Recent Developments in Psychedelics With Andrew Penn

Andrew Penn, RN, MS, NP, CNS, APRN-BC, associate clinical professor, University of California, San Francisco, California, recently sat down with Psych Congress Network Associate Digital Editor Meagan Thistle to discuss recent developments in psychedelic medicine, barriers to integrating psychedelic medicines into psychotherapy, reasons why patients and practitioners may be hesitant to use psychedelic medicines.

At Sana Symposium, Penn, a steering committee member presented in sessions covering the state of research in different mental health disorders, as well as what’s next for psychedelics. The Sana Symposium was presented virtually October 13-15.

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Read the transcript:

Andrew Penn: Hi, I’m Andrew Penn. I’m a psychiatric nurse practitioner and associate clinical professor at UC San Francisco. I do clinical work at the VA here in San Francisco, and I’m also a researcher on psychedelic studies in the TrPR lab, which is a translational program in research in psychedelics at UC San Francisco.

Megan Thistle: What are some exciting recent developments in psychedelic medicine since we last spoke at Psych Congress in San Antonio?

AP: We’re inching closer towards FDA approval of these compounds. So where we’re at now is that the study of MDMA assisted therapy for PTSD is inching closer to completion. My understanding is that study, the Phase 3 study is close to wrapping up, and that will go into data analysis soon. And the Phase 2 studies of psilocybin for major depression have either been completed or are close to being completed.

And presumably will proceed on Phase 3, if those results are favorable. So there’s slow, but steady, incremental movement in the research space. I think culturally, we’re hearing just more and more about psychedelics. I suspect the session that I’m going to give today will be largely people that have heard about this, but may not know the details that we’re working on in the research space, but there has been a lot of movement in that area.

There’s also increasing interest in something called decriminalization, which, it’s not legalization. It’s different than legalization, but municipalities, even whole states such as Oregon making plant medicine, such as psilocybin, not criminal to possess, which is different than legalization. Those 2 are often used synonymously and they’re subtly different. But the big movement in that space in Oregon is the implementation of initiative 109, which will allow a legal pathway for people to experience psilocybin in a nonclinical, more like retreat type setting with people who have been certified by the state to deliver that kind of care.

MT: What barriers remain when it comes to integrating psychedelic medicines into psychotherapy? And are there any common misconceptions?

AP: I think the part that’s going to be a big shift for those of us who have worked in psychiatry, whether as psychotherapists or as psychopharmacologists for a long time, is really starting to think about how to integrate these 2 modalities. Because one of the things that we’ve really learned with psychedelics is that they are deeply contextual, which is to say that where they are taken and with the intentions in which they are taken really has a big bearing on the outcome.

And so what that’s going to mean for us as clinicians is to bring the psychotherapy part and the psycho-pharmacology part together. And so it’s going to require specific training in this modality. Whereas historically, if you were trained like I was as somebody who works in psycho-pharmacology, learning to use a new medication was relatively straightforward. You needed to learn what to expect from it in terms of side effects and how long it would take to have benefit and dosing and such.

But the framework in which it was delivered was ostensibly the same. Whereas this is really quite different because what we’re doing here is we’re using a drug only a handful of times in the context of psychotherapy. And it’s a particular type of psychotherapy. The psychotherapy model is still evolving. We talked a lot about that at the Sana Symposium last year, the directions that’s evolving, incorporating things such as ACT.

But really the therapy is delivered both before and after the drug session and during the drug session. And so that’s quite different than say a 50-minute session that a psychotherapist might be used to and very different than the 15- or 20-minute medication adjustment visit in which most of the time is spent away from the office where the person is taking the drug, obviously, and then they’re going to come back and report.

This is a shorter period of psychotherapy, usually, but much more concentrated. So anywhere in our studies running a subject can be anywhere between 20 to 50 hours of psychotherapy. Psychotherapy plus drug, but up to 50 hours total, which might be how much a therapist spends with a patient in an entire year. We’re doing that in the space of a couple of months, maybe 3 months. So it’s much more concentrated and that’s a different model than what we’ve been doing up till now.

MT: For clinicians in interested in incorporating psychedelics into their practices, what recommendations would you make? Where should they begin? And maybe walk us through your experience with patient treatment plans that incorporate psychedelic therapies.

AP: The one place where this is already happening is in ketamine space. As many people know, there are 2 variants of ketamine available. There’s racemic ketamine, which has been around for a long time as used in an off-label fashion as an antidepressant medication. And then there’s esketamine, which has been around for about 1 years now as an intranasal spray.

And there are different ways to do this. Esketamine is a little more prescribed because of the REMS program that goes along with it. But racemic ketamine, because it’s being used in an off-label capacity allows for a certain degree of flexibility. So there’s really 2 primary models that I’m seeing. One is more of a biologically focused model, which is an IV infusion, not always done with psychotherapy attached to the infusion. And then there’s ketamine-assisted therapy, which really uses much more of a psychedelic therapy model in which you have preparatory therapy without drug.

And you have integrative therapy after the drug session also without drug. And then those same people who are doing the therapy with you and those preparatory and post-session meetings are there with you while you’re having the drug. And the drug is usually administered either sublingually or intramuscularly in that setting. And so the idea is similar to the same models we’re using with MDMA or psilocybin which is to allow the drug to have a period of action. Those 2 methods allow for somewhat more flexibility in dosing than usually the IV model utilizes. Although I’m seeing more variance in how people are dosing, IV infusions as well. The historic model was half a milligram per kilogram, over 40 minutes, but some clinicians are opting to use higher doses in the IV setting for people that don’t respond to the lower doses. So there’s already ketamine assisted therapy that’s happening and that’s legal and that’s possible.

With regards to using this with patients, I think people are going to need additional training, and that is something that is still being worked out. There are a couple of boards that are forming to create expectations and criteria for training programs and also to administer a certification exam. And this is not dissimilar from the certification exams that we’ve all gone through, which give us certain consistency to the qualifications of a particular type of clinician. And so that’s still being worked out.

Meanwhile, there are a lot of training programs that are cropping up that are attempting to really kind of speculate on what will those competencies need to be. And some of these have been around longer than others, and they all are sort working on a somewhat speculative basis because nobody knows exactly what the requirements of a psychedelic therapist will be in the future.

It’s remains to be seen if the FDA will weigh on that either on the drug label or in a REMS program that would be attached to any given therapy that is being utilized. So all these programs are really attempting to imagine what that looks like and try to create programs that would probably meet the needs of any future certification body. But that is still very much a work in progress. With regards to integrating with my patients, I get to do this in studies, which is a very uncommon thing. Most of us don’t get to work on studies, but if one has the opportunity to do this, I highly recommend it because it’s been very interesting to me to of see how studies get done. How many small decisions need to get made along every step of the way and really how much work and time they take.

Even for relatively small studies is a lot of work. For people that are working with patients who are utilizing ketamine, either working directly in ketamine type clinic or patients who are using ketamine as an adjunctive treatment. I certainly have seen this at the VA where I work. We do have some availability for racemic ketamine at my particular VA site, but some veterans are choosing to go outside of the VA and pursue some of these at-home ketamine services that are available, that again have varying degrees of quality. And I think it’s helpful to at least even if you are not the one administering the drug to at least have familiarity with these modalities so that when it comes up with your patients, you can talk about things such as what are your intentions for the treatment. So some of my colleagues here at Psych Congress, this is a project that Saundra Jain initiated some years ago called the psychedelics and wellness study.

And along with Rakesh Jain and Chuck Raison, we’ve just recently published a paper in Frontiers of Psychiatry, looking at about 2500 people who answered a survey, talking about their pre- and post-psychedelic measures of wellness, anxiety, and depression. And we did see a fairly reasonable signal in all of those measures from naturalistic self-reported use.

I was thinking about that many of those people may not have had the opportunity to ever talk about their experiences. And so I think if you’re a therapist and your patient comes and tells you that they had a psychedelic experience, there’s value in knowing how to talk about that. First of all, not to necessarily approach that as drug abuse, of course, that’s up to somebody’s clinical decision making. But not to just reflexively assume that if somebody has had a single psychedelic experience that is necessarily a sign that they are developing a substance use disorder.

But to have some capacity to talk about that experience with the patient, because we found that for many of these patients, many subjects, I should say, that these experiences were very meaningful to them. And I think it’s important to be able to discuss what that meaning is. And what we’re working on now is really trying to see if people, when they have these changes in self perceived wellness, does that translate into behavioral change? Because that’s really where the proof is kind of going to be in the pudding. Is it’s one thing to talk about wellness. It’s another thing to begin meditating or begin exercising, or make an effort to connect with other people. All of things that we know have association with improved wellness and wellbeing.

MT: First, what would you say to clinicians who are hesitant about using these psychedelic medicines? And then what would you say to patients who are hesitant?

AP: I think the hesitancy is reasonable. We’re still working this out. It’s very much a work in progress. One of the things that gives me a little bit of pause in the sort of hype that’s happening around this is that there’s an impatience that’s forming. Psychedelics are interesting in that every year at Psych Congress, we hear about new compounds that are coming out of the market. Yet nobody is seeking those things out outside of clinical trials in the same way that people are talking about psychedelics and seeking out psychedelics.

I think for patients, know that we are working really hard on this. And a lot of people are seeking this out on their own. And that honestly, for some people that may be okay. There’s certainly long histories of this being used in indigenous cultures. And there are places in the world such as Holland and Jamaica, where these things have some degree of legal status and that there are places where that people can obtain this and have these experiences in a relatively safe, monitored setting.

But it’s very much a kind of “buyer beware” situation. We don’t have those sort of places. They’re outside of the purview of the regulatory system here in the United States. And so if people choose to do that, it would probably be wise to work with a clinician here who understands these medicines and understands the effects that they can have. And also some of the profound changes that they can ask people to make. And I think that’s where the integration part is so important. Because a lot of focus gets put on the drug effects, but these can be very profound experiences and they need to be held with a lot of care and a lot of intention. Because if they’re not, it can be like drinking from fire hose. It can be very overwhelming. And so to be able to do this with clinicians who really know what they’re doing, I think is quite critical.

MT: Lastly, on this topic, do you have any final thoughts or anything we haven’t discussed?

AP: One thing is really clear is that when this is available, following FDA approval, we’re going to need a lot more clinicians who know how to do this work right now. You could probably list the number of people who’ve been trained in this particular modality in the low thousands. At this point, maybe even even less than that. There are a number of organizations, such as MAPS, that are working very hard to really try and roll out training programs. And one of the places where I’ve been doing a lot of work around this is with nurses, which I’m trained as a nurse. And so we began some classmates of mine from the program that I went through, which was the California Institute for Integral Studies Certificate in Psychedelic Therapies and Research Program. We began a nonprofit organization called OPEN Nurses. It’s opennurses.org, and it’s the Organization of Psychedelic and Entheogenic Nurses.

One of the reasons why we did that is because we feel like nurses are very well suited to deliver this care, because when you think about it, these are long days. When I do a psychedelic session with a patient, we’re there for 7, 8, 9, 10 hours, which is not unlike a hospital shift.

And sometimes that person is going through various states of emotional excitement and distress, which again, not like being somebody... Not being in the hospital with somebody who’s experiencing delirium. And we really feel like nurses are very well suited to deliver this care because that’s the primary focus of our profession is delivering care. And the good thing is there are a lot of us, there’s almost 4 million nurses in the United States. And I don’t think it would be too much to add on to a nurse’s training to be able to deliver this care. So that’s something that we’re actively working on in order to try and solve this therapist bottleneck problem that we’re going to have when these treatments are available.