EPISODE 385

“A Fascinating Time to Be Involved in This Work”- Dr. Al Garcia-Romeu, Assistant Professor of Psychiatry and Behavioral Sciences at Johns Hopkins University

06-01-2023

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Shiv Gaglani: Hi, I'm Shiv Gaglani, and today I'm actually recording a special episode in person at the Johns Hopkins Bayview Medical Center in Baltimore from the office of Dr. Al Garcia-Romeu. So Al, it's a pleasure to meet you. Thank you for joining us. 

 

Dr. Al Garcia-Romeu: Yeah, nice to meet you. 

 

Shiv Gaglani: So we always like to ask our guests to put in their own words kind of what brought them to their position now. What brought you to your interest in psychedelics and mental health therapy, et cetera?

 

Dr. Al Garcia-Romeu: Yeah, I mean, it's been a long journey. I think some of the early things that caught my attention...it was really just growing up in South Florida. I was doing a lot of reading of existential philosophy and reading different types of basic anthropology. I remember picking up the teachings of Don Juan by Carlos Castaneda when I was young, 16 years old, and reading about that and these different practices that were involved in shamanism and different indigenous cultures. I found that all fascinating. I think it sort of planted the seed in a way of just becoming interested in other cultures and how they viewed the world.

 

But it wasn't anything that I acted on for the time. I was just mainly just trying to pick up information, I suppose. And college was, I think, similar for me. I was a PhD undergraduate. I went to New Orleans and I was there for a few years. I really enjoyed my time there in many ways, and made a lot of great friends. It had the benefits of a really nice liberal arts education, which allowed me to both study philosophy and psychology and study consciousness and Eastern religions. All of those things, I think, were really formative for me in my late teens, early 20s. Again, just picking up information about different cultures. 

 

Certainly, ideas about the mind became really central to what I was interested in at the

time. I ended up majoring in psychology specifically. I loved the work that I was able to engage in there. But a lot of it was from a very Western psychological standpoint. I was studying behavioral neuroendocrinology and cognitive neuroscience and psychopathology and diagnosis.

So, a lot of that is very much in the Western canon of mind. That has a lot to do with neuroscience and biology, which I think is fascinating, and then a lot to do with the clinical side, including pathology. 

 

But it also felt like it was missing pieces of the puzzle to me and that was something that became more apparent when I was studying Eastern religions and philosophy and things like Buddhism and Taoism and Hinduism. Eventually, one of my philosophy of mind professors started a meditation club and we would meet in the chapel on campus every other week, I think it was, and do different types of meditation practice. We started with very basic “mindfulness of the breath” types of stuff and moved through different types of meditation over time to just kind of get a taste for these different techniques and experiences. 

 

I think that experiential learning was huge for me because so much of what I had been doing before was book-based. I loved that and I was good at it, but actually sitting and doing a meditation practice was a different thing altogether. And I had some really big experiences during that time, particularly using these meta loving kindness meditation practices. I had this really strong emotional, visceral response. I remember just kind of opening my eyes at the end of one of the practices. The bell would ring and it was over. I just had tears streaming down my face. I didn't really understand why it had happened, but I knew it felt very powerful. 

 

So, that continued to sort of propel me towards understanding states of consciousness and altered states of consciousness and their significance for psychology and philosophy of mind.  Those are all the things that, as a young man, I kind of dipped my toes in those waters and gotten really fascinated. I didn't really know, though, what to do with that at the time. It was not like there was a great demand for me to go do that in any capacity after finishing my undergraduate degree. I also kind of had like a little...I don't know, I have had friends call it “a quarter-life crisis.” 

 

I was in my early 20s and didn't really know what my next step was.  I went home to South Florida. I was having a little bit of a mini mental crisis, breakdown type exercise. I was kind of existential, trying to figure out what in the world am I doing here? What am I supposed to be doing? And during that time, I just kind of saw my family. But, I was in South Florida. We partied a lot and I would work in bars and I did different types of odd jobs, like working for Federal Express. It was fun and there's a great scene down there...dance music and nightclubs and stuff like that. But eventually that started to wear thin. 

 

I kind of felt like I needed to be doing something else. I wasn't really sure what that was. It was towards the end of my undergraduate career when I had taken a Nietzsche course with my professor, Michael Zimmerman, at the time. He noticed I was getting a little bit out there, like, I was becoming quite nihilistic. We read basically the complete works of Nietzsche, most of his important works cover to cover, and it was a fantastic class, but I got really kind of down, depressed and feeling like there is in a way no meaning to doing much of anything. That was where I was at when I was finishing my undergraduate degree.

 

I had this interim period where I was doing odd jobs. At that time, I eventually kind of came back around to a book that my professor recommended to me, which was Ken Wilber’s, A Brief History of Everything. He said, “You should read this new philosopher. He’s more contemporary. He's a friend of Dr. Zimmerman's.” Actually, I later got to meet Ken and it was a great honor because his work had such a huge impact on me. A lot of Wilber's work was focused specifically on interweaving and connecting, building bridges between Eastern philosophies, Western psychology, and looking for these sort of systems approaches to understanding mind and consciousness, but also even bigger systems like the universe. Really trying to come up with this coherent philosophical system that brought all this stuff together that I had been really interested in. 

 

One of the things I picked up on in his books was transpersonal psychology, what they often call the fourth force in psychology. As psychology developed, there was different schools that were popular in different eras. Transpersonal psychology is one that kind of came a little bit after the humanistic existential psychology that started to pop up in the mid 20th century. That caught my attention for some reason, perhaps because a big focus of transpersonal psychology is altered states of consciousness. So, I ended up going online to find places, and there didn't turn out to be very many places where you could study that kind of thing. But, I found a place called the Institute of Transpersonal Psychology, which has been in Palo Alto since the 1970s.  

 

I decided to go there and visit and talk to people and it was beautiful. I had never been to Palo Alto...the Bay Area is beautiful. The people at the school were really inviting and there were great professors there, including people like Jim Fadiman and Charles Tart and others who had done some really seminal work, including early psychedelic research. Actually, Jim Fadiman was working on that back at Stanford in the 60s. 

 

Shiv Gaglani: We had Jim on the podcast, too. Yeah, he's great. His book, Your Symphony of Selves, was very influential to me personally. 

 

Dr. Al Garcia-Romeu: Well, he's a really close friend, a great mentor. I mean, I took classes with him over and over again just so I could hang out with him and spend a lot of time with him because I felt like I learned so much being around him. 

 

So, anyways, that was the environment that I found when I got there and I sort of looked back at what I was doing in South Florida -- which was fine for the time -- but it felt like I needed to take some next steps and make some moves, and so I ended up moving to Palo Alto in 2007. I was working there in the library on the student job program and just taking all my classes, getting through the master's portion and then finishing the Ph.D. 

 

I had gone there with this grand design to come up with some sort of unified theory of quantum physics in mind. Then I realized, when you're doing a dissertation, you want to not bite off more than you can chew, and doing a focused project was quite good. And so I had some help and some professors who sort of steered me towards things that were of interest. In particular, I was interested in transcendence and transcendent experiences that people have, which you could think of as similar to peak experiences, as Maslow called them, or people talk about flow states or mystical type experiences that we study in the psychedelic literature. How do those experiences sort of interact with mental health and personality? Because we often think of those as very positive experiences and for some people, they are. They can help people overcome addiction. They can help people become very resilient to life stressors. But they can also have actually some pretty negative consequences for some people -- lead them into delusions, psychotic states, sometimes hospitalization, sometimes worse -- and so how does all of that happen?

 

So, I started taking a deep dive into that for my dissertation work. It was a wonderful time learning about both the different systems of psychology and spirituality there in Palo Alto, but making great connections with my peers and my professors. It was really towards the end of that period that I made a really important connection, sort of serendipitously. I'd gone to a conference in Tucson in 2012, and I was giving a small talk there about some of my dissertation research -- self-transcendent experiences, what are their outcomes and how do they come about -- and there was a lady in the room by the name of Dr. Katherine MacLean.

 

She used to be here at Hopkins for a while and had been doing some research with psilocybin. At that time, she was actually presenting on this paper they had just published on personality openness being increased after high dose psilocybin in some of the lab studies they had done here with Roland Griffiths earlier on. She kind of approached me, we chatted, had a good conversation and had dinner. Eventually, towards the end of the conference, she said, “We have postdoctoral openings, and you seem to be near completing your Ph.D. Would you be interested in coming to work at Hopkins? There's a lot of research going on. There's a need for more people with a different perspective like yours.” 

 

I basically jumped at the chance. I was planning on taking it slow, just sort of completing my doctorate and my dissertation over a period of a couple of a few more semesters, but I had the offer and it was time limited. This was, I think, April when I met her and I interviewed in May and then they made an offer, but they said you have to finish everything by June 30th and move to Baltimore or we can't make you the offer. And so, I basically just put the pedal to the metal and wrapped everything up really quickly. I had a ton of support from my friends and my roommates and my professors and my committee and I finished. Sure enough, I drove cross country and then I've been here ever since. That was 2012, and that's more or less how I got here. 

 

Shiv Gaglani: That's awesome. There are so many threads to pull on, and I really love that your original interest was very much at the intersection of the Western psychology framework and then Eastern -- both experientially with your meditation practice, which you developed, and also, I think in the literature. We had a guest on the podcast a couple months ago named Scott Carney, who has since become a friend of mine. He wrote the book, What Doesn't Kill Us and it helped popularize the Wim Hof method for breathing. I think one of the books he's working on now is this intersection of when do you apply holistic, more Eastern style of medicine versus Western style medicine? There's definitely a nice balance, an interplay.

 

So, I want to get into what you've been up to over the past decade at Hopkins. You've clearly been very productive. I've seen a lot of your talks and read your papers. Maybe we can start with the last decade and then move into where you see the next couple of years going. How do you formulate your specific research interests and what are some of the accomplishments that you are most proud of in that time here?

 

Dr. Al Garcia-Romeu: Well, when I was hired on here for the postdoc, I basically was handed a project that was a small pilot project Matt Johnson had come up with in the prior years. I think he started the study back in 2008, actually, but because everybody was busy doing other stuff -- including the healthy volunteer studies and later on the cancer study and so forth -- there was sort of a lack of bandwidth for anyone to formally work on this small pilot study that Matt Johnson had conceived, which is specifically helping people who want to quit smoking cigarettes by using a combination of talk therapy with high dose psychedelics, specifically high dose psilocybin. That really is kind of a throwback to a lot of great work that happened in the

1960s, including here in Baltimore. 

 

There were a number of studies done both using high dose LSD to treat alcohol dependence, some of those showing a lot of promise, and then there was also a very nice study that was done here that was used in men who had a history of opioid dependence and showing that, again, high dose LSD treatment really seemed to help facilitate prolonged abstinence even long after they had received the treatment. So, that early work really suggested that this could be a feasible type of intervention for substance use disorders. It's an area where we still struggle today. I'm working right now on an article called Splitting the Atom of Addiction, and it's really about thinking about how do we help people deal with this because it's such a big, endemic problem. We made slow, but not spectacular progress, I would say, over the last 50 years on this problem. 

 

Anyways, Matt Johnson had come up with this idea to study specifically cigarette

smokers because nobody had done it yet. Back in the 1960s, smoking still wasn't really considered a big problem, and so that study had been slowly moving along. I think they had run four or five participants between 2008, 2012. The idea is they're trying to target somewhere around a dozen people so that they can just take a look at what happened. If they received this treatment, how would they respond to it? And so my job basically for that first couple of years was just finish the study. That was a really great, fertile period for me to learn how to get in there and work with these individuals. Many were high functioning and they were not coming here to have a spiritual experience at all. They were really focused on solving a specific problem, which is how do I get off of this horrible habit that I find myself stuck with? And lo and behold in 2014, we were able to publish the findings of that study. 

 

So, after a couple of years, I've run another ten individuals, most of whom quit smoking and stay quit and so we ended up with that final sample size, fifteen people. Many of them were successful quitting. Eighty percent were successful six months down the road, and we had two thirds of them still successful a year later. That's something that is much higher than you normally find in regular tobacco smoking cessation treatments -- nicotine patches or medicines that are available now like Wellbutrin or Chantix -- they work well for some people, but not for the majority. Usually you're seeing between 25% and 35% of people quit and stay quit for six months, so we definitely felt that was promising.

 

It just so happened that that really opened the door for me to stick around here longer, actually, because Matt and I were able to develop a bigger randomized trial. We wanted to test this with a control condition instead of just open label, which is what the initial pilot study was.

We were able to get a big influx of funding through Heffter Research Institute to do this big study, which then allowed me to transition on the faculty here, and that's actually something I've been working on to this day. I think we had to design the study initially in 2015 and then we started running into participants. So far, it’s the largest study of psilocybin we've done here at this laboratory.

 

There's eighty-two people that we enrolled and randomized and half of them got nicotine patches, half of them got high dose psilocybin. Everybody got Cognitive Behavior Therapy, the same type of programs we'd used previously, and then we just kind of see what happens. We follow them up three months later, six months later, a year later. We will be having the final study visit in a week or two so that we can finally finish getting all the six-month data from all these eighty-two individuals, which took a long time, of course. COVID didn't do us any favors, but it feels really nice to get to that place of soon to be publishing those results. 

 

Because this was not a double-blind study -- we know what group people were in -- all of the data we've seen as of now have shown superiority of psilocybin at every follow up over eight to ten weeks over the nicotine patch, so that's pretty remarkable. That's been a huge amount of the work that I've been doing here doing that, collecting neuroimaging data on these smokers as well as they move through the treatment program and really doing a lot of the psilocybin dosing and the hands-on work, because that's something I personally enjoy...is working with people as they go through this process, including going through these high dose psilocybin sessions which can be really intense, but also really transformative for a lot of people.

 

Shiv Gaglani: Yeah, let's pull on that a bit, too, because I know the way these sessions are set up are they're fairly inward, right? Psilocybin and other psychedelics can have a lot of outward visual changes, auditory changes, et cetera. My understanding is you're doing CBT in the non-treatment or non-psilocybin sessions beforehand - people give their life story and all that -- but then during the actual session, they're encouraged to be as inward and it's non-directive as possible. I'm curious, what type of training do you need to go through? Because a lot of our audience may be interested in being guides or pursuing this line of work. What type of training do you go through to get good at this now that you've done so many of these? 

 

Dr. Al Garcia-Romeu: Well, there's not actually a good consensus on that. What I would say is that probably in the next few years we'll be getting some formal criteria that will be pushed down from regulatory bodies like the Food and Drug Administration. They're going to decide what kind of training is needed to be able to do psychedelic therapies as they become approved medicines. MDMA is going to be probably the first one of those since it's very close now to finishing both of the Phase 3 trials necessary for approval. Psilocybin has not gotten there yet, but I would anticipate that's going to happen in probably about two or three years. 

 

Getting back to your question, a lot of the type of training that I had was similar to training that psychotherapists get -- whether they're PhD, PsyD, Masters in Counseling - different types of psychotherapy tracks are really important because that's part of the process, particularly if you're focusing on clinical populations, not healthy volunteers. But then having a really in-depth understanding of both the pharmacology of the drug, how it works, and a good grounded theory of what altered states of consciousness are like and what they mean and how they can be utilized in these types of therapeutic settings. 

 

There are not a lot of programs like that out there. People are developing them now. I teach in some of these programs through which I try to provide my perspective. But actually what we had when I arrived here -- which I think has been really great -- is a sort of apprenticeship model. I had to work with Katherine MacLean and I got to sit with Matt Johnson. I got to sit with Bill Richards and I got to sit with Mary Cosimano, who have done hundreds and hundreds of sessions. By sitting with them and seeing how they work with people and then also having all the theoretical background knowledge that I was able to get in graduate school and undergraduate, I think that was what sort of informed my clinical approach. That apprenticeship model was hugely influential for me to feel comfortable doing this type of thing. 

 

I've gone through other trainings now, including the Multidisciplinary Association for Psychedelic Studiestraining for MDMA therapy, and that is great because you also have these other master therapists there, like Michael and Annie Mithoefer, who are there and they're able to give you that perspective of how they work with people, including video sessions of what they're doing and explaining why they say certain things. Probably most to the point is they give you a window into understanding what the sessions can be like, because I think that's probably the most far moved from what you would consider your regular standard psychotherapy practice.

 

The reason I say that is because when people go into these altered states, our ability to predict what that's going to look like is very poor. We've seen all sorts of different responses, from very blissful and giggles and happy, spiritual or positive experiences, feelings of intense gratitude and love to the much more challenging experiences people can have... feelings of paranoia, panic, fear, anxiety. When you're coming into a high dose session, you never know what's going to happen, even though we usually would have spent at least a month with that individual by then getting to know them and building that therapeutic alliance. But nevertheless, when you go into the session and the person takes the medicine, then you're going to have to respond to the experience as it unfolds in real time. And that's, I think, something that can be difficult. 

 

But again, having the experience of people who have done it for many years to help you,

guide you through that, for me, it was really, again, formative and helpful. 

 

Shiv Gaglani: Yeah, that's really good advice. One of the things that makes it so challenging, it seems, to do this type of work, is the variability in the set and setting, right? Because the same person can have a different reaction to it, so I know that's a challenge. That's why I've been very impressed with the number of studies you personally are doing here. Do you want to take us through a hit list of some of the other studies, including the one that maybe our audience could be most interested in maybe participating in?

 

Dr. Al Garcia-Romeu: Oh, yeah. We've been able to kind of build on the work over the last several years. We've been really fortunate to have philanthropic support from Tim Ferriss, the Cohen Foundation and a lot of really generous supporters who believe in the work, which is great, including a lot of the early work I mentioned. That allowed us to sort of take it to the next level where we're at right now, where the lab is able to investigate a lot of different conditions. 

And again, we're starting to sort of dip our toes in the water. We're not doing a lot of these huge, full-on, randomized controlled trials. Strategically, it makes sense to do a smaller study, and make sure that it seems to be well tolerated and effective in some way before investing the resources to do these big studies. But some of the small studies that have since been published from the group here have included major depression; there's work that's wrapping up now on anorexia nervosa; Fred Barrett does have a nice, big, randomized trial now on people with co-occurring major depression and alcohol use disorder; and Dave Yaden is working on a study of people with obsessive compulsive disorder. So, we’re really starting to see the field expand, and it's a really exciting time because of that. 

 

Some of the work that I've since initiated, in addition to the smoking cessation work, has included studies in people with early-stage Alzheimer's disease. A lot of those folks are often dealing with comorbid neuropsychiatric symptoms, including apathy and depressed mood. As you can imagine, it's pretty depressing to get one of these diagnoses and to know that it’s going to be life-limiting and it's going to come along with some pretty serious debilitating symptoms down the road. For some people, the idea of losing their sense of self and losing their memory can be tremendously challenging existentially, I think. 

 

So, the idea there was really trying to use psilocybin as part of intervention with people in the early stages of mild cognitive impairment and Alzheimer's to see if moderate and high dose psilocybin can have a positive impact on their mood, on their quality of life, if it does anything at all to their memory function, which we were testing as a sort of exploratory area. That study is about halfway done. We're still recruiting and looking for people for that.

 

Shiv Gaglani: On that one, my understanding -- based on your other interviews and other conversations I've had -- is there are two kind of mechanisms, potentially. One is reducing their anxiety, similar to the original cancer trials. Somebody has an end-of-life cancer diagnosis and experiences reduced anxiety of death with psilocybin. So, that's one mechanism...reducing the comorbid, depressive, and anxiety symptoms, which we know psilocybin probably does. 

 

The second is maybe on a neuronal level, right? The neuroplasticity, BDNF, all that stuff

that potentially could actually improve memory, or I think you're also doing stroke research. Are those the two mechanisms, most likely, or are there other ones that are missing? 

 

Dr. Al Garcia-Romeu: I think the cancer study is a great parallel, because we just knew that the people had a very bad cancer diagnosis -- which was biologically difficult for the system, obviously -- but psychologically, that's also extremely challenging, because it comes along with a lot of anxiety, depression, and adverse impact on quality of life. So, the time that people have left, whatever that might be, they're still not really able to deeply enjoy that or engage with that because they're so preoccupied with worrying about their illness. 

 

With the Alzheimer's study, specifically, the idea was that even if there's no impact on the Alzheimer's-specific symptoms, at least by reducing the depression and anxiety around that it would lead to potentially improved quality of life so that they can get the most out of the time that they do have, and that's something that is congruent with that cancer study. 

 

But from the biological standpoint, there's also this idea, mainly from animal research, showing that in cellular and preclinical studies with psychedelics, one exposure to a classic psychedelic, like psilocybin, can lead to both increased excitatory activity in the brain. That can also lead to changes in the way that the brain is processing information at the network level, and that could also lead to formation of new synapses, formation of new connections, dendrites between neurons in important parts of the brain, like the prefrontal cortex or the hippocampus

 

The animal literature has shown that there's a role for these psychedelics in enhancing learning and memory processes, like object consolidation, and so testing that out with people who are having memory impairment is kind of a first step to see, does this do anything one way or another? Is it going to have no effect? Is it going to actually make things worse, or is it going to make things better? So, we're doing that now as sort of an exploratory step before deciding whether or not this is a line of research that needs to be pursued any further. 

 

Shiv Gaglani: Very interesting. And how about that one study, I think, that our audience could be interested in participating in? Do you want to talk a bit about that one? 

 

Dr. Al Garcia-Romeu: Yeah. We do a lot of online studies, crowdsourced data. We just finished a really nice study with Unlimited Sciences. We had almost a thousand people who took surveys before and after they used psilocybin out in the real world, so not in the laboratory. 

 

Shiv Gaglani: Citizen science.

 

Dr. Al Garcia-Romeu: Yeah, so it allows us to get data from a lot more people, including people who we might have to rule out of our studies often because of different types of pre-existing conditions. And so, to be able to track them over time and see what's going on with them is really fascinating. 

 

But the study that you're talking about specifically is an online survey that we're doing right now for healthcare professionals, broadly speaking -- that includes doctors and nurses, therapists, social workers, pharmacists -- and really what we're trying to do is just gather information about attitudes about uses of psychedelics in the therapeutic setting and knowledge. We have little quizzes built into the study where we're asking people both what they think is appropriate or not appropriate and what their concerns are about therapeutic applications. 

 

This is not just about psilocybin. It's about psilocybin, MDMA, ketamine, and cannabis, actually. 

We're asking about all those classes of drugs broadly and all those types of drugs and asking people what they think about medical uses and how much they know about that. That's one that we have going on the website right now. It's Hopkinspsychedelic.org. It's our healthcare professional survey. We're trying to understand how the current generation and the next generation of medical professionals perceive psychedelics and other types of substances and what they think about their utility, potentially, as medical and healthcare treatments. We're definitely inviting people to take the survey online. Usually, it takes about 20-30 minutes, but we certainly appreciate that.  

 

Shiv Gaglani: Yeah, we'll definitely put that in the show notes and send it out. This is one reason we even have the podcast. We're training clinicians of the future to skate where the puck is going, as Wayne Gretzky said. As I've been reviewing my own Osmosis content, all the psychiatry videos are about SSRIs, SNRIs, antidepressants, MAOIs...a lot of which we don't actually know how they work and certainly are not often that effective. So, the research out of your lab is very interesting, and the Center in general, because that could potentially be a much more effective alternative to what we traditionally have been using over the past thirty or forty years. 

 

Dr. Al Garcia-Romeu: Yeah, and that's also what I think is so exciting about this is because where we're at right now is studying psilocybin, studying MDMA, starting to scratch the surface of some of these other compounds too because there's so many others out there such as LSD, 5-MeO-DMT, ayahuasca, novel psychoactive substances like 2C-B -- I mean, Sasha Shulgin just came up with so many -- and then there's a potential for so many more. People are developing these and trying to understand the mechanisms behind them --and just like you said, the mechanisms even in the standard therapies that we use in psychiatry are not always well understood. I would say the same for the psychedelics. We're learning more but as we learn more, the rabbit hole gets deeper and so it's a really fascinating time to be involved in the work and to see the expansion in all these different areas -- both the clinical utility but also just to help promote basic human flourishing, spirituality and well-being and things like enhancing the creative process -- I think there's so much potentiality there. 

 

Again, going back to my early interest in psychology, I really remember just studying all the psychopathology and diagnosis and saying, “This is like a really long list of things when things go wrong.” And then finally getting to Maslow and then going to study with Jim Fadiman and others like him where he said that that part of psychology is really focused on when things go wrong but what about when things go right? What about when you have somebody who's really highly self-actualized, highly developed, high functioning, what's going on there and how do we replicate that or how do we help nurture that? I think psychedelics have a huge role to play on that side of the fence as well. So again the future is full of possibilities right now. 

 

Shiv Gaglani: So, prognosticating a bit, like you mentioned there’s really great Phase 3 results for MDMA with PTSD -- we had Rick Doblin on the podcast in January...

 

Dr. Al Garcia-Romeu: Nice.

 

Shiv Gaglani: ...and there’s obviously big conferences coming up, like Psychedelic Science in June in Denver. Hopefully MDMA will be approved in the next year to year and a half. You had mentioned it right here that potentially, if all goes well, psilocybin will be approved in the next year and a half to three years. Once these medications are approved -- like ketamine is already FDA approved -- where do you think things will go? Will the system rapidly increase the amount of research off-label use? What are your hopes there versus maybe the mix of exploring DMT, ayahuasca and all these other substances? How do you see that playing out over the next five, ten years?

 

Dr. Al Garcia-Romeu: It's really hard to say. I have to say I don't know. But what I hope is that first you're going to see a roll out of MDMA-assisted therapy. And I would just point out briefly that there's a difference with ketamine because ketamine is approved for use as an anesthetic, which is how it's used in medicine and how it can be reimbursed in medicine. Now, if you're using it for psychiatric conditions off-label, you can have a clinic and do that because it's not a Schedule I drug, so it can be prescribed. But that's not something that insurance is covering and even though there's a strong basis of research showing that it has rapid and robust antidepressant effects, most people can't get it.  I think that’s really challenging right now. 

 

With MDMA, my hope is that because it's getting approved as a treatment for PTSD, and because PTSD is such a big problem in terms of public health, that there's going to be pathways

for people to access this treatment. MAPS is working on providing infrastructure for training and eventually, there will be therapists and clinics and then people can go get these types of treatments for post-traumatic stress and then for other conditions as well -- as you suggested off-label -- as data continue to grow on use in other types of clinical conditions. 

 

Then expanding that on further to see something similar happen with psilocybin, because a lot of the work with psilocybin is focused on major depression. Again, you see these robust, rapid-acting antidepressant effects which seem to be fairly long-lasting in many individuals. That seems to be the tip of the iceberg, because you're also seeing studies with LSD for anxiety, and psilocybin for substance use disorders. And so I think that work can really pave the way for, hopefully, accessibility in medical settings where people can go get treatments and have some kind of insurance coverage for these types of treatments. 

 

Because as I'm sure you know as a physician training now, there are a lot of challenges of access and the health disparities that we deal with...there's all these other structural issues involved, whether we're talking about poverty or we're talking about just lack of direct access to health care or lack of access to something like insurance. So, how those things are going to play out and how, at a high level, rescheduling is going to move forward is still a little bit up in the air. But people like Rick Doblin of MAPS and other colleagues in this space, I know, are advocating heavily to get this into a place where people can get it. 

 

Because it's not just about studying it. For me, I would say a big part of the end goal here was to get this in a place where you don't just have 100 participants in a research study at Johns Hopkins, but anybody who wants to quit smoking in the country can go to a clinic and get this type of treatment because we’ve shown that it seems to work. 

 

Shiv Gaglani: That'd be incredible. What an incredible vision to skate towards, both for the so-called pathologies, but then the human flourishing aspect. I know we're coming up on time, so I have two other questions. The first is, we like asking our guests for advice that they have. So put yourself in the shoes of a young trainee right now, or early-stage healthcare professional or researcher. What advice would you give to them about meeting the challenges of this moment and going forward?

 

Dr. Al Garcia-Romeu: It's a difficult time, and it's hard for me to gauge this against any other time that people have been around. But I know that what we've seen in terms of the major sort of big picture events -- COVID and climate change and just the mental health challenges that we're facing -- and potentially other stuff that's coming down the line is troubling. Technological innovations have been great in some ways, but in others, perhaps have detracted from mental health as we get hyperconnected and flooded with all this media. So, yeah, I think that the challenges are pretty great at this moment.

 

But we continue to find a way to push forward.  I think the main thing is to get training and education in the area that is of interest. A lot of people ask me about getting specifically involved with doing work with psychedelics, and I always tell them, “Just get good training to do what you would do without psychedelics first, and then the psychedelic piece is likely to be easy to add on afterwards.” If you're already somebody who's proficient in helping people doing therapy for trauma, if you're somebody who is a well-trained in dealing with mood disorders or substance use disorders, if you're somebody who is fascinated by being in the palliative care space and working with people near end of life, go do that. Go get that type of degree, certification or licensure that will allow you to do that work. 

 

Then, as we see these bigger kind of approvals come along at the federal level, that's going to open up opportunities for people to get that specialized training to do something like MDMA assisted therapy with people with PTSD or to get a psilocybin assisted therapy licensure certificate to work with people dealing with whatever type of condition. I think that's the path of least resistance in terms of using the existing structures. 

 

There are people who are kind of going outside of that and trying to build other structures, and there’s something to be said for that. But it's challenging and risky in its own right. I would say as somebody who went outside of the medical school system, had a successful foray into doing something, building something, and then now coming back into it you've been there, but it can be scary to try to get out there and build new structures and challenges. 

 

Shiv Gaglani: Totally. I think the interplay is where a lot of the productivity comes from. It's like that real hardcore substantial academic research that informs the scalable access to a capitalistic aspect of the economy, and figuring out that balance is difficult because people often go too far in either direction. Translational opportunities are very interesting. 

 

Dr. Al Garcia-Romeu: I agree with you 100% because what you're doing is really kind of getting a survey of like, what are the systems that I'm going to have to be working within? And how do I make them work together towards the ends that I find most meaningful and appropriate? So that seems like the way to do it. 

 

Shiv Gaglani: Totally. So my last question for you for now -- because my hope is we'll have many future conversations, and obviously now that I'm here at Hopkins, I'd love to interact more -- is there anything else that you want our audience to know about you, your research program, psychedelics, or transpersonal psychology...anything at all? 

 

Dr. Al Garcia-Romeu: I can't think of any big sort of items that we haven't covered today. Definitely, I think we covered a lot of ground and I got to talk on a lot of the important stuff.  I do think more about diversity in science since I've been in the field for a while now, and also I've been observing the challenges that we can have getting diverse participant populations in here. That's also been a microcosm of the macrocosm that we see or vice versa...getting medical students, getting faculty, getting researchers who are coming from diverse backgrounds. 

 

So, it's just something I want to encourage because I feel like it's really important to be able to make this viable for everyone to have a stake in and to get benefit from. 

 

Shiv Gaglani: Totally. I think that's a really great, great note to end on. My hope is that some of the people listening to this podcast are from those less represented groups that would be interested in pursuing this and other fields. So with that, Al, thank you so much for your time and more importantly for the work that you've been doing for many years now to, as we say, raise the line and strengthen our health care system. 

 

Dr. Al Garcia-Romeu: Thank you.