For decades, Johns Hopkins University in Baltimore, Maryland has held the distinction of being home to the foremost psychedelic research laboratory in the United States. Led by behavioral biologist Roland Griffiths, the lab has greatly expanded our scientific understanding of how psychedelic substances ranging from psilocybin to salvia affect the human brain. Historically, the lab’s focus has been on the use of psychedelic substances to treat mood and substance disorders, but it also conducts basic research like brain imaging studies to see how the psychedelics affect our neural activity.
In September, Griffiths and his colleagues announced that they received $17 million from a group of private donors, including billionaire philanthropist Steven Cohen, famed technology author Timothy Ferriss and Blake Mycoskie, founder of TOMS shoes. In the world of psychedelic research, where government grants are basically non-existent, a cash infusion of this size is like winning the lottery, and Griffiths and his colleagues knew exactly what to do with it. The newly minted Center for Psychedelic and Consciousness Research at Johns Hopkins will be the first of its kind in the United States and the largest psychedelic research center in the world.
It’s a big day for psychedelic therapy, so PRØHBTD caught up with Fred Barrett, a cognitive neuroscientist at Johns Hopkins University, to learn more about the Center and the future of psychedelic research.
John Hopkins University has been a leader in psychedelic research for a long time. How is this new center different from what you and your colleagues are already doing?
I’ve been conducting psychedelic research with humans for more than 20 years now. That research effort has really been largely supported by a small number of private funders who themselves are very generous, but the level of funding that is required for a comprehensive program of research into the behavioral clinical and neurobiological effects of psychedelics is far more than any individual can typically provide.
The government has really been reticent to fund clinical research and therapeutic research on psychedelic drugs. So the traditional funding mechanisms that academic researchers and medical researchers would typically approach like the NIH and maybe even the National Science Foundation haven’t really been large sources of funding up to this point. We’ve really had to piece together a research program from a variety of small sources. The large financial commitment that’s been provided really allows us to greatly expand our program without the fear of funding running out quickly or the need to spend so much time writing grants. Oftentimes, academics in our position will spend an exorbitant amount of time writing grants to try to secure funding for their programs.
This [funding] allows us to put that aside for at least a few years and really focus on the important part: collecting data, conducting studies and trying to understand these drugs a little better.
What kind of research are you going to be doing at the center?
The center is going to fund eight separate clinical trials over the next five years. In particular, we’re going to be able to expand our understanding of the therapeutic effects of psilocybin to try to determine whether there is any evidence of clinical efficacy outside of the few indications that have been studied so far. Recent literature has shown that psilocybin may be effective in treating various aspects of mood, anxiety and substance use disorders.
Matt Johnson is going to lead a trial into the study of psilocybin to help treat opioid use disorder and will also lead a clinical trial to see if psilocybin will be helpful for patients with post-traumatic stress disorder. Our other colleague, Albert Garcia-Romeu, is going to lead a study looking at the effects of psilocybin in treating mood and cognition in patients with early Alzheimer’s dementia. He’s also going to run a pilot study in patients with post-treatment Lyme disorder. Our colleague Natalie Gukasyan, a Hopkins-trained psychiatrist, will be looking at the treatment of anorexia nervosa with psilocybin.
I will investigate whether co-occurring major depressive disorder and alcohol use disorder can be treated by psilocybin. This is a really understudied and unmet need. Patients with co-occurring mood disorders and alcohol use disorders can often be very difficult to treat, and it’s often challenging to find funding to study this population. So that’ll be an important step forward. I’m also going to expand our understanding of the neurobiology of psychedelics by collecting data on brain and biomarker changes that can be found in the blood and saliva to see if we can predict who will respond well to psychedelics and to see if we can learn more about the mechanisms that underlie successful treatment with psychedelics.
Finally, Roland [Griffiths] is going to be leading studies that can be characterized as trying to understand the betterment of healthy people. One study will look at the acute effects of high doses of psilocybin on creativity, and the other study will look at microdosing. The center is really going to greatly expand our research scope. It’s a quantum leap forward in the breadth and depth of psychedelic research.
Why do you think psychedelics have been so understudied in psychiatric medicine over the years, and why do you think this is important research to be doing now?
I think it’s fairly clear and uncontroversial that current pharmacotherapies can be helpful for some, but not for all people. We are in dire need of new approaches to treating a wide variety of disorders including substance use disorders, mood disorders and other disorders like anorexia.
I want to be clear: We’re not here to prove that psychedelics work. We’re here to determine if, and under what circumstances, they might work. We’re driven by the data. We want to know the real answer to this. We’re not here to do whatever we can to show that they work; we’re here to do whatever we can to test if they work and under what conditions.
The most recent findings are rather compelling. They suggest that it’s possible that with just a small number of interventions, one or two, you may radically change the course of incredibly difficult and sometimes intractable disorders. People are really suffering, and after a certain limit, modern psychiatry doesn’t really have many options for them. I think we would really be remiss if we were not to pursue these treatments scientifically when the data looks so promising. We need to follow up on them and really try to determine if and when they really work.
Psilocybin has been getting a lot of buzz right now, due largely to decriminalization efforts in Denver and Oakland. Did this inform the center’s decision to focus on the therapeutic effects of mushrooms?
I want to be careful in highlighting that our model is not “take two and call me in the morning.” Our model is really focused on a well-controlled environment with proper monitoring and aftercare for these types of experiences. So we’re not saying that anybody should go off and do this on their own, but I do think that these efforts may reflect a shift in public understanding that these compounds may have medical value.
Matt Johnson and a number of my colleagues recently published a paper suggesting that if psilocybin were to be approved for a medical indication by the FDA then, going by the standards of the Controlled Substances Act, it might most reasonably be put into Schedule IV as a controlled compound, which is far different than the current schedule. The current Schedule I designation requires that psilocybin [must] have no known medical use and high toxicity and abuse liability, which I think people are beginning to understand may not be true. The public opinion is beginning to mature around these drugs to really understand the real risks and benefits. But again, we are following the data and seeing what the data actually say about these drugs.
Psilocybin was recently classified as a breakthrough therapy by the FDA. Does that make it easier for you and your colleagues to study this Schedule I substance, or is it still an onerous process getting federal approval for human psilocybin studies?
It’s just as onerous of a process as it was before, really. The only thing that will make it easier to use these compounds in a research context will be if they are approved for an indication and then subsequently rescheduled.
Have you already begun seeking approval for the first psilocybin studies at the center?
They’re going to be rolled out at various times. We’re not going to just jump in all at once. The Alzheimer’s study actually has all of its regulatory approvals and is what you would call shovel-ready. They will begin recruitment for that study as soon as possible. We just have to wrap up and finalize a couple of hiring moves and some training then we’re basically ready to go. The anorexia study is almost completely approved. It almost has all of its regulatory approvals in place so that will be the next one to roll out. I am currently developing the regulatory documents right now for the co-occurring depression and alcohol use disorder study, so that will likely be the next one out of the gate.
When do you expect the first trials to begin?
Likely within the next few months.
The kind of research the center is doing reminds me a lot of the initial psychiatric research on psychedelics and various mood and substance disorders. Obviously that research paradigm kind of went downhill at some point, largely due to the antics of people like Tim Leary. What went wrong in psychedelic research 50 years ago, and what lessons does that hold for psychedelic research today?
Well, there were obviously a lot of mistakes made in the past. Frankly, I think the careful, controlled and objective study of these drugs from an empirical perspective—not in a sensational way or a way that encourages reckless behavior—is probably one of the biggest things we can do differently. I want to be careful because these drugs can be abused in the sense that they can put people in harm’s way. I think one of the biggest things we can do is to be clear about that and to understand that the safest way to approach these compounds is under controlled circumstances. That’s a much more scientifically rigorous approach than what Leary was saying about everyone tuning in and dropping out.
What can a participant in one of these research trials expect to experience at the center?
We have a very careful screening process in which we try to determine whether there is any clear indication that these compounds may not be healthy or safe for an individual. Nothing is ever completely safe, but we try to identify whether a person has a clear indication that it would not be safe for them.
After you’ve gone through the screening process and you’ve been enrolled in the study, you meet with study team members on multiple occasions to tell your life story, to really get to know us and so that we can get to know you. We try as hard as we can to build trust and rapport as well as a safe environment where volunteers will be comfortable exploring and communicating their experience during the acute effects of the study compound. Once we’ve completed that preparation process, we also try to communicate as best as possible what these experiences may be like and what a person may encounter during these experiences.
When the preparation phase has been completed, we invite people back to have an all-day session where we administer the research compound. We stay with the volunteer all day, providing supportive care and making sure they’re comfortable. We also monitor the volunteer for vital signs such as heart rate and blood pressure in the unlikely event that something unexpected would happen. At the end of the day, we ask volunteers to complete a number of questionnaires to communicate and to record at least briefly what their experience might have been like. The following day we ask people back for a debriefing and try to talk through what happened during the day in a way that hopefully will help an individual integrate their experience into their daily life.
Looking to the future, what is the ultimate goal of the center? What do you hope to accomplish for psychedelic research?
I think our goal is really to try to determine whether psychedelics can truly be effective therapies and treatments for people, and to determine what the boundaries of those treatments are. Hopefully we can predict who will get the most benefit out of these experiences and maybe optimize the experience so that even those who otherwise wouldn’t see therapeutic benefit might change their minds. We want to develop precision medicine and individualized medicine approaches for the use of psychedelic therapies.