EP 213: Brian Richards | Psychedelic Insights for Mental Health
31 Oct 2024 · 62 min
Podcast interview (EP 213, 31 Oct 2024) in which host Fleet Maull speaks with Dr. Brian Richards (licensed clinical psychologist; Johns Hopkins affiliate; Sunstone therapies) about psychedelic-assisted psychotherapy. Major topics: psilocybin and MDMA therapeutic applications (cancer-related distress, PTSD, depression), trial design choices (dosing, music, preparation, integration), a published hybrid simultaneous group-administration trial (JAMA Oncology) with cancer patients using 25 mg psilocybin and group integration, the clinician’s role (holding safe space, limited interpretive input), safety and scalability challenges (therapist workforce limits, cost, regulatory/reimbursement barriers), and forthcoming multisite palliative-care psilocybin trials for patients near end of life.
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Welcome to Radical Responsibility, the podcast dedicated to ridding the world of blame and shame, where we explore the issues you care about from a unique perspective. 100% ownership for each and every circumstance we face in life, day in and day out. Hi.
Welcome to the Radical Responsibility podcast. This is your host, Dr. Fleet Moll. In this episode, I'll speaking with Dr. Brian Richards, a clinical psychologist and faculty investigator at Johns Hopkins University, about the transformative potential of psychedelic experiences in mental health. We explore how these experiences move beyond symptom suppression and allow deep personal transformation. Dr. Richards shares his insights on how altered states of consciousness can reframe existential concerns and and the role of therapists in helping patients integrate these profound experiences into their everyday lives. So tune in and understand how psychedelic insights can revolutionize mental health and well being. And by the way, if you'd like to take advantage of an incredible opportunity to purchase my book, Radical Responsibility, we have a special offer available on the book website now, which is radicalresponsibilitybook.com. if you go there, order the book online at your favorite bookseller, get the order number, load it up on our website. You'll receive over $1,000 in valuable bonuses, so take advantage of that now@radicalresponsibilitybook.com okay. And now let's enjoy this conversation with Dr. Brian Richards.
And I'm really happy to be here today with Dr. Brian Richards. Welcome, Dr. Richards.
Thank you. Honored to be here.
Well, it's an honor to have you. So I'm going to share a bit of your background and then we'll jump right into the conversation. Sound good?
Sounds great.
All right, so Brian Richards Saidi is a licensed clinical psychologist. He's a faculty of a faculty affiliated investigator, John Hopkins University School of Medicine where he works on states of consciousness research at the Behavioral Pharmacology Research Institute. He completed a master's degree in existential phenomenological physical psychology, a PsyD for professional psychology, and a postdoctoral fellowship at John Hopkins Behavioral Pharmacology Research Unit, now the center for Psychedelic and Consciousness Research, where he contributed to the original research administering psilocybin with cancer patients and healthy adults. Dr. Richard also teaches students at the California Institute of Critical Studies, the leading psychedelic medicine certificate program worldwide. He was a lead psychologist on an innovative simultaneous group administration high dose psilocybin trial with cancer patients. Dr. Richard's clinical and research interests include meaning centered psychotherapy, mystical experience and brain science based approaches to wellness.
Quite a background.
Thank you.
And.
I love that your interest Spanish clinical practice, psychotherapy, wellness, spiritual, well being the mystical and how all that interfaces with what's emerging with psychedelic medicines and so forth. So you've been engaged in. In clinical and research work for quite some time now with psychedelic assisted psychotherapy and other modalities of therapy and at John Hopkins, and currently you're working at Sunstone therapies as well. So I'm wondering if you could just share a bit of your background, how you kind of ended up in this area. I would imagine that.
Some influence from your father, Dr. William or Bill Richards. I would imagine it had some influence, but I wonder if you could talk about your journey into the work you're doing now.
Thank you. Certainly. Completed a doctorate, had a internship at Springfield Hospital in Maryland, and then was offered the opportunity to do a postdoctoral fellowship at Hopkins, where my father and also Roland Griffiths were working. And that was a wonderful, extraordinary opportunity and introduction to the kind of nascent resurgence of psychedelic medicine. And really at that time, it was the respectability of Johns Hopkins and the scientific questions around a whole class of medicines that really hadn't been characterized. So behavioral pharmacology looks at abuse liability, whether there's any potential signal of therapeutic efficacy. And so it's really the kind of rigorous, objective science that needed to be done around psychedelics. And that was about the time I joined behavioral pharmacology as a postdoc and really an opportunity to.
Learn something about psilocybin and what it is about consciousness and this medicine in a really thoughtfully conveyed therapeutic envelope where people felt safe, they were physically comfortable, felt adequately prepared, were supported throughout the experience, and also supported with integration to kind of unpack and make sense of what can be extraordinary experiences that for some people, in a sense, go beyond any language to try to convey.
You know, we were.
Both recently at the MAPS conference in Denver, and I was very happy to be able to attend the Roland Griffiths keynote and also dinner and his honor. And I was incredibly moved by. By his presence, by his words, and what he's journeying through right now himself. I'm just curious if you could just say a little something about working with two giants in the field like your father and Roland Griffiths there at Hopkins. I mean, I mean, such a. And the credibility John Hopkins brought to get this science moving forward at the. With the right timing and everything to. To be where we are now. I don't think you can say enough about how important it was like Hopkins to be able to do that research.
Yeah, really honored to be one person at Roland's life and to support him and be with him through part of the arc of his career and just the steady methodical discernment, the dedication to do good science, to not get inflated around ideas of what could be, but to really be as objective and as grounded as possible, month after month, year after year, and to support the evolution of really good science. Continuing not only at Johns Hopkins, but also at one point in collaboration with nyu, our cancer study, and then other universities.
And I can't speak for Roland or Bill, but certainly for myself, when we were just beginning this work, there was not a lot of support from other physicians or other groups. It was respectable to be doing work at Johns Hopkins in research, but no one had any follow on questions around psychedelics. And a couple of decades later, hundreds and hundreds of companies, novel molecules, different worldwide, various clinical trials being conducted. It's extraordinary to see the evolution of psychedelics in so many ways. And I hope that it will continue in a way that is really helpful to lots of people.
And you're certainly playing a key role in that. So again, speaking of your father for just a moment, Bill Richards, who is fairly renowned for, I think, conducting the first psilocybin study.
The Bill Richards center for Healing has been described as a prototype for future psychedelic medicine clinics. And I'm wondering if you could talk about what are some of the unique aspects of that center and why that might lend itself to be a prototype model for the future.
Thank you. A couple of architectural design ideas that are really focal. One is the Bill Richards center for Healing. It's on the third floor of the Aquilino Cancer center in Rockville, Maryland. Michael Aquilino, whose wife died from cancer years ago, very graciously supported the build out of the Aquilino Cancer center on the grounds of Shady Grove Adventist Medical Center. But also he wanted a space that was where essentially all care could be provided. Radiation, chemotherapy, surgery, immunotherapy, imaging.
Oncology, dietitian, wellness programming. And the third floor was not built out until three years ago where the idea was wellness, a whole person healing model and creating a unique purpose built space. This was designed with the help of Gensler Architectural Group. And the idea was a space where you come in, it's expansive, a naturalistic setting. There's an area to meet as a group or kind of a community area. And then a kind of inner sanctum where the work with medicine is completed for consulting rooms there. And behind a wall is all of the clinical staffing, supervision, oversight. So the feel is coming into the space. It really feels very comfortable and welcoming. Not a kind of Typical medical setting, not a lot of environmental noise. A window, the entire wall is windows overlooking a beautiful Zen garden. And people can make themselves an espresso, have bottled water, a snack, and really kind of feel like the staffing and the space is conducive to feeling at peace, trusting, letting go, being open.
I've watched quite a few films of various clinical trials of psychedelic medicines. And while in some, clearly there was an effort made to make the room a bit more homey and comfortable, many of them look pretty much like a classic hospital room. And even though the staff may be making effort to even present the medicine in somewhat ceremonial way or do different things, but still it's hard to get away from the feeling of being in a hospital room, which is hardly the favorite environment for any of us to find ourselves in, I don't think. Yeah.
I would add that some of the pieces we've learned along the way is to invite every participant to really make the room or the space their own for the day. So that could, for some people, mean bringing in, like, a Tibetan Tonka or other artwork, personally meaningful objects, photographs that might be meaningful to reflect on throughout the day. And so as much as possible, although it still is very much a medical setting to help the person kind of feel comfortable taking ownership of that space. Like, that'll be where they have their inner journey throughout the day.
So, Dr. Richards, in this summit, we're exploring.
The use of psychedelic medicines in a therapeutic context, their impact on changing consciousness, on healing, healing often difficult to treat human maladies like depression, anxiety, addictions, and PTSD and so forth. And. And in particular, today we're focused on the research. So I wonder, in terms of the work you've been doing over the last couple of decades, if you could talk about, just generally, to begin with, some of the strategies of the research around.
Researching the therapeutic and clinical application of these psychedelic medicines. Kind of give us an overview of the research a little bit. I know that's asking a lot, maybe, but what have been some of the strategies of some of the trials you've been involved with? And then I want to circle again after that and talk about some of the work you're involved with now, especially the work with cancer patients and terminally ill patients and so forth. But I wonder if you could give us a sense of what you've learned along the way with the research and the research strategies.
Very good, thank you. So, dosing, which psychedelic medicine and why psilocybin has a history of Sacramento use going back possibly thousands and thousands of years. In the archaeological record, it also is a medicine that can be taken orally that on an empty stomach occasions a gentle but progressive shift in consciousness at about 30 to 45 minutes, depending on what the person had for breakfast, but also takes them through a meaningful arc of about four to six hours of deepening experience that is supported by not only the clinical staff, but also the music which be created to follow the pharmacokinetic profile of the medicine. So the music supports, occasions, differing emotions and takes people deeper and deeper throughout and helps bring them back to their familiar state of consciousness, self concept at the end of the day.
So, and in terms of, you know, collecting data and assessing the, the impact of various strategies and approaches to working with the psychedelic medicines, is it both mostly self report interviews following the sessions? Has there been biomedical research done? Are there biomedical markers that are tracked? Has there been any brain scan immunoassaying, anything like that going on? The biomedical aspect of the research?
Oh wow. Yeah. Depending on the lab or institution, lots and lots of different work is being done from our perspective. Although we're not doing any imaging, we do have clinician administered scales to assess pre post what the outcomes are and optimally, these should be pretty much right in line with the self report instruments as well. Assessments of depression, of anxiety, and also secondary markers that we'll be evaluating in far greater depth in our follow on study around pain. For example, anecdotally, it's startling, how is it that a medicine that can occasion a very compelling and memorable psychological experience ultimately, or this shift in consciousness and expanded state, but a medicine that is metabolized in 24 hours? Part of the mystery is how is it that months out, even 18 months out, that person might report attenuated pain, meaning they're not catastrophizing their physical pain or their illness. They may need fewer medicines, benzodiazepines, lycopene, sedatives, narcotic or opiate medicines to manage their pain, they can be potentially much more active. So I guess part of the mystery is the paradigm, kind of until psychedelic medicine has often been really symptomatic treatment, what are the symptoms, what's indicated to treat those symptoms, and is that medicine tolerable or what are the side effects potentially? And over what period of time, what dose, what polypharmacy helps this particular person. So I, I think it's extraordinary that we can have experiences internally that completely reframe the fear we have towards the inevitability of our own death or the sense of connection we feel with other human beings, with animals, with. With all of life. Like, what is it within us that exists as a possibility in the present moment? But it's very difficult to access. And psychedelic medicine with adequate preparation, courageous inner journey helps people reconnect in a way with something that was already there. And I guess again, as a clinician, and by no means do I, you know, pretend to have a sense of the nature of reality, but I do appreciate the, the compelling narratives my patients have given me. Sometimes people feel like it's like, oh, how could I, how could I have forgotten that? Now I remember. And of course, I'm more than my mind and my physical body. How could I have forgotten that? So with death, consciousness will continue. And it's not necessarily a spiritual experience. We've had atheists, agnostic people, or Diwali religious people, or people who identify with a sense of spirituality, but nevertheless, really, whatever their preexisting beliefs, sometimes people have transformative experiences, and then it's really per their discretion. Will they continue to embody or feel inspired by that experience, or will they relegate it to kind of compartmentalized as an experience with drug, not consistent with their beliefs, et cetera. So the threat of our lives, every human being, these big experiences that for many people do happen spontaneously or can happen in a much more consistent way. With psychedelic medicine in a medical setting, it's still up to the individual to decide what they're going to do with the experience.
Yeah. So it's, it's got to be quite amazing to see such a transformation in psychiatry. This move away from just symptom suppression, symptom control and pharmacological psychiatry to witnessing clients and patients having subjects having these extraordinary experiences. And, and I, and I really loved, again, listening to Roland Griffiths at the recent conference. You know, that he really just was always encouraging everyone to trust the science, follow the science. We're going to see where that takes us. And of course, it has now taken the field to extraordinary places. But I would imagine it's hard not to become an enthusiast and sort of get ahead of the science a little bit when you're witnessing these profound transformations. And then there's this whole kind of mysterious area. If you're seeing benefits like attenuated pain down the road, you're seeing various benefits and shifts in worldview and, and a different relationship around the possible one's own mortality. These kind of things you were referencing, these seem to be changes in the psyche, changes in mind, changes in consciousness. But one would think if they're lasting there's some relationship to the brain, and something about this could be discovered neurobiologically and that kind of research and so forth. But it's still a pretty big gray area, as far as I know, what's really going on there. Would you. Would you agree with that? It's.
I sure would. And Fleet has sometimes been described as the hard problem of consciousness. You know, we have this intricate, extraordinary biology, all of its complexity, all of its nuance and intricacy. And then we have the experience of consciousness, our individuality, our subjectivity. I think it's important to recognize that the same drug, the same dose, the same route of administration taken recreationally, taken at a concert, or in an intentional, methodical therapeutic process, you can have wildly varying experiences. And the drug effect alone doesn't necessarily occasion meaningful change in perception or necessarily other therapeutic benefits. So there really is something about the intentionality and the safety, the accountability of staff and their training and supervision and ongoing support, a collaborative model where we're fellow human beings. I have a particular role as a clinician to support a person having a deep experience.
For example, the boundaries of therapeutic touch are explicitly understood and agreed. So if they need me to hold their hand or break contact at any time, just fine. And my role is to help them encounter their inner world, their mind. And what that means is sometimes encountering monstrous aspects or going into some utterly dark places and looking out through the very eyes of whatever is most feared. That's very, very difficult to do individually. We need other human beings there with us. And so there's. There's a real kind of beauty to the human beings supporting one another in this way. To have potentially very deep experiences, to move beyond our kind of name and form way of experiencing everyday life, and then coming back to it with some realization that was really helpful, maybe some deeper wisdom we've reconnected with or realized for the first time that also helps us not only be more at peace with ourselves, but more at peace with others.
I wonder if you could talk a little bit about the role of the clinician there. My understanding is that the FDA clinical trials with MDMA and other trials going on with psilocybin, and so we have fairly prescribed protocols and that the role of the clinician or the therapist, or sometimes called the sitter, is pretty much to hold a safe space, a safe, reassuring space, and not like in some other forms of psychotherapy, to be evoking an experience or interpreting experience, but really holding a safe space for the subject, the client, the patient, to really have their own experience and make their own discoveries. Is that accurate?
Yeah, that's absolutely accurate. And that's also very important. For example, with Sunstone we're working with psilocybin, but also with maps, expanded access with MDMA and people who have refractory ptsd.
For example, the MAPS study, One of the deeper ideas is what the Midhofers described as our inner healing intelligence. What is that within us that we can reconnect with, which is an innate aspect of who we are that can help show us what we need to confront or work through or heal. And so in a sense, the therapist creates a physical space of safety. The boundaries are very clear. But the therapist's role, other than support, I think it's largely to really encourage the person to put the eye shades back on, even if it's terrifying, breathe, go into the present moment, encounter that aspect, be in dialogue with it, move in and through it, whatever it may be. And that's all within the mind of the participant. So in a sense, a lot of those meditative ideas.
Breathing the present moment, being present, being the witness to whatever is manifesting in the mind, being open, curious, recognizing one's own courage to take that kind of inner journey, which for many is a crucible in some aspects, but not all for some people there's a lightness of being, a levity at play in moving into those spaces.
Yeah, you mentioned courage. For me, what I've been with, it seems like courage is a big part of this, both for the client or patient and for the clinicians. In that again, watching some of the films of the clinical trials I've seen where a subject went through a pretty difficult trip or journey like really surfaced some repressed traumatic memories had went through some really difficult passages and when they were describing it post session, seem to be able to describe it with a certain. I don't know if detachment is the right word, but it's a kind of courage and a perspective, a broader perspective. So it seemed like something about that experience allows them to witness it in a way that they're not necessarily re traumatized or that part of ourselves that kind of can collapse into being over identified with our traumas and become a very limited place from what kind of fear and survival based place from which orient our lives. They seem to be able to witness it from a different part of the psyche or different of the brain or something and then have a different relationship.
Yeah, that's really well said, Fleet. And I'm seeing that clinically, which is extraordinary. So to qualify MDMA or methylene dioxy. Methamphetamine is a different medicine. It's an empathogen. It does have psychedelic properties, can be psychedelic for some people, but really does attenuate the activity of the amygdala. And the. A good way to convey its efficacy as a specific indication for the treatment of PTSD is people have access to, I mean, granular, moment by moment, access to some absolutely horrific experiences that in memory could have been utterly fragmented, partially dissociated, not recollected in its entirety. And there's the memory. And I've seen, for example, I can think of one woman I worked with who at one point was kind of reliving, being choked, kind of peeling away these invisible fingers. And then her breathing normalized, the redness around her neck cleared, her facial features relaxed, and she opened her eyes and she was sitting up facing myself and the co therapist. And she said, I. I think that memory is done.
And what was really compelling, it was like as if she needed to move through that experientially again in a way she could tolerate. She knew she was safe. It wasn't really happening again. And then the clarity of perception, like, oh, that's why I can't. I was chronically hypervigilant and unable to feel safe and secure and at peace. And as if that therapeutic process helped her brain recontextualize it as a memory in the past, like, that was a horrible event. It occurred in the past. It's not happening now. It's not about to happen again. You're safe in the present moment. And so some of the work people do is very much spontaneous. It really manifests within them. And the therapist may not even fully know what's happening other than they're present to offer support. And so what can present as this awful reliving is also potentially profoundly therapeutic. Also, I think a couple of things I'm learning as I continue working as a therapist with these medicines, one is provided the person's adequately prepared, properly screened, to trust the medicine. And as the Mithoffers also said, don't get ahead of the medicine. Follow that thread. The medicine is a CO therapist. The music can be thought of as a co therapist.
And really to also appreciate that even experiences that seem utterly overwhelming and obliterating in the moment, meaning the person goes through absolute catastrophe. They're sobbing for hours. Everything seems like it's imploding. From a supervisory perspective, it can look like the session is really going sideways. The person is inconsolable, help rejecting whatever a week later, that same person may have gratitude and perspective, like they had the courage to touch on some things that they've been avoidant of for years and years and really feel they're healing and growing. So even when it presents as a difficult session or challenging session, both for the participant, but also for the therapist to be there to offer support a week later, people often retrospectively, really value the experience. And the narrative I hear often is, oh, my God. Having been through that, there's nothing in the outer world that could be as challenging. So there's something. And that's also, I think, part of the mystery of consciousness and life. The deeper a person goes into their own mind, so to speak, or into an expanded state of consciousness that can also reframe how they relate to the real and imagined challenges of ordinary everyday life.
Well, you know, the other aspect of this courage, there seems to be kind of an emerging.
Clinical or therapeutic courage in the field at a sense. I mean, back in the 60s with the human potential movement and a lot of things that were going on. Gestalt therapy, a lot of intense group processes. I've been leading a very intense group process. Well, prior to the pandemic setting in the lockdowns, I was leading it for over 20 years. A very, very old school, intense group process involving various forms of psychodrama, all kinds of things, all kinds of techniques. But it was really the group process that provided the intensity and take people deep into childhood traumas and re experiencing things and shifting their relationship to them in powerful ways. But we kept that work pretty much under the radar because the field had moved to psychotherapy. In many cases, it had moved to a very safe, maybe for good reasons, but really emphasizing safety, fear, re traumatization and. And things like that. And, and, you know, the wonderful intersection of mindfulness and psychotherapy, which has been very important, but also has kind of led to, you know, trying to find ways to help people that don't push anybody's buttons. It's all very safe and very, you know, and. And this is like, you know, wild stuff again going on. This is like back in the 60s and 70s. And. But maybe one of the reasons that there's able to be the courage is many of those processes. The catalyst is the clinician, the trainer, the therapist, or at least, or the process they're facilitating or the group process they're facilitating. Whereas here it's really the medicine and the role of therapist is to keep things safe and hold a safe space. So maybe that allows the field and allows us to move more into a more courageous realm and let people have these experiences. I interviewed Stan Grof and Brigitte Goff for the summit just a few days ago. And I had assumed that the holotropic breathwork evolved out of Stan studying some Eastern breathwork traditions. But it actually came up spontaneously in work he was doing with people in sessions where they're going into some extreme states and memories. And he spontaneously learned a kind of bodywork. And then the breath work kind of arose. People just started doing this. And Brigitte was commenting on the courage he had at that time to hang in there with that process, that they really didn't know what was going on, but there was something going on and they just followed it and were able to turn it into a therapeutic modality or something. So I don't know if this resonates with you. It just seems to be a reimagining of therapy and its possibilities and more courage around the whole process.
I would agree. And I also think perhaps we're at a tipping point in the culture. But I'd like to see is of course, sunstone. And the Aquilino Cancer center being one perhaps of many community cancer centers where psychedelics are available to cancer patients, but also people from the community who might have PTSD or refractory depression. Very importantly, a pathway where there's a $20 copay for a fixed series of procedures involving multiple clinicians, known GMP drug delivered in a particular way in a consistent manner where there's adequate support and adequate integration. From a personal perspective, the human being who is suffering can think, well, I could look to psychiatry for symptomatic treatment. I could look outpatient. I could do integrative medicine, acupuncture, craniosacral therapy, other modalities. I could consider psychedelic medicine. And I know it's safely delivered at the center locally. And this is what the cost would be. And I have a sense of what commitment would be in terms of time and energy. Then fundamentally, the idea of expanded states being integrated into our culture, safely supported, really becomes normalized. And why not? One of my supervisors once said, we tend to forget that every single night when we dream, we hallucinate wildly. We move into a state of consciousness where there's no laws of physics, things are bewildering, and then we wake up and we rapidly forget our dreams as we shift our brain function into wakefulness. But we're moving through different expanded non ordinary states at various times in our lives. And for people who dream or go through REM cycle normally every single night so why not have this available? Because there's potential utility in expanded states beyond the self concept, the limitations of our physical body. These drugs are safe to administer, they're non addictive and with the right therapy envelope then it's accessible to people. And for those who are open to it, then perhaps that can be helpful and that may be part of their therapeutic process. They might also take sertraline, they might also see a massage therapist, that's just fine. So if we can individualize care, but also make available psychedelic medicine in a medical model, I think that's a real contribution.
Well, you emphasize the safe delivery and that's so important. It reminds me there's a teacher of kind of circle work. I've been involved in various kinds of circle work and process work in many areas for a long time. And this person said circles are safe places to do unsafe things. And you know, so it's like places where you can do the work that normally we might consider a little edgy. Right. You know, going revisiting these kind of traumatic memories or going through these difficult, even almost dark night of this whole kind of experiences. But to be able to do that in a safe space where you're really supported and you know you're going to be well taken care of, quite amazing. So I wonder if you could talk more about, you know, then bringing this out of the laboratories and, and the, the research programs and the trials and into the world in beneficial ways. You to describe that maybe in particular the example of supporting people at the end of life.
And how do we do that? Because you did begin to describe something there that seemed like it sounded like was economically viable there. But I know one of the challenges people have been talking about a lot is these clinical trials. To replicate those would be very expensive. The number of clinicians involved, et cetera, et cetera. And some people have talked about group work may be an answer. And I think you did a group group study around end of life care. So I wonder if you could explore both your work around supporting people end of life and then also the practicalities of bringing this into the world in ways that can be really widely available and beneficial.
Yeah. Thank you. So our first study, which we recently published in JAMA Oncology, was really a kind of hybrid simultaneous group administration study groups of three or four participants. Part of it was individual meeting with their therapist who was assigned to them throughout the study, and part of it was meeting in these small groups with their therapists. Part of the construction of the study was thinking about healthcare systems at Scale and the necessity to work with insurers so that we have a feasible model that's sustainable. Eight weeks. How much preparation is needed? The dosing session and the integration. What is sufficient, what is, is too much, what is not quite enough? Those kind of key questions around scalability. But the first study, one of the important takeaways was that there was something very, very meaningful that these participants encountered, sharing their experiences with one another. The preparation, the apprehension, anxiety, anticipation, and then the integration as well. And so part of what we realized was not only is it perhaps a cost effective approach, managing efficiencies, operations, et cetera, but also human beings really connect with one another as they go into these remarkably memorable experiences. And we're now just about 24 months post study and once a month, every Wednesday evening, we have a completely voluntary integration call, meaning anyone who participated in the study is welcome to call in and reconnect. And people still call in to reconnect with one another, to share memories, sometimes a salient memory that was very meaningful, sharing it again, feeling heard, supported around that. And so this was with a single 25 milligram dose of psilocybin. Our follow on study, which we'll initiate in the next month or two, is very similar in its architecture, but offers a second optional 25 milligram dose. The takeaway from the first study was many of the participants were naive to having ever taken a psychedelic, so they were trusting their oncologist recommendation. They were novel to the idea of taking something that dramatically expands consciousness. And for some people, they verbalized to us that they really wish there had been a second drug condition optional. The reason being these are unknown waters. And the sense was, learning the basic geography, they felt like if they had another opportunity to take the medicine, they could dive much more deeper, deeply. And so we'll have that as an option for our follow on study.
So in the first study, there was one session with the psychiatric medicine psilocybin done as a group, like sitting in a circle, all journeying at the same time or no.
What we learned, and this is partly from research that was done in the uk, is that.
The preparation can be partly with the individual therapist and also in a group context, the drug administration. Every participant, we have four consulting rooms, so we had up to four participants on a given day would be in a private space with their therapist attending throughout the day. That could be master's level or higher. And so they were in adjoining rooms and might kind of wish the other person the best or.
But not be really interfacing. With one another, because at least with this model, it does seem that people find it beneficial to have their own safety and privacy during the day. But then the following morning we met again less than 24 hours after drug administration for the integration session.
And so you said it was an eight week program, so they met as a group for integration sessions once a week or something over eight weeks or how did, what did that look like?
So there was screening and then four hours of preparation. And we wanted to think of a model of preparation that would also be replicable. So if there were another cancer center that was interested in doing psychedelic medicine, how can they do that safely and efficiently? So some of the preparation involved review of video. Robin Carhart Harris, for example, talking about the pharmacology of psilocybin, patient testimonials, boat journey video to give a person a model of kind of trusting being with their therapist, welcoming everything that arises. And those videos would be watched with a therapist individually. And then there was a meeting with the group introductions. This was a totally randomized group of cancer patients, meaning not stratified to type, type of cancer, stage of disease, anything. So there were people who were likely terminal alongside a person with no evidence of disease, who's still locked in fear even though years have gone by with no recurrence of cancer of any kind. And so really.
If we think about a busy clinic that might have 700 to 1,000 people come in a week of that group, people who were interested in psychedelic medicine, we found that it makes sense to just bring in people who are interested in psychedelic medicine without trying to micromanage all the intricacies which would be typical for a high volume outpatient clinic.
One thing you brought up has been a curiosity of mine. I came of AIDS in the 60s and 70s and was a very enthusiastic and active participant in that wave of the psychedelic era, both plant medicine and really everything in both in the US and South America. And you know, that really shaped my worldview back then. And of course it was kind of a generational thing that was going on as well. But when I think of some folks like now being invited by their physician or somehow finding about and, you know, deciding to try one of these psychiatric medicines, who've lived with a pretty conventional worldview all their lives, never suspecting there was anything other than this ordinary reality and not really existing within social structures that even entertain that if anything, maybe would demonize any notion of the same, and then suddenly have these. They're willing to do this is quite amazing. I guess, trusting their Physician, their clinician. But then you know, what a, a dramatic change. And it does seem that people fairly readily convert to a new worldview like, oh, there is a bigger reality out there. It doesn't seem, it seems if you have that experience, it, it, you get sold pretty quickly on the fact that your previous view was somewhat limited. I don't know if that's been your experience or whether there's some people that resist that. I'm sure there are, are.
Yeah. And I think it, there's the idea and I don't know if it was Roland Griffiths who coined this term. I could have been of what, what's called ontological shock.
Exactly.
Good term.
Personal conviction of the nature of reality, our world view, who we are in the world, what we believe about life and death, the meaning of life, etc. Etc. And these experiences that go beyond name and form meaning. There could be a time, if I were a participant, where I can't find Brian Richards anywhere. I know my physical body is safe, but I am somehow inexplicably in some other universe billions of light years away. How is that even possible? That consciousness can experience itself in that way? And then I come back to my body and then okay, yeah, I'm Brian Richards and oh yeah, like this is my life. And so even those really staggering mystical type experiences, poignantly, no matter how enlightened a person might imagine themselves to be, in one point in time, we come back to the vicissitudes of our lives. The inevitability of death, of serious illness or inescapable trauma, the loss of people we love, the hardships that lie ahead. And that's what we must contend with. So the experience of ontological shock is an opportunity to re envision the meaning of having a human life and what we contribute to the world and what we do while we're here. But it importantly is really up to the individual to decide if they're going to embody that. And so integration is vital in having a space that's non judgmental and confidential, where with their therapist, who may have their own distinct worldview, but is not imposing that worldview, just supporting the person, making sense of what happened so that they can then select which insights they really want to practice, what will support them feeling connected, taking better care of themselves. And also I think the subtle aspect of those therapeutic lifestyle changes that become apparent from quitting smoking, for example, to more exercise, more connection with other people socially, that then we look out, out 12 months, we look out 24 months and that person is psychologically medically healthy. But it's not just the memory of the experience. It's all these changes they've made in how they live their everyday life that sustains it over time.
So.
I know you've, you, you've. Well, the one question specifically about the trial first. So the integration sessions in the trial, these were in person. I realize they have a weekly call available to them, but these original integration sessions were in person.
That's exactly right. And importantly, the integration sessions would begin with often a practice to occasion some reconnection with the preceding session. So when I was leading the integration sessions, what I would select was one of the most evocative pieces, about three and a half minutes of, of very high intensity Vedic music that was at peak drug. That's when everyone's blood level was highest, when they were in presumably state neurobiologically in terms of drug effect. And I wanted to begin the integration session with something evocative of that moment in time that they had recently experienced. For some people, that actually cascaded them right back into visceral memory of that moment in time. But then music is an incisive pathway to reconnect people, to help them integrate. The music playlist is constructed in such a way that we gave it to our participants because they're neurobiologically encoding new memories with psilocybin that entire day. So then the music is a non drug pathway to touch on some of those really deep experiences again. And so then the integration sessions would proceed with more of a just nothing is unspeakable, everything is welcome, jump right in, Tell us what was the hardest part of the experience. Tell us all about where you got stuck. Not everyone is going to have a positive outcome. Not everyone is going to respond to psilocybin as we would hope therapeutically. But nonetheless, everybody is kind of experiencing life moment by moment and just to encourage expression of kind of learning from one another and sharing deeply of what the person experienced.
Oh, that's fascinating that you're continuing to use the music as part of the integration process. We know that memories are state specific to a high degree. So very likely that you're bringing back some, some of the contextual states that people were in there. And that's a whole nother rabbit hole we could go down with the music. I have interviewed both David Starfire and Mendel Kalin who are doing great work around constructing some of the music for psychedelic sessions. And it's really a fascinating discipline in of itself.
I wonder if you could say a Little more about what some of the, maybe some of the real obstacles that are there in order to bring this further into the community. And then also what are some of the key unanswered questions we have from a research perspective?
Great. I guess what I'm most interested in currently and again, I've moved away from focal research. I still have Hopkins affiliation, but Sunstone is really a vehicle for clinical trials in a community cancer center. And so what models can we create that really help occasion meaningful experience that is optimally lasting, safely with a degree of consideration of cost? And that can be a challenging area, but it's one that has to be thoughtfully addressed. Not only the cost of administration, but also how can we create a structure? Rick Doblin said on a call a year and a half ago, he was like, hey, we need, I think he was like 30,000 therapists at the time. And of course that number has grown. But we need therapists who can create a part time or full time living doing this work where it's not a sacrifice, or they're working pro bono, or they're volunteering lots and lots of hours, hours of additional time. There need to be meaningful, fulfilling career pathways where there are behavioral health psychologists, psychiatrists, nurses, pastoral counselors who are able to get properly trained in psychedelic medicine, receive supervision, ongoing support, their own personal experiences if helpful, so they can really understand and connect deeply with their participants whatever they're experiencing. But how can we create a structure where there are tens of thousands of therapists available who have very good boundaries, are ethical, do not transgress with their patients, and are consistently able to be helpful? That also means the therapist has got to take care of himself and be a friend to themselves. We're finding that the maximum is probably two dosing sessions a week For a therapist, that eight hours is a intensive meditation in the present moment on that human being. We're there to support and help, and it's exhausting. It's very highly demanding work that brings into our own consciousness our own ontological shock when we have an experience with a participant that is so radically different from everything we've ever known before.
I found myself struck by some of the experiences my participants volunteers had. And it's really made me reflect sometimes wrenchingly on the way I think about aspects of life. The therapist as well as the patient can both really grow and develop with these expanded states. They can be very instructive for the therapist.
So I mean, that points to another scalability issue there. But therapists can only do two of these sessions a week. And I realize the psilocybin sessions tend to be five, six hours, sometimes longer. And the therapist really needs to sit there and be present for that amount of time and really effective and skillful and present. You can imagine that would be exhausting.
So that, that point to, you know, some of the research going around, shorter acting, psychedelic medicines like ketamine, like DMT, 5 DMT, things like that, where the sessions are more like 45 minutes or so, which might allow a therapist to conduct more sessions in a given week. But my understanding is the people participating in these clinical trials right now, this is all supported by research grants by the government, by so forth, I mean, until these drugs are rescheduled, there is no third party reimbursement, is that correct? I think even though ketamine is legal to use off label in therapeutic settings, I think it's still challenging to get third party reimbursement for that.
That's correct. And so there are some huge pieces that hopefully will come into form at some point, which is kind of rescheduling, perhaps third party reimbursement, enough data that major insurers will really be agreeable to new codes, an eight hour procedure, code for drug administration, lots of follow up.
Economic modeling. Is it a 30% reduction if we do a group model in terms of overall cost? If that's an accurate assessment, that would support kind of moving forward with more of this hybrid group model at scale. But there are some enormous pieces to really continue to contribute to and ultimately live into whether this will become something that is accessible to people as an option in terms of their health care in a medical setting. But I do feel I'm really honored and glad to be working in a medical context because of the safety, accountability, the multiple disciplines that are in these systems. That's really, for example, in a cancer center, administering oncology drugs every single day, infusions, et cetera, you can almost modularly add a psychedelic medicine. And there's already the staffing, there's already the system in place, the REMs, which is often quite burdensome in terms of regulatory requirements, paperwork, this cumbersome volume of work that needs to be done properly every single time to the letter. I think if we think of private practices, other clinics, oncology centers might be uniquely suited to really deliver the care. Well, at least that's what we're finding with our initial group and we'll see how that develops over time.
Well, it may be that part of the economic scale will be that this is more of a short term treatment and compared to long term treatment, may prove to be economically advantageous. We'll have to see how that goes. A couple of quick questions. We're just about out of time here. One was circling back to the trials, this group or hybrid model. So the sessions were done with the person's therapist, or a therapist anyway, in an individual room, and then the integration work is done with a group. So were all those individual therapists also part of that group? Or was the person's personal therapist part of that group, which again would raise the cost, or was it simply facilitated by a clinician or a pair of clinicians?
Yeah, the way that we structured this first study, the therapist was with them throughout. So their study therapist was there to provide support individually and in the group roof all day during drug administration and all integration sessions. So yes, that would be significantly greater cost than kind of piecemealing it in such a way that would be perhaps more efficient. But I will say that it's important also to really advocate for a structure that supports meaningful outcomes, even if that's more expensive. And I know there's kind of a rush towards cost and efficiencies, but I also think it's very important. This is so new and we want to really do it well so things don't once again fall apart. I think that it's important to kind of thinking about Rowland and Hopkins to do the science methodically and what is the clinical application and be methodical about the clinical application so that we really do have a treatment model that is supportive of positive outcomes at scale without cutting corners preemptively.
Absolutely, absolutely. And maybe that point to where our hope for scalability is more in the short term nature of the treatment as opposed to other forms of long term treatment that are less effective and highly costly. So. But absolutely, we don't want to let efficiency drive us into either poor outcomes or a lack of outcomes. So one final question for you. I know as you described in these trials, you're working with cancer patients, broadly, some of whom are ostensibly in remission, others who may have a terminal diagnosis. So is there any research going on? I believe Stan Groff even did some research back in the 60s, if I'm not mistaken, with, with terminally ill patients. But is any work or research going on with clearly terminally ill patients who maybe are not on hospice care yet, but who are definitely on that trajectory where this is really actively helping someone prepare for death?
Oh, absolutely. And we'll be initiating, we'll be a partner site for a couple of different studies. One will be specific to psilocybin and palliative care. That'll be a multi site, multi center study. So that's pending and that we'll hope to initiate within the next six months. So absolutely larger scale work has been approved, is funded, will be proceeding with people who have a year to live or are posited to be very much towards the end of their lives, not only with a cancer diagnosis, but all medical conditions that are terminated terminal.
Well, Dr. Richards, thank you so much for the amazing work you're doing and for everything you've shared with us today. Incredible valuable contribution to the today's day on the summit where we're focused on the research. Thank you.
Honored to work with you. Thank you, Fleet.
Yeah, be well. Thank you.
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