fluence and has related FDA-approved clinical trial experience, underscores the need for honest and unbiased discussions around these stigmatized drugs. “Our clinical experience and review of the literature offer a way forward for the field of psychotherapy to engage psychedelics, even when patients’ psychedelic experiences occur outside of psychotherapy,” says Nielson. “By learning how to have honest, respectful, and non-judgmental conversations with patients about psychedelics, clinicians can counter the harms of years of prohibition, misinformation and stigma associated with these experiences.”

As the public’s interest in psychedelic use continues to expand, ongoing studies in the field and peer-reviewed papers by informed researchers may provide therapists with another instrument in the clinician toolkit when working with patients who use, have ever used or are considering using psychedelics.

Checking in with Watchorn this week, now three years since his MDMA treatments have concluded, he shares his perspective on integration. “My integration sessions were so confronting and profound, the feelings of relief and optimism were overwhelming for a long time,” he says. “Experiencing such radically different perspectives, feeling more universally connected than disconnected, noticing clarity in thoughts, colors, textures, smells. I’d find myself in tears, often daily, over the next eighteen months. Some of it was sadness — mourning the past. There was also the incredible sense of relief and strong unfamiliar feelings of freedom and optimism.”

Watchorn says while he has frequently thought back on his experience through the MDMA treatments, he has not felt it necessary to have another MDMA treatment — integration is enough. He is echoing a sentiment by MAPS founder Rick Doblin, who said, “It’s not just about the MDMA experience itself, it’s about what you do with it. The whole point is not to need any MDMA.”

Watchorn can attest to that. “In a nutshell, the treatment got me to a place where I could appreciate healthier perspectives and make conscious decisions,” he says. “The MDMA treatment wasn't a ‘cure switch,’ although it initially felt like one. It was a window of opportunity. Integration has been a whole new challenge. These days my focus is on being more present, curious and authentic — and it's making a world of difference.”
 
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Scott Ostrom has suffered from PTSD since 2007.

MDMA passes a big test for PTSD treatment*

A new study shows that MDMA can bring relief when paired with talk therapy to those with severe PTSD.

by Rachel Nuwer | New York Times |3 May 2021

In an important step toward medical approval, MDMA, the illegal drug popularly known as Ecstasy or Molly, was shown to bring relief to those suffering from severe post-traumatic stress disorder when paired with talk therapy.

Of the 90 people who took part in the new study, which is expected to be published later this month in Nature Medicine, those who received MDMA during therapy experienced a significantly greater reduction in the severity of their symptoms compared with those who received therapy and an inactive placebo. Two months after treatment, 67 percent of participants in the MDMA group no longer qualified for a diagnosis of PTSD, compared with 32 percent in the placebo group.

MDMA produced no serious adverse side effects. Some participants temporarily experienced mild symptoms like nausea and loss of appetite.

“This is about as excited as I can get about a clinical trial,” said Gul Dolen, a neuroscientist at Johns Hopkins University School of Medicine, who was not involved in the research. “There is nothing like this in clinical trial results for a neuropsychiatric disease.”

Before MDMA-assisted therapy can be approved for therapeutic use, the Food and Drug Administration needs a second positive Phase 3 trial, which is currently underway with 100 participants. Approval could come as early as 2023.

Mental health experts say that this research — the first Phase 3 trial conducted on psychedelic-assisted therapy — could pave the way for further studies on MDMA’s potential to help address other difficult-to-treat mental health conditions, including substance abuse, obsessive compulsive disorder, phobias, eating disorders, depression, end-of-life anxiety and social anxiety in autistic adults.

And, mental health researchers say, these studies could also encourage additional research on other banned psychedelics, including psilocybin, LSD and mescaline.

“This is a wonderful, fruitful time for discovery, because people are suddenly willing to consider these substances as therapeutics again, which hasn’t happened in 50 years,” said Jennifer Mitchell, a neuroscientist at the University of California, San Francisco, and lead author of the new study.

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Jennifer Mitchell, a neuroscientist at the UCSF, is a lead author of the new study. "In people with PTSD," she said,
"MDMA combined with therapy seems to help the brain process painful memories and heal itself."

But some mental health experts urged restraint. Allen James Frances, a professor emeritus and the former chair of psychiatry at Duke University, who was not involved in the new study, warned that "new treatments are never as wonderful as first they seem.”

“All new treatments in medicine have always had a temporary halo effect by virtue of being new and by promising more than they can possibly deliver,”
Dr. Frances said.

Unlike traditional pharmaceuticals, MDMA does not act as a band-aid that tries to blunt symptoms of PTSD. Instead, in people with PTSD, MDMA combined with therapy seems to allow the brain to process painful memories and heal itself, Dr. Mitchell said.

Critically, MDMA taken in isolation, without therapy, does not automatically produce a beneficial effect.

“It’s not the drug — it’s the therapy enhanced by the drug,” said Rick Doblin, senior author of the study and director of MAPS, a nonprofit research group that sponsored and financed the clinical trials.

For this process to work, a person must be primed to engage with their trauma. Participants first undertook preparatory sessions with two trained therapists. Then in three sessions of eight-hours each, spaced a month apart, they received either an inactive placebo or MDMA. Neither the participants nor the therapists knew which. While most participants correctly guessed whether they received a placebo or MDMA, this did not undermine the study’s results or its methodology, which was agreed to in advance by the F.D.A.

Scott Ostrom, who participated in the study, had suffered from PTSD since returning home from his second deployment in Iraq in 2007. For more than a decade, he experienced debilitating nightmares. “Bullets would dribble out of the end of my gun, or I’d get separated from my team and be lost in a town where insurgents were watching me,” he said.

Mr. Ostrom’s days were punctuated by panic attacks, and he dropped out of college. He pushed friends and family away, and got into an unhealthy romantic relationship. He was charged with assault and attempted suicide. Therapy and medication did not help.

But after participating in the trial, he no longer has nightmares. “Literally, I’m a different person,” he said.

During his first of three sessions in early 2019, lying on a couch with eye shades, and in a lucid dreamlike state, Mr. Ostrom encountered a spinning, oily black ball. Like an onion, the ball had many layers, each one a memory. At the center, Mr. Ostrom relived the moment in Iraq, he said, that “I became the person I needed to be to survive that combat deployment.” Over the next two sessions, Mr. Ostrom engaged with “the bully,” as he calls his PTSD alter ego, and asked permission for Scott to return.

Mr. Ostrom, 36, now works steadily as an HVAC specialist and owns a home near Boulder, Colo., which he shares with his girlfriend, Jamie Ehrenkranz, and his service dog, an English lab named Tim.

“The reason I like calling this medicine is it stimulated my own consciousness’s ability for self-healing,” Mr. Ostrom said. “You understand why it’s OK to experience unconditional love for yourself.”

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“It’s not the drug — it’s the therapy enhanced by the drug,” said Rick Doblin, director MAPS.

Merck pharmacists invented MDMA, which is short for 3,4-methylenedioxy-N-methylamphetamine, in 1912. But the compound was largely forgotten until 1976, when Alexander Shulgin, a well-known psychedelic chemist, synthesized MDMA and tried it himself. Realizing that his discovery could have therapeutic value, Dr. Shulgin shared MDMA in 1977 with Leo Zeff, a psychotherapist who introduced it to other mental health professionals. Over the next eight years, hundreds of therapists and others administered an estimated half a million doses of MDMA. Some reported that, in just a few sessions with the medication, patients achieved an amount of progress that normally took years.

In the early 1980s, however, MDMA escaped from the clinic to the dance floor, where it became known as Ecstasy. In 1985, the Drug Enforcement Administration criminalized MDMA as a Schedule I substance, defined as having “no currently accepted medical use and a high potential for abuse.”

Some mental health professionals continued to administer MDMA-assisted therapy underground, but most stopped. The numbers of scientists who pursued studies with MDMA also dwindled. But a few individuals continued to push strongly on behalf of MDMA research, including Dr. Doblin, who founded his association in 1986 to focus on developing MDMA and other psychedelics into medications approved by the F.D.A. It took nearly two decades to overcome alarmist claims about Ecstasy’s dangers, including that it ate holes in users’ brains, to finally gain approval to begin studies. Research in animals and humans confirms that MDMA produces no neurotoxic effects at the doses administered in clinical trials.

MDMA, on the other hand, can be adulterated with other potentially dangerous substances, and users may take far higher doses than are safe. In 2011, MDMA accounted for 1.8 percent of all U.S. drug-related emergency department visits, according to a database maintained until that year by the Substance Abuse and Mental Health Services Administration. In Europe, MDMA was responsible for 8 percent of drug-related emergency visits to 16 major hospitals in 10 countries from 2013 to 2014.

Scientists still do not fully understand the source of MDMA’s therapeutic effects. The substance binds to proteins that regulate serotonin, a neurotransmitter that can, among other things, lift mood. Antidepressant medications like Prozac bind to these same proteins and block their reabsorption of serotonin, but MDMA takes this process further, causing the proteins to pump serotonin into synapses, strengthening their chemical signal.

MDMA also elevates levels of oxytocin, dopamine and other chemical messengers, producing feelings of empathy, trust and compassion.

But its primary therapeutic effect may come from its seeming ability to reopen what neuroscientists refer to as a “critical period,” the window during childhood when the brain has the superior ability to make new memories and store them. Evidence from a mouse study published in Nature in 2019 indicates that MDMA may return the adult brain to this earlier state of malleability.

An estimated 7 percent of the U.S. population will experience PTSD at some point in their life, and as many as 13 percent of combat veterans have the condition. In 2018, the U.S. Department of Veterans Affairs spent $17 billion on disability payments for over one million veterans with PTSD.

For the approximately half to one-third of people who do not find relief through treatment, PTSD can become chronic, lasting years or even a lifetime.

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Nathan McGee was able to revisit a traumatic memory, assisted by therapists, while on MDMA.
“This allowed me to accept myself and recognize who I am,” he said.

The 90 participants who took part in the Phase 3 trial included combat veterans, first responders and victims of sexual assault, mass shootings, domestic violence or childhood trauma. All had severe PTSD and had been diagnosed, on average, for more than 14 years. Many had a history of alcohol and substance use disorder, and 90 percent had considered suicide. The trial included data collected by 80 therapists at 15 sites in the United States, Canada and Israel.

Albert Garcia-Romeu, a psychopharmacology researcher at Johns Hopkins University School of Medicine, said that "additional research is needed to explore the therapy’s efficacy for people of diverse races and ethnicities, because three-quarters of the trial participants were white. This limitation also underscores," he said, “the importance of accessibility of these types of treatments to people of color and folks with lower socioeconomic status, who already suffer from health disparities and high rates of trauma.”

"But, overall," Dr. Garcia-Romeu said, "the findings “make a clear case for medical approval - something that represents a sea change that could revolutionize health care.”

Nathan McGee, 43, is another example of a patient who benefited from the drug. Since he was a teenager, he has been in and out of therapy and on and off medications for depression and anxiety.

“I was always angry, without cause,” he said. In 2019, Mr. McGee was diagnosed with PTSD stemming from an event that happened when he was 4 years old.

As a trial participant, he first thought that he had received the placebo. But about an hour into his initial session at a study site in Boulder, Colo., a calm awareness settled over him and he felt himself moving inward.

Under the influence of MDMA, and guided by his therapists, Mr. McGee was able to revisit his traumatic memory through the eyes of his 4-year-old self, unclouded by stigmas, adult interpretations or heavy emotion.

“This allowed me to accept myself and recognize who I am,” he said.

Since taking part in the trial in early 2020, he is less easily angered and more able to enjoy the moment.

“I’m continually discovering new things and improving,” Mr. McGee said. “It’s made me really understand what the feeling of joy is.”

*From the article here :
 
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Therapists work with a patient during a trial to determine if MDMA could ease symptoms of PTSD.
A majority of patients were no longer diagnosed with the disorder after the trial ended.

MDMA found to ease symptoms of severe PTSD*

Along with talk therapy, the drug led to some patients no longer having a PTSD diagnosis.

by Laura Sanders | Science News | 17 May 2021

The key ingredient in the illicit drug known as Ecstasy or Molly may offer profound relief from post-traumatic stress disorder. When paired with intense talk therapy, MDMA drastically eased symptoms in people who had struggled with severe PTSD for years, a new study reports.

“This is a big deal,” says Steven Gold, a clinical psychologist in Fort Lauderdale and professor emeritus at Nova Southeastern University in Plantation, Fla. “All other things being equal, the use of psychedelic medication can significantly improve the outcome.”

The results, published May 10 in Nature Medicine, are preliminary. But the findings offer hope to the millions of people worldwide who have PTSD, for whom new treatments are desperately needed. Antidepressants such as Zoloft and Paxil are often prescribed, but the drugs don’t work for an estimated 40 to 60 percent of people with PTSD.

Ninety people participated in the new study, which took place at 15 clinical sites in the United States, Canada and Israel. All the participants received 15 therapy sessions with therapists trained to guide people as they experienced the drug. Half of the participants received MDMA in three eight-hour therapy sessions; the other half received placebos during three eight-hour therapy sessions.

True to its nickname Ecstasy, MDMA evokes feelings of bliss and social connectedness. The participants took the drug (or the placebo) while wearing eye covers and listening to music, and occasionally talking with their therapist about their experience.

On average, the participants improved by the end of the 18-week trial, showing fewer PTSD symptoms such as unwanted, intrusive memories. But the benefits were far greater for people who took MDMA. By the end of the trial, 67 percent of the participants who took MDMA had improved so much that they no longer qualified as having a PTSD diagnosis. Among people who took placebos, 32 percent of the participants no longer met the criteria for PTSD at the end of the study. Those evaluations came from independent clinicians who assessed people without knowing who had taken the drug.

Many of the people in the trial had been living with severe PTSD for years. “Typically, we see PTSD as a disorder for life. Now, we may begin to let that go,” says Eric Vermetten, a psychiatrist at the Leiden University Medical Center in the Netherlands who works with veterans and members of the military with PTSD and was not involved in the new study.

It’s not clear exactly how the drug changes the brain. Some imaging studies suggest that MDMA dampens activity in the amygdala, a brain structure involved in fear. Other results from mice hint that the drug may open a window of heightened social learning, a scenario that may strengthen the relationship between a patient and a therapist.

The study included weeks of therapy before, during and after MDMA sessions. Those sessions required hard emotional work from the participants, says study coauthor Amy Emerson. “MDMA is not a magic pill.” The study was funded by MAPS. Emerson is the chief executive officer of MAPS Public Benefit Corporation in San Jose, Calif., which organized the trial.

Over three-quarters of the participants in the trial were white. Without a more diverse group of people in the studies, it’s not clear whether therapy with MDMA would yield similar effects more generally, says Gold. Nor is it clear how long the benefits might last.

Another clinical trial comparing MDMA’s effects on PTSD symptoms to a placebo is in the works, Emerson says, as well as expanded use of MDMA in clinics. And researchers are following the health of the people in the current study to see whether the improvements last.

For now, the research is complicated by restrictions on MDMA, which remains an illicit drug in the United States. “There are a lot of barriers to break down related to this treatment,” Emerson says. “And there’s a lot of hope.”

*From the article here :
 
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Coming Back to Life | My Story of MDMA-Assisted Psychotherapy for PTSD

by Rachel Kaplan | Psychedelic Frontier

As I sit in a field of tall green grasses, feeling the earth beneath me and listening to the songs of meadowlarks, I am overwhelmed with gratitude for not only being alive but for finally wanting to be alive. I am overwhelmed with gratitude for often feeling a sense of peace in my self and feeling connected with myself, with others and the world. These are all new experiences for me that I never believed where possible until now, after being a participant in the MDMA-assisted psychotherapy study in Boulder.

This last year, after integrating the healing that happened in my MDMA-assisted psychotherapy sessions, has been a drastic contrast to the rest of my life. For the majority of my life I prayed to die and fought suicidal urges as I struggled with complex PTSD. This PTSD was born out of chronic severe childhood abuse. Since then, my life has been a journey of searching for healing. I started going to therapy 21 years ago, and since then I have tried every healing modality that I could think of, such as bodywork, energy work, medications, residential treatment and more. Many of these modalities were beneficial but none of them significantly reduced my trauma symptoms. I was still terrified most of the time. I would have flashbacks that would leave me debilitated, having nightmares, dissociated, and self-harming, and I fought to keep myself alive each day. I had some of the best therapists, but I was so terrified from childhood trauma that my system would not let down its guard enough to let anything from the outside affect it. I was desperate for healing, and felt trapped by my level of fear.

It was this desperation to heal that lead me to enroll in the Boulder MDMA-assisted psychotherapy study. I was terrified to take a medicine that would put me in an altered state, but it was more terrifying not to try it, because I knew that if I did not find a way to heal then I would not have the will to keep living.

When I would go to therapy to try to talk about the memories, I would immediately become numb, and leave my body. In some cases, I would black out and end up curled in a ball, screaming. The MDMA session was the first time that I was able to stay present, explore, and process what had happened to me. This changed everything.

When I would go to therapy to try to talk about the memories, I would immediately become numb, and leave my body. In some cases, I would black out and end up curled in a ball, screaming. The MDMA session was the first time that I was able to stay present, explore, and process what had happened to me. This changed everything.

In my first MDMA-assisted psychotherapy session I was surprised that the MDMA helped me see the world as it was, instead of seeing it through my lens of terror. I thought that the MDMA would alter my perception of reality, but instead it helped me see if more clearly. As I sat with my two incredible therapists in my MDMA sessions it was the first time that I could really let in love, first time that I felt completely safe, respected and fully seen. I was blessed to have two therapists who were authentic, truly cared, and felt love for me. The MDMA allowed me to hone in on the real feelings of care that they had. For the first time in my life, I felt safe enough to let their love and respect into the core of my being. I had the felt experience of being completely vulnerable and seen while at the same time being loved, safe, and respected. This planted the seed in me that it is actually safe to let in love and be seen by other trusted people as well as to let in my own love towards myself. This in itself has transformed how I am in relationships with other people and how I am in relationship with myself. The first couple MDMA-assisted psychotherapy sessions organically ended up being about understanding safety from the inside out, and learning that it was safe to connect to others. After the safety was deepened, I naturally began to process traumatic memories.

For the majority of my life, I had suppressed my memories of trauma and only understood fragments of it through my flashbacks and body memories. I hated myself for having such horrible memories and believed that I was psychotic and just making the memories up. I did this because it was easier to blame myself then to face the pain that these horrible things actually happened. This left me in a state of hating and not trusting myself, which only added to feelings of shame and depression. When I would go to therapy to try to talk about the memories, I would immediately become numb, and leave my body. In some cases, I would black out and end up curled in a ball, screaming. The MDMA session was the first time that I was able to stay present, explore, and process what had happened to me. This changed everything.

I thought that the MDMA would alter my perception of reality, but instead it helped me see if more clearly.

A life-changing moment happened at the beginning of my third MDMA session. There was this horrible feeling of darkness that I felt, and I was afraid to look at it. Part of my intention for this session was to see that darkness clearly, because I knew that it was something that needed healing. After I took the medicine, my therapist gently held my hand. I felt the relaxed support of the MDMA, the safety of the room, and the respect and care of my therapists, and I allowed myself to see what was behind the darkness. What revealed itself was another level of trauma that I had suppressed. As I explained the images that I was seeing to my therapist, she gently put her hand on my arm with so much kindness and named the category of abuse that it was. As I continued to remember horrific things, I was also keenly aware of the safety, love, presence, and respect of my therapists. For the first time, I was able to look at and feel the pain of those memories. As I did this the love and respect that I felt from my therapists was able to touch the darkest memories of my life where I had felt so alone and terrified. It was as if their love entered into those memories and helped the child part of me know that I was loveable and innocent, no matter what had happened to me. Now whenever I think of those horrible things, I am also reminded of the goodness in that room.

That moment will stay with me forever. It gives me faith when I see the horrible pain that happens in the world. I know in my bones the goodness that is possible in people. Being able to fully look and feel my memories enabled me to come back to trusting myself. After a lifetime of thinking that I was psychotic for having such memories, I could finally accept the truth that my mind and body had been trying to tell me my whole life. I could finally honor the truth of what happened to me, and stop fighting against it, fighting against myself. This enabled me to find a sense of peace in myself and inner empowerment in knowing and trusting my truth.

After the MDMA sessions, the integration of the work was often turbulent, since so much healing and change had happened in the last eight hours. After my sessions I often felt emotional waves of deep grief, anger, and fear of being in the world in a different way, as I assimilated new information and explored new ways of living more authentically with myself and others.

So much happened in those sessions that the full integration took me years during which the healing that I did in those sessions built on itself. Before being in the MDMA-assisted psychotherapy study, I lived in my own bubble of fear and was too terrified to recognize that my current life was safe. Like many trauma survivors, I instinctually shut down the part of my brain that integrates sensory input from the outside world. Therefore, decades after the abuse, I still could not see the goodness or safety in my life. I saw everything as dangerous and even life-threatening, no matter what. This only reinforced being stuck in my world of terror. After being in the study, this changed. I started to be able to sense what was actually happening, and I continued to have experiences where I could see that the world might actually be safe, and people might actually have good intentions.

Something extraordinary happened. After a lifetime of being numb and dissociated as a way to cope with pain, I started to feel good physical sensations again. The feeling of the warmth of the sun on my face and the feeling of the cool rushing creek was incredible.

Something extraordinary happened. After a lifetime of being numb and dissociated as a way to cope with pain, I started to feel good physical sensations again. The feeling of the warmth of the sun on my face and the feeling of the cool rushing creek was incredible.

A powerful example of this happened a few months after I had completed the study. I was in my house and suddenly had the most horrible pain in my stomach, which left me on the floor, throwing up, afraid that I was going to pass out from the pain. To make a long story short, I ended up have an emergency open abdominal surgery to remove a grapefruit-sized ovarian cyst, and was in the hospital for a week. I was surrounded by people that I did not know, put under anesthesia, and woke up unable to move, with staples from my pelvic bone to past my belly button. What I was most aware of was that these doctors, nurses, and strangers were fighting to save my life—to keep me safe—and they did not even know me. When I was at my most vulnerable these strangers cared for every part of me. Maybe it was not just my therapists in the study that had such good intentions: maybe the majority of people do? If I had had this surgery before I was in the study, it would have severely re-traumatized me, as I would have felt like all the people around me wanted to hurt me. Instead, the surgery turned into part of my healing. Experiences like this, although not as intense, continued to happen where I could see that there was actually goodness and safety in people.

As I continued to integrate the sessions and heal, something else extraordinary happened. After a lifetime of being numb and dissociated as a way to cope with pain, I started to feel good physical sensations again. The feeling of the warmth of the sun on my face and the feeling of the cool rushing creek was incredible. It reminded me that I was alive, and for the first time I was profoundly grateful to be alive. I can’t even express how deeply grateful I am to be able to feel the world again. I am reminded every day of the gift of feeling sensations as a way to resource and feel connected to others and the world. Three years after completing the study, I am now amazed every day when I realize that I feel a sense of peace in myself. I often wake up with a love for myself, other people, and this earth.

Of course, things are not perfect. I still struggle with a lot of anxiety. I feel devastated by what happened to me and the pain that happens in the world, but I also fully experience the extraordinary love, goodness, and beauty in the world. I am finally able to do things that I have dreamed of forever, like finishing graduate school with a degree in Transpersonal Counseling Psychology and a focus in Wilderness Therapy, going out into the backcountry for a month to do a training to become a rite-of-passage guide, and doing a somatic trauma training to learn how to help others heal from the effects of trauma. After going through this journey, what I want the most is to guide and support other people in their healing. I am not sure exactly how this will look yet, and I am giving myself time to listen to myself and explore the best avenue for me to support others. Even though I am able to do so many more things that I could not previously do, it is the ability to be present and connected in my life that is the greatest gift.

There are no words for the gratitude that I feel. Thank you to everyone who has been part of my healing and to MAPS and its many donors for making this work possible. It is my greatest hope that I can now take what I have been through, and help support others who are in pain. It is also my hope that my story can bring at least a little hope to those in pain, who still believe it is not possible to heal. I know the agony of that place well, and I now know in the core of my being that healing from anything is possible.

 
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Ketamine infusions reduce the severity of PTSD*

by Adriana Feder, MD | Icahn School of Medicine | 5 Jan 2021

Repeated intravenous (IV) ketamine infusions significantly reduce symptom severity in individuals with chronic post-traumatic stress disorder (PTSD) and the improvement is rapid and maintained for several weeks afterwards, according to a study conducted by researchers from the Icahn School of Medicine at Mount Sinai. The study, published January 5 in the American Journal of Psychiatry, is the first randomized, controlled trial of repeated ketamine administration for chronic PTSD and suggests this may be a promising treatment for PTSD patients.

“Our findings provide insight into the treatment efficacy of repeated ketamine administration for PTSD, an important next step in our quest to develop novel pharmacologic interventions for this chronic and disabling disorder, as a large number of individuals are not sufficiently helped by currently available treatments,” says Adriana Feder, MD, Associate Professor of Psychiatry at the Icahn School of Medicine at Mount Sinai and lead author of the study. “The data suggests repeated IV ketamine is a promising treatment for people who suffer from PTSD and provides evidentiary support to warrant future studies to determine how we can maintain this rapid and robust response over time.”

Previous to the current study, Mount Sinai researchers conducted the first proof-of-concept, randomized, controlled trial of a single dose of intravenous ketamine for PTSD, which showed significant and rapid PTSD symptom reduction 24-hours post-infusion. First approved by the U.S. Food and Drug Administration as an anesthetic agent in 1970, ketamine acts as an antagonist of the N-methyl-d-aspartate (NDMA) receptor, an ionotropic glutamate receptor in the brain. In contrast, widely used antidepressants target different neurotransmitters – serotonin, norepinephrine, and dopamine – and can take weeks to even months to work. These drugs are considered ineffective in at least one third of cases, and only partially effective in an additional third.

“The data presented in our current study not only replicates, but also builds on our initial findings about ketamine for PTSD, indicating that in addition to being rapid, ketamine’s effect can be maintained over several weeks. PTSD is an extremely debilitating condition and we are pleased that our discovery may lead to a treatment option for so many who are in need of relief from their suffering,” said Dennis S. Charney, MD, Anne and Joel Ehrenkranz Dean of the Icahn School of Medicine at Mount Sinai and President of Academic Affairs for the Mount Sinai Health System and senior author of the paper.

For the current study, participants were randomly assigned to receive six infusions of ketamine, administered three times per week over two consecutive weeks, compared to six infusions of the psychoactive placebo control midazolam (chosen because its pharmacokinetic parameters and nonspecific behavioral effects are similar to those of ketamine) administered and evaluated over the same schedule. Individuals in this study had severe and chronic PTSD from civilian or military trauma, with median duration of 14 years and nearly half of the sample taking concomitant psychotropic medications. The primary traumas reported by participants included sexual assault of molestation, physical assault or abuse, witnessing violent assault or death, having survived or responded to the 9/11 attacks, and combat exposure. All study participants were assessed at baseline, at week 1 and week 2, as well as on each infusion day by teams of trained study raters who administered the Clinician Administered PTSD Scale for DSM-5 and the Montgomery-Asberg Depression Rating Scale (MADRS), standard rating scales for the assessment of PTSD and depression.


Dennis Charney, MD and Adriana Feder, MD, discuss their research.

Significantly more participants in the ketamine group (67 percent) attained at least 30 percent or more reduction in symptoms from baseline at week two than those in the midazolam group (20 percent). Furthermore, ketamine infusions were associated with marked improvements across three of the four PTSD symptom clusters – intrusions, avoidance, and negative alterations in cognitions and mood. In the subsample of ketamine responders, improvement in PTSD symptoms was rapid, observed 24 hours after the first infusion, and was maintained for a median of 28 days following the primary outcome assessment day. In addition to PTSD symptom improvement, the ketamine group exhibited markedly greater reduction in comorbid depressive symptoms than the midazolam group, which is notable given the high comorbidity of depression in individuals with PTSD. Study findings further suggested that repeated ketamine infusions are safe and generally well-tolerated in individuals with chronic PTSD.

“Future studies may include administering additional doses over time and examining repeated ketamine infusions combined with trauma-focused psychotherapy, to help us determine how we can maintain this robust response over the long term,” added Dr. Feder. “We want people suffering with PTSD to know that hope is on the horizon and we are working diligently to collect the information that will help bring them the relief they so desperately need.”

Drs. Charney and Feder are named co-inventors on an issued patent in the United States, and several issued patents outside the U.S., filed by the Icahn School of Medicine at Mount Sinai for the use of ketamine as a therapy for PTSD.

*From the article here :
 
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Veteran who cured PTSD with MDMA-Assisted Therapy

"This treatment is the reason that my son has a father instead of a folded flag," a once-suicidal Iraq War veteran tells Savannah Guthrie.

by Greg Gilmanon |PSYCHEDELIC SPOTLIGHT | 8 NoV 2021

Just a few days after Psychedelic Spotlight explored the complicated question of whether we’re being exposed to psychedelics more than ever before in the media, NBC’s Today show validated industry insiders’ view that yes, we most definitely are, by giving MDMA therapy for PTSD center stage.

Wow,” marveled the Today team of anchors after watching Savannah Guthrie interview Iraq War veteran Jon Lubecky. He told the NBC anchor that he was once suicidal but no longer suffers from severe PTSD after participating in three, eight-hour MDMA-assisted therapy sessions guided by a team of professionals at the MAPS.

“Every single day, no matter how good or how bad the day was, my brain was trying to figure out how to kill myself,” Lubecky told Guthrie. He said during the 2014 therapy sessions, “I was able to talk about things that I had never brought up to anyone.”

When asked if he still has any symptoms of PTSD, he answered, “No, not at all,” and that he feels “100%” healed.

His experience echoes that of others who participated in a groundbreaking MAPS clinical trial, which showed that MDMA produced no serious side effects, and cured 67 percent of participants from PTSD symptoms.

“If we do succeed with our second Phase-3 study, it means that the whole field of psychedelic psychotherapy has been proven in one instance, and it’s the pathbreaker for the FDA,” said Dr. Rick Doblin, the MAPS founder and executive director, who expects full FDA approval for MDMA and DEA rescheduling by 2023.

“This treatment is the reason that my son has a father instead of a folded flag,” Lubecky told Guthrie when asked for his message to other veterans suffering from PTSD. “I want all of you to be around when this is FDA approved. I know you can make it; I know what your suffering is like. I will tell you, it’s all gone.”

“This seems revolutionary,”
commented Carson Daly, who said he suffers from a panic disorder, which renders him unable to control fear or worry. “It has that potential,” Guthrie added.

Click here to watch the full report, which appears to have awakened the Today team to the incredible benefits that psychedelics can offer society.

*From the article here :

 
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New Clinical Trial Treating PTSD with Psilocybin*

by James Halifax | PSYCHEDELIC SPOTLIGHT | 4 Nov 2021

Compass Pathways has announced the launch of a new psychedelic clinical trial, using psilocybin (the active ingredient in magic mushrooms) to treat PTSD, and there are multiple reasons to be excited about it.

The Phase-2 clinical trial will use Comp 360, Compass Pathways’ proprietary synthetic crystalline psilocybin, paired with talk psychotherapy, in 20 adults who suffered trauma as an adult.

Patients with PTSD in this trial will be given 25mg of Comp 360 psilocybin, which is a large dose and should cause a full psychedelic experience in most participants.

This trial is “open-label,” meaning there will not be a control group. That, paired with the small sample size of 20 participants, limits how much we will be able to extrapolate from the eventual results. This is because we will not be able to separate any perceived benefit of the drug from the placebo effect, and the small population will make finding statistical significance difficult. Nevertheless, if the results come back positive, it will be enough to justify larger-scale clinical trials.

While using psychedelics for mental health may seem controversial, when it comes to the science, psychedelics like psilocybin and MDMA, when paired with therapy have been shown to work.

For example, MAPS recently completed a Phase-3 clinical trial using MDMA therapy to treat PTSD, which showed 67% of people improving so much they no longer qualified to be diagnosed as having PTSD. Another 21% of people improved significantly.

This Compass Pathways trial is exciting because once it is complete, we will be able to compare the results of their psilocybin trial to MAPS’ MDMA trial, to start to have an understanding of which psychedelic compound works better for treating PTSD.



This news comes as we are waiting for the results of Compass Pathways’ Phase IIb clinical trial, testing effectiveness of Comp 360 for Treatment-Resistant Depression, to be released before the end of the year.

The results of that trial will be significant, as it will be the largest ever clinical trial studying psychedelics, with 216 patients. It will also be the most advanced clinical trial studying psilocybin, being in Phase-2b.

In sum, these are very exciting times to be watching Compass Pathways. Controversies surrounding their patents aside, Compass is one of the companies pushing the frontiers of psychedelic medicine, and we’re on the edge of our seat waiting to see where the company goes from here.

*From the article here :
 
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The FDA just expanded access to MDMA as a therapy for PTSD*

by Troy Farah | Jan 21 2020

Under the FDA’s Expanded Access program, more folks can legally get access to medical-grade MDMA for psychotherapy.

The U.S. Food and Drug Administration just made it a lot easier for patients with hard-to-treat post-traumatic stress disorder to use MDMA, a popular rave drug, to treat their condition. Under an FDA program known as Expanded Access, 10 sites across the nation will receive approval to administer the drug under a doctor’s supervision. Just 50 patients will be enrolled, but it could open the door to wider availability of MDMA and give real-world evidence that the drug works as effectively as studies suggest.

The moment MDMA was made illegal in 1985, activists and psychiatrists who saw value in this psychedelic amphetamine immediately began work to undo the ban. One organization formed in this wake was MAPS, the Multidisciplinary Association for Psychedelic Studies, which has funneled millions into clinical trials for MDMA and is expected to make it available for prescription by 2021. Now 34 years after MAPS formed, those aspirations are being realized, at least in part.

On Friday, MAPS announced the FDA had given it permission to enroll PTSD patients who have tried unsuccessfully to treat their condition in MDMA psychotherapy under Expanded Access, sometimes known as “compassionate use.”

It allows patients with serious or life-threatening conditions who can’t participate in clinical trials to try experimental drugs that haven’t yet been FDA-approved. In 2017, the FDA labeled MAPS’s MDMA program a “breakthrough” therapy, granting it a priority review process based on promising results.

MDMA, sometimes called Molly or ecstasy, is in a class of drugs called empathogens, which boost social connectedness, self-love, empathy and euphoria. The drug floods the brain with feel-good neurotransmitters like serotonin and dopamine, while also temporarily extinguishing the brain’s ability to process fear.

For patients with complex, treatment-resistant PTSD, this brief reprieve from the plague of traumatic emotions can allow them to effectively process difficult memories. (To be truly effective, however, the drug typically needs to be combined with therapy. Taking MDMA at Coachella with your buddies probably won’t be as therapeutic as doing the drug with a trained professional.)

The resurgence of research into using drugs such as MDMA to catalyze psychotherapy is the most promising and exciting development I’ve seen in my psychiatric career,” Michael Mithoefer, acting medical director for MAPS Public Benefit Corporation, said in a press release. “Combining the powerful effects of pharmacology with the potential depth of psychotherapy is a compelling model for harnessing advances in neuroscience and psychopharmacology without ignoring the complexity, richness and innate capacity of the human psyche.”

MAPS sees great potential in MDMA-assisted psychotherapy and over the years has undertaken a $26.9 million plan to turn MDMA into a prescription drug. The nonprofit is currently in the final phase of research before the drug is made available to the public, pending the FDA’s blessing. More people taking the drug under clinical supervision could bolster evidence that MDMA works.

After the first 35 patients enroll in the Expanded Access program, MAPS plans to submit its patient data to the FDA so the agency can decide whether or not to broaden the program. One caveat: insurance won’t cover treatment, so patients must pocket expenses themselves. According to DoubleBlind Magazine, the therapeutic treatment may average around $15,000, although MAPS is working with health insurance companies to change that.

The Expanded Access announcement comes the same day as research from the Medical University of South Carolina demonstrated even more efficacy for MDMA as a treatment for PTSD. A review of six clinical trials in four countries found that “MDMA-assisted psychotherapy was significantly more effective at treating patients with persistent PTSD than unassisted psychotherapy,” according to findings presented at the annual meeting of The American College of Neuropsychopharmacology.

Between 6-8 percent of people suffer from PTSD, but for a third of these folks, conventional treatment does not work. Surviving traumatic experiences, such as child abuse or a warzone, can create neurobiological changes in the brain that provoke uncontrollable nightmares and flashbacks, especially after triggers reminiscent of the traumatic event. There are currently only a handful of FDA-approved medications for PTSD, and all have about the same efficacy. New treatments for PTSD are desperately needed, whether it’s MDMA or something else.

We commend FDA for recognizing the great unmet medical need of PTSD by allowing access to MDMA-assisted psychotherapy on a compassionate basis for people with treatment-resistant PTSD,” MAPS founder and executive director Rick Doblin said in a statement. “We are delighted to begin generating real-world evidence about this potential new treatment.”

*From the article here:

 
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