Dr. Michael Bogenschutz is a Professor of Psychiatry at the NYU Grossman School of Medicine, and Director of the NYU Langone Center for Psychedelic Medicine.
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For more information:
https://centerforpsychedelicmedicine.org/
Visit our website for more insights on psychiatry.
Podcast producer: Jon Earle
Dr. Michael Bogenschutz is a Professor of Psychiatry at the NYU Grossman School of Medicine, and Director of the NYU Langone Center for Psychedelic Medicine.
Topics:
Cited:
For more information:
https://centerforpsychedelicmedicine.org/
Visit our website for more insights on psychiatry.
Podcast producer: Jon Earle
NOTE: Transcripts of our episodes are made available as soon as possible. They may contain errors.
[00:00:00] DR. THEA GALLAGHER: Welcome to NYU Langone Insights on Psychiatry, a clinician's guide to the latest psychiatric research. I'm Dr. Thea Gallagher. Each episode I interview a leading psychiatric researcher about how their research translates into clinical practice. Today, I'm speaking with Dr. Michael Bogenschutz. Dr. Bogenschutz is a professor of psychiatry at the NYU Grossman School of Medicine, and Director of the Center for Psychedelic Medicine. In our conversation, we talked about his recent work on using psilocybin to treat alcohol addiction and dive into the details of psychedelic assisted psychotherapy.
Well hello, Dr. Bogenschutz, and thank you so much for being on the podcast today.
[00:00:38] DR. MICHAEL BOGENSCHUTZ: Oh, it's my pleasure.
[00:00:39] DR. THEA GALLAGHER: Well, I'm gonna ask you a broad question first, and then we'll get into the specifics. But can you tell our listeners a little bit about the overview of your research?
[00:00:48] DR. MICHAEL BOGENSCHUTZ: Well, at the Center for Psychedelic Medicine, we're focused primarily on clinical research. And the overall goal is to develop new treatments for hard to treat psychiatric conditions such as addiction, depression, post-traumatic stress disorder, taking advantage of the exciting effects that we've observed in early studies with psychedelic medications such as psilocybin, MDMA, and a number of others that are also being studied currently.
[00:01:23] DR. THEA GALLAGHER: And how long have you been doing this research? How long have you been somewhat allowed to do research with these substances?
[00:01:32] DR. MICHAEL BOGENSCHUTZ: As most people probably know, there was quite a bit of research done in the 1950s and 60s with psychedelic drugs—primarily LSD, but some other compounds as well. And that came to a fairly abrupt halt around 1970 with the passage of the Controlled Substance Act and the social climate at the time, which, the psychedelics were strongly associated with the counter-cultural movement and protests against the war in Vietnam. And there were a lot of things going on at the time that generated a lot of fear of psychedelic drugs and awareness of harmful effects, which they can have, but I think people got a rather exaggerated view of the dangers and lost sight of the fact that these drugs really did have a lot of clinical potential, which was just beginning to be studied during the 1960s. And so there had been active research on psychedelics to treat—alcohol use disorder, for example, was studied a lot. And promising studies. And also in treatment of anxiety and depression around the end of life. People with life-threatening illness. And, really, a number of other conditions as well. That really came to a halt. And there was almost no clinical research on psychedelics from between the early 1970s to just before the turn of the 21st century. And then gradually there started to be some work done primarily with psilocybin this time around. And I got interested in the field after having seen one of the first studies that came out— seminal study in 2006 from Johns Hopkins on the effects of psilocybin in healthy normal volunteers. And it showed not only that the drug appeared to be safe under controlled conditions, but also that the vast majority of people had experiences that they considered to be highly meaningful, highly significant, and associated with significant benefit, in terms of their overall outlook and well-being and in their relationships and in their functioning. That was an eye-opener to me that A, that you could even give these drugs to people, and B, that they seemed to be well-tolerated and that most of the effects were positive. I was somewhat aware of the work that had been done much earlier in alcohol use disorder and thought that would be an ideal condition to study this time around with psilocybin. Started to work on some study protocols and started our first study in 2012.
[00:04:17] DR. THEA GALLAGHER: Wow.
[00:04:18] DR. MICHAEL BOGENSCHUTZ: And, yeah, so have been studying psilocybin since then. And more recently have gotten involved in the research on MDMA for post-traumatic stress disorder and expanding into other potential indications for psilocybin.
[00:04:33] DR. THEA GALLAGHER: Well, it sounds like this work does excite you. This research excites you. What is so exciting about being able to look at the impact?
[00:04:42] DR. MICHAEL BOGENSCHUTZ: Well, the field of psychiatry, in terms of the medications that we have, I mean, there's been some steady progress, but really, the major classes of medications that we use were all discovered over half a century ago—the anti-depressants, the anti-psychotics, the mood stabilizers. And also, in addiction, the sort of replacement-type medications and blockers. And we've refined the treatment. We've come up with medications that are potentially somewhat more effective that may not have as many side effects. But there haven't really been huge breakthroughs in terms of medications for the major classes of psychiatric conditions, really since over half a century. These drugs work in a very different way. And one of the amazing things is that we appear to be seeing effects that persist for weeks to months, potentially indefinitely, after administering a drug only once or two or three times to a person. it's not—with most medications, not only psychiatric medications, but for any other kind of chronic condition, normally a person will experience the benefit of the medication while they're taking the medication on a usually daily basis, and when they stop taking the medication, it's no longer going to be doing anything for them. And these treatments are really quite different. The medication's in the body for only a few hours, but it triggers change processes that continue and evolve over time and potentially result in improvements that are very enduring, if not permanent.
[00:06:27] DR. THEA GALLAGHER: A shorter time in needing the substance, but then a longer-term maintenance of gains?
[00:06:34] DR. MICHAEL BOGENSCHUTZ: Yeah. And that the gains persist after the person stops taking the medication. You're really changing the person and/or their brain and their behavior. And you're not just affecting them through the time-limited effects of the drug.
[00:06:50] DR. THEA GALLAGHER: Yeah, that's really powerful. And I know, on the psychology side of things, a lot of my patients, A, don't wanna be on something forever, but then get worried that when they do go off something that they've been on forever, that all of their other symptoms are gonna come back and, with things like anxiety disorders we do see that. This seems pretty groundbreaking to me in that it's—you're saying you're seeing sustainable changes and even maybe functional changes for the long term.
[00:07:16] DR. MICHAEL BOGENSCHUTZ: Yes, that's right. And another very interesting thing about these medications is that they, psilocybin in particular, seem to have beneficial effects across a fairly wide-range of conditions. we're talking about addictions, mood disorders, possibly anxiety disorders. And they seem to be acting on some abnormalities that we think of as trans-diagnostic. In other words, it's not that they're treating a disorder. They're treating some process or function within the brain that is out of balance and that is associated with a number of different forms of psychopathology or behavior issues.
[00:08:04] DR. THEA GALLAGHER: And do we understand the mechanism of action of how they work? Or is that still somewhat opaque? Do you have a sense of what's actually happening?
[00:08:15] DR. MICHAEL BOGENSCHUTZ: Well, this is—it's a great question and to me this is really one of the most exciting questions. Because we really—we don't know that much. We know that psilocybin, for example, binds primarily to the serotonin 2A receptor. That's true for all of the, what we call classic psychedelics. Which would include LSD, mescaline, DMT, which is the active ingredient in ayahuasca, which many people might have heard about. they all bind to the, and activate the serotonin 2A receptor. That's probably responsible for most of the immediate effects, in terms of altered consciousness and the experience that people have. And then there are downstream effects of that, which appear to cause a cascade of neuroplastic events. you have remodeling of the neurons, the brain cells, which form new attachments to other neurons. New pathways may be formed and, so over time, you get subtle or maybe even not so subtle rewiring of the brain and new patterns of, of connection and of, communication among the neurons in the brain.
[00:09:31] DR. THEA GALLAGHER: Yeah—
[00:09:32] DR. MICHAEL BOGENSCHUTZ: But how that leads—
[00:09:33] DR. THEA GALLAGHER: —that sounds different. Yeah.
[00:09:33] DR. MICHAEL BOGENSCHUTZ: Yeah. It's very—it's, it's different and how that works and why you get a particular kind of change and why you might get different kinds of results depending on what the underlying condition was that the person had in the first place, there's a lot that remains to be teased out. And I think, you know, we talk glibly about neuroplasticity, but I think it's important that people know, being neuroplastic is just what our brains do, really. Our brains are constantly changing. Every time we have a new memory, every time we have some kind of emotional experience, it causes some changes in the brain. There's nothing magic or spectacular about that by itself. But it's the fact that somehow these treatments are reliably producing changes that are beneficial and in a positive direction. At least in the context of therapeutic setting and careful preparation and monitoring and combined with psychotherapy to make the most of these experiences. I think that's another important thing for people to know—that when we talk about these treatments, we're really talking about not just the drug, but the combination of the drug with some kind of a psychotherapy platform that helps to channel this potential for neuroplasticity and behavior change in a particular direction. I think we couldn't assume that if people just randomly took these drugs with no particular intention and with no particular preparation that you'd get anything like the same kinds of benefits. And you would probably have a lot more in the way of potential harmful consequences, as well.
[00:11:15] DR. THEA GALLAGHER: And what are some of these controls that are, like—have you figured out the right dose? I think so much of this seems like, opaque, or, how did you come to what's the right dose, what's the right environment? Just anecdotally you hear about ayahuasca shamans. Like, is there someone who's with the person as they're maybe experiencing some of these internal changes? So what does it look like to actually be administered in this controlled way?
[00:11:41] DR. MICHAEL BOGENSCHUTZ: There's really a lot of similarities in how the medication is used, and most of the models that have been used, both of psilocybin and MDMA really, there's a lot of commonalities. And I think it's important to note that the beneficial effects that have been reported in these trials—they're all in the context of this kind of model. So we can't say anything about what might happen if we were doing things very differently.
[00:12:04] DR. THEA GALLAGHER: Right. Right.
[00:12:04] DR. MICHAEL BOGENSCHUTZ: The first thing is that people who participate in these studies are initially—they're carefully screened for any serious medical or psychiatric conditions that might make it dangerous for them to participate. And there aren't a lot of those, but people with out of control, hypertension, high blood pressure, heart disease, high risk to have a stroke. All of those things would increase the risk and would probably disqualify somebody from being in the study, because the drug does raise blood pressure somewhat. Just the same extent as maybe walking up a flight of stairs or something. But it's not an extreme effect. But if you're not in good health, it could be risky. And similarly, if you had a history of psychosis or a strong family history of psychosis, you might be at increased risk to have something like that triggered by a medication like psilocybin. Assuming the person is—there's no medical or psychiatric reasons they shouldn't be in this study and receive the medication, there will be some amount of preparatory psychotherapy. And most of the studies have used a team of two therapists, rather than just a single therapist to support the person through the process. And so this is one of those things that—some features of this model really were inherited from the way things were done back in the 1950s and 60s. And it's just the way it was done and people thought it was good. We don't know that you have to have two people in the room. But the idea is that support and a feeling of safety is very important for people going through these intense experiences. And if you have two people who are grounded and not on the medication and providing support, you're just that much more likely to feel supported. And if you had some kind of—you might feel more comfortable with one of the individuals than the other in a particular situation, and it's a little—might be a little bit hard to predict what kind of support you might need. It's just an extra measure of support.
And the preparation consists of explaining to people how the—what kind of effects they might experience, how to manage those effects if they get to be pretty intense. People on a high dose of psilocybin might feel overwhelmed. They might feel that they're not in control of their thoughts or not in touch with their body in the same way as usual. And this—it's a very highly altered state of consciousness, which can be disorienting and potentially frightening for people. We want them to be prepared and have some ideas about how to manage that and to feel comfortable enough with the therapists that they'll feel safe to be going through that. And the general instruction that's given to patients going through these experiences is to be open and trust the experience and to trust themselves to go through it. And to be curious. And invite whatever experience might come up, rather than to try to control it or avoid it. And that, yeah, just accepting and learning from the experience, rather than trying to direct it or worry about it, is the best way to get the most out of it.
And after two or three sessions with a pair of therapists in preparation, the patient will hopefully feel comfortable with those people, feel that they have some idea of what to expect in the session and how to deal with anything challenging that might come up. Then the actual sessions are, for both psilocybin and MDMA, they're about eight hours long. The drug effects for both of those drugs last about four to six hours. And there's some [unclear] and discussions afterwards. It's pretty much a full day.
And during much of the session, the patient will be just lying on a couch. Often people wear eyeshades and listen to a program of music through headphones. And the idea is for them to focus on their internal experience rather than, say, looking at objects in the room and noticing that they look different, and rather than engaging in a lot of dialogue with the therapists. Now, that's a little bit different for psilocybin and MDMA. In the psilocybin treatment, with a high dose of psilocybin, it's not terribly fruitful for people to be trying to do a therapy in that state, to be talking about things and trying to—just even putting things into words can be very challenging. And people in the high-dose psilocybin sessions will spend more of their time focusing inward and not interacting all that much with the therapists unless they just really wanna say something or they're feeling anxious or need to go to the bathroom or something like that.
With the MDMA, people are in a more lucid state and they're altered and they're in a state of feeling generally open and trusting and safe in the context of whatever is coming up. And in the case of PTSD, the advantage of the MDMA state is that it does provide this sense of safety and dampens any feelings of fear or threat that people experience, and particularly when dealing with memories of traumatic experience or any other kind of painful issue. One of the biggest barriers to the therapeutic process is avoidance and resistance. We call it resistance if a person is not doing what we think they ought to be doing. But they're not doing it because it's too painful or it's too frightening. And so they're trying to take care of themselves. And it's an appropriate defense.
But, in this context, under the influence of the MDMA, they are able, many times, to look at things and to experience memories and the feelings around them without being overwhelmed by fear or overwhelming negative emotion. And that allows people to process and reintegrate their memories in a quite profound way. Often quite rapidly. More so than—much more rapidly than they would in an ordinary, usual psychotherapeutic format. With the MDMA, there often is a fair amount of conversation between the patient and the therapist as they're working through this material and verbalizing what's going on.
[00:18:52] DR. THEA GALLAGHER: And they're prompted to think about the traumatic memories? When I do, like, prolonged exposure, we're asking people to go back and talk about what happened. And is there some shaping around, "We want you to talk about the traumatic memory, but you can now do it in a space where you're not—your fear is not so activated and heightened?”
[00:19:10] DR. MICHAEL BOGENSCHUTZ: We do bring that up. But it's not—in the model that's been used so far, it's not exactly an exposure therapy in that there's not a—the goal was not necessarily to bring up that intense trauma or any particular traumatic event and focus on that.
[00:19:27] DR. THEA GALLAGHER: Okay.
[00:19:27] DR. MICHAEL BOGENSCHUTZ: If it comes up, if it doesn't come up at all, the therapist would invite the patient to think about that, bring up that memory and see what they might be able to learn about it at this point.
[00:19:40] DR. THEA GALLAGHER: At this point, it's pretty broad. Like, you really want someone to almost take you on the journey of what they're experiencing, rather than curate it externally.
[00:19:51] DR. MICHAEL BOGENSCHUTZ: One of the suggestions we give people is that they should trust their own sort of inner healing intelligence, if you will. There's some way in which they, their body, their mind knows what they need to do. And if they just allow that to happen, they're the best person to figure out what that is and to do that. And so that's similar to what I said earlier about being open to the experience. It's, yeah, just inviting whatever needs to happen. And that—it does seem that, in many cases, people at least feel that is what is happening, in that there's, in this sort of very special situation where they have the support of two therapists and they have this medication that's helping them to be open to their internal process in a way, much more than they usually are, that things that need to come up.
DR. THEA GALLAGHER: Yeah, and it sounds like when they come up, it's a less traumatic experience. Or not that—thinking about it is always traumatic, but it sounds like it's less heightened because of how they feel internally?
[00:20:58] DR. MICHAEL BOGENSCHUTZ: It's not—I mean, it's not as though it’s an anesthetic kind of experience. But it selectively dampens the fight or flight aspect of the response. It might still be acutely painful to, to think about what happened or to, to visualize this memory. But somehow there's a part of the individual that feels safe and is able to experience the reality: ‘That is not what is happening right now.’ I mean, in PTSD, one of the core features is that it's just these memories and the feelings around them are experienced as an immediate threat, even though they are not. But it really feels like it's existentially threatening even to go there. And that makes it really hard to change your relationship to those memories if you can't even approach them.
[00:21:50] DR. THEA GALLAGHER: Right. And being able to—it sounds like somehow this substance is able to create space for people to have a little bit of that distance to be able to do that work.
[00:22:01] DR. MICHAEL BOGENSCHUTZ: Yeah. It's as though within them there's some, kind of a safe harbor, or just a—yeah, they're in a place of safety with these memories that, under other conditions, would be overwhelming or threatening.
[00:22:16] DR. THEA GALLAGHER: Yeah, that's really interesting. And like you said, very different from what most psychiatrists would be prescribing today. And I wanna get a little bit into this really groundbreaking study that you published in August about psychedelic drug therapy helping alcohol addiction. Can you tell us a little bit about that study and maybe why it created such a buzz?
[00:22:39] DR. MICHAEL BOGENSCHUTZ: Yeah. Well, it was the first, randomized controlled trial of, of psilocybin for, an addiction that had been published. And we had 95 randomized patients. Ninety-three received medication. And that may not sound like a really huge study. But in the context of psychedelic studies that have been done—I mean, at the time it was the largest one. Now there's been one that's considerably larger, and there will—there will be more, hopefully. But it was—it was a good-sized study. And what we found was that this model used two sessions of psilocybin, relatively high-dose psilocybin, one month apart. And those sessions were in the context of a 12-week therapy or counseling program, which was standardized and included both some basic evidence-based treatments for alcohol use disorder, including motivational interviewing and cognitive behavioral skills training. So there were some alcohol-focused components to it. And also the standards preparation and support and integration or debriefing after the medication sessions to help people consolidate those memories and make meaning out of what had happened and decide—try to understand how they might be helpful to them going forward. It was, again, an integrated medication therapy treatment.
And we had—psilocybin was the active drug. There was an active placebo, which was diphenhydramine, which is the active ingredient in Benadryl. It's an antihistamine. It's sedating and mind-altering. But certainly not a psychedelic drug. And then we followed these were people with alcohol use disorder. They were drinking heavily, at least four heavy drinking days in the month prior to their starting the study. And that's, and they met criteria for what, for the old diagnosis of alcohol dependence. Which, which means they really were pretty severely addicted and impaired by their—by their drinking, it was having a major impact on their lives. And what we found was that during the first four weeks when people were having the preparatory psychotherapy sessions, their drinking decreased by about 50 percent in both groups. The therapy was helpful, just getting ready to get the—to receive the medication. In preparation for that people were able to cut back by roughly 50 percent. And then, after receiving the first dose of medication, the psilocybin group cut their drinking by another 50 percent, roughly.
[00:25:27] DR. THEA GALLAGHER: Wow.
[00:25:28] DR. MICHAEL BOGENSCHUTZ: They were now drinking about 25 percent as much as they were initially. The control group really stayed almost exactly the same. I mean, they maintained the benefit that they had from the first sessions of therapy, but they didn't gain any more. During the follow-up period, and we followed people for 32 weeks after that first medication session, overall, the psilocybin treated patients were having—were drinking about half as much as the control group. And about a quarter as much as they had been drinking initially. And if you looked at—people often want to know, "Well, did people quit drinking?" And some people did, some people just cut down. But if we looked at the very last month of follow-up, which was 28 to 32 weeks after receiving the first dose of medication, during that month, 48 percent of the psilocybin group, almost half, were completely abstinent. Versus 24 percent in the control group. There were people there that also benefited. But it was twice as many. And 50 percent, close to 50 percent is, it's pretty good. These were clinically very meaningful effects. And again, they persisted for months, in this case six months after they first received the medication.
[00:26:51] DR. THEA GALLAGHER: And you said this was only two doses of psilocybin?
[00:26:54] DR. MICHAEL BOGENSCHUTZ: That's right.
[00:26:55] DR. THEA GALLAGHER: Wow. It wasn't that they were leaving treatment and then using psilocybin regularly on their own. It was just for the trial, but it had an impact on their drinking behavior outside of the trial and then ongoing?
[00:27:10] DR. MICHAEL BOGENSCHUTZ: Yes, that's right. Yeah. And I'm not aware of anyone that went and used psilocybin outside of the trial. There did not seem to be any desire on the part of people to keep using. I mean, there were people who thought a booster session might be helpful maybe at some point. We did—I didn't mention this before, but after they finished that follow-up, the 32 weeks of follow-up, we offered both groups a third session in which everybody received active psilocybin. The control group got a single dose of psilocybin at that point, too, if they were still in the study. And most people did choose to take advantage of that.
[00:27:48] DR. THEA GALLAGHER: We were talking about the mechanisms and some are not fully understood. But it seems like with PTSD and MDMA, again, maybe creating that safe harbor internally, which made it safe to look at the past or feeling less irregulated emotionally, to be able to see those things. What is happening with alcohol use disorder and psilocybin? What's going on there, do you believe?
[00:28:13] DR. MICHAEL BOGENSCHUTZ: Well, this is probably my favorite question.
[00:28:17] DR. THEA GALLAGHER: [laughing]
[00:28:17] DR. MICHAEL BOGENSCHUTZ: If you ask people about their experience and how they think it worked, the prevailing theory going into this was that there's something about the—what people have called the mystical-type experience or the ego-dissolution or ego-death experience. It's the experience of ceasing to be a separate person and merging into the cosmos or whatever you wanna call it. And the idea was that was really what needed to happen, and what helped people to—what made the difference for people. In this study we're still trying to unpack this. But we didn't find any particular association with that kind of experience in particular. If you asked people about what happened and why do you think this worked, we did a qualitative study on this. And some people had those types of experiences and they felt that they were one with the universe and that gave them a new perspective. Other people felt that they experienced self-love or self-compassion or forgiveness in a way that profoundly changed how they felt about themself. Some people had very difficult, painful, cathartic-type experiences, revisiting painful episodes in their past, perhaps things that they had done because of their drinking and how they might have hurt other people. There was one person who just felt physically that he was being put through the ringer and said it was literally the most painful experience of his life and declined to have a second session, but was, did not have another drink for as long as we ever had contact with him, which was a couple of years.
Those experiences were all over the map. But we really haven't designed studies that are adequate to try to unpack what's happening. I mean, we know that, from our questionnaires that we gave people, that there was a significant decrease in craving for alcohol that persisted. There were improvements in, in mood or decreases in negative emotion states, I think is maybe a more accurate thing to do. But increases in positive emotional states as well. There was a sort of just change to more positive experience, in terms of emotion. And there was also evidence that people felt that they had better executive control, in terms of feeling less impulsive. Being more planful and deliberate, perhaps being more mindful. Those features map pretty well onto what we think of as the core areas of psychopathology in addiction, which are intense craving or desire to use the drug, the kind of persistent negative mood states that people get into when they're not taking the drug. The drug makes them feel better temporarily. And I say drug, I mean, alcohol or drug. We think of the process as pretty similar between alcohol and most drugs of abuse. But people, yeah, if they're used to taking the drug and they don't take it, they will tend to be in an irritable or dysphoric state, because the drug has kind of altered their baseline. And then they have problems with executive function and control of their behavior and their thoughts. That is one of the things that makes it harder for them to figure out how not to drink, for example. We have some preliminary evidence in alcohol use disorder, just based on these questionnaires that people are having less craving, less negative mood, and better executive function after these treatments. But we haven't done an object study. That's one of the things we're planning to try to do in the very near future.
[00:32:12] DR. THEA GALLAGHER: Yeah, and one, one thing that stands out to me is—it's interesting, and I don't know if like, the spread or the percentages, but it seems like some people have a really positive experience, some people have maybe a more neutral experience, and then some people have a difficult experience. But it all led to the same outcome?
[00:32:31] DR. MICHAEL BOGENSCHUTZ: Yeah, that is one of the very interesting things. And that's not to say that the experience isn't important. But it's just that there's not a particular kind of experience. And you know, one thing about all of those experiences, for the most part, is that they're intense, they're memorable, and they're meaningful. They're interpreted as meaningful. That's another key feature of these experiences, is that people can—they're held as highly meaningful and the memories are very vivid. And so they have a—they, they appear to have a lasting impact.
[00:33:06] DR. THEA GALLAGHER: That's really, like you said, it's almost like, maybe it meets the person where they're at or what they need. It's really interesting, because, if you—someone takes a benzodiazepine, you would assume they would have a lot of the similar, a similar experience. Which is interesting that this might have a different—it might show up differently in people. But like you said, it might be important for people to have a variety of experiences.
[00:33:29] DR. MICHAEL BOGENSCHUTZ: Well, and even in the same person, in these studies where we have two or three sessions, the flavor of those experiences may be very different. With psilocybin, the first one might be very challenging and difficult and dark. And the second one is joyful and expansive and so forth. Or the other way around. It's, yeah, there certainly is a lot of variability.
[00:33:52] DR. THEA GALLAGHER: What do you see for the future of this research and when do you see that psychiatrists could implement this on their own? Or should they be thinking about maybe referring their patients to academic research centers that are having studies? Like, what is there for a psychiatrist listening to this today, what should they do with this information at this point?
[00:34:11] DR. MICHAEL BOGENSCHUTZ: Well, we'd love to have people, clinicians, refer people to our studies, of course. But these are relatively small studies. And they're just not—there's not the ability for very many people to get these treatments at this point. But MDMA, the second of the two pivotal trials of MDMA for PTSD has been finished and will be published in the near future and presented to the FDA within the year. And there's a good chance that MDMA could be approved as a treatment as early as next year.
[00:34:45] DR. THEA GALLAGHER: Wow.
[00:34:46] DR. MICHAEL BOGENSCHUTZ: That's—that, that could be here really pretty soon. Psilocybin is not as far along. The first Phase III studies are just beginning. That will be probably a couple years behind at least. But still on the horizon. I think, in the meantime, people read about these studies and hear about the impressive results, and there's been a strong push to try to make these drugs more widely available through these state initiatives and, or other efforts to broaden access. And, it's really understandable. We're excited too, but we have an FDA process and it's really to ensure that treatments are effective and safe. And if the drugs—either of these drugs is approved, it will be safe and effective in the context in the kind of treatment that it was, that the studies were conducted. I think, on the one hand, we wanna get these drugs, if they are found to be safe and effective, to have as many people as possible be treated as soon as possible. And that will be the next big area for research and thinking is how do we make these treatments available at a large scale, and to do it as efficiently as possible so that people can afford it, without sacrificing the safety or the efficacy. I mean, I think in the meantime, we should try to be somewhat patient and not try to cut too many corners, which could jeopardize the whole enterprise. But, to be ready and to be learning about what the treatment models are, how this might work, and to be able to counsel our patients who might be in a position to benefit from these treatments when they do become available.
[00:36:36] DR. THEA GALLAGHER: Absolutely. And it seems like, from what I've seen, that there was—there's been some research with cannabis and then moving into, like you said, MDMA, psilocybin. What do you see even with the future? Do you see, I don't know if there already are, but like, ayahuasca trials, or other things that, again, have been more culturally complicated, that we'll see used in clinical research?
[00:36:57] DR. MICHAEL BOGENSCHUTZ: Yeah, well, there are hundreds if not thousands of psychedelics that are already characterized, very few of them have been given to humans. And with the exception of the ones that are well-known, such as LSD and mescaline and psilocybin and DMT, they're not nearly as far along. But there's a lot of interest from pharma now in developing new chemical entities that—one kind of interest is, are there drugs that are not psychoactive in the same way, that would be easier to use, potentially, but that have a lot of the same benefits, or not? If the experience that's intense and meaningful is a big part of how these drugs work, then there might be some limitations to that. But there may be effects that are completely independent of that. If we're talking about just neuroplasticity, per se, there might be ways of causing some of the same effects to happen that can still be used together with some kind of behavior change therapy and could have good efficacy. Shorter acting drugs, these all day sessions are labor intensive and relatively expensive. If the same kind of benefits could be achieved in a brief, 15 or 30 minute intravenous infusion or just, or, something that's insufflated through the through the nose, that would be great. We don't know if that's possible. And again, there may be something about an experience that unfolds over time and also the amount of time that the drugs are in the brain and can actually do their thing might be important. There's a lot of interest in finding ways to get the same benefits in less time with less challenge in terms of managing these intense experiences. but we don't know to what extent that can be separated. Time will tell. And there's just an awful lot of different directions that this research needs to go all at once. we're hoping there will be an increased interest in funding this kind of research, so we can get moving.
[00:39:03] DR. THEA GALLAGHER: It seems like it’s, yeah, it's really trending very positively, initially, which will likely probably give it the legs to get it to, like you said, to get into more specifics and different ways of dosing, et cetera. And my final question for you—in the beginning you were talking about the Johns Hopkins study that looked at healthy controls, and it sounds like your research has been focused on people who are really struggling with acute challenges. What are your thoughts in the future for maybe, I don't know, like, the worried well? Or people who don't necessarily meet criteria for a clinical level disorder? Is there some kind of belief that psilocybin could help even just the everyday person?
[00:39:45] DR. MICHAEL BOGENSCHUTZ: Well, that's—I mean, again, it's a really good question. And, I mean, on the one hand, in medicine, we tend to focus on, treating disorders and fixing what is broken, but there's legitimate criticism for that in a more positive, preventive and wellness approach, or positive psychology approach is, I mean, it's reasonable. If we're gonna talk about it as part of treatment, we still need to be able to demonstrate some kind of benefit. I think there are certainly people who believe they have benefited in ways that didn't have to do with treatment of any major illness. Before we want to endorse something like that, we would really need to show that overall that there'd be more benefit than harm, and that it's something that was actually worth supporting, rather than something that's unproven and put—because there are real risks to these treatments. And if somebody is actually doing very well, then the risk benefit might be very different for them.
[00:40:36] DR. THEA GALLAGHER: And just quickly, with the risk benefit, some of the risks that you have seen, it sounded to me like when you were talking earlier, maybe more of an emotional risk, if it wasn't monitored well? Or maybe taking too much or too little. Are there other risks that you observed?
[00:41:05] DR. MICHAEL BOGENSCHUTZ: Well, the main risks are the sort of the acute psychological risks due to overwhelming experience or, if somebody's not in a controlled environment and they become disoriented and they walk in traffic or something. there's that. But there's also more subtly, I mean, these experiences do change people. And for people who, want to change, need to change, have some particular thing they need to work on, that's a good thing. But, it's never going to be completely predictable how a person might be changed by one of these experiences. I think change can be good. Change is inevitable, but it—change is not always desired or beneficial. I think that's just part of the calculus when you're talking about people who don't particularly need to change. They may want to change in some particular way and then that's a somewhat different question.
[00:41:58] DR. THEA GALLAGHER: Yeah. And we're getting all philosophical, but this has been such a fascinating discussion. And my last point here, so for clinicians, obviously, keep your eyes on the research. There could be some promising developments in the next year or so, even with MDMA, maybe the next few years with psilocybin. And then are there—NYU is actively recruiting for participants. And any other academic medical centers you would recommend if psychiatrists wanna refer their patients?
[00:42:28] DR. MICHAEL BOGENSCHUTZ: Well, they're popping up like mushrooms! [laughing]
[00:42:31] DR. THEA GALLAGHER: [laughing]
[00:42:31] DR. MICHAEL BOGENSCHUTZ: I think, just, the best place to look, for somebody who's interested in being in a trial, I think is on the clinicaltrials.gov website. That has all of the active trials and some that haven't started yet. And often it will list the sites where they're being conducted. And that's a comprehensive list where people can look. But if you wanna—if you're interested in participating in one of our studies, you can go on our website, Center for Psychedelic Medicine, and there's an interest survey where you can leave your contact information, say what kind of study you might be interested in. And when we're recruiting we'll, we'll, look you up.
[00:43:09] DR. THEA GALLAGHER: Wonderful. Well, that's great news. And, I feel like it's exciting news as we look toward the future of personalized medicine and treating people who may have otherwise suffered and stayed in a state of suffering. Thank you so much for the work that you're doing. And thank you for being with us on the podcast.
[00:43:26] DR. MICHAEL BOGENSCHUTZ: Okay. Thank you for having me.
[00:43:28] DR. THEA GALLAGHER: Thanks so much again for that conversation, Dr. Bogenschutz. If you enjoyed this episode, be sure to rate and subscribe to NYU Langone Insights on Psychiatry on your podcast app. For the Department of Psychiatry at NYU Langone, I'm Dr. Thea Gallagher. See you next time.