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

I'm a drug and alcohol counselor. I currently work in a methadone/buprenorphine clinic in Minnesota. My question to you is, who and how should these therapies be administered by? Psychiatrists, Psychologists, or me as a Licensed Alcohol and Drug Counselor?

We are still developing the requirements for the team that would be responsible for administering these therapies post-approval. From a risk management point of view, we would probably need a psychiatrist to oversee drug administration and safety, who would work with a team of psychologists and counsellors to conduct the psychotherapy component.

-Berra Yazar-Klosinski, Ph.D., Clinical Research Scientist MAPS

It would seem strange to me to have someone guiding me through the experience when they themselves haven't used MDMA.

Hi Will, A major component of our development of MDMA as a medicine is concomitantly developing a training program for potential therapists and treatment providers. This program includes participation in a Phase 1 healthy volunteer study of MDMA, where the trainee is administered MDMA in a therapeutic context.

-Ben Shechet, Clinical Research Associate, MAPS Public Benefit Corporation (MPBC)

A question about contributing to the field of drug policy was deleted. Here is a response:

The best way to contribute to the field of drug policy would be to start small— I recommend applying to volunteer with MAPS, or look into ways you can help organizations like Students for Sensible Drug Policy (SSDP) or the Drug Policy Alliance.

MAPS may have new internship opportunities available in the near future, so I recommend signing up for our monthly email newsletter to hear about new opportunities to contribute.

-Bryce Montgomery, Web and Multimedia Manager, MAPS

Have you done any work on microdosing or low-dose LSD? A bit of a hot topic lately.

Yes, the media attention surrounding microdosing LSD and psilocybin has been exciting to follow! MAPS is not currently sponsoring any research into the risks and benefits of microdosing. Funding for this work is limited, so we have to be very intentional with how we spend the money that we have.

I believe that medical microdoses of psychedelics will be a legal prescription treatment option within my lifetime, though it may take a while.

To learn more about this subject, I recommend starting on reddit! Check out /r/microdosing.

-Bryce Montgomery, Web and Multimedia Manager, MAPS

I've started a chapter of SSDP at my school, and we're currently planning a local Global Psychedelic Dinner, in efforts to raise some support for your phase 3 trials.

I've read from a lot of different sources that this type of work often isn't enough to support stable living, how accurate is this statement, and if this is the case, what type of hobbies and skills seem to benefit this field the most?

Thank you so much for your support, and especially for hosting a Global Psychedelic Dinner! Which SSDP chapter are you a part of?

I think a passion for knowledge is the best trait that will benefit people involved in this field. I hope everyone involved in this field has a stable living situation, though I can't speak for everyone! We're doing fine at MAPS.

-Bryce Montgomery, Web and Multimedia Manager, MAPS

Does the risk of mental disorder raise the more you use psychedelic substances or is it nearly proven at this point that a pre-existing condition must be involved? I generally hear/read the latter but I figure I'd ask the people actively doing studies.

Sorry if this question is off topic thank you.

This is not off-topic at all. It is an interesting question.

There is good evidence that pre-existing conditions are related increased risk of mental disorders. The short answer with respect to increased risk with increased use is that increased use may have effects in some instances and conditions but not others - separating out "increased use" from whether a pre-existing factor was involved to start with. I am basing my answers on studies of classic psychedelics (LSD, psilocybin) and MDMA, with which I am most familiar. I know there is also literature on cannabis and that it is complex and a long-standing question. Key point is that most to nearly all studies are "retrospective" and make it hard to sort out causality.

There is even a report that failed to find a link between psychedelic use and mental illness or suicidality. On the other hand, some conditions, like post-hallucinogen persisting disorder (continued visual or perceptual alterations) may increase with increased use of psychedelics. Likewise, though it appears that people who take up repeated ecstasy use (ecstasy being material purported to be MDMA) start out more likely to be anxious, it also may be true that anxiety or depression are greater in people reporting heavy use.

Sample readings:

Psychedelics not linked to mental health problems or suicidal behavior: a population study.

Psychological and cognitive effects of long-term peyote use among Native Americans.

Abnormal visual experiences in individuals with histories of hallucinogen use: a Web-based questionnaire.

Mental disorders in ecstasy users: a prospective-longitudinal investigation.

Psychiatric disorders and their correlates among young adult MDMA users in Ohio.

-Ilsa Jerome, Ph.D., Research and Information Specialist, MAPS Public Benefit Corporation

• Why not use the MDMA from the previous trials?

• Why an entire kilogram? That's a lot of MDMA

The MDMA used in previous trials is pure and stable, but it was not manufactured following Good Manufacturing Practices. FDA and EU regulations stipulate the use of drugs manufactured using GMP. This process includes not only controlling features of the laboratory but also includes documenting every step of the manufacture and source of all materials. Hence to conduct Phase 3 trials internationally, we need GMP MDMA.

We need MDMA for hundreds of subjects receiving up to 3 sessions that can include initial and supplemental doses of MDMA.

-Ilsa Jerome, Ph.D., Research and Information Specialist, MAPS Public Benefit Corporation

Psychedelics can certainly be a very sharp double edged sword.

Besides Erowid’s Fundamentals of responsible Psychedelic Use, what else can be said about best practices that can help us journey safely and in a way that enhances life? How can we, or should we even, make these ideas and practices integral to a psychedelic renaissance?

Great question! The MAPS mission is to develop medical, legal, and cultural contexts for people to benefit form the careful uses of psychedelics and marijuana. In my opinion, the word careful is the most important.

The set (mindset/psychological state) and setting (physical surroundings) can be some of the most influential factors on the psychedelic experience. Doing some self-exploration prior to the experience, knowing your psychological state, and setting an intention help influence the set. Having a familiar, safe place that you feel comfortable in helps create a beneficial setting.

The MAPS Treatment Manual (specifically section 1.2) describes how these principles and others are integrated into the current research for MDMA-assisted psychotherapy for PTSD.

Another thing to keep in mind is that the journey doesn’t end when the effects of the substance wears off. The integration process can be one of the most beneficial (and sometimes challenging) parts of the experience. This means taking what you’ve learned and experienced under the influence of the substance and working it into your everyday experience of how you live your life. That’s why we’re studying psychotherapy with the assistance of psychedelic substances. It’s not just the psychoactive effects of the medicines that make a difference, but using these powerful tools as an aid to healing!

-Merete Christiansen, Executive Assistant to Rick Doblin, Ph.D., MAPS

MAPS is committed to looking into the potential benefits and risks of psychedelic substances. While our studies with MDMA-assisted psychotherapy are progressing and showing good results about the potential benefits of this modality, we are also aware that people are taking psychedelics at parties and festivals without the kind of support they would get in a therapeutic setting. The Zendo Project is MAPS’ psychedelic harm reduction effort. Knowing that people are using psychedelics recreationally, the Zendo Project offers needed support at music festivals around the globe.

There are four principles to psychedelic harm reduction: creating Safe Space, Sitting not Guiding, Through not Down, and Difficult is not the Same as Bad. You can read more about them on the Zendo Project website and view the full Zendo Project Training Manual.

These four principles go beyond helping someone in a psychedelic crisis at a music festival, they outline a way for us to treat each other well. We can all promote safety, validation, acceptance, and meeting challenge. Psychedelics have a unique way of inviting a person to face themselves and others but these values go beyond the hours the substance is working in the body.

Psychedelic experiences are influenced by the set and setting. Set is mindset, a person’s mental state. This considers a person’s mood, what is happening in their life at the time, how are they feeling about taking a psychedelic, etc. The setting is the environment, the people around, noises, smells, what is happening in the area, the situation, etc.

The Erowid article outlines some safety measures. At the Zendo Project, we also pay attention to resources like water, shade, comfortable place to sit or lay down, snacks, sunscreen. We work closely with medical services at events and often collaborate with them to check in on a person when we are concerned about their biological safety.

In addition to physical comfort and safety and substance concerns, the mindset of a person influences the journey. We also have a phrase in the Zendo Project: Trust, Let Go, Be Open. It can be an intention for a journey or a mantra or reminder throughout an experience.

You may also be interest in the Psychedelic Explorer’s Guide by James Fadiman, PhD.

-Shannon Clare Petitt, Executive Support and Harm Reduction Coordinator, MAPS

Along with Erowid, you guys were selected to get a chunk of donations from reddit a while back. How'd you use it? Was it significant?

Also, I thought I'd share this lecture on the effects of psilocybin. Its quite interesting.

You guys do great work! Keep it up.

Receiving a donation worth over $82,000 from reddit was definitely significant! We typically work a long time on receiving such large donations, though this donation came as a complete surprise to us. We didn't think we were going to win— we even stopped campaigning and shifted our support toward Erowid!

The donation was used toward our research into MDMA-assisted psychotherapy as a treatment for PTSD, as well as general support.

Again, thanks to every person who voted for MAPS during reddit donate! One of the highlights of my career was contributing to this campaign, especially seeing the reddit Snoo logo wearing a MAPS shirt: http://imgur.com/BQnGGlh

-Bryce Montgomery, Web and Multimedia Manager, MAPS

What psychedelics would you say people should avoid?

This is in some sense a hard question to answer, since for nearly any psychedelic substance, you are bound to find someone who loves it and someone who hates it. That said, Borax (below) is probably right, in that the NBOMe series have been linked to a number of adverse reactions in people, and can be lethal in doses that would fit on blotter paper. I would also say that although there are people who enjoy them, the DOx series (DOB, DOI, etc.) can have some unpleasant physical effects, and last much longer than many people are willing to endure--DOB can last for up to 24 hours.

-Ben Shechet, Clinical Research Associate, MAPS Public Benefit Corporation (MPBC)

I do not encourage drug use, though I acknowledge the realities of drug use.

I think people should avoid ingesting substances if they have not seen the results of a reagent test. Illicit drugs can often contain unexpected adulterants, and may not even be the drug that you were told it is. Drug testing kits can be bought online from harm reduction organizations such as DanceSafe or Bunk Police.

-Bryce Montgomery, Web and Multimedia Manager, MAPS

Hi there! So glad you're doing this work! Have you guys studied psychedelics and Borderline Personality Disorder? As someone who has it, I'm always interested in new therapies that might help me cope. Thanks!

We currently exclude BPD from our clinical trial protocols. This is because we are still figuring out how the treatment works in specific populations. Treating people who have both Borderline PD and PTSD is significantly more difficult than just treating PTSD, and it makes determining the efficacy of the treatment more difficult as well. Having multiple diagnoses is very challenging to live to with and to treat. We anticipate that we can do more studies after MDMA-assisted psychotherapy is approved for PTSD to further explore new indications.

-Berra Yazar-Klosinski, Ph.D., Clinical Research Scientist, MAPS

Hey guys,
First I'd like to thank you for your awesome job in research and helping treatment of people with all kinds of ailments with these drugs.
My questions for you are:
What are your thoughts on the EmmaSofia project that have as goal the production of legal LSD and MDMA.
In April UNGASS 2016 will be held and I was wondering the following. If you had the opportunity to hold a speach for all visitors there. What would you say to all of them?

I’ll actually be at UNGASS, and we’ve applied to speak. Here (attached) is one of our submission papers stating our recommendations in detail, but in summary:

1. Ground drug scheduling in scientific research.
2. Actively promote and protect unbiased research by ensuring access to controlled substances for medical and scientific purposes.
3. Recognize cannabis as an essential medicine.
4. Prioritize health and safety, and decriminalize all drugs. Encourage regulatory frameworks to oversee non-medical substances, including both NPS (Novel Psychoactive Substances) and currently illicit substances.

One of the most interesting highlights: did you know that MDMA was scheduled internationally in 1985, based on research with MDA, not MDMA, in rats? And, the chair of the Expert Committee responsible for the scheduling, Paul Grof “felt that the decision on the recommendation should be deferred awaiting, in particular, the data on the substance’s potential therapeutic usefulness and that at this time international control is not warranted.” [emphasis added] So, I also plan to remind the audience at the UN that they have failed to listen to their expert committee’s recommendations to encourage therapeutic research with MDMA; MAPS is responsible for the only therapeutic MDMA research at this time.

-Natalie Lyla Ginsberg, Policy and Advocacy Manager, MAPS

How far away do you think we are to having full legal protection for using MDMA or LSD? Is there any other reason why it's not being funded as much other than big Pharm knowing that their current business model is basically hooking people on drugs rather than curing them?

Our goal is to develop MDMA-assisted psychotherapy into a Food and Drug Administration (FDA)-approved prescription treatment for PTSD and other conditions by the year 2021, which would provide new legal treatment options.

Schedule 1 drugs are deemed as having no medical value, which makes it more difficult to initiate and conduct studies into their potential benefits. We are developing clinical research that may provide evidence in favor of these substances having medical value. The government tends to favor funding research into the negative effects of Schedule 1 drugs, so we rely on donations from the public and grants from foundations.

-Cara LaChance, Web and Multimedia Assistant, MAPS

We anticipate having FDA and DEA approval for MDMA-Assisted Psychotherapy as a legal prescription treatment for PTSD in 2021. At that time, people suffering form PTSD would be able to go to an approved clinic and have this treatment administered by trained therapists. Showing that these substances have medical value, and that the risks associated with using them can be mitigated is the first step on a long journey toward legalization. Once it is shown that these substances have benefits for people suffering from psychological disorders, hopefully it will open the doors further for looking into how psychedelics can benefit those who we consider to be healthy individuals as well.

-Merete Christiansen, Executive Assistant to Rick Doblin, Ph.D., MAPS

Hi there,

Thank you for your service. To keep it short, is there any REAL evidence that the use of MDMA damages your serotonin receptor system and makes it difficult to produce/process serotonin in the brain naturally afterwards?

Thanks!

Short answer: Yes, there is evidence for reduced serotonin transporter in people reporting heavy ecstasy use. Evidence for this occurring in people reporting moderate use is less strong. Nearly all of the support comes from "retrospective" studies, meaning that these studies looked at the brains of people who chose their substance use paths. These studies often do not match groups for substance use overall. One study looked at brains of people who intended to use ecstasy and later, after some had done so and others had not, and this study found no reduction in serotonin transporter, but a study in the same sample did find some difficulties with learning and memory. The findings re serotonin receptors to date have focused on 5-HT2A receptors, with some studies using radioactively tagged drugs and finding an increase in detectable 5-HT2A receptors.

Longer answer: Studies in rodents and monkeys find reduced brain serotonin transporter. Most studies suggested that heavy but not moderate Ecstasy users had impaired verbal memory and lower numbers of estimated serotonin transporter (SERT) sites, assessed via imaging with radioactively labeled ligands in PET or single photon emission tomography (SPECT), with heavy use often defined as 50 or more times or tablets. Except for a single prospective (before use/after use) study, most studies look at people after they have used ecstasy, at one or more times. There isn't a consensus about "heavy" use but several studies use reporting taking 50 tablets or times of use as demarcation between "moderate" and "heavy" use.

There is a long history of this research being conducted for many years, making it hard to refer to even some of the studies involved.

There are now several reviews on the topic of serotonin transporter imaging, with one concluding that there is evidence for reduced SERT sites (in studies of mostly heavy users) and one failing to find evidence for changes in brain activity in moderate users."

So the answer to this question somewhat hinges on what is intended by "real" evidence. The reports and findings are real. There are potential qualifiers, such as degree of use. The study methods used have problems, some of them major. A cautious and accurate response is that there are many studies supporting this claim, at least / especially in people reporting heavy rather than moderate use. Evidence for this being a risk for low to moderate use, as occurs in our studies, is minimal but can never be stated as non-existent.

Here are a few readings to view if you are still interested:

Neuroimaging in moderate MDMA use: A systematic review.

Meta-analysis of molecular imaging of serotonin transporters in ecstasy/polydrug users.

A prospective cohort study on sustained effects of low-dose ecstasy use on the brain in new ecstasy users.

-Ilsa Jerome, Ph.D., Research and Information Specialist, MAPS Public Benefit Corporation

Let me begin by saying that I am highly skeptical of the value of recreational psychedelic experience, particularly when it is compared to the value of mindfulness practice, such as meditation.

How do you articulate the value of the recreational psychedelic experience? How can you measure whether the experience is in fact valuable enough to be defended? If it were the case that the value of the psychedelic experience was purely neutral (it didn't tend to make people's lives better, it didn't tend to make people's lives worse), would it still be worth advocating for legalization?

Hi Captain Sock,

Nice to hear from you again...I enjoyed interacting with you in our last AMA. This is more my personal perspective than that of MAPS (we've all got different ways of looking at these kinds of questions), so take it as such. I would say that 'by their fruits ye shall know them' is the gold standard for evaluating extraordinary experiences, psychedelic or not. Does the experience allow you to open, to let go of things that have been causing you suffering, to move in the world in a way that is more harmonious and in alignment with who you really are? Or does it just become another set of beliefs ("everything is love" or "we are all one" can be direct experiences, or they can be conceptual structures) that bind and restrict our experience of life? Both have certainly happened as a result of people using psychedelics. I think it's one thing to hold people accountable for their actions that ensue from certain experiences, and it's entirely another to tell people 'we've determined that this subset of experiences--even if they don't impinge upon another's rights--are not ok for you to have.' There is something that doesn't sit right with me about legislating that certain aspects of an individual's subjectivity are off-limits.

-Ben Shechet, Clinical Research Associate, MAPS Public Benefit Corporation

Thank you all SO much for the work you do!

I have used both Ayahuasca and Iboga in ceremonial settings, and these are things that absolutely deserve to have an organization working to ensure that they are better understood. The amount of help and hope that my Iboga/Ayahuasca ceremonies have given me over the past year has been absolutely immense, it would be absolutely heartbreaking to not see these medicines available for those that need them any more than they are already unavailable, or further criminalized and taken away from future generations.

What do you see as the future for psychedelic based treatments for addiction/psychiatric treatments in the future? Much of the current structure for the proper use of Iboga and Ayahuasca is heavily ceremonial and involves a lot of spiritual elements. It's hard for me to imagine these parts of the treatment being recreated in a clinical setting with, or without traditional healers. That said, is there research that shows these elements of the treatments are important/influence efficacy?

If so, do you see the future of psychedelic medicines (at least for specifically Iboga/Ayahuasca) being based on referrals to traditionally trained healers, or traditional training being included as a specialization of the psychiatric/medical profession?

Working with addiction is a passion of mine and I am rooting for more research on psychedelics for the treatment of substance abuse. Luckily there have already been some trials looking into this condition. MAPS sponsored an Ayahuasca-Assisted Therapy for Addiction study in British Columbia with PI Gerald Thomas, published in 2013.

This was an observational study working with people who participated in ayahuasca ceremonies. I do not know of any specific research that compares ayahuasca ceremony to ingesting the brew without the ceremony. You may be interested in this article, Bring Ayahuasca to the Clinical Research Laboratory.

As ayahuasca has been a part of a religious practice, many people feel that it should not be removed from its traditional ritual use. Many researchers have not pursued clinical trials with ayahuasca since it is available in certain contexts under the Religious Freedom Restoration Act.

As for other trials with addiction…

The Heffter Research Institute is completing a study looking into psilocybin as a treatment for alcoholism.

Michael Bogenshutz, MD, of the NYU School of Medicine has several publications on the use of psychedelics for addiction.

MAPS has conducted two observational studies of the Long-Term Efficacy of Ibogaine Therapy, used for opiate addiction. Ibogaine treatment is legally available in Canada and Mexico. Since it can be lethal it is important to include medical supervision for people receiving treatment. The Global Ibogaine Therapy Alliance formed to create standards of care and inform the public about ibogaine treatment.

Currently the main focus of MAPS’ clinical work is on MDMA-assisted psychotherapy for chronic, treatment-resistant PTSD, working towards FDA approval of this modality as a legal prescription medicine. After this MAPS is likely to continue clinical work on other conditions and psychedelic substances. MAPS often researches conditions that affect large populations and have devastating impact with poor treatment options. 22 veterans commit suicide each day. We hope to be a part of the solution for these issues facing our society. Addiction is certainly another one.

-Shannon Clare Petitt, Executive Support and Harm Reduction Coordinator, MAPS

Fantastic answer, thank you!

I do have a follow up question though, I notice that both in this answer and on your website that all material referee to Ibogaine and not Iboga. Has the difference in efficiency between the full Alkaloid version of Iboga versus the isolated alkaloid in Ibogaine been studied?

Evan, I am not an expert in Ibogaine and have not been able to locate any research comparing TA (Total Alkaloid) Iboga to Ibogaine HCL. There is a trend in Western medicine and science to use isolated compounds and chemicals. Often when a person is studying a substance with approval by the FDA or the equivalent, the agency asks the researchers to choose one or a couple of isolated compounds to research. Studying whole plants in Western medicine is difficult since plants are organic and will vary in alkaloids and other compounds from batch to batch. Using a whole plant also makes it difficult to say which of the ingredients is producing the mechanism for action (there are usually many active ingredients in a single plant).

Sometimes when an active component of a plant is isolated, it can produce more predictable and sometimes stronger results. One Ibogaine clinic in Canada states they believe Ibogaine is better suited to addiction treatment whereas TA Iboga fits with people seeking spiritual growth and not battling addiction.

GITA has brief articles on both Iboga and Ibogaine, including a note that the Iboga plant may currently be over-harvested. More research and understanding of the risks and how to prevent them will be necessary as will a sustainable approach to sourcing the plant.

-Shannon Clare Petitt, Executive Support and Harm Reduction Coordinator, MAPS

Hi Evan,

Because the ibogaine studies we have been working on are observational (meaning we are collecting data from clinics that are already providing treatment, rather than providing treatment ourselves), we haven't been able to study these differences effectively. Some clinics administer pure ibogaine HCl, and some providers use the total alkaloid. We don't have a sufficient N yet to do a real comparison of efficacy between the two.

-Ben Shechet, Clinical Research Associate, MAPS Public Benefit Corporation

How much did your previous kg of MDMA cost? Such a shame that it can't be used for Phrase 3 trials, despite being super pure already.

And which company is going to produce the new one, now that Nichols lab is no more?

Hi Roionsteroids, Our previous batch of MDMA cost ~$4,000 to synthesize in 1985, so we are looking at a 100-fold increase, mainly due to certification and documentation requirements in the GMP manufacturing process. The manufacturer will be a UK-based firm called Shasun.

-Ben Shechet, Clinical Research Associate, MAPS Public Benefit Corporation (MPBC)

Why is it so expensive? The World Drug Report states that US MDMA retail prices range from $15,000 to $32,000 per kilogram.

Quality might be a bit lower I guess, but still...

In order for something to qualify as GMP-certified, every single step of the process must be certified, from the equipment used for manufacture, to the precursor chemicals, to the process itself. The cost of all of this documentation and certification is quite steep, hence the price tag. It's not really related to the physical costs of manufacture, but rather the cost of establishing that it has been manufactured to the FDA's standards.

-Ben Shechet, Clinical Research Associate, MAPS Public Benefit Corporation (MPBC)

I know a woman who took MDMA and during the afterglow her communication with her 5 year old child was extraordinary. The child seemed to have opened more, started asking questions and remembering things he never did before. He seemed to feel the effects of the drug without taking it. Do you have information if this could be used in treatment of children with difficult early psychological traumas - the mother takes mdma and starts talking with the child?

Hi there,

This is really fascinating, and points to something we often overlook in our day-to-day experience--that we are far more sensitive and attuned to other people than we realize, and children are especially sensitive in this regard, as they have yet to engage in the kind of psychological armoring that comes as a result of trauma. A major part of children feeling secure is their ability to stay 'in sync' with their caregiver, so if the caregiver is able to be open, empathic, and loving, the child will attune to and mirror that, and likewise, if the caregiver is anxious, angry, or judgmental, the child will learn to mirror that as well. It also points to the fact that, while this kind of empathic opening is often facilitated by MDMA, it's not created by the drug. We just sometimes need a bit of help remembering that we have that capacity within ourselves all the time.

I think from a purely investigative standpoint, what you propose could be helpful, but I also think there would be major concerns on the part of regulatory authorities about placing a child in an environment where the parent is in a substantially altered state of consciousness.

-Ben Shechet, Clinical Research Associate, MAPS Public Benefit Corporation

As someone who is currently working towards a major in chemistry and then a doctorate in pharmacology, do you have any advice for someone looking to do similar research to MAPS?

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?

I firmly believe that you would find a lot of value in attending major events surrounding the scientific and medical potential of psychedelics and marijuana. You're invited to join us for MAPS 30th Anniversary Banquet and Celebration in Oakland, California on April 17, 2016, and for Psychedelic Science 2017 in Oakland, California from April 19-24, 2017. These events are great because you will often be able to connect with the most significant psychedelic researchers, and meet people that you may want to collaborate with in the future.

-Bryce Montgomery, Web and Multimedia Associate, MAPS

Can psychedelics help social anxiety? and how?

We are currently conducting a clinical study into MDMA-assisted therapy for social anxiety in autistic adults. Here is some of the anecdotal research that inspired us to conduct this trial:

"Co-investigator Alicia Danforth, Ph.D., gathered 100 surveys, 90 anecdotal reports, and conducted interviews with 24 individuals on the autism spectrum who have taken Ecstasy, a street drug purported to contain MDMA, in non-medical settings. A majority of these individuals reported the experience to be helpful in their learning to cope more effectively in social situations. From a list of commonly reported MDMA effects:

• 72% of survey respondents (N=100) reported experiencing “more comfort in social settings,” with 12% indicating that the change lasted over two years.
  
• 78% of respondents reported “feeling at ease in my own body,” with 15% experiencing this effect for over two years.
  
• 77% reported “easier than usual to talk to others,” with 18% reporting that the effect lasted up to a year or longer.

These anecdotal reports suggest that MDMA may be a suitable pharmacologic agent for the treatment of social anxiety in autistic adults and warrants further investigation in a randomized controlled clinical trial.

The information above is from mdma-autism.org.

-Bryce Montgomery, Web and Multimedia Manager, MAPS

Have you co-ordinated which countries (or even study sites) that phase 3 will take place yet? What do you anticipate will be the entry route, e.g. self-referral or referral from counselling or psychiatric services?

I remember reading that the Wellcome Trust wouldn't fund any of the research due to reputational risks. The FDA is on board but do you think you'll face resistance from other international regulatory bodies (e.g. MHRA) for approval in other countries, once the studies are completed?

Yes, we are planning on coordinating with EMA for our second Phase trial, and also possibly submitting data from our first Phase 3 trial to them. We are hoping to have a couple international sites for our first Phase 3 trial (possibly in Canada and Israel). We don't expect resistance, as we will design our studies to be compliant across regulatory agencies, and move forward in concert with all of them.

-Berra Yazar-Klosinski, Ph.D., Clinical Research Scientist, MAPS

Hi, thank you for the amazing, vital work you're doing. I wanted to ask: does MAPS distinguish between (Complex)-PTSD- trauma sustained over a long period (like childhood abuse and neglect), and PTSD from a single traumatic event, or a more short-lived period of time (like being involved in horrific car crash)? I read that C-PTSD isn't officially recognized in the DSM-5, but it seems to be gaining ground among psychologists and patients. It also seems to be somewhat fundamentally different from PTSD. I might be incorrect, but that's just my observation. Thanks again!

Hi there, For the purposes of enrollment in our studies, we don't distinguish between single-event PTSD and complex PTSD, and we have enrolled subjects with both kinds of trauma backgrounds. And you're right, complex PTSD can be more challenging to treat, but we are finding people who respond well to treatment in both groups. And for what it's worth, it's interesting to note that even in our study that was specifically targeted at combat veterans, first responders, etc. (i.e. people with more 'event specific' trauma), most participants found themselves working with traumatic childhood events as well. So those categories may not be as cut and dried as they seem on the surface.

-Ben Shechet, Clinical Research Associate, MAPS Public Benefit Corporation

Hey MAPS! Firstly, I'd like to say how much respect I have for your organization and the people it employs. I think psychedelics have the potential to be a very powerful tool in many situations. Thanks for doing this AMA, and please keep up the great work.

1. What are your thoughts on analogues of psychedelics, such as 1p-lsd or 4-Aco-Dmt? . It's my understanding (and my pharmacology prof) that due to a very similar structure, these substances likely possess very similar pharmacodynamics as their mother molecule. Is this accurate?

2. How would one get involved in an organization such as yours? I'm very interested in pharmacology, and may pursue it as a graduate degree, but currently, I'm in molecular biology.

I think there’s a certain disadvantage to working with analogues, in that so much basic research has already been done on ‘classic’ psychedelics, which lets us investigate more interesting applications.

With analogues, there’s all this basic mechanism of action and safety stuff that needs to be done before we can even really start to look at applicability.

-Ben Shechet, Clinical Research Associate, MAPS Public Benefit Corporation

Transgender people in general have been shown to exhibit much higher rates of anxiety and depression as well as suicide than the general population. We also tend to struggle with dysphoria, self-acceptance, and body image issues. Have you considered MDMA-assisted psycotherapy studies for those of trans identity struggling with any of the above issues? How do you see MDMA-assisted psychotherapy playing a role in helping this specific population? We are required to work closely with therapists and psychiatrists in order to gain access to HRT and gender-affirming surgeries (as well as general mental health dealing with above issues), and I am earger to know if any thought is given to exploring the topic in your circles.

Thank you so much for this very important question. I am happy to report that we indeed have been thinking about how to develop a pilot study focused on PTSD in transgender populations, and I’m actually meeting with a Professor from the UCSF Center of Excellence for Transgender Health today to discuss this potential pilot study.

I believe MDMA therapy holds tremendous potential for trans populations, and if you are interested in helping us work to develop this study please email me: natalie (at) maps (dot) org

-Natalie Lyla Ginsberg, Policy and Advocacy Manager, MAPS

Let me say first that I see MAPS doing good work, but questions:

(1) Many societies that incorporate hallucinogen use have been extremely violent, have incorporated violence and psychedelics simultaneously (eg Aztecs) or at least have not given up war/tribal violence/gender violence - so are people who expect a world of peace via psychedelics being naive ?

(1b) If not, why not ? Or is it not a concern or responsibility of MAPS ?

(2) There was successful work on shell shock sufferers in hospitals during world war 1 (eg. Craiglockhart War Hospital, Scotland), and the military saw successful treatment as a reason to send troops back to the front. Will this happen with latterday PTSD treatments ?

(2b) If not, why not ? How would you stop it ?

Thanks.

Interesting questions.

Your first points to the fact that psychedelic experiences are very sensitive to context and intention--psychedelics used in the context of cultural rituals that are oriented toward violence are very different than those used for healing purposes. I think it's worth noting that there is still a lineage of healers working with psilocybin in Mexico, long after the Aztec empire has disappeared. I also think you're right that to expect psychedelics to be a panacea for the whole world's ills is not an expectation grounded in reality. But they can certainly be a part of a cultural shift toward greater openness, compassion, and sensitivity to each other.

We certainly hope that our work will not be used to justify greater risk to human life. On the whole, at least in modern times, psychedelics have tended to reduce people's willingness to take part in institutionalized violence. We have not enrolled any active duty servicepeople in our studies thus far, and I agree that the issue does raise some ethical concerns. I would be concerned about helping someone to open up, then allowing them to go right back into a potentially traumatic life situation.

-Ben Shechet, Clinical Research Associate, MAPS Public Benefit Corporation

If you don't mind (and I appreciate you may not have time to answer all this), but your point "I would be concerned about helping someone to open up, then allowing them to go right back into a potentially traumatic life situation." is something I have been wondering about. Do we know that psychedelics will always make people sensitive to traumatic situations ? I may lack the correct anthropology reading here, but didn't the priests of South American cultures perform human sacrifice time after time, almost as a career, in conjunction with psychedelic plants (Moche etc.) ?

Presumably they weren't too traumatised by this to carry on. So why not ? Most people would think cutting live people up while under the influence would be a bad trip, but is this always the case or can it actually be a facilitator if the motivation is there to continue ? I don't expect that study to pass an ethics board any time soon, but we do have historical account so i wonder if that tells us what is possible ?

Thanks.

It's less a concern about psychedelics, and more about the dynamics of healing trauma. First of all there is some evidence to suggest that undergoing early life trauma predisposes individuals to developing PTSD in response to trauma later in life--there seems to be some sort of cumulative effect, although the mechanism isn't known. So perhaps individuals like I hypothesized above would be more susceptible to re-traumatizing themselves. But beyond that, PTSD symptoms are actually an adaptive response to violent or unsafe circumstances--hypervigilance is quite useful when people really are trying to hurt you. To help someone peel away their psychological defenses, and then return them to the environment that engendered them in the first place seems borderline cruel to me.

-Ben Shechet, Clinical Research Associate, MAPS Public Benefit Corporation

I am a documentary filmmaker who wants to get involved in helping MAPS push forward in its amazing cause. Any advice/tips/connections you could offer?

Thanks for your offer to help us spread our message! The world definitely benefits from having more well-produced content about this field of research. I recommend immersing yourself by going to local events, or by starting events on your own. I also recommend strengthening your education about psychedelics and marijuana so that you can become a more knowledgable ally.

Please send us an email to askmaps@maps.org and we can talk about potential opportunities to collaborate.

-Bryce Montgomery, Web and Multimedia Manager, MAPS

Why should I use you instead of GPS?

Our work is largely focused on the exploration of minds and emotions, not roads.

-Bryce Montgomery, Web and Multimedia Manager, MAPS

GPS will get you there physically, MAPS will get you there internally.

-Cara LaChance, Web and Multimedia Assistant, MAPS

Hey, MAPS, I donate to you guys, and encourage others to!

Can you tell us what's next specifically with the MDMA research? What's next from here, and is medicalization by 2021 really realistic? I'm here in Boulder, where I believe the MDMA-PTSD study just wrapped up, and I hope you all are successful in this historic effort; MDMA is amazingly well-suited for people with severe trauma, for sure.

MAPS is currently wrapping up six Phase 2 FDA-approved clinical trials that investigated MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder. Data from all of these studies are being analyzed by our statistics team and prepared for presentation to the FDA at our End of Phase 2 meeting that is planned to take place in summer of 2016. The results are confirming findings of the first pilot study (Mithoefer et al. 2011, http://www.ncbi.nlm.nih.gov/pubmed/20643699) with large effect sizes for MDMA-assisted psychotherapy in reducing PTSD symptoms, and minimal adverse effects from the treatment. Participants in these studies had chronic PTSD brought on by a number of different traumatic events, including childhood abuse, war, sexual assaults, and accidents, and we have found that MDMA in conjunction with therapy and non-drug integration sessions profoundly improved the quality of life of individuals independent of the cause or duration of PTSD.

MAPS is intensely working on plans for Phase 3 trials where intend to open approximately 7-10 study sites world-wide to enroll approximately 400-500 subjects. Many of the details won't be finalized until we meet with the FDA to discuss our plans and come to an agreement about the number of subjects needed for approval of MDMA as safe and efficacious pharmacological adjunct for therapy. MAPS is on target for our projected timeline of making MDMA into legal medicine by 2021, and we are enthusiastic to bring rigorous scientific evidence to medical professionals and the public to support the utility of MDMA therapy as a treatment strategy for PTSD.

-Alli Feduccia, Ph.D., Clinical Trial Leader, MAPS Public Benefit Corporation

Phase 3 trials where intend to open approximately 7-10 study sites world-wide to enroll approximately 400-500 subjects.

Can you tell us, where these locations are going to be?

We are in the midst of discussions and interviews for Phase 3 site selection. Two of our established Phase 2 sites, Boulder and Charleston, are highly likely to be Phase 3 sites. We have a number of exceptionally qualified therapists who have applied to be investigators for Phase 3 studies and we are having to make some really hard decisions, considering a number of factors, for where the sites would be best suited.

I can say they will be spread out geographically across the US, Canada, and possibly Israel and Europe to draw cultural and racial diversity in our study population. Some locations under consideration, in no particular order, are Vancouver, Fort Collins, San Francisco Bay area, Boulder, Charleston, New Orleans, Boston, New York, Los Angeles, Baltimore, Austin, and Montreal.

-Alli Feduccia, Ph.D., Clinical Trial Leader, MAPS Public Benefit Corporation

So cool! What do you think would help elevate your cause? Treating conditions with pyschodelics is still widely taboo, so what is it that could help to create more of a norm?

This question is one of the main reasons we decided to encourage people to host or attend a Global Psychedelic Dinner! Establishing an open, honest conversation about positive and negative experiences is one way to reduce the stigma. Here’s the “Conversation Menu” for the dinners, a complication of conversation suggestions that we thought would stimulate open, honest conversations.

Educating the public honestly about the risks and benefits of these substances is another way to reduce stigma. When people are able to make informed decisions, they’re more likely to engage in using these substances in a responsible way. Much of the stigma that exists today was perpetuated by fear and misinformation. Conducting rigorous scientific research to gain a more clear understanding of the safety and efficacy of these substances will help provide a basis for education.

-Merete Christiansen, Executive Assistant to Rick Doblin, Ph.D., MAPS

Hello! Thank you for taking the time to spread awareness and answer others questions!

I have a question regarding the studies being done, and how that relates to recreational use.

Most of the studies that I have seen, there has been a lot qualitative studies, and when assessing the association between psychedelics and mental health status, there often seems to be a lot of biases (recruitment bias for example), and a lot of limitations in the external/internal validity.

All of that being said, I believe that based on the studies, its hard to generalize which people in the population will benefit from psychedelic therapy. I personally believe that psychedelics have a huge potential to revolutionalize psychiatry, and even our own beliefs of the nature of mental disorders and how it relates to neuroscience. However, I feel like there are only certain contexts where therapy would be beneficial. For example, one can do psychedelics too much, or be in the wrong mental/physical setting, or even therapy might not even be indicative for the individual- all of these could talk away the therapeutic potential of psychedelic drug therapy.

My questions:

1) with your studies, do you think that they generalize to the normal population? I have seen people post your studies that are indicative for people with PTSD or end-of-life anxiety, and using your studies to justify irrational drug use, and actually recommending drug use to minors.

1b)In that sense, what kind of people do you feel will benefit from certain therapies, or do you think that everyone can (both long term and short term)?

2) What limitations do you see in your studies, and what does that mean in terms of your results and the potential for type 1 or type 2 error?

3) What could the potential adverse effects of drug therapy with psychedelics be?

4) Where do you see psychedelic drug therapy in 10 years? As a leading question, do you think they should be distributed by prescribers where they are able to monitor, or do you think they should be free to the population.

5) What do you see as the optimal dosage for mushrooms/LSD, and how often would you recommend usage per year to see the most optimal benefit?

I understand that I am asking a lot of 'skeptical' questions, and I hope that doesn't cloud my interest in the work you are doing- this is just so that I can learn (and hopefully others as well). Keep up everything you are doing - I see huge potential for these drugs in not only in therapy, but also in our understanding of the human condition.

Answering any of the 5 questions would be greatly appreciated,

Thanks

Here's an answer to parts 1-3 of your question:

Our Phase 2 studies of MDMA-assisted psychotherapy enrolled adult subjects with chronic PTSD who had failed to respond to other currently approved medications and therapies; therefore, the positive study findings are specific for this population and can't be extrapolated to other indications or people with different demographics, such as minors. We strongly believe the effectiveness of this treatment strategy lies in MDMA's action to facilitate the therapeutic process, and not solely a pharmacological effect of MDMA. For this reason, we wouldn't expect recreational use without therapy to be very effective in reducing PTSD symptoms. As with any therapeutic regimen, medication or therapeutic modality, not everyone will respond well to the same approach due to individual differences, such as genetic makeup and environmental factors. Currently approved treatments for PTSD are only effective for approximately 25% of people, while MDMA-assisted therapy in Phase 2 studies was much higher, with an 83% clinical response in one published report (Mithoefer et al. 2011 http://www.ncbi.nlm.nih.gov/pubmed/20643699), which is very encouraging that MDMA-therapy will be useful for a number of suffers of PTSD. With 105 evaluable subjects and similar trends in results from all 6 double-blinded, placebo-controlled studies, we have a lot of confidence that we are measuring a real treatment effect and are forward-looking to repeat these results in Phase 3. An added assurance to our findings is the thousands of case reports of efficacy of MDMA therapy before it was placed as a Schedule 1 substance and all medicinal use banned.

With that being said, we are following the same highly regulated FDA drug development pipeline as other pharmaceutical companies and will need to have a larger sample of individuals to unequivocally and statically prove MDMA therapy is a safe and bona fide PTSD remedy. By expanding the research program into Phase 3, we will learn more about which patients are best suited for this type of treatment and how to maximize the benefits while reducing undesired effects.

MDMA therapy does have adverse effects, as do all substances, however our evaluation of the degree and intensity of the side effects have led to the conclusion that the beneficial outcomes far outweigh the transient, generally well-tolerated, aversive reactions. Participant monitoring and integration sessions after MDMA sessions are an essential component of the study to assure people are supported by their therapists as the healing process continues long after the experimental session has ended. Our data from 12-month follow-up visits show that most people continue to improve after completing therapy and report overcoming the debilitating nature of their trauma by having been given the necessary tools to grow as individuals into the persons they aspire to be in their relationships, work, and spiritual lives.

-Alli Feduccia, Ph.D., Clinical Trial Leader, MAPS Public Benefit Corporation

When MDMA becomes first prescribable do you think it will only be specifically available for treatment resistant PTSD? Could is be prescribed to someone who hasn't sought other treatments or only suffered trauma but doesn't have clinical PTSD? Is the testing for the treatment of social anxiety for those with autism separate, or once it is declared a medicine by the FDA then doctors can prescribe as they see fit?

I wish I could give you a more definite response, but at this point, we are not sure. A lot of these questions will be answered, at least provisionally, at our End of Phase 2 meeting with the FDA, which is scheduled for this summer. I will say it is very unlikely that it will be available to people without a PTSD diagnosis, at least at first. Same with social anxiety--each indication must be researched separately. While there is precedent for 'off label' use in other drugs, we are not in a position to say whether that is going to be possible or not with MDMA.

-Ben Shechet, Clinical Research Associate, MAPS Public Benefit Corporation

Hello! I am a researcher in clinical psychology, and am about to begin a doctorate program with a focus in using virtual reality to create new measurement tools and clinical interventions. I recently heard about your collaboration with Johns Hopkins to create a space at Burning Man for people who are having negative experiences on psychedelics. I am curious whether you might be interested in creating a paradigm to expand this intervention into the virtual realm?

A major advantage of virtual reality is the ability to automatically quantify behaviors and responses to environmental changes that are carefully manipulated by researchers. The HTC Vive enables people to walk around a 15x15" tracking area - imagine if we created a room that could change as users interact with objects. It could also dynamically change according to physiological responses such as heart rate variability or galvanic skin response (stress). They could self-report which drugs they have consumed, and we could measure the impact on cognition and emotion.

Is this something that would be of interest? I was wondering whether such a study could be set up at Bonnaroo or another festival on the East Coast. Or maybe Burning Man could be the best venue. It could provide some interesting data, as the sample of drug users would be diverse with many different substances.

I am interested in exploring the potential of combining virtual reality with psychedelics, and wonder whether this might be a way to establish an empirical base for such research. I would love to hear your thoughts on this!

Wonderful enthusiasm! A few points of clarification: Our psychedelic harm reduction program, The Zendo Project, provides safe spaces at events for people to rest and work through difficult psychological experiences (we prefer “difficult” to “negative” ;) ). The Zendo Project had two locations at Burning Man last year and will be attending this year as well. This is, however, not a collaboration with JHU.

I share your interest in virtual reality and psychedelics and I am excited to reflect on your proposal. Please be aware that these opinions are my own and do not reflect that of MAPS as a whole:

Immersion and interactivity are the pillars of the virtual experience, often viewed by theorists as being at odds with each other. Fascinatingly, this is also a practical concern when conducting research into a drug-assisted therapy, because the important task of “going inwards” can be disrupted by frequent interruptions with, say, the blood pressure monitor. Incorporating physiological monitors into the virtual apparatus, allowing you to collect data without overtly impact the participant’s experience, is a very intriguing proposition.

I believe the kind of project you are suggesting, investigating psychedelically-attenuated emotional and cognitive interactivity in a virtual space, would yield the most scientifically useful data in healthy volunteers in a clinical environment where you can control the dose and type of drug and monitor participants’ safety. You already have a lot of variables at play here, you don’t need dose and drug variability confounding the results, and you definitely do not want to unwittingly endanger your participants by not taking proper safety precautions or screening for pre-existing conditions that could be aggravated by psychedelic use/the virtual environment/both together.

If you’re going to have people on psychedelics in any environment, virtual or otherwise, it’s critical to take harm reduction/benefit maximization into account. There are ethical questions to be raised here. Would the harm reduction space be offered within the virtual environment? Would the participant be encouraged to stay inside the virtual environment even if they begin having a difficult experience? Is virtual harm reduction as effective as harm reduction in the physical space?

In theory, the principles should still apply: 1) Create a safe space, 2) “Sitting”, not guiding, 3) Talk through not down, 4) Difficult is not the same as bad. However, the creation of an empathic connection between the harm reduction “sitter” and the guest within a virtual context needs to be further explored. A new paradigm indeed!

Harm reduction spaces at festivals are, without a doubt, not the appropriate venues for this type of work. The guests at Zendo are there to work through an often already overwhelming experience, not to be catapulted into an entirely new, chaotic environment. It is not advisable for you to recruit your volunteers from an event's harm reduction space, and certainly Zendo would not allow it. Festivals in general, however, are wonderful spaces for novel idea exchange and I bet if you brought your set-up to one you’d find a number of people curious to test it out outside of a harm reduction context. Good luck to you!

-Allison Wilens, Clinical Study Assistant, MAPS Public Benefit Corporation

What do you think about microdosing lsd or psylocibin. Are there any positive effects and are you planning studies in this field?

Thanks for the awesome work by the way :) I am a big fan...

I've learned a lot about the topic from browsing /r/microdosing for educational information. Some anecdotal experience reports suggest that there can be positive effects, though I am not aware of any studies from the past, nor does MAPS plan to conduct any soon. I would love to see a clinical trial into the risks and benefits of microdosing— I think we would learn about many potential applications for therapy and creativity!

-Bryce Montgomery, Web and Multimedia Manager, MAPS

What would happen if everyone in the world between the ages 18-70 would consume a dose of psilocybin mushroom? Also I appreciate everything MAPS is doing and has done for the community <3

Are you suggesting that everyone takes psilocybin mushrooms at the same time? That would be an interesting day for humanity.

-Bryce Montgomery, Web and Multimedia Manager, MAPS

Specifically in regards to MDMA, how do you determine dosages for testing and how do those dosages compare to people who use the drug in a recreational capacity?

Hi Browndog, A major part of our Phase 2 studies has been determining the optimal therapeutic dose of MDMA. We have looked at initial active doses ranging from 75-150mg. These doses, by and large, fall on the low to moderate end of the spectrum relative to recreational use, although there is obviously a large range of preference and tolerance when it comes to recreational users.

-Ben Shechet, Clinical Research Associate, MAPS Public Benefit Corporation

Do you ever see traditional psychedelics like psilocybin mushrooms and LSD ever being legal as medicine in our life time?

We anticipate that MDMA-assisted psychotherapy will become a legal, FDA-approved treatment by 2021. We aren't currently conducting psilocybin research, though the Heffter Research Institute is working hard on making psilocybin into a legal medicine.

I imagine that LSD will become a legal medicine after MDMA and psilocybin become legal medicines. It's unfortunate that LSD is further behind in terms of progress despite it being extensively studied in past decades. Our study into LSD-assisted psychotherapy for anxiety associated with life-threatening illness was the first study of LSD in humans in over 40 years, though we don't have any additional studies planned at this time.

-Bryce Montgomery, Web and Multimedia Manager, MAPS

Hi MAPS!

I'm so excited that you're doing another AMA, thanks! I wish my question was a little more helpful to other people, but it's pretty specific to my situation so I apologize.

Since learning about and beginning to experiment with various psychedelics to determine their helpfulness with my depression and anxiety, I've been self-teaching myself about these compounds and their histories. I've made the decision that whether in the US or a country with a little more legal freedom, I want to provide guided psychedelic therapy professionally. I obviously follow MAPS and Rick Doblin in particular on different platforms to keep up with newer research (along with Heffter etc.) and read any books/ articles/anything I can get my hands on the compounds themselves or the people who have researched and utilized them. After all this, I think I've finally boiled potential fields of study down to two options: Ethnobotany or Psychopharmacology. I want to work with your organization or one like you to provide treatment assisted by these amazing drugs for so many reasons. So I suppose I'd just like to ask you, am I going in the right direction? Thanks so much if you get time to answer, and for everything you do!

Hi Yaacotu, If your interest is primarily in providing treatment, you will probably be best served by getting clinical licensure in some form of psychotherapy--that could be an MFT, a Psy.D, or a Ph.D. in clinical psychology or counseling. While studying ethnobotany and psychopharmacology will definitely be useful, from a practical standpoint you need to be a licensed therapist in order to provide therapy. We also recommend that individuals who want to become psychedelic therapists involve themselves in specific therapeutic modalities that lend themselves to the kinds of work we do--Hakomi therapy, Somatic Experiencing, and Holotropic Breathwork are all modalities that some of our current study therapists have a background in and have found useful.

Hope that helps!

-Ben Shechet, Clinical Research Associate, MAPS Public Benefit Corporation

If the research goes well, in what time frame would you expect it to be legalized for medical use? And would that give it the same status as medically available marijuana?

Do you think it could get, or even should - be legalized for recreational use?

We are expecting FDA approval in 2021 for legal MDMA therapy! But, that is quite different than the current status of medical cannabis. Medical cannabis is currently legal on a state-by-state basis, but not federally, and has not been taken through the drug development process, (though MAPS is also sponsoring research to this end). MAPS is taking MDMA-therapy through the federal drug development process. However, we seek approval of MDMA-therapy— not MDMA available at a pharmacy or dispensary, like cannabis.

MDMA, like all drugs, should, and will, be legal one day ! Hopefully the world will continue to understand the scope of the horrific damage created by drug war prohibition. Legalization and regulation reduce harms associated with drug use, and prioritize public health and safety over punishment. MDMA will be legal when we realize that criminalization makes our country more dangerous, and legalization makes us all safer. I’ve attached a piece called “The Case for Ecstasy Regulation.”

-Natalie Lyla Ginsberg, Policy and Advocacy Manager, MAPS

Have members of your team used psychedelics in a recreational context in the past? What's your view on how society should approach recreational use of these substances?

I find the distinction between recreational and therapeutic use to be a bit of a blurry one. My “recreational” experiences with psychedelics have nearly always been therapeutic—they showed me capacities I did not know I had, showed me that I was putting myself in a much smaller box than I deserved to be in, and showed me that I was fundamentally not who I thought I was. These were, without a doubt, disruptive experiences, but very necessary ones. To me, this is the function of psychedelic experiences—to shake up stagnant viewpoints and crack the glass of our habitual selves, so that something much brighter and more beautiful can emerge.

-Ben Shechet, Clinical Research Associate, MAPS Public Benefit Corporation

---

I can not speak for everyone at MAPS, but speaking from personal experience, I have used psychedelics in recreational contexts in the past and found the experiences to be both self-healing and self-learning experiences that I greatly benefited from. We do not condone recreational drug use at MAPS—However, we do believe that some psychedelics (such as MDMA) have the potential to provide healing when combined with therapy.

-Cara LaChance, Web and Multimedia Assistant, MAPS

What do you think are the chances that LSD and other psychedelics become legalized? (Sorry, i don't know if this has been answered or i'm asking something stupid.)

Great work tho, keep it up!

I believe psychedelics, and all all drugs, will be legal one day! As the world will continue to understand the scope of the horrific damage created by drug war prohibition, and replace criminalization with regulation. Legalization and regulation reduce harms associated with drug use, and prioritize public health and safety over punishment. Psychedelics will be legal when we realize that criminalization makes our country more dangerous, and legalization makes us all safer. Rick Doblin has proposed a system comparable to getting a driver’s license for getting a “license” to buy psychedelics, to ensure harm reduction in legal settings.

Learn more by reading the attached document; “The Case for Ecstasy Regulation”

-Natalie Lyla Ginsberg, Policy and Advocacy Manager, MAPS

The emergence of novelty treatment options for mental health has made me realise I want to pursue a career in neuroscience/neuropharmacology.

Are there any research opportunities within MAPS new graduates would be able get involved with to further the development of new policies/treatment options?

That is wonderful and exciting that the reemergence of psychedelic science has driven you to pursue a career in neuroscience/neuropharmacology!

Have you visited the MAPS Student Resources page yet? We have tons of resources available for people in your position!

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

Are you going to use a US manufacturer for cGMP production of the API?

I like the new sign on Mission St :)

This new batch of cGMP MDMA is being made by Shasun, a company based in the United Kingdom.

Thanks for the compliment about the sign. I love it— I think it adds a lot to our presence in Santa Cruz.

-Bryce Montgomery, Web and Multimedia Manager, MAPS

Have you found any links between marajuana use and atrial fibrillation during your research?

Since we have not yet started our triple blind clinical trial investigating cannabis in veterans with PTSD, we do not have our own data on cannabis and atrial fibrillation. We will be measuring safety data carefully throughout the trial due to start in the next few months. We will obtain safety information on four different concentrations of marijuana ( High TCH/Low CBD, High CBD/Low THC, High TCH/High CBC and Low TCH/Low CBD (Placebo)). These safety measures include withdrawal symptoms, subjective effects of smoked marijuana, cardiovascular effects, effects on vital signs and a review of all adverse effects.

The full study protocol can be read here.

-Rebecca Matthews, Clinical Trial Leader, MAPS Public Benefit Corporation

Currently we have no hands on experience with marijuana research. MAPS is supporting a study of smoked marijuana as a treatment for PTSD, but the study has not begun yet.

Searches of the PubMed database using either "cannabis" or "marijuana" and "atrial fibrillation" turned up four and ten records respectively, so there are reports of atrial fibrillation occurring in people smoking marijuana.

So there may be a link between the two - what that link is, at least from this quick view - is not clear, beyond atrial fibrillation being reported after marijuana use.

Below are the search results from PubMed:

PubMed search results: cannabis atrial fibrillation

PubMed search results: marijuana atrial fibrillation

-Ilsa Jerome, Ph.D., Research and Information Specialist, MAPS Public Benefit Corporation

Do you think that there will be a future working with psychedelics on the population level? To clarify, I mean using statistical analysis to track the usage of psychedelics within society, and the benefits/harms that stem from them. Kind of like epidemiology but with more focus on using the stats for harm reduction purposes.

As someone who's very math based and looking for grad programs soon, it'd be nice to know a good route to pick to help with the psychedelic society. I've already started up a chapter of Psychedelic Club at my university (with 35,000+ undergrads, the word definitely has gotten out).

If I understand your question correctly, then this has occurred and has been occurring since the early 21st century. Visit PubMed (a database maintained by NIH) or other science or medicine databases and conduct a search and you will see research publications examining benefits and harms of psychedelic use. Some studies work with existing programs or databases and others are conducted specifically for looking at questions of drug use, including psychedelic use, and other sample characteristics. These studies still leave plenty of questions unanswered since they are all essentially correlational but they are conducted and results are being published.

-Ilsa Jerome, Ph.D., Research and Information Specialist, MAPS Public Benefit Corporation

What is on the horizon for cannabinoid research at MAPS? Are there specific cannabinoids of interest that warrant interest?

We are currently in the process of starting a triple blind cannabis trial in veterans with PTSD. We have two research sites, one at Johns Hopkins University in Maryland and one at the Scottsdale Research Institute in Phoenix. The study is slated to begin in the coming months.

This pilot study will gather preliminary evidence of the safety and efficacy of four potencies of smoked marijuana to manage chronic, treatment-resistant PTSD among veterans. We will test High TCH/Low CBD, High CBD/Low THC, High TCH/High CBC and Low TCH/Low CBD (Placebo).

The objectives of this study are to evaluate whether i) smoking whole plant marijuana attenuates PTSD symptoms, ii) to compare the efficacy of varying ratios of THC and CBD to placebo using standard clinical measures, and to iii) collect safety data.

The full study protocol is available online.

-Rebecca Matthews, Clinical Trial Leader, MAPS Public Benefit Corporation

Would you be interested to start a maps institution in Venezuela? Where there's easy access to marihuana and ayahuasca

Right now, MAPS is conducting ongoing studies in the US, Canada, Israel, Mexico and New Zealand and working in collaboration with many other researchers across the globe. There’s also a study starting in Brazil looking at MDMA-assisted psychotherapy for PTSD related to the drug war.

What’s really exiting is seeing that there are groups forming all over the world. For example, a group in Colombia is coming together with the goal of conducting MDMA/PTSD research, and a Psychedelic Society is forming in Mexico. We’ve received a huge response to the Global Psychedelic Dinners, with over 200 people in 24 different countries saying they’d like to host a dinner. We’re also seeing the coalescence of Psychedelic Societies all over the globe. I don’t see a dinner planned for anywhere in Venezuela yet, maybe you could host one!

-Merete Christiansen, Executive Assistant to Rick Doblin, Ph.D., MAPS

When you look at the current status of society and it's understanding of psychedelic medicines, do you believe we are trending toward legalization, and regulation of psychedelics on a broad scale?

Furthermore, as public perception of cannabis has clearly been changed in the last few years, what steps do you think will be most beneficial to bringing these medicines to the point where they will be covered by insurance, and the populous will agree that they are indeed beneficial?

We believe that the steady progression of scientific research into the therapeutic application of psychedelics is shifting society towards accepting the concept of legalization. In certain places in the U.S., marijuana moved from being illegal, to medical, to recreational. It's possible that psychedelics follow the same pathway.

MAPS currently expects MDMA-assisted psychotherapy to become a legal prescription treatment for posttraumatic stress disorder (PTSD) and other debilitating disorders caused by trauma by 2021. The concept of insurance covering some of the cost for treatment is something that we are actively thinking about.

The best steps for bringing forth cannabis and psychedelics into prescription medicines is to continue to fund clinical trials. If you would like to learn more and stay up-to-date with our ongoing clinical trials with both MDMA-assisted psychotherapy and medical marijuana you can sign up for our monthly email newsletter.

-Cara LaChance, Web and Multimedia Assistant, MAPS

i am currently suffering from really intense anxiety, and depression, and some alcoholism. I'm getting therapy, but I want to be well faster, and I'm suffering a lot day to day. How can I get enrolled in a study? I actually live in Santa Cruz, as well, but I've never been by your offices.

We are only currently recruiting participants for our ongoing study into MDMA-assisted psychotherapy for anxiety associated with life-threatening illness. Sign up for the MAPS email newsletter to be notified of future opportunities to participate.

Please come visit us in our office! We're kind of busy today, but any other weekday works great!~

-Bryce Montgomery, Web and Multimedia Manager, MAPS

Is there any plans for trials with any of the drugs you mentioned after MDMA?

We published the results from our study into LSD-assisted psychotherapy for anxiety associated with life-threatening illness in March 2014. We also have ongoing studies into the therapeutic applications of ayahuasca and ibogaine as treatments for addiction, and an upcoming study into medical marijuana for PTSD in veterans. Our Research page has a good overview of the treatment methods that we are studying.

-Bryce Montgomery, Web and Multimedia Manager, MAPS

Hey, huge fan and supporter, keep doing great work!

How are you all feeling about the future of psychedelic research with the next presidential election coming up?

As far as I know, none of the candidates have spoken out against psychedelic science or psychedelic therapy, so I think the future is looking bright.

As we get closer to reaching our goal of developing MDMA-assisted psychotherapy into an FDA-approved treatment by 2021, I often wonder if our research results and overall progress will force presidential candidates in the 2020 elections to address the validity of psychedelic therapy.

I personally feel like it would be a bad political move for a presidential candidate to publicly argue against the data we've begun to collect.

-Bryce Montgomery, Web and Multimedia Manager, MAPS

I just graduated college with degrees in Psychology and Criminal Justice and a minor in Philosophy. I'm currently doing substance abuse research but the idea of making psychedelic research or psychedelic psychotherapy a career really intrigues me. Working for MAPS would be a dream come true. I'm constantly checking the careers page on the website. I have been trying to get involved with as much as possible to set me on the right track before applying to grad school, but I've found that opportunities here on the East Coast are not plentiful. Currently I volunteer with dancesafe and erowid (although I haven't gotten any assignments from erowid yet). I would love to volunteer with Zendo but most of the festivals are not accessible to me.

What kinds of things can I be doing to get experience before getting into the field? Any plans for Zendo to expand to the East Coast? Also, What would be a good course of study for someone who wants to do psychedelic research?

Your commitment to volunteering with DanceSafe and Erowid are great ways to gain experience now. We love them both! As for a career in psychedelic research, there are many options: work directly with people in therapy as a co-therapist, study the chemistry of the drug or the mechanism of action in the brain, analyze the results as a statistician or work on the administrative side as a coordinator scheduling all of the visits and submitting paperwork to the FDA. The research setting is much different than working with a legally approved medicine or treatment. And there is much still to be revealed about how MDMA-assisted psychotherapy will look, if approved.

One thing we do think will be true is that MDMA-assisted psychotherapy will require an MD to store, prescribe, and administer the drug. Our studies employ psychiatrists who are trained to work clinically with people and handle medicines. Many of the site staff are not MDs though, but are psychotherapists or psychologists, trained in the complexities of the human psyche and the therapeutic relationship. We find that these two approaches work synergistically in our co-therapy teams. Since this approach is novel, not just using a psychedelic but even the combination of a drug and therapy, it takes people with the respective backgrounds to make a qualified team.

If you plan to work with people on the therapy side of things, I recommend looking into pursuing licensure as an MFT, LPC or Psychologist. A Master’s or Doctorate program will include experience working with people and there are a certain number of clinical hours one must achieve in order to qualify for a license. SO experience working with people therapeutically is very beneficial, crucial!

We would love to have you apply as a Zendo Project volunteer! We are hoping to expand to the East Coast. Our first East Coast event was Catharsis last November in DC and we hope there will be more, though we do not have anything on that side of the country currently on our calendar. Stay Tuned!

To gain experience beyond Counseling Psychology people have been trained in Holotropic Breathwork, Hakomi, Somatic Experiencing, and/or EMDR. Schools that offer an education in transpersonal, depth, or integral psychology include: CIIS, Sofia, Naropa, John F. Kennedy, Pacifica, Saybrook, and others listed here.

Here are some more resources for students.

-Shannon Clare Petitt, Executive Support and Harm Reduction Coordinator, MAPS

Thank you for doing this AMA! I have a bad case of paranoia that prevents me from trusting people. I think that people are always saying things behind my back and it poisons a lot of my friendships and interactions. I tried some 1P-LSD at a party and had a wonderful experience. My personality seemed to completely stabilize; I didn't doubt myself at all. Interacting with people became natural and easy because I wasn't concerned about their motives anymore so I was finally able to have a natural interaction with them without checking myself constantly.

My question for you is, do you think that the personality-stabilizing aspects of drugs like 1P-LSD can be localized and used to treat people with severe anxiety and paranoia issues?

I'm actually not familiar with 1P-LSD, but MAPS is currently conducting research on MDMA-assisted psychotherapy for social anxiety in adults on the autism spectrum, which is similar to your experience. So in short, yes, we do think there is applicability to these issues. It may also be important to engage in an integrative process with yourself--what about that experience allowed you to relax? Is there any part of you that still feels that way, or can access that state? It's not practical to dose yourself every time you need to be in a social interaction, so coming to an understanding of how that experience helped you can be very useful.

-Ben Shechet, Clinical Research Associate, MAPS Public Benefit Corporation