CIIS Public Programs Podcast

transcript

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This is the CIIS Public Programs Podcast featuring talks and conversations recorded live by the Public Programs Department of California Institute of Integral Studies, a non-profit University in San Francisco. To find out more about CIIS, and public programs like this one, visit our website ciis.edu and connect with us on social media @ciispubprograms.  

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Gisele: Good evening everybody. Hi Rick [Rick: Hello Gisele, yes]  so nice to be here with you tonight in this virtual event to talk about the therapeutic use of psychedelics in clinical context, that's something that goes back to the 50s, and you founded MAPS in 1986 and have been dedicated more than three decades to rekindling the therapeutic use of psychedelics. We're now at a moment with so many innovative research studies with psychedelics all over the country, and the world. There are changes in law enforcement with measures to decriminalize psychedelics, and a tremendous interest in the healing potential for psychedelics in the mainstream society and media. We are living a psychedelic renaissance. How do you understand the potential for the therapeutic use of psychedelics in this moment in history? 

Rick: Well I would say that in this moment in history, humanity is in a car speeding over the cliff.  The planet is at risk. We're destroying and killing; innumerable species are dying. It's a great massive die off. We have incredible destructive technology in terms of weaponry. There's just a need for humanity to become more spiritual, become more compassionate, become more tolerant of differences to, to really understand our common humanity and that we're part of the web of life on earth and that we're not disconnected from nature. And so, it's a question will humanity survive and how many species will we take down with us if we don't.   

But the potential is that we can wake up spiritually that we can also work through all of the multi-generational traumas that have been tumbling down through history for thousands of years and that we can move forward in a more compassionate collective manner so that we both understand our commonality but also appreciate our differences, rather than be scared by our differences. And I think there are many tools that can help us to make this transition and psychedelics are one of the most reliable, effective, and powerful of all the tools that are available to us. And so I think the psychedelic renaissance is a sign of great hope and optimism that we will be able to find ways to use these tools in a productive context both as medicines, that's primarily what we'll be talking about is developing these drugs as therapeutic tools, but also finding numerous sort of spiritual religious contexts, and then also through drug policy reform and eventual licensed legalization for people to use them throughout the life span for personal growth, for vision questing, for couples therapies, for all sorts of things and what I also hope—we're doing a study with Israelis and Palestinians who are doing ayahuasca and MDMA together, small groups of it—so we think that psychedelics could be great for psychedelic reconciliation between cultures. And one of the metaphors I think that's been so powerful for me to be thinking about is when we talk about the environment, we talk about climate change, we talk about becoming sort of carbon neutral or net zero for carbon, but think about it as being trauma neutral or trauma zero. How do we develop a society that's not producing more traumas, that's not emitting traumas, that's trauma neutral?  And I think that psychedelics can play a big role in in that transition. 

  
 
Gisele: Yeah so if we start with this large vision, this context of psychedelics bringing psychological healing mixed with spiritual experiences, what is the connection of that with political action? Do you think psychedelics can help us evolve to face the challenges of this time? 

Rick: Yeah well, I think first off let's look back to the 60s where psychedelics really emerged in more popular awareness. You know psychedelics have been going for thousands of years and have been used in all different contexts but I think in the western world there was this big explosion of interest in psychedelics in the 60s, and it turned out that a lot of the people that used them had these spiritual experiences and then got involved in political struggles. Particularly opposing the Vietnam war, working on women's rights, civil rights, the environmental movement, and the culture at the time wasn't really prepared for it. Either for the kind of challenging of the status quo or also wasn't prepared really for the kind of psychological material that psychedelics could bring forth.  

I mean in the 60s women were tranquilized to give birth; men were not allowed in the delivery room, in, in the western world. The first hospice wasn’t until 1974. And so, death was something that was not really talked about. Meditation and yoga were scary to a lot of people. There was a lot of resistance to them. They weren't widespread that we had  people in these silly robes coming from India and, you know, telling us about Transcendental Meditation or, you know, people were scared if you did yoga you would be falling a victim to be turning into a Buddhist or a Hindu or something that that you'd lose your religious orientation. So, I think that psychedelics, when they first came, did have a spiritual element that did motivate people for action in the world. And I think now we have made incredible progress in in many ways in culture is that you can go to the YMCA and learn meditation and yoga. 

Mindfulness has been mainstreamed. We see it all over the place. Yoga is very comfortable. We have over 6000 hospices, we have a new approach to, to death and new approaches to birth and we've integrated pretty much everything. Even when we think about art and movies and imagery the psychedelic kind of imagery has appeared in a lot of our art and movies and advertising so we've basically integrated everything except for the psychedelics, and so that's why I think we're going to be able to do it, and also I think the political understanding that I've, sort of the lessons from the 60s, is that if you self-identify as part of a counterculture that you build a certain kind of resistance and the culture is more dominant and will suppress and block. So, what we're talking about really now is the mainstreaming of psychedelics woven into the heart of the culture not being seen as something that necessarily is involved with tearing down the structures, but that is more about evolution rather than revolution.  

And I think the decision for me when I was 18 and 1972 to devote my life to psychedelics, was precisely because of the political aspect of it. I really felt that we are causing a lot of problems by how we identify ourselves in these limited ways by our race, by our gender, by our religion, by our nationality, by our socioeconomic status. Now these are all important ways to know who we are to differentiate to become who we are but, we've often lost track of the common elements that bind us together, the common humanity, the common life on earth, the connection with nature. And so I think that it's that experience of that commonality seemed to me when I was 18 as the antidote to genocide, to the holocaust, to nuclear destruction, to racism, and so I think it's precisely the political aspects of psychedelics that really motivated me and then I see the medicalization and the use as therapy as a tool to try to bring about a larger move towards mass mental health or mass spiritualization you could say.  Albert Einstein said that our technology has exceeded our humanity and so I see that what we need to do with psychedelics is expand our humanity. 

Gisele: Beautiful. So that's some differences between what we're living right now and the 60s. And how about some differences between the MDMA which is the main medicine used in the studies and the trials, we're going to get deep into that in a minute in our conversation, and what's considered the classical psychedelics like LSD or DMT or mescaline or psilocybin. You want to say something about the how does the MDMA change the brain and and the therapeutic effects and in contrast. 

Rick: Yeah well to use another kind of a metaphor I'll I'll say that the the classic psychedelics like LSD psilocybin mescaline, which comes from peyote ayahuasca, ibogaine. The classic psychedelics are ego dissolving and they kind of move you towards this larger flow.  Aldous Huxley talked about the brain as a reducing valve, and so the modern neurosciences has demonstrated that there's a series of structures in in the brain that are called the default mode network that are somewhat equivalent to our ego to our sense of self, and the classic psychedelics reduce activity in the default mode network so that we can,  we don't, filter all the information the way we normally do. And so this is where we can get into  Abraham Maslow and humanistic and transpersonal psychology where you know Maslow many of us know about the hierarchy of needs, which has been portrayed often in a pyramid with your basic survival needs and then you move up to self-esteem to belonging and eventually  there was self-actualization. And that's sort of the basis for humanistic psychology. In the last few years of Abraham Maslow's life in consultation with Stan Groff and others they formed the Transpersonal Psychology on the top of it was now self-transcendence. It was no longer self-actualization, but it was self-transcendence, so the classic psychedelics move you in this kind of ego dissolving way.  

MDMA acts completely differently. MDMA doesn't really do ego dissolution in that same way. What it does is it centers us in our ego in such a comfortable and loving and self-accepting way that then we can open up to the larger world and we can open up to other people that we may be in dialogue with. We can become better listeners, we can become speaking more honestly without so many worries about what we'll say or or or what people will say in response. And so MDMA reduces activity in the amygdala which is the fear processing part of the brain. It increases activity in the prefrontal cortex where we think logically and then MDMA also increases connectivity between the amygdala and hippocampus to help us take dramatic memories and move them into long-term storage. MDMA also stimulates oxytocin which is the hormone of love, nursing mothers. it's the hormone of connection. There's Gul Dolen, a great neuroscientist at Johns Hopkins, has given mice MDMA and shown that it releases the oxytocin and then it produces new neural connections in prosocial areas of the brain and opens up a critical reward period for connecting with others.  

So, they all deserve I think the word psychedelic in that category. Psychedelic means mind manifesting that's how the word was originally created. Humphrey Osmond wrote a poem to Aldous Huxley “to fathom Hell or soar angelic, just take a pinch of psychedelic". And Delio's to to reveal or to manifest psyche the mind so it's the mind manifesting. And so, I think MDMA does it in a different way than the classic psychedelics. MDMA being more gentle, being less of a distance from our normal way of processing, just kind of less fear defensiveness, more self-love, more acceptance. I think it's easier to integrate the lessons from MDMA than it is from the classic psychedelics and that's why I think because of its gentleness and ease to integrate, that's one of the reasons why I felt that MDMA would be the psychedelic that would go first through the system.  

The other thing I'll just say is that we believe that therapists who want to work with these substances would be more effective if they've had a chance to do them themselves and knew what they were doing. I mean you wouldn't go to a meditation teacher that never meditated or a yoga teacher that never did yoga. I don't think it's essential for therapists to do these drugs to be good therapists but I think it would be helpful to them and I think there's going to be less resistance in the field of psychiatry and psychotherapy for them to try MDMA than there is to try psilocybin or LSD, which are more challenging in the sense of letting go of how we normally see things so people tend to feel more in control in a way under MDMA. Although, in therapy settings when traumatic memories or other kind of difficult things are emerging, people still need to learn the art and the skill of letting go of having these experiences manifest fully. 

Gisele: So, we'll get into the training of therapists and the skills that needs to be in place and developed in a moment. But let's start out with MAPS and the research that's happening that is now in phase three and it's happening here in the United States and Canada and in Israel and it's a revolutionary contribution to the fields of psychology and psychiatry. We know that in psychiatry for the treatment of severe depression the most established treatment has been electroshock ECT, and so as MDMA comes into proposing a treatment, it's really a huge change in the field, and so we'll address that in a minute. But I would like you to speak about where the research is at in phase three at this moment, what are the expected outcomes, and and what's next. 

Rick: Ah, well what we, okay so I started MAPS in ‘86, it took us 30 years to have what's called an end of phase two meeting with FDA which was November 29, 2016. That's where we did pre-clinical studies learning about toxicity, we did basic phase one safety studies in humans, then we started working in patients and we refined our approach for MDMA-assisted psychotherapy for PTSD. Once we negotiated this end of phase two meeting with FDA and then they said we can go into phase three, we negotiated all of the studies that we need to do to make the drug into a medicine, assuming the data turns out, and we agreed to do two 100 person phase three studies. So basically 200 people in phase three two 100-person phase three studies. The FDA said to us that they felt that we could prove efficacy with smaller numbers than they wanted to see for safety and so we have to do these two 100 person studies.  

We also negotiated with FDA that we could do what's called an interim analysis of each of these phase three studies, and that's for what's called sample size re-estimation so in a way it's a gift to the pharmaceutical companies that if your original study with the size that you've developed that is not going towards statistical significance you can add extra people into your study. So, the purpose of the interim analysis is to see if you need to add people to get statistical significance. And so, we had the interim analysis for our first phase three study in March, of this year. The FDA has only granted two drugs breakthrough therapy for PTSD. One is MDMA-assisted psychotherapy, it's not really a drug, it's psychotherapy that the drug makes more effective. The other was a repurposed sleeping pill from about 30 years ago. The theory was if it helps people not have the nightmares that then they can get over some of their PTSD symptoms. That was done by Tonix Pharmaceuticals. They had their interim analysis in February, and they were told to shut the study down for futility. The drug didn't work after they'd spent substantially over 100 million dollars.  

So, our interim analysis was the opposite. It was the best possible news that we could get. It was that we didn't need to add anybody to our study, that we had a 90 percent or greater probability of success once we were to complete the whole study, at at least a medium effect size, so effect size is a measure the magnitude of the clinical impact. That was in March. Right after we got the interim analysis things got shut down because of COVID, and research shut down, and we had some people in the midst of treatment but we were able to continue with some of them, others didn't want to continue, some of the therapists didn't want to continue and the FDA reached out to us and to other sponsors of different research and they said because of COVID we would give you the opportunity to negotiate with us to end the study sooner than you would have otherwise. And so, we thought about it a lot and we decided to enter into these negotiations and so we agreed with FDA that we would end the study with 90 people instead of a hundred. And we did that, completed all those people in August. We've been analyzing the data since then and this discussion that we're having is only one week away. On October 30th we are going to find out if our first of two phase three studies was statistically significant. And if so, that means in conjunction with the safety data that it is a successful study and then we just have to do one more phase three study and some associated other studies and then present the data to the FDA to try to make the drug into a medicine. 

We've already started the second phase three study, just barely. We've got 14 sites, two in Israel, one in Canada, and 11 throughout the United States. We have about eight of them are enrolling, so we are trying to screen and enroll subjects now, the rest of them will hopefully come online in the next couple months. We think by the end of or beginning to middle of 2022 is when we think we're going to finish with the second phase three study and then we submit all the data to FDA and we hope by the beginning of 2023 that we'll have approval for prescription use. We're also starting research in Europe.  

So, we have negotiated with the European Medicines Agency and they gave us permission to move forward to phase three in Europe. And they said that they will accept all the data from the FDA, and therefore we only need to do one phase three study in Europe and it only needs to be 70 people. So, what we're doing now is we're working at 10 sites in seven countries in Europe, and we are in the what's called the open label phase two stage. It's about training of therapists. The last step of training therapists is to supervise them as they work with the PTSD patients and then we have our team watch the videotapes and give them tips about our therapeutic method. 

Gisele: Very exciting! So, let's talk about the context in which this research happens, in which this healing and these outcomes that will be soon made available and hopefully approved by the FDA.  The importance of the set and setting in these studies, the presence of two therapists, the music, the preparation, the integration sessions as well as the three different moments in which the patient takes the medicine. So, would you give the audience a clear picture of what a treatment looks like? 

Rick: Yeah, so the the first thing I think I need to say is that our operating principle has been how do we maximize therapeutic outcomes? How do we get the best results? When you're moving forward with something that's controversial, that has been suppressed by society, where there's a lot of fears built up. We need to get the best outcomes and we also need to work with the hardest patients and patients that are appreciated by the public.  

So, what we've decided to do is to develop a therapeutic process that takes about three and a half months. There are three day-long MDMA sessions, each eight hours. In most of our sites we actually ask the patients to stay overnight in the treatment center. To rest and then the very next day there's a integrative work as well. So, three day-long MDMA sessions three to five weeks apart and there's 12 90 minute non-drug psychotherapy sessions as well. Three roughly on a weekly basis before the first MDMA session, and that's to develop a therapeutic alliance and to teach people what they can expect under MDMA, how to process bodily feelings and emotions and thoughts as they come up, and for the therapists to really understand better where the patients are coming from, and then we have three of these 90-minute sessions after each MDMA session again more or less a week apart to help with the integration. And then we have a follow-up, which is what's called the primary outcome measure, is two months after the last MDMA session. And that's going to be where we compare the group that gets therapy without MDMA versus the group that gets therapy with MDMA and that's going to be the data at the two months follow-up for whether it gets approved by the FDA. We also do a 12-month follow-up, which is more for insurance companies. To try to show that it's durable or is it durable and what number of patients relapse you know how many on average. What we've shown is that people keep getting better and that the 12 months, results are even better than the two-month results.  

Now that's the the structure of the intervention. The other part of this is that we've decided to work with two therapists. Now not always male female team or however, you know, but we're open to all genders or non-genders, non-binary, but in general we our standard model is somebody who identifies as a man somebody who identifies as a woman and the reason is that it's eight hour sessions people get tired, somebody goes to the bathroom, somebody gets something to eat. We want there to be always a therapist in the room. It's not absolutely essential but it's better and then also many of us suffer trauma in our life but only a fraction of people develop PTSD. And those people that develop PTSD are often people that have had a series of traumas, not always but often that go into childhood. So, to have a well-functioning male/female team can actually offer a kind of balanced support that people might might not have got when they were growing up. Also, about 60-65 percent of the subjects are women, and for women who've been sexually abused, or assaulted, or you know to just have a one male therapist you know might not be as safe or as supportive as having a woman in the room.  

For veterans who have war-related PTSD, you know sometimes for them having a woman in the room is kind of permission to feel more that they might not have had otherwise, and also then they can relate to the male sometimes, sometimes to the woman so where we're going to go forward with this is that we think the standard model is going to be two sessions. Two MDMA sessions not three, and nine non-drug psychotherapy sessions. We don't really want the one session model, the one session miracle cure. There are people that that do great with one session and that may be enough for a lot of people, but we see that people go deeper on the second session, they've learned about the what the drug does, they've learned about how to process emotions under the influence of MDMA, they've learned to trust the therapists, and so we see that the second session often goes deeper than the first session.  So that that's the the basic structure. 

Gisele: Great, and you were mentioning the population served right? Veterans, women. How do they arrive at the clinical trials are they self-referred? And also, the results of this population that have been a part of the MAPS clinical trials. Is this outcome easily transferable to any individual in society or is this kind of treatment just good under certain conditions to, to treat certain populations with PTSD? 

Rick: Well one of the things that you do in phase two, is you try to figure out who's your patient population. Who's going to respond, who's not going to respond. There's two drugs that are approved by the FDA for PTSD both SSRIs, Zoloft and Paxil. Those drugs worked better in women than in men and they failed in combat-related PTSD. 

So, what we did in our phase two studies. Our first study was with women with complex PTSD from childhood sexual abuse, adult rape, and assault and we showed that it worked great in in that population and near the end of that we enrolled one or two veterans. Then we've also done studies in first responders, in veterans, firefighters, and police officers. And what we found is that it worked great in that population. We've had people that have had PTSD from a whole range of experiences…car accidents, natural disasters, and so our main finding was that we can enroll people with PTSD from any cause, and not only that we can enroll people who have had PTSD recently, we have to take people that are chronic…that means at least six months PTSD, but we can also treat people that have had PTSD for 40 years. We've had people from Vietnam that are able to get over PTSD, so even if though you're stuck in certain kind of patterns, emotional and mental patterns for decades and decades and decades it's still possible to to heal. And so, I think that we now have that ability in phase three to enroll people with PTSD from any cause.  

Now how do they come to us?  Some of them are coming to us because of therapists that we've reached out to to send us their patients who are non-responders.  So, we work with a lot of trauma therapists and again we say send us your hardest cases. We have been trying to spread the word in the veterans community and so a lot of people ourselves are referred by others that they've heard from that have been through our treatments. There's an awful lot of media that we have, like for example I said next week on Friday we're gonna find out if our first phase three study was statistically significant. We've given the New York Times an exclusive on that, and so in the middle of November there's going to be a New York Times article about whether our first phase three study was statistically significant. And sometimes people will see those media articles and then they will contact us. There's also something people should know about, if you go to clinicaltrials.gov, which is a website that lists all the clinical research that's going on, not just in the United States, but a lot of it in around the world as well, pharmaceutical sponsors are now obligated to put their studies on clinicaltrials.gov, but you can people, can go to clinicaltrials.gov and put PTSD in one of the search terms, or you could put PTSD and then MDMA and another of the search terms and you will find out all the MDMA PTSD studies, or you will find out just all the PTSD studies. So, some people find us through clinicaltrials.gov and then through all the different sites occasionally we would try to do local advertising. I think it's very important that from our drug development perspective, that we enroll people as quickly as possible. Then it's less expensive for us, the sooner that we can do it. So, we're looking for all those people that are listening now that may be treating trauma patients to think about referring them to our studies. And if you go to clinicaltrials.gov you'll find our it's called MAPP2, MAPP MDMA assisted psychotherapy for PTSD MAPP2 and it lists all the cities all and there's contact information for the study coordinators at each site to have patients start the screening process. 

Gisele: And so the the main clinical focus of the research has been for individuals suffering from PTSD, but there's also other studies that have been done with treatment resistant depression, with eating disorders, with substance abuse…could you speak a little bit about the variety of research findings with the use of MDMA?  

Rick: Yeah yeah I realized that I didn't quite give the results either, but you asked, so let me just say that the results that we presented to FDA for our phase two results…now again, for phase two we work with treatment resistant, chronic, on average severe and unlike a lot of PTSD studies we enroll people who have previously attempted suicides we don't exclude them. And so, we're using a three-session model, it's basically 42 hours of therapy, over this three-and-a-half-month period. What we showed is that 23 percent of the people that got the therapy without active MDMA, either very low dose MDMA or no MDMA at all, 23 percent of them no longer had PTSD at the two-month follow-up. Which is really really good these are treatment resistant people, on average severe chronic PTSD, so 23 percent of them no longer have PTSD. And this is not really due to MDMA, this is due to the therapy itself, when you add in the MDMA 56 percent no longer have PTSD at the two-month follow-up, more more than double. And at the one-year follow-up, 68 percent no longer have PTSD. People learn how to process their trauma and they keep getting better. Alright so that that's the basic results and and we'll find out more when we see how our first phase three study did.  

We have also done studies with people with life-threatening illnesses who are anxious about dying, anxious about their illness with MDMA, that paper has just been accepted for publication and scientific reports, so that will be coming out fairly soon. We've done studies with autistic adults with social anxiety. So, it was a study focused on social anxiety and those results were tremendous. That's also been published. We're about to start studies with MDMA for eating disorders, but we don't have any results. But there are anecdotal reports of people with eating disorders who've tried MDMA and found it to be particularly helpful. 

We also have been associated with, we've not funded it, but we've provided MDMA and trained the therapists, Ben Sessa in England did a study that was MDMA for alcoholics. So what we've, what he found is that if you help people who've just been detoxed from alcohol process their traumas, their difficult emotions then they don't feel the need to escape so much in in alcohol or or other addictive behaviors. So we're doing a long-term, we've funded Ben to do a long-term follow-up to that, which he is in the process of doing, and the results look pretty good. Well, actually very good. We've not done studies with depression. Most of the people in the PTSD studies also have depression and the depression goes down quite a bit, but the primary outcome has been PTSD, so we've not done any studies yet with depression by itself.  

That's more been the studies by Usona, Heffner, and Compass. The different groups that are doing work with psilocybin for depression. Compass doing psilocybin for treatment resistant depression, Usona for major depressive disorder. And I would say that one of the most important developments in the history of the last 30, 40 years of psychiatry has been the development of ketamine for the treatment of depression. It's more rapid acting and even though the results fade, with a series of ketamine experiences sometimes people can get over their depression. What we're finding is that when you combine ketamine with therapy it works a lot better and you don't need as much ketamine. But the pharmaceutical company Johnson and Johnson that approved s-ketamine doesn't understand psychotherapy, so they just deliver it as like you said before about electroconvulsive therapy for depression, that's how they see ketamine. It's like it's just a shock to your brain and they don't think it matters, your subjective effect. I think they're completely wrong about that but but sometimes people are able to get better that way. And we also want to look at group therapy. That's going to be the other big thing that we need to go into exploring and MDMA for couples therapy. MDMA for even autoimmune disorders, fibromyalgia, irritable bowel syndrome. There there's postpartum depression. I think MDMA would be great for, there's going to be so many uses for MDMA. But we felt that MDMA for PTSD was the opening wedge.  

Gisele: Wonderful. Fantastic results, yeah I last month doing the interdisciplinary conference on psychedelic research, I heard about the study currently being done in Canada with the cognitive behavioral co-joint [Rick: Yes, yes, yes, right] because when the person is traumatized, it has an impact on their relationships, on their partnerships, on their families, And so this model was talking about the use of MDMA in couples therapy… 

Rick: Well I would say that that you know since 1990 we have been trying to do work inside the VA system with MDMA.  We're very close to starting that in the next couple months so it's a 30-year process, but about seven years ago when we were negotiating with the VA they said that they weren't going to pay for anything but we could work with one of their researchers Candace Monson who developed cognitive behavioral conjoint therapy and we could work with her to blend MDMA with her therapy. And that she had to do it outside of the VA, that no subjects would come from the VA, the VA wouldn't pay anything but so it's it's tremendous and and recently Candace and I presented to the Boston VA. And she presented all the results that she did developing cognitive behavioral conjoint therapy without MDMA and then she presented the results when she blended MDMA with cognitive behavioral conjoint therapy and the results were better than anything she got before. Candace is now the president of the International Society of Traumatic Stress Studies which is the group, the largest group in the world of PTSD researchers and clinicians. Now getting MDMA approved by the FDA and then covered by insurance for couples therapy is not likely to happen because couples therapy is not a disease. Unfortunately, we can only treat diseases you know PTSD is considered a disease, a difficult relationship feels like a disease, but it's not considered a disease. So with cognitive behavioral conjoint therapy we're sort of backing into couples therapy because we give both members of this dyad one who has PTSD, one who's been affected by it, both of them get MDMA and their relationships improve, the PTSD improves even better, it's a tremendous modality and I think one of the reasons why I think we need drug policy reform as well as medicalization is that there's so many uses of psychedelics that are not diseases that we need to find legal context for people to have access to them and and for therapists to be able to work with them. Maybe insurance would cover it, maybe not, but it's hard to see getting it through the FDA for certain things. 

Gisele: Okay so the clinical trials have been tied down to the possibility of a diagnosis and being able to study the reduction of symptoms and in that the focus has been in individual treatment, but from what you're sharing, the understanding of the impact of trauma on partnerships, on family members, and the possibility of group psychotherapy for more access and affordability are all being considered and are possibilities for the future is that right? 

Rick: Yeah very much so. So, we’re talking about a possible project, one at the Portland VA, one at the Bronx VA, where we study group therapy as well. A lot of times I think individual therapy will be more effective than group therapy. There may be ways that we can leverage the group to optimize outcomes, but I think there's less individual attention. But if group therapy is 80 percent as good as individual therapy but it's 20 percent the cost, that's going to be a profound benefit. You know there's 8 million people with PTSD in the United States as the national center for PTSD at the VA has estimated.  

The the other thing is that we're trying to work in Africa and in Europe with traumatized populations. When the European medicines agency said that for this phase three study in Europe they want us to study refugees and migrants as well that we could bring them in because they're so heavily traumatized. You know in Rwanda, where there was genocide, in South Africa where there was apartheid, in Somaliland where there's just massive violence and PTSD, we need to find new models because they don't have hardly any psychiatrists or psychotherapists and they have massive numbers of people that are traumatized. So that's where we need sort of like Indigenous healers or other kind of models that we will develop, that would most likely involve groups and may not be strictly supervised by psychiatrists or licensed psychotherapists.  

In the U.S. where there are a lot of psychiatrists and psychotherapists, we still really, I’m very interested in trying to see how we can develop group therapy. There have been some models of group therapy where there is, the group comes together, there is group preparation, then there is individual sessions, then they come together for group integration, but we've never had really a group of people treated at the same time. Now you go to ayahuasca circles, or peyote, Native American church peyote circles, you know groups are taking it at the same time but there's not as much of a therapeutic intervention, it's more about religious services and there there is a lot of healing, but we want to see what we can do with groups with significant and severe psychiatric indications as well. 

Gisele: Yeah so there's a lot in there, and I hope that some of the that focus for groups and traumatized communities are also the focus here in the United States because we do have a lot of immigrants and people of color and lots of populations who have been systemically traumatized and could use that support in formats that are clinical and also non-clinical ways [Rick: Yeah, yeah] like you said community based and and other ways. But if we can just stay with the clinical aspect for a little bit longer because [Rick: Yeah, yeah, for sure, for sure] because conducting psychedelic sessions is not a classic clinical experience.  

Then with the development of the field of psychedelic-assisted psychotherapy for individuals, for couples, for groups there has to be the development of training so what are the, and you have mentioned that you believe that it's important for therapists to have that experience themselves, to have that awareness that the the experience of being in non-ordinary spaces of consciousness and having their own healing done that way, but what are the other important skills that you think therapists would have to have, what's involved in the training, and who do you think would be ensuring safety and ethical standards for the use of MDMA in psychotherapy? 

Rick: Well what we want to do is similar to what's happened for integrative medicine. You know so complementary and integrative medicine has become its own specialty, but it's taken you know 40 years for that to happen. What we want is a new specialty psychedelic psychotherapy and and what we find is that those people that are working with ketamine or those people that were working with MDMA that the therapists really want to be cross-trained to be able to work with ketamine with psilocybin with MDMA it's really about developing the field of psychedelic psychotherapy, we have to bring drugs through the FDA, through the regulatory systems one drug at a time for one particular patient group, but in the end, when these drugs are legally available as prescriptions, what we hope is that people will develop kind of personalized psychedelic medicine they'll you know say you know they'll talk about what the therapist will talk about with patients and they'll say let's start with MDMA then let's see when we're ready to go to MDMA, or I mean psilocybin, or LSD you know maybe you end up with MDMA, maybe you do a ketamine system experience within that…so I think that that…we need to develop a new specialty.  

Now the credentials that are going to be required right now we're negotiating with FDA they are starting to permit some work with psilocybin where four or five people are treated at the same time, but each in their own room, each with one person instead of two, and then there's several people that roam that are sort of more of the experts that will then consult if the one person one therapist with the one patient needs help or needs advice so it's, they're simultaneously treated in different rooms but it's really still individual therapy the the skills that we need, a lot of times people really have to unlearn what they've learned because what we call our method, there's a treatment manual we've standardized it, we have a manual we have adherence criteria we have sort of therapist competencies of what we think people should be doing and learning ,and those are reflected in the adherence criteria, and all that is posted on the MAPS website, so if you go to the MAPS website under research, then you go to the MDMA, and then at the bottom of the MDMA page it's called the treatment manual. And the the core hypothesis is that in an eight-hour session, that it's we call it inter-directed therapy, before that we were calling it non-directive therapy, so it's not it's more like Freudian free association you could say, but catalyzed by a psychedelic. So in an eight-hour session people are listening to music, there they have eye shades on usually, and of an eight-hour session about half the time people are eyes closed having an incredible flow of imagery, metaphors, experiences, bodily sensations and the other half the time they're talking to the therapists and explaining what's going on or asking questions or just describing what's been happening. With psilocybin or LSD, it's more like of an eight-hour session maybe 90 80 to 90 percent of it sometimes even more, people are quiet having this inner experience and there's a lot less dialogue between the patients and the therapists, that happens afterwards.  

So we do like this idea that people understand meditation, mindfulness, that the therapists often need to be quiet, I mean during this period of time that they're sitting with the patients when they're having this inner experience, about every hour you check in to see how they're doing but you're looking at body language, you're looking at are they letting the energy flow through them. So, there has to be people that are comfortable being quiet while the focus of attention is on the patient.  

So, the training program that we have has got five parts to it. The first part is about a 14 hour online where you learn about our treatment manual learn, the history of MDMA, history of PTSD, a little bit of neuroscience…the next is a week-long program watching videotapes of therapy sessions and talking about the kind of interventions that the therapist did. Then we have the opportunity for people to volunteer to take MDMA. We think that that should always be optional, we're never going to require that, we don't think it's essential, but we think it's it's very helpful. Then we also have role play exercises that people do, which are videotaped and then they send the videotapes to us, and we review the videotapes, and then give feedback. Then the final part of the training is where people work with a PTSD patient, and they're supervised by our therapy training team while they're doing that, and so they watch the videotapes of the non-drug sessions and some of the the first drug session, and then in in within a matter of a couple weeks we have our adherence raters watch the videotapes and talk to our supervisors and then they talk to our trainers then they give feedback to the patients and then we watch what they do with the second session or the third session…I think the most important thing is that people have done their own work. That the therapists have done their own work so that if the patient is getting near sensitive material that you have not addressed in yourself, it could trigger you and it could produce a certain kind of resistance in your own self for them going deeper because it kind of triggers your own self, and patients are exquisitely aware of their therapists when they're in a psychedelic state, so we we do feel that a big part of the training is people that have done their own work in non-ordinary states, have faced a lot of their own inner shadows and and found that these things that are so scary that you can bring them to the surface and try to integrate, and you can come to a better balance. Now of the two people, what we want to end up with, the two therapists, is one is a licensed therapist the other is an intern or a student working like an apprentice and working for a lot less money than the first person or working for free. We like the safety and added efficacy of two therapists, they're not twice as good as one therapist, most underground therapists are just one person, most therapists are just one person unless, it's a group therapy context, but we'd like to keep the two-session model, but we want the second person to be an apprentice. 

Gisele: Okay, so there there is space for non-clinicians and alternative healers to participate and to be involved in clinical work, and I know MAPS has this very strong focus on the medical, the therapeutic model but there's also the harm reduction and the recreational aspect of MAPS as the Zendo Project, do you want to talk about that a little bit?  

Rick: I would love to, thank you for bringing us around to that Gisele! That is really good, and that's part of our our mission is mass mental health, that's how we started talking about helping humanity evolve and there's two main aspects of that again, medicalization of psychedelics for clinical uses, and then  licensed legalization to help people have these experiences on their own within a context where there's pure drugs, where there's honest drug education, and where there's harm reduction.  

So the the harm reduction aspect is something that we realize that we're, actually this is about 20 years ago, I was starting to think about where could there be a backlash to stop what we're doing you know there was a backlash in the 60s, the backlash was more for political reasons. A lot of people think the backlash was because psychedelics went wrong and a bunch of people had difficult experiences or emotional breakdowns, that did happen but the backlash was psychedelics going right, and people having these spiritual, interconnected experiences, and then getting politically motivated to work on social justice against the Vietnam War, so the crack down there was political. Where there could be a backlash now, and where the drug war has been focused is it's on scaring parents about their kids doing drugs, we got to protect the kids.  

So a lot of young people go to festivals, and a lot of them take psychedelics, and a lot of them are not prepared for what they're doing, and they end up having difficult experiences, and they end up often going to the medical staff, they get tranquilized, they get evacuated, they get potentially arrested…and so we're trying to have a whole new model in society of psychedelic harm reduction, and that's one of our donors Vanya Palmers, who's an expert in Zen meditation, he's done some incredible work combining psychedelics with Zen, but he donated a cardboard Zendo for us at Burning Man for our 20th anniversary in 2006, and that became where we do the psychedelic harm reduction, that's how we got it called the Zendo Project.  

So, we are now about to expand the Zendo Project, the training is run by therapists who have worked on phase three, so it's very similar therapeutic approach to helping people that have difficult experiences when they took it in a recreational setting. So it's really designed to facilitate this larger group of people taking MDMA outside of therapeutic context, but how do we help society manage that…so for example Denver has made mushrooms the lowest enforcement priority ,Oakland has decriminalized plant psychedelics, Ann Arbor has now gone forward to decriminalize plant psychedelics, the Oregon psilocybin initiative is going to be on the ballot to see whether a whole new kind of state license program is going to be created for guides and therapists to give people psilocybin who may or may not have a clinical indication.  

So in all of these cases, we really need to develop harm reduction methods because we want these social experiments and drug policy reform to succeed, if there's a lot of people having these difficult experiences, that could cause a lot of backlash. Dnd so the the Zendo Project has been extremely successful, at Burning Man for example, Burning Man this year was just canceled, but the year before we we had over 800 people apply to volunteer and we we picked around 250 people to volunteer at Zendo. We had two different locations, 24-7 for seven days, it was staffed, about 550 people came for help, and so we think we really need to make this larger. And Sarah Gale, who really helped develop the Zendo Project, lives in Boulder ,was a phase two MDMA PTSD therapist, working on phase three, and we now have a contract with the city of Denver, where Sarah is going to be educating the police, the emergency room doctors, the EMTS, the firefighters, the first responders are going to be educated now in how to handle and de-escalate problems with people having difficult trips, and how to avoid arresting them, tranquilizing them, you know we will have people that they can turn them over to and we'll teach them about how to really handle that.  

So, the harm reduction is really very important policy as far as helping society move forward as we integrate these drugs. and as we make them more widely available, and the reason that we have to use the word harm reduction is talking about benefit enhancement is like you're trying to you know encourage illegal use, but it's basically the same therapeutic approach it is designed to help people get more benefits but it is designed to reduce the harms but we speak about it as harm reduction for political reasons. 

Gisele: That's a wonderful initiative, and important model, complementary…and so talking about models and paradigms you know the structure of MAPS, both as a philanthropic a non-profit organization and as a corporation, how is that? What are the blessings and the curses of operating under two different paradigms Rick? 

Rick: Man [laughter] you've got…well, your questions are terrific let me just say that, I'm very glad to respond to this. So right now, we have about 100 people at MAPS and the MAPS public benefit corporation, so MAPS was started in April 1986. The public benefit corporation we started it in December 2014. And why we did that is right now about two-thirds of our staff works at the public benefit corporation and one-third works at the non-profit. But the non-profit is the hundred percent owner of the for-profit, the benefit corporation.  

The reason that we created the benefit corporation was because of a policy actually that Ronald Reagan signed into law in 1984, and the FDA was to provide incentives for people for developing drugs that are off patent. MDMA invented by Merck in 1912, the molecule is off patent. In the early 90s, late 80s early 90s, I hired a patent attorney to develop an anti-patent strategy so for the uses of MDMA, so all the uses of MDMA will be in the public domain. But what the law that Reagan signed into law was it provided what's called data exclusivity, so what that meant is that if you make a drug into a medicine even if there's no patent protection, nobody can use your data for a certain period of time to market a generic drug. So that we have exclusive use of the data, somebody else could develop their own data, but it'll take them five years or more, it'll cost them twice or three times as much as it costs us because we have so many volunteers, and people giving their time and working for less than market. So, we've raised over 100 million dollars in donations in the history of MAPS. 100 million dollars in donations. [Gisele: Impressive] But one of the things that's been important to the donors is to say that there are an endless number of uses of MDMA. Maybe not endless, but an enormous number of applications and if we just keep needing to come to donors, we will exhaust the donors. So we thought okay, because we have data exclusivity as an opportunity, we can decide that we will sell MDMA at a profit, and we will use the profits for more research, and for the mission of MAPS, so that we will become if not completely sustainable, we will supplement philanthropy with earned income from the sale of MDMA.  

Now that the profit motive has warped healthcare in America beyond all good sense. beyond all recognition. we have the most expensive per capita expenses in the world for health care, but our outcomes are like 40 or 50 among the countries. Because we leave so many out people out and so many people are not insured, and so I think when you maximize profits in health care you're really doing a disservice, and so what we wanted to do is on the one hand demonstrate a new approach to mental illness, which is psychedelic-assisted psychotherapy, but also a new approach to marketing pharmaceutical medicines where they are marketed in a public benefit way where we maximize public benefit, not profit. And also, where the whole profit, for-profit company is owned by the non-profit.  

So that's our corporate structure. People make donations to the non-profit, and get a tax deduction, the non-profit then invests or transfers the funds to the for-profit, the for-profit spends the money on the research, and then assuming the research works out, and we get permission to market MDMA, the for-profit will market MDMA. That's something that is taxable, we couldn't keep that inside the MAPS, the non-profit, we could have if we wanted to sell the MDMA at cost, but we felt like for raising the sums of money that we need to raise, and for speaking to the donors that…so we call that the virtuous circle in a way that that people donate to the non-profit get a tax deduction, and then we invest it in a wholly owned for-profit company, and as I said we've got 100 people, two-thirds in the  benefit corp, and a lot of them we call them the refugees from big pharma.  

We have a lot of expertise from big pharma, the sweetest thing actually is that a lot of them are the the senior leadership team, a lot of them has come from Novartis. And what what's so nice about that is that Novartis is the company that bought Sandoz, and Sandoz is the company that Albert Hoffman worked at where he invented LSD, and then also synthesized psilocybin and figured out what was in the mushroom. 

Gisele: Fascinating. The patent for psilocybin, what are your thoughts on that, and the development of that and how does MAPS differ from COMPASS Model? 
 
Rick: Yeah, well first off, psilocybin itself is in the public domain, I mean it was invented in ‘58 by Albert Hoffman, and that's when he figured out the psilocybin. So, what COMPASS has patented is not the psilocybin, but the process of manufacturing the psilocybin. So that you can have composition of matter patents, that's when you invented a molecule, those have expired, then you can get all these use patents, much of that is in the public domain. The process patents is what COMPASS has, Usona the non-profit organization that's developing psilocybin, has decided to take their method of synthesis and make it public for making psilocybin. So the the patent that psilocybin, that COMPASS has on the manufacturing of psilocybin is just about their method and it doesn't block other people from coming up with other methods. COMPASS is now talking about the possibility of patenting psilocybin for use for certain kind of uses but a lot of those uses are in the public domain, and I think what COMPASS is going to be patenting is going to be sort of a unique combination of digital technology psilocybin therapy…so I am in general sympathetic with people, if they want to patenting their original inventions. If the patents are used to block other people from doing things, if they're over-broad patents, I don't think that's a good thing, but if they take money from investors, and COMPASS has now raised over 200 million dollars from investors, and we'll see but I don't think that their use patents are going to block anybody anything that that Usona wants to do…so I'm not actually that concerned about it…but MAPS’ approach has been different again because we don't have investors, we don't have to return money to investors, we want mass mental health if people want to adopt our methods, or improve on them, we want to foster the whole field. So we're not going to try to block anybody from doing anything and in fact all the things that we're doing we're going to be putting in the public domain, like our treatment manual, our survey of the literature of MDMA, our protocols are up on the web, all of these things are designed to facilitate other people following in what we're doing and maybe even improve on it.  

Gisele: That's fair. And so, sometimes it gets a little political, yeah? [Rick: Yeah] And I've heard you talking about psychedelics being a bi-partisan issue…[Rick: Ah, yes, yes] any comments on that? 

Rick: Yeah, okay, well…we all know, or maybe many of us know, that when one of the more progressive members of The House of, House of Representative is Alexandria Ocasio Cortez (AOC). One of the more conservative pro-Trump members of Congress is Matt Gates from Florida. So, one of the only bi-partisan things that has happened in Congress is that AOC and Matt Gates got together to sponsor a bill to try to make it easier to do research with psychedelics. [Gisele: That's fantastic] The bill was not passed by the House of Representatives, but there is bi-partisan support. We also have got bi-partisan funding. Rebecca Mercer on one hand, who is a big Trump and Bannon supporter. All the way on one side, the other side George Soros, who funded us to do a training for therapists of color.  

So we we have bi-partisan support, and also the fact that the people who have PTSD, as I said roughly 60 plus percent are women with domestic violence or or sexual abuse, but also a substantial number are veterans with war-related PTSD, so our patient populations also are appreciated by a bi-partisan group of the public. So I think it's been very important to think about and try to get people focused on healing as a bi-partisan endeavor ,you know we we all want to see healing, and also when we start thinking about the treatment of addiction, psychedelics can make a major role in the treatment of addiction, and there's people across the political spectrum that get into trouble with dependence on different drugs. 

Gisele: Mhm…wonderful. Thank you so much Rick for being here tonight, for all the work that you have been doing, for inspiring, for training, for opening frontiers for healing, for not only the mental health field but society in general… 

Rick: And yeah, and I guess I would like to thank all those underground psychedelic therapists who've kept the flame alive, um…there's been a lot of people with courage who have decided that for ethical reasons, they need the best tools available to work with their patients, even if they're against the law, so I do think that there's been a large number of people that have kept the flame alive over these dark decades, when things were completely squashed…and now things are coming to the surface, and I just think we have a very good chance at a time of great need to mainstream psychedelics.  

Gisele: Mhm, so since we're giving our gratitudes here to you, to the movement, to all of those who have been working, to CIIS for sponsoring, and all these different institutions who have been supporting the work, for all the donors, all the people who have been involved…let's give thanks also to our ancestors, those who came before us, those who have been doing this work for a long time, those who continue to protect and guide us in this path. 

Rick: That's beautiful, and I would like to bring to mind Stan Groff. So, Stan is now 89, he's really been the keeper of the flame in the darkest days, the developer of Holotropic Breathwork. I think Stan has been my mentor, he's mentored a lot of the people that have really started psychedelic research, psychological psychotherapy - Michael Midhover, George Greer, Charlie Grubb, Bill Richards…yeah that there's a lot of people to give gratitude to, and we we are looking forward to all sorts of new people to do tremendous things that we can then be grateful for as well. 

Gisele: Yeah so gratitude to our teachers, to our mentors, to those who influenced us, who inspired us, who taught us, and to those who are gonna come after us and continue this work. 

Rick: Yeah.  

Gisele: All right…thank you Rick for being here. 

Rick: Thank you, Gisele. Terrific questions, it's been a pleasure to speak with you and and with everybody listening tonight.  

Gisele: Same here. Have a good night everybody. 

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Thank you for listening to the CIIS Public Programs Podcast. Our talks and conversations are presented live in San Francisco, California. Podcast production is supervised by Kirstin Van Cleef at CIIS Public Programs. Audio production is supervised by Lyle Barrere at Desired Effect.  

The CIIS Public Programs team includes Kyle DeMedio, Alex Elliot, Emlyn Guiney, Jason McArthur, and Patty Pforte. If you liked what you heard, please subscribe wherever you find podcasts, visit our website ciis.edu, and connect with us on social media @ciispubprograms.  

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