We are the Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit organization studying therapeutic applications for psychedelics and marijuana. Ask us anything!

In terms of the actual neuroscientific processes, do we know exactly how psilocybin "rewires" the brain?

I know that is a very high level question, but when I took a handful of neuroscience classes in undergrad on drugs and behavior (circa 2007), I recall researchers not having a clear answer as to what exact process(es) caused the underlying physical structures in the brain (dendrites, glial cells, etc.) to change and create various new and/or stronger connections in the brain. I believe one theory at the time dealt with psilocybin acting on the glial cells to sort of temporarily weaken them to allow for neuroplastic changes, but I'm about 15 years behind on the literature in this field so I'm curious if you all could shed some more light on this topic. Thanks in advance!

I think Gül Dölen's research about opening the critical period would be good to bring into the answers today 🙂

At the deepest, most complicated level, the octopus paper proved something intellectual but important about psychedelics: the common story of how psychedelics work may be incomplete.

Nowadays, when scientists look at why psychedelics work in the human brain, they use brain imaging studies to identify regions that are activated or dampened during psychedelic experiences. They then tell stories about what happens in, say, the parietal lobe or the nucleus accumbens.

I know I do this. When I talk about how MDMA works and I want to sound smart, I say MDMA quiets down the amygdala or the prefrontal cortex, the part of the brain involved in emotional responses such as fear and cognition.

Gül explains to me that this is not wrong, exactly. MDMA does do those things in humans. But octopuses don’t have an amygdala or prefrontal cortex. And since octopuses apparently “roll” just like ravers do, MDMA must do at least some of its work at the level of molecules. So referring to components of the brain’s structure, such as the “amygdala” or “default mode network,” might not be the best or most accurate—let alone only—way to describe how psychedelics work…

“It doesn’t have to do with my default mode network or my amygdala,” Gül says. “What I say is, psychedelics reopen critical periods, they make an old brain young again, they allow you to go back to that state where you’re receptive to the world like a child.”

—Amy Emerson, Chief Executive Officer (CEO), MAPS Public Benefit Corporation (MAPS PBC)

What can undergraduates do to prepare for employment in the world of psychedelic assisted therapy? - thanks for all that you do!!

The MAPS Student Resources page has many resources that can point you on the right path, including;

• Making Your Mark on the Psychedelic Renaissance
• How Does One Go About Performing Research with Psychedelics?
• So You Want to be a Psychedelic Researcher?

—Bryce Montgomery, Associate Director of Communications and Marketing, Multidisciplinary Association for Psychedelic Studies (MAPS)

These maybe questions better suited for the individuals answering and not MAPS as a whole but....

If you had your druthers what would your ideal drug policy in the US be?

What is the best way to regulate drugs?

Would you consider rebranding the term “harm reduction” to “health and happiness” or another term for reasons described by Dr. Carl Hart in “drug use for grown ups?”

Licensed legalization for all adults with educational requirements for the licenses and punishment for misbehavior under the influence of drugs (for the behavior, not for the drug use), and potential loss of license for a period of time, during an educational period. This would be for people 18+ years old. Use by minors would be forbidden unless their parents approve, so there is a parental override for laws against minors, the same way that 23 states allow parents to give alcohol to their own children.

Honest drug education, training, and peer support, as well as availability of pure drugs, licensed legalization, and treatment on demand would be paid for with tax money.

Great that you mention Dr. Carl Hart. He addressed our staff meeting yesterday and started the 6-month process to join MAPS’ Board of Directors. Now for the substance of your question, “harm reduction” as a term was intentionally chosen. One possible change would be to talk about "risk reduction" which doesn’t inherently imply harm. “Health and happiness” or “benefit enhancement” are more positive and more difficult to be widely accepted, so I don’t know if we’re ready for that rebranding yet. We’re going to be educating the Denver police on how to handle people experiencing challenging mushroom and other psychedelic experiences, since mushrooms are the lowest enforcement priority in Denver. When working with the police, “harm reduction” is a better term than “health and happiness.” Eventually, we would like to talk about “benefit enhancement” as well as “risk reduction.”

—Rick Doblin, Ph.D., Founder and Executive Director, Multidisciplinary Association for Psychedelic Studies (MAPS)

Has microdosing been shown to be an effective method of treating depression and anxiety? R/redlighthollandtrip

In a randomized controlled trial—no.

—Amy Emerson, Chief Executive Officer (CEO), MAPS Public Benefit Corporation (MAPS PBC), and Berra Yazar-Klosinski, Ph.D., Chief Scientific Officer, MAPS Public Benefit Corporation (MAPS PBC)

Studies looking at microdosing for other variables (two studies that I know of) suggest a large role for expectancies.

—Ilsa Jerome, Ph.D., Medical Coder, MAPS Public Benefit Corporation (MAPS PBC)

Hey MAPS thanks for doing this AMA,

I was curious if you use a radioactive tag on a drug to observe what regions of the brain it binds to, how do you know if the tag has no effect on the affinity and efficacy? Or effects the drug receptor interaction.

Many thanks 😊

We aren't doing this type of research currently. I have insufficient knowledge of nuclear medicine or imaging to answer. I presume there are ways in which people test this, but I do not know what they are.

—Ilsa Jerome, Ph.D., Medical Coder, MAPS Public Benefit Corporation (MAPS PBC)

Hello team and thank you for doing this IAmA and groundbreaking work.

Context: People with complex trauma, developmental trauma, CPTSD often re-experience a lot of trauma by simply opening the door of their trauma and I personally can say that I would not have been able to heal with just 3 sessions. Many in the r/CPTSD and r/mdmatherapy communities believe that the 3 sessions protocol isn't enough to help deconstruct the entire self-referential, world-referential constructs that complex trauma engineers for survivors.

• Can you comment on the findings of the clinical trial phase 3 when it comes to developmental complex trauma?

• I wonder if in the future we are going to see some clinical studies that look beyond PTSD and more specifically at Complex Trauma (CPTSD) with a different protocol?

It may be the case that three sessions of MDMA-assisted therapy are not sufficient for certain patients and we're working towards a flexible approach post-approval. However, it is anticipated that in the initial approval, the FDA will most likely agree to an "up to 3 session" model—we need to generate more clinical trial data for a modality to include more doses. However, in our Phase 2 program, we have given more doses.

—Corine de Boer, M.D., Ph.D., Chief Medical Officer, MAPS Public Benefit Corporation (MAPS PBC)

People with complex trauma may also benefit from additional integration sessions. Some of the participants in our Phase 3 trial requested these.

—Allison Coker, Ph.D., Regulatory Affairs Manager, MAPS Public Benefit Corporation (MAPS PBC)

Is rebound depression with MDMA administration ever a concern? If so, is it mitigated with careful observation and counseling?

We have seen evidence of a minor dip in mood two days after MDMA-assisted therapy sessions in our Phase 2 trials, but this has not been at the level of depression. In Phase 3 trials, research participants get phone calls on Day 1, Day 2, Day 4, and every other day or so thereafter to follow up for two weeks after MDMA. In our Phase 3 trial, we found a significant reduction in depression symptoms at the end of the treatment.

—Berra Yazar-Klosinski, Ph.D., Chief Scientific Officer, MAPS Public Benefit Corporation (MAPS PBC)

When will MDMA Therapy be available and how do I sign up to get on those waitlists NOW?

MAPS has launched Phase 3 research into MDMA-assisted therapy for posttraumatic stress disorder (PTSD) at multiple study sites in the U.S., Canada, and Israel. Participants in MAPS trials represent people from diverse backgrounds with historical roots of PTSD originating from various traumas including, but not limited to, interpersonal or sexual violence, childhood abuse and/or neglect, vehicular accidents, combat, and more. The Phase 3 trials are expected to be completed in 2022, meaning that the FDA could approve the treatment as early as 2023. Clinical trials are highly regulated; there are currently limited opportunities to enroll as a study participant. Our study recruitment website is accepting applications for select study sites.   

• Application to the second Phase 3 clinical study: mdmaptsd.org 
• Phase 3 trial listing and specifics on study enrollment and clinical sites: clinicaltrials.gov 
• Study protocol, timeline, and site locations: maps.org/phase3  

Please note: Qualified participants must live within range of each of the clinical sites for the Phase 3 trials of MDMA-assisted therapy for posttraumatic stress disorder (PTSD). Clinical trials are highly regulated by the FDA and we are unable to override the distance criteria or make any exceptions.  

—Bryce Montgomery, Associate Director of Communications and Marketing, Multidisciplinary Association for Psychedelic Studies (MAPS)

Hello! Thank you for doing this AMA.

Congrats on the clinical trial results! I’ve been following the MDMA and psilocybin research pretty closely :)

I wanted to ask- are there potential job opportunities for psychedelic research in the future? What sort of education would be recommended for becoming a researcher in the field?

Thanks for your questions! It’s great to hear of your interest in psychedelic research.

In the past, the stigmatization of psychedelics led to a sense of uncertainty for people who are interested in pursuing psychedelic research, though as we see an expansion of the psychedelic field, there are many ways to get involved!

There are many online resources about which degree may be the best fit for your interests and aspirations, but a general reply is that if you want to focus on clinical work directly with people, consider a Master’s, if you want to focus on research, writing, and publishing, consider a Doctorate. You might also consider the time commitment and cost of each option. MAPS contracts both mental health therapists and psychologists as well as psychiatrists, nurses, and general practice doctors.

It is also important to note that one does not necessarily need to achieve a college or graduate degree to have a successful career in the psychedelic field. It takes some creativity and an open mind, and the psychedelic field will benefit from all individuals with diverse backgrounds, skills, and talents.R. Andrew Sewell, M.D., also provides some insight on this topic in the article “So You Want to be a Psychedelic Researcher?” which is available on the MAPS website.

Best of luck on your journey!

—Whitney Wilhelmy, Communications and Marketing Associate, Multidisciplinary Association for Psychedelic Studies (MAPS)

I have one more question :)

Has MAPS done any research on HPPD? There are some horror stories on reddit (r/HPPD) which are difficult to read and I’m sure scare people off. Wouldn’t it take only 1 of these to happen during a clinical trial to set us back decades (yet again)?

The screening of participants seems very strict for lost studies, and rightly so (history of mental illness, hereditary factors, certain personality traits, even physiological ones), however there seems to be a serious lack of understanding regarding the ostensibly random nature of, dare I say, permanent, HPPD in some individuals.

Is this concern shared, or do you believe it is something else (anecdotal only, caused by other factors, etc)? And if so, what do you believe is going on?

Thanks so much!

It is believed that the risk of developing HPPD in the general population is low.

Some researchers have suggested that LSD is more liable to produce HPPD, but I have read case studies implicating a variety of substances, including MDMA, cannabis, and psilocybin.

—Ilsa Jerome, Ph.D., Medical Coder, MAPS Public Benefit Corporation (MAPS PBC)

Is it at all on the horizon that someday psychedelics could be used in treating OCD, schizophrenia, bipolar disorder?

MDMA or psilocybin might be good for OCD. MDMA might be good for schizophrenia and there is some interest in studying that. Bipolar we are not sure it would be helpful and it will be one of the last things that gets researched because there are so many other promising conditions.

—Rick Doblin, Ph.D., Founder and Executive Director, Multidisciplinary Association for Psychedelic Studies (MAPS)

With your struggles in the court with the DEA, what has been the biggest obstacle?

DEA political leadership that rejects the recommendations of the DEA administrative law judge rulings. It’s the zeal for the drug war that overwhelms the value and interest in science and research.

—Rick Doblin, Ph.D., Founder and Executive Director, Multidisciplinary Association for Psychedelic Studies (MAPS)

If the MAPS clinical trial candidates are ultimately approved and cleared by the FDA for prescription to patients, does MAPS ultimately stand to generate revenue from the medications even as a non-profit organization? Would MAPS sell the rights to these medications to another organization more capable of marketing, distributing, and operating as a pharmaceutical company?

I may be uneducated here but I am not aware of 501c 3s, especially research and education focused, ultimately becoming pharmaceutical sales organizations.

I also may be completely mistaken on how the whole process works.

Thanks for everything you’ve done for the psychedelic community and for patients. Your team should be very proud of the many accomplishments achieved!

Because we don’t think there are any currently existing pharma companies that know how to market psychedelic-assisted therapy, and that we can do a better job, we’ve created the MAPS Public Benefit Corporation (MAPS PBC) that will be the vehicle for which we will sell MDMA at a profit. MAPS PBC is a wholly-owned subsidiary of MAPS. Profits will be used to maximize public benefit, not profit.

You’re exactly right: selling MDMA for a profit is taxable but we didn’t want to do it in a profit-maximizing matter. That’s why we created MAPS PBC.

—Rick Doblin, Ph.D., Founder and Executive Director, Multidisciplinary Association for Psychedelic Studies (MAPS)

I'm a lawyer who works in tech transfer for a major non-profit and I've somehow never run across this type of corporate structure. This is fascinating!

For anyone who doesn't know, a public benefit corporation (i.e., a "PBC" or a "B-Corp") is still a for-profit corporation. However, compared to typical C-Corps and other traditional business formations, B-Corps have much more leeway in pursuing social goals beyond merely maximizing shareholder value (i.e., "shareholder primacy"). For law nerds, this law review article is a great primer on B-corps and their history.

The interesting thing here is that a 501(c)(3) non-profit designated company (MAPS) owns the MAPS PBC (as Rick mentioned). Under the non-profit tax laws, a non-profit organization needs to be "organized and operated exclusively for religious, charitable, scientific" and other specified purposes and will be regarded as doing so exclusively if it only engages primarily in activities which accomplish one or more exempt purposes. An organization will not be so regarded if more than an insubstantial part of its activities is not in furtherance of an exempt purpose. Reg. 1.501(c)(3)-1(d)(1)(ii) provides that an organization is not organized or operated exclusively for exempt purposes unless it serves a public rather than a private interest. Thus, even if an organization has many activities which further exempt purposes, exemption may be precluded if it serves a private interest. Applying the Supreme Court rationale in Better Business Bureau Of Washington, D. C., Inc. v. United States, 326 U.S. 279 (1945), the presence of private benefit, if substantial in nature, will destroy the exemption regardless of an organization’s other charitable purposes or activities.

I won't go much further into the weeds here because these tax laws are super complicated, but the gist is that non-profits can't give benefit to one for-profit company over another (I'm oversimplifying here, but if you're interested in a deeper discussion check out this IRS article)

So what makes this all interesting is that the technologies developed by MAPS will presumably have to be sold, licensed, or otherwise transferred to MAPS PBC. And since MAPS PBC is a wholly-owned subsidiary of MAPS, there is the potential for MAJOR conflicts of interest and subsequent private benefit, which could potentially destroy MAPS's 501(c)(3) designation.

In my opinion, this seems like a pretty crazy threading-of-the-needle with these laws. I'm not saying that MAPS and MAPS PBC are doing or will do anything wrong -- I really have no idea. But as a lawyer who does the tech transfer stuff for a living, this is pretty interesting.

/u/workingatbeingbetter: This educational overview is great!

You may be interested to know that we are currently accepting applications for an In-House Corporate Counsel.

—Bryce Montgomery, Associate Director of Communications and Marketing, Multidisciplinary Association for Psychedelic Studies (MAPS)

So MAPS PBC would sell the MDMA, but clinics like Numinus, Field Trip, and Novamind etc. would be allowed to administer the treatment, correct? I assume MAPS PBC alone will not have the infrastructure to bring the treatment to the masses.

Yes! We are actively working to build a network of trained providers who would be able to administer the MDMA-assisted therapy treatment modality following FDA approval. These providers may work in a variety of settings, including private clinics that may also administer other types of treatments.

We just launched our largest training cohort ever and will have another starting in September.

—Allison Coker, Ph.D., Regulatory Affairs Manager, MAPS Public Benefit Corporation (MAPS PBC)

Who funds your research?

MAPS’ research has been funded by philanthropists and a few foundations. We have never received funding from federal governments. You can see MAPS’ latest giving report in our annual MAPS Bulletin, posted online here: https://maps.org/about/fiscal

—Liana Sananda Gillooly, Development Officer, Multidisciplinary Association for Psychedelic Studies (MAPS)

When do you guys think that these treatments, like psilocybin and MDMA assisted therapy, will be publicly available?

It’s already available now in research and we encourage people with PTSD to volunteer for our research. It will be available in a couple of months on a compassionate basis in Expanded Access and we predict approval for prescription use of MDMA in the first half of 2023. Depending on funding, a year later in Europe, with psilocybin becoming available in 2024/2025.

—Rick Doblin, Ph.D., Founder and Executive Director, Multidisciplinary Association for Psychedelic Studies (MAPS)

Hi friends! :)

Regarding your recent announcement where you will be able to give MDMA to healthy volunteer therapists, do you anticipate being able to use data from this study to show that MDMA can have beneficial effects for individuals without a clinical diagnosis? If so (and assuming the effects show an overall net positive), what effects do you think this could have on psychiatry or the medical system when you're able to show that MDMA can help people that don't "need" it due to an underlying issue?

Our studies to give MDMA to healthy therapists are testing personality change, self-compassion, and other measures. I think this will impact psychiatry by proving the model that psychiatrist and therapists who want to work with their patients with psychedelics would benefit by trying them themselves. I don’t think the study with therapists will lead to broader legalization.

—Rick Doblin, Ph.D., Founder and Executive Director, Multidisciplinary Association for Psychedelic Studies (MAPS)

Can you provide more information of the research being done with psychedelics for ADHD treatment/management?

I am not aware of any studies for ADHD with psychedelics.

—Berra Yazar-Klosinski, Ph.D., Chief Scientific Officer, MAPS Public Benefit Corporation (MAPS PBC)

What are some of the questions in psychedelic research you'd like to see answered that are not being addressed today? Of course medicalization is an excellent path forward to begin with but what else would you like to see in the coming years?

For starters - More careful examination of setting components, such as music, lighting, self-selected vs experimenter-selected art/objects - do these things make therapy better or worse, and in healthy controls, what effects do they have?

Studies that specifically examine the effects of psychedelics and entactogens in people with disabilities, especially sensory-related ones (blind, deaf)

(If this is even feasible) differences in brain 5HT2A receptor distribution in individuals affecting subjective effects (experience, phenomenology) and outcome in a treatment (therapy) setting

Is the "closeness to others/prosocial" effect of MDMA seen across all, many, or only some cultures?

Do effects of psychedelics and MDMA remain the same or differ across the menstrual cycle (psychological, endocrine, efficacy)?

—Ilsa Jerome, Ph.D., Medical Coder, MAPS Public Benefit Corporation (MAPS PBC)

Do you think that growing and using your own psychedelics should be legal, or at least decriminalized?

Absolutely, yes. I am actually the originator of the “Grow, Gather, Gift” meme popularized by Decriminalize Nature!

—Ismail L. Ali, J.D., Policy, Advocacy & JEDI Counsel, Multidisciplinary Association for Psychedelic Studies (MAPS)

A few questions, pick whichever:

1. Where do you believe the line to be between the placebo effect and psychedelics? Rick had mentioned on a podcast a few months ago that he sees the placebo effect becoming big time relevant in the next 50+ years. Curious to hear more on that.
2. Do you see a future in America where psychedelics are used to treat illnesses that live mostly in the body? (I.e. the way ayhuasca has been claimed to cure major diseases)
3. Does the loose concept of a brave new world not scare you? That MAPS and the subsequent future you're fighting for implies a world of potential social control where the people who sit with the patient might subconsciously be leading that person to think more like them? Or a world where the patient develops an existential reliance on the power structures (and/or medicines) that are providing them "healing"?
4. Do you see a difference between "man-made" drugs and "plant-medicines"? MDMA and LSD versus ayahuasca and psilocybin, for example. On one hand I want to subscribe to the "man is nature, what we make is nature, everything is in balance" argument. On the other hand, I have a hard time finding trust in lab-grown compounds as it relates to the ethics of potential future unknowns given my (and millions of other's) experiences with SSRIs and other compounds for maladies of the mind that did not work and had potentially damaging side effects.

Thanks. Love you and this long, strange trip.

Where do you believe the line to be between the placebo effect and psychedelics? Rick had mentioned on a podcast a few months ago that he sees the placebo effect becoming big time relevant in the next 50+ years. Curious to hear more on that.

We will hopefully eventually learn how to mobilize our own immune system to fight disease willfully rather than through placebo, thinking we’ve been given something. We’ve had several instances where people received placebo in our research and acted as though they had a full MDMA experience and fooled very experienced therapists. At other times, I’ve found I’ve slipped into an MDMA state without taking MDMA. I’ve also had dreams where I’ve been tripping but hadn’t taken LSD before falling asleep. Hopefully, over time, we’ll learn how to generate these states of mind on our own, but that’s a massive accomplishment. Especially for the classic psychedelics. It may take over 50 years.

​

Do you see a future in America where psychedelics are used to treat illnesses that live mostly in the body? (I.e. the way ayhuasca has been claimed to cure major diseases)

Yes. There is a lot of interest in mind/body illnesses like Fibromyalgia, irritable bowel syndrome, Crohn's, pain, even recovery from stroke could potentially be helped.

Does the loose concept of a brave new world not scare you? That MAPS and the subsequent future you're fighting for implies a world of potential social control where the people who sit with the patient might subconsciously be leading that person to think more like them? Or a world where the patient develops an existential reliance on the power structures (and/or medicines) that are providing them "healing"?

Those are important things to be concerned about. The essence of our therapeutic approach is to help people heal themselves, to support them where they’re going, and to empower them to think and feel for themselves. The power dynamics of therapy are very important to examine and keep ensuring it’s about empowering the patient.

​

Do you see a difference between "man-made" drugs and "plant-medicines"? MDMA and LSD versus ayahuasca and psilocybin, for example. On one hand I want to subscribe to the "man is nature, what we make is nature, everything is in balance" argument. On the other hand, I have a hard time finding trust in lab-grown compounds as it relates to the ethics of potential future unknowns given my (and millions of other's) experiences with SSRIs and other compounds for maladies of the mind that did not work and had potentially damaging side effects.

I don’t see a difference. It’s true that for some plant psychedelics, we have thousands of years of history, and synthetic psychedelics are new. Even LSD is less than 85 years old. However, our ability to evaluate side effects has never been better, with our advances in technology. Plus, some plants are poisonous. Let’s evaluate psychedelics by their outcomes, not by their origins.

—Rick Doblin, Ph.D., Founder and Executive Director, Multidisciplinary Association for Psychedelic Studies (MAPS)

First off, thank you (read: entire staff) for continuously shining a light on the remaining mysteries around psychedelics, having to work around their legal status.

I fondly remember the podium discussion with Mrs. Booher - and, of course, Mr. Doblin in the audience - at the Psychedelic Science Panel Event in Vienna early last year, back when an audience member could still try to squeeze between dozens of collegues to snatch the chance of shaking both of your hands. Since then, inspired by the event, I myself have found an opportunity to contribute a very tiny little bit towards a potential therapeutic future of hallucinogens (psilocybin, specifically).

Towards that point: In most countries, unlike legal drugs, recreational use of hallucinogens is always perceived as (criminal) abuse. Due to the increased public awareness of the potential to achieve incredible therapeutic effects (thanks, Dr.Google), a lot of people find it hard to accept to wait many years until a legal therapeutic scheme can be developed and instead increasingly turn towards a non-professional application (speaking of Germany, Switzerland and Austria).

1. if it was up to you, how would the legal therapeutic procedure for treatment resistant depression, PTSD, OCD, schizoid symptoms and all the other conceivable applications for hallucinogens look like, considering the ever widening schism between the socioeconomic classes, higher incidence of psychological afflictions in those lower rungs and probable high costs or barriers?
2. I`ve seen Mr. Doblin answering similar questions in previous AMA`s, but, again, regarding a likely future necessity for safe environments in case of national decriminalisation (as we`ve seen in the states of Denver, Colorado and Oakland) or even legalisation and the following interest of possibly thousands or millions of people; if you had the chance to have a place at the political discussion table, how would you design a recreational option for relatively harmless drugs e.g. MDMA or Psilocybin? Or would you prefer decentralised, informal opportunities, even in the absence of trained "tripsitters"?

​

Thank you so much for your work, time and patience. If I had managed to squeeze past my collegues last year, this post would probably have been far shorter.

Thanks for your questions!

A baseline goal and hopefully a governmental directive in all jurisdictions is public safety and the individual safety of all people who use drugs. There are perhaps innumerable nuanced approaches to achieving such safety goals with regard to psychedelics (e.g. basic and clinical research to create risk profiles of the drugs people use; drug decriminalization and legal and accessible drug checking to end the cycle of harm of criminalization and reduce harms of unregulated markets; legal regulation of drug markets to insure safe supplies and any additional necessary oversights given the contexts of the market; etc.) and we don't believe there is a single framework that meets every need and has therefore proven itself above all others. Some people seeking relief from serious psychological ailments will require the strict regulation, intensive multidisciplinary care, and defined structure of a medical delivery framework (e.g. FDA- and EMA-approved). At the other end of the spectrum, some people will benefit from safe adult use of psychedelics, absent those infrastructure and institutional requirements.

—Leslie Booher, J.D., M.B.A., Policy and Advocate Associate, Multidisciplinary Association for Psychedelic Studies (MAPS)

Because of this variation in need and infrastructure, and the opportunity for us to build out novel approaches to transition out of drug prohibition toward decriminalization and legal access, we support a variety of strategies and believe in evidence-based adaptation and iteration to find the best fit for different communities and jurisdictions.

Learn more in the MAPS Bulletin article “Beyond Oregon: A New Drug Policy Horizon in the U.S.”

—Ismail L. Ali, J.D., Policy, Advocacy & JEDI Counsel, Multidisciplinary Association for Psychedelic Studies (MAPS)

How do you prevent individuals with anxiety from having a bad trip? In the psychadelic community people often talk about set and setting, I always thought that having anxiety is a bad “set”, but your research proves otherwise.

MAPS’ Zendo Project provides professional comprehensive harm reduction education and support for communities to transform difficult psychedelic experiences into opportunities for learning and growth. Neither MAPS nor Zendo Project encourages the use of illicit substances, though we are dedicated to providing educational information.

The Zendo Project’s four principles of psychedelic harm reduction are:

• Create a safe space
• Sitting, not guiding
• Talk through, not down
• Difficult is not bad

More information and support resources are available at zendoproject.org/resources

—Whitney Wilhelmy, Communications and Marketing Associate, Multidisciplinary Association for Psychedelic Studies (MAPS)

Any ideas how principles might one day translate to treating teens with PTSD/depression/anxiety? From what I understand mj is believed to be harmful to youths development, it seems this growing population of youth suffering from mental health issues could benefit in some way.

Three years after we gain approval in adults, we will conduct trials on adolescents with PTSD. If this turns out to be safe and effective, we hope that teens can be helped one day with MDMA-assisted therapy. These trials are complicated and have to be conducted very carefully in this age group.

—Berra Yazar-Klosinski, Ph.D., Chief Scientific Officer, MAPS Public Benefit Corporation (MAPS PBC)

Additionally, these trials with adolescents are required by the FDA when researchers are seeking approval in adults.

—Amy Emerson, Chief Executive Officer (CEO), MAPS Public Benefit Corporation (MAPS PBC)

Do you have any advice for mental health counselors who want to get involved in this line of work?

Check out the training programs of the sponsors of MDMA and psilocybin research. Considering getting involved in providing therapy with ketamine. Have your own experiences with psychedelics. Read The Way of the Psychonaut by Stan Grof.

—Rick Doblin, Ph.D., Founder and Executive Director, Multidisciplinary Association for Psychedelic Studies (MAPS)

Do you believe that psychedelics as a whole will follow the path of Medical Cannabis as a slow, state by state acceptance while remaining a federal grey area, or is there hope that these clinical trials and the broad acceptance of medical MJ have the potential for federal rules to actually act first this time?

Federal rules will go first for medical uses through the FDA. There is no need for state-by-state uses. However, even for medical uses, approved by FDA and DEA, states still need to reschedule, but the federal government must go first. This is for insurance coverage, so even though we have the Oregon Psilocybin Initiative, those treatments are not covered by insurance. Oregon Psilocybin Initiative was justified on the basis of federally approved research. For decrimalization and various forms of legalization for psychedelics, reform will begin on the city and state level and only slowly filter up to federal. We predict a decade of psychedelic clinics will be needed before federal licensed legalization of psychedelics, currently predicted in 2035.

—Rick Doblin, Ph.D., Founder and Executive Director, Multidisciplinary Association for Psychedelic Studies (MAPS)

Why did MAPS decide to work with Numinus out of all the other psychedelic companies?

This is a non-exclusive collaboration. We are not limiting ourselves from working with other psychedelic companies.

—Berra Yazar-Klosinski, Ph.D., Chief Scientific Officer, MAPS Public Benefit Corporation (MAPS PBC)

How can I pursue a career with your organization? The study of psychedelic medicine is a huge passion of mine and I've earned my degree in chemistry, working for MAPS is one of my longtime dream jobs.

We are currently hiring! Visit maps.org/careers to explore opportunities.

—Bryce Montgomery, Associate Director of Communications and Marketing, Multidisciplinary Association for Psychedelic Studies (MAPS)

Another question. The model of MDMA assisted therapy with two therapists present the whole time is just a experimental setting or it will be the way it'll work in the clinical practice?

This model sounds expensive (two therapists dedicated exclusively to one pacient for up to 8 hours) and therefore will not be available to everyone who needs it

One of our top priorities to ensure access, irrespective of ability to pay, is to get the treatment covered by insurance.

—Joy Sun Cooper, Head of Commercialization and Patient Access, MAPS Public Benefit Corporation (MAPS PBC)

Hello,

Thanks for doing this AMA.

Can you tell us more about the cardiovascular risk of taking Ibogaine? The molecule seems to often have astounding effects on addiction, curiously rather specifically. But as I read, risk of sudden cardiac death, and other serious cardiovascular complications, is real. is there a way to screen out patients ineligible for the procedure? And what is your take on the risk/reward profle?

Thank you

Great questions! Although MAPS has not conducted clinical trials involving ibogaine, there is some information available through observational studies and published literature.

Opioid use disorder has a high level of mortality risk. Available treatments such as methadone maintenance also have the risk of QT interval prolongation which can lead to sudden death. Ibogaine is typically administered a limited number of times and would present a reduction in risk levels compared to available treatments and the indication itself.

More information about ibogaine research is available on our website: maps.org/research/ibogaine-therapy

—Berra Yazar-Klosinski, Ph.D., Chief Scientific Officer, MAPS Public Benefit Corporation (MAPS PBC)

I've wanted to work for MAPS for a decade as I am a huge proponent of the research being done, but my skills are in audio visual technology (collaboration tech, telemedicine etc), business management, and project management.

How can I get involved to benefit the organization as a whole, and thereby indirectly support and benefit your research?

We are currently hiring and we are always accepting new volunteers! By subscribing to MAPS emails, you can receive the latest updates about opportunities to support our work.

—Bryce Montgomery, Associate Director of Communications and Marketing, Multidisciplinary Association for Psychedelic Studies (MAPS)

First of all, thank you all for everything! Especially to Rick!

So as far as I know, 2023 is the targeted year when MDMA will be fully approved by the FDA. When do you think this will happen in Europe, especially in Germany?

Do you have to start all over with the Phase-I/II/III trials for the EMA or can you just copy-cat the FDA trials?

We don’t need to replicate Phase 1 and 2 because EMA will accept that data. EMA will also accept our Phase 3 data, but we’ve been asked to do one 70-person Phase 3 study in Europe. Interestingly, we’ve been asked to include refugees and migrants in that study.

—Rick Doblin, Ph.D., Founder and Executive Director, Multidisciplinary Association for Psychedelic Studies (MAPS)

Will MAPS open psychedelic assisted therapy centres in future?

We believe that potential FDA approval of MDMA-assisted psychotherapy for PTSD will be followed by regulatory approvals around the world. This will be followed by the establishment of thousands of psychedelic clinics with therapists cross-trained to provide therapy assisted by MDMA and other psychedelics, including ketamine and psilocybin, as other sponsors obtain approval from regulators. Eventually, in a post-prohibition world, there could be a licensed regulatory system for adults to legally access psychedelics to take on their own without supervision by therapists with access to minors only with permission from their parents or guardians.

—Rick Doblin, Ph.D., Founder and Executive Director, Multidisciplinary Association for Psychedelic Studies (MAPS)

Am seeing right now that Tom Daschle was just brought in as a Special Adviser for Field Trip. What is MAPS's position on these sorts of strategic alliances with former pols - common in cannabis but only beginning for psychedelics? Is MAPS planning for any similar synergies?

MAPS is a non-profit charitable organization, and because of that status, we are prohibited from applying significant resources towards efforts to lobby and/or influence governmental outcomes. Therefore, we stand to benefit less from the revolving political/industry door and instead focus our efforts on the development and support of evidence-based public policy and research which we share through education and relationship building. MAPS has built and nurtured relationships with regulators, politicians, and other members of the federal and local governments over the years, to unlock permission to conduct studies from the FDA and more recently from the Department of Veterans Affairs (VA). MAPS has also recently advised Senator Scott Weiner on legislation he is proposing for the decriminalization of drugs in California. More policy work will be required to obtain state-level rescheduling of MDMA after FDA approval, so more synergies with government agencies will be required.

—Fede Menapace, Director of Strategy, Multidisciplinary Association for Psychedelic Studies (MAPS)

Do you see street MDMA being rescheduled at a federal level? Or will we have a Dronabinol/THC sort of scheduling?

The FDA does not have the authority to ask the DEA to reschedule a non-approved substance, so MDMA could be rescheduled at a federal level, but the FDA approval alone won’t do it—it’d have to happen through an act of Congress or a separate, affirmative regulation by DEA. The Dronabinol/THC scheduling (also known as bifurcated scheduling) seems likely, in my opinion.

—Ismail L. Ali, J.D., Policy, Advocacy & JEDI Counsel, Multidisciplinary Association for Psychedelic Studies (MAPS)

—Leslie Booher, J.D., M.B.A., Policy and Advocate Associate, Multidisciplinary Association for Psychedelic Studies (MAPS)

What became of your initiative with Dr. Lyle Cracker (sp?) of the University of Mass. Amherst to establish an experimental cannabis growing operation to provide an alternative to the CSA designated monopoly schwag grow at the University of Mississippi, which was once denied IIRC.

Although we can’t share any specifics about the details of Professor Craker’s application at this time, we are hopeful and acknowledge the shift represented by the news of DEA moving forward with at least a handful of additional domestic manufacturer applications, including one for our close collaborator Scottsdale Research Institute (home of Sue Sisley, Principal Investigator on MAPS’ cannabis studies).

—Ismail L. Ali, J.D., Policy, Advocacy & JEDI Counsel, Multidisciplinary Association for Psychedelic Studies (MAPS)

Hello! Is there any research being done right now regarding addiction cessation with psychedelics? I feel like a few years ago there were numerous reports of psychedelics being used to aid the healing of alcoholism, as well as plenty of anecdotal experiences from trippers, but lately that doesn't seem to be the case (as far as I know). I absolutely love the work being done with mental health and psychedelics, but as a casualty of the nicotine vaping crisis, one of my biggest points of interest personally is how psychedelics can be used to help those suffering from addiction. It's my dream one day to be able to go to a psychedelic psychotherapy clinic and finally make real progress in quitting nicotine, but even with things like ketamine therapy in my state, addiction cessation isn't an option. Thank you in advance!

MAPS has completed two observational studies of the long-term effects of ibogaine treatment on patients undergoing therapy at independent ibogaine treatment centers in Mexico and New Zealand.

We also completed an observational study that investigated the safety and long-term effectiveness of ayahuasca treatment for individuals suffering from addiction and dependence.

A recent study (not sponsored by MAPS) investigated MDMA-assisted therapy for alcoholism, which led to promising results.

—Bryce Montgomery, Associate Director of Communications and Marketing, Multidisciplinary Association for Psychedelic Studies (MAPS)

Hi MAPS!

I have a couple of questions for you.

How do you plan on training therapists and educating the public on the different types of psychedelic treatments when they become more readily available?

Will there be a standardized screening process to help determine candidates for psychedelic treatment? Will it be similar to those used in your studies?

Thanks for doing this, keep up the great work!

How do you plan on training therapists and educating the public on the different types of psychedelic treatments when they become more readily available?

The MDMA Therapy Training Program is our primary method of training therapists. We are exploring how our plans for commercialization can be optimized to simultaneously support public education. In addition to our platforms for public communication, such as our website, emails, and social media, we are thankful that prominent coverage from mainstream media is supporting public education about psychedelic science.

—Bryce Montgomery, Associate Director of Communications and Marketing, Multidisciplinary Association for Psychedelic Studies (MAPS)

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Will there be a standardized screening process to help determine candidates for psychedelic treatment? Will it be similar to those used in your studies?

In a post-approval treatment, MDMA will have an approved label, which will indicate any contraindications, medication interactions, and warnings as a part of the FDA review and approval process. This will be based on the findings from the studies in our clinical development program. We also anticipate MDMA will have an Approved Risk Evaluation and Mitigation Strategies (REMS) which will help to ensure that the benefits of a drug outweigh any risks. Together, the labeling and the REMs will help to screen patients to ensure that MDMA-assisted therapy is only administered to patients that it will be safe for.

In a clinical trial, not only do we screen participants for safety criteria, but some of the criteria and trial design are intended to support the ability to detect a difference in effectiveness due to the confines of a Phase 3 clinical trial. These types of selection criteria will not be necessary in a post-approval landscape.

—Allison Coker, Ph.D., Regulatory Affairs Manager, MAPS Public Benefit Corporation (MAPS PBC)

How do you do a placebo control group in a experiment with psychedelic as the grupo who received placebo will notice they aren't tripping?

Blinding is a challenge in most psychiatric clinical trials, where physiological effects of the medication can provide clues to research staff and patients that can reveal treatment assignment and introduce bias, including SSRIs.

It was originally believed that low dose MDMA would be the ideal control condition and a series of Phase 2 studies with a range of low doses were conducted in an attempt to demonstrate this point. Analysis of blinding surveys in these studies indicated that administration of a low dose of MDMA (25, 30, or 40 mg) could improve blinding (though more so for the patients than for the therapists). Unfortunately, therapy with low-dose MDMA was less effective than therapy with inactive placebo: unanticipated anxiogenic effects were associated with low-dose MDMA as a comparator and most participants receiving 25 or 30 mg MDMA reported increased anxiety and difficulty tolerating the sessions. Many of these participants also reported difficulty in managing their PTSD symptoms after each of these low-dose MDMA sessions.

Using therapy with low-dose MDMA as a comparator in Phase 3 would therefore have inappropriately advantaged the therapeutically active dose of MDMA. As a result, the FDA and the sponsor (MAPS) came to agreement in the SPA process that evaluating whether there was a statistically significant difference between the groups was more important. In addition, using therapy with inactive placebo as an active control made the safety analysis more meaningful since all adverse events and side effects in the control condition were not confounded by the low-dose MDMA.

The strategy of separating safety data collection from endpoint assessments is currently the best available option among many unsatisfying choices to adequately blind clinical trials with MDMA. Although complete blinding is always a challenge with powerful and immediate psychotropic agents, when subjects were contacted to inform them of their treatment assignment at the time of study unblinding, it became apparent that some had inaccurately guessed their treatment arm. Although anecdotal, at least 7 of 44 placebo participants (15.9%) believed they had received active drug, and at least 2 of 46 MDMA participants (4.3%) believed they had received placebo. This unplanned observation has been noted in the limitations section of the manuscript.

This Phase 3 trial is part of a clinical development program that is guided by methodology selected by FDA in the context of an FDA Special Protocol Assessment process. Methodological design and approach to blinding measures were agreed upon in advance with the FDA and also met the standards of EMA through a Scientific Advice process.

—Allison Coker, Ph.D., Regulatory Affairs Manager, MAPS Public Benefit Corporation (MAPS PBC)

Hello and thank you!

I am hoping to begin a process of self-education along with my formal undergrad training in biology. Can you guys provide links to particular websites which have access to relevant research papers? Are your papers available on your website for review?

Additionally, I am looking to have a broad understanding of these drugs, and how they impact the body/psychology. I want to study the important relevant topics but with a specific focus on psychedelics, and would love some recommendations for specific resources (books, PowerPoints, other educational materials) to get started. This would include things like basic mycology, neurology, chemistry, relevant psychology, anthropology, etc.

Anything and everything you'd be willing to share would be immensely helpful, and I'm sure there have to be books out there which bring many of these disciplines together.

Thanks again for the AMA and also the wonderful work you're all doing!

Can you guys provide links to particular websites which have access to relevant research papers?

The Psychedelic Bibliography on our website is a great resource for exploring research papers.

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Are your papers available on your website for review?

Yes: maps.org/resources/papers

​

I am looking to have a broad understanding of these drugs, and how they impact the body/psychology. I want to study the important relevant topics but with a specific focus on psychedelics, and would love some recommendations for specific resources (books, PowerPoints, other educational materials) to get started. This would include things like basic mycology, neurology, chemistry, relevant psychology, anthropology, etc.

Erowid is a great resource for this pursuit: erowid.org

—Bryce Montgomery, Associate Director of Communications and Marketing, Multidisciplinary Association for Psychedelic Studies (MAPS)

Naive question, but is it even possible to use a placebo control when studying psychedelic drugs, given that it's very obvious whether you have ingested it or not? If not, what control groups are used when studying these drugs?

And thank you for your years of work, you are personal heroes of mine.

A similar question was answered here.

What about HPPD? I've seen polls here on reddit about it and up to 30% of psychedelic users have noticed HPPD symptoms, including me, I have full fledged HPPD after trying psychedelics ~5 times over the span of a couple months.

Do patients who want therapy with these therapeutic drugs just have to risk it? There's no known treatment for HPPD at the moment, almost nobody is researching it or looking for a cure. Do you think MAPS will ever do research on it? This might be controversial or downvoted, but I believe that HPPD is not as rare as people think.

A similar question was answered here.

Has the remote training coordinator position at MAPS PBC been filled yet? I applied in early April and have not heard back yet.

Thank you so much for your interest! The hiring team is in the final stages of selecting candidates for the interview process. If you are selected, we will reach out to you directly.

—Jamelia Avalos, Human Resources Manager, MAPS Public Benefit Corporation (MAPS PBC)