Dr. Jennifer Mitchell: Psychedelic medicine
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Some U.S. states (e.g., Oregon, Colorado) and municipalities (e.g., Oakland, CA; Washington, DC) are legalizing, decriminalizing, or funding research into therapeutic uses of psilocybin and other psychedelic drugs. Several others are considering doing so.
On Thursday, January 26, 2023, SciLine interviewed: Dr. Jennifer Mitchell, a professor in the Departments of Neurology and Psychiatry & Behavioral Science in the School of Medicine at the University of California, San Francisco. She discussed topics including: what psychedelic drugs are and how they work; which types are being studied by researchers for potential therapeutic use; what scientists have found, so far, about whether they are effective in treating mental health problems like PTSD or chronic pain; what is involved in therapeutic treatment using these drugs; and the current regulatory landscape around psychedelics.
Declared interests
I serve the California Department of Justice as a member of the Research Advisory Panel (RAP-Cal) and the VA as the Acting Associate Chief of Staff for Research at the SFVAMC.
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Introduction
[0:00:20]
JENNIFER MITCHELL: My name is Jennifer Mitchell, and I am a professor in the department of neurology at UCSF in San Francisco. And our group is interested in developing novel therapeutics for disorders that are related to emotional processing and affect. And in particular, over the past five plus years, we’ve been interested in evaluating the promise of psychedelics for a number of different disorders.
Interview with SciLine
What are psychedelic drugs and how do they work?
[0:00:54]
JENNIFER MITCHELL: Psychedelic basically means mind manifesting, and the suggestion there is that the compound assists one in uncovering subject matter that perhaps is otherwise deeply hidden from the conscious mind, and it’s a slightly different term than hallucinogen, which you also see used almost interchangeably at times with the term psychedelic. So, a hallucinogen by definition is something that makes you see, hear, smell something that isn’t otherwise there, so you can imagine there’s a lot of overlap between psychedelics and hallucinogens. But by definition, psychedelics would include compounds such as MDMA.
Which types of psychedelic drugs are being studied by researchers for potential therapeutic use?
[0:01:43]
JENNIFER MITCHELL: I think the two most well studied drugs at this point are MDMA and psilocybin. MDMA is being evaluated mainly for treatment of post-traumatic stress disorder treatments, and psilocybin mainly for treatment resistant depression and major depressive disorder. MDMA is perhaps the furthest along because there’s phase three data and the possibility that a new drug application would be submitted to the FDA sometime later this year—so 2023. LSD is also being evaluated for a number of different indications, most notably obsessive compulsive disorder. And then a couple of sort of heavier hitters are now in play as well. Some in just healthy control populations, drugs like mescaline, ayahuasca, ibogaine, etc.
What have scientists found, so far, about whether these drugs are effective in treating health problems like PTSD or chronic pain?
[0:02:45]
JENNIFER MITCHELL: Well, the drugs so far appear to be quite effective. I think one key though, is that they’re typically being administered in conjunction with some form of psychotherapy. So, the idea that, I think the FDA in particular is embracing, is that these are experiential medicines and, therefore, very dependent on the environment in which they are administered. And so, it’s important to keep that in mind when we look at the results from some of these recent trials that these are not drugs that are being administered in isolation. You are not taking home a bottle of pills and, you know, taking those twice a day you would, say, an antidepressant. These are administered in a very particular way.
What is involved in therapeutic treatment using these drugs?
[0:03:32]
JENNIFER MITCHELL: Typically, prior to taking the drug at all, the subject participates in a number of preparatory sessions so that they understand a little bit about what is going to happen on an experimental session day. And then once those preparatory sessions are completed, subjects come into a room that looks very much like a comfortable living room, and they spent all day in that comfortable living room. The drug is administered typically in the morning, and for psilocybin, you’re typically looking at a six-hour dosing session, and for MDMA, and an eight-hour dosing session at present. And you are in the company of a group of trained providers: therapists, psychedelic facilitators, psychiatrists, clinical research coordinators, etc. And then after that dosing day, there are typically a number of integration sessions, often spaced about a week apart, in which the participant has the opportunity to further unpack and process whatever came up during those day-long dosing sessions. And then for psilocybin, that’s often just one dose that’s administered, and for MDMA right now it’s typically three doses spaced about a month apart.
What are the potential risks of using psychedelic drugs for therapeutic purposes?
[0:04:52]
JENNIFER MITCHELL: One concern that we’ve had is sort of a cardiovascular risk, and so we are taking great care in some of the clinical trials at present to evaluate cardiovascular burden, during and after the experiment. And then, in addition, I think we are quite worried about suicidality, in part because these are very treatment-resistant populations that we’re starting off with, and so there’s a concern that perhaps, if they’re destabilized—either by the psychedelic or just by tapering off their other meds in order to be part of a psychedelic trial—that we could run the risk of suicidality. So, that’s something else we’re looking at. And then lastly, I think the FDA has been very concerned about the possibility that psychedelics are addictive, and so we’ve been following up with study participants to ensure that they aren’t engaging in a drug seeking or drug taking outside of the study.
What does the current regulatory landscape look like around psychedelics? Is it changing?
[0:05:50]
JENNIFER MITCHELL: There are lots of regulatory and compliance pieces that are involved in researching a Schedule I substance. So, a Schedule I substance means that the DEA considers that compound to be addictive and also to not hold any therapeutic value. And so, I think that there are some that would say that they feel that the psychedelics should not be Schedule I compounds, but at present they are. And that means that in order to begin research with a psychedelic, you must first approach the FDA and the DEA in order to obtain an investigational new drug application and a DEA Schedule I license, and then you must of course report and pay copious attention to how the drug and when the drug is used.
What is the funding landscape like for research into psychedelic medicine?
[0:06:42]
JENNIFER MITCHELL: Our hope is that soon there will be more federal funding for investigation of psychedelics as therapeutics, and unfortunately because of their Schedule I status it’s been very complicated to obtain federal funding to investigate these compounds, or at least to demonstrate that there’s any therapeutic value to these compounds. So, my hope is that the result from some of the recent clinical trials will change that.
What do we know about the safety of taking psychedelics outside the clinical context?
[0:07:15]
JENNIFER MITCHELL: Because they are experiential medicines, they don’t do the same thing in different environments, right. And so, I think we’ve all heard stories from the 60s and 70s of people taking psychedelics and having very bad experiences. And so, what we know now is that the container, the environment in which you take the psychedelic is of the utmost importance. And so, one of the things that we have in play during these clinical trials is the presence of a very seasoned and trained group of psychedelic facilitators. And so, I think one of the things that we want people to note is that it’s not appropriate at this point to try to take some of these substances or replicate some of these protocols on your own without that level of oversight. And so, we’re concerned about safety, as people get very excited and passionate about potentially moving forward and getting therapeutic access to some of these substances. We want to make sure that they’re considering their safety and well being first.
What might be behind the recent interest in psychedelics?
[0:08:19]
JENNIFER MITCHELL: Some of us have been in great discussion about what the tipping point has actually been that has allowed this, sort of this psychedelic renaissance, and I think that there are several factors that have contributed. I think that one of them has been Michael Pollan’s book on psychedelics because he was able to share his own experience in a way that, I believe, reached a lot of people, people of a particular demographic, especially, that perhaps had previously thought that psychedelics were potentially bad and could lead to long term toxic effects. And so he was able to sort of right that wrong. And then in addition to that, I think that it was sort of the the right time in terms of our global pandemic because even though we’ve been studying these compounds for a number of years now, I think that there was less interest in identifying new therapeutics for mental health disorders until we were suddenly in the throes of a mental health crisis in our country, due in no small part to the COVID pandemic.
