Last June, the American Psychedelic Practitioners Association appointed a new executive director whose background many in the psychedelic field found surprising. Few expected that APPA would be led by a former three-star general. But then, they probably didn’t know much about Brigadier General (Ret.) Stephen N. Xenakis.
Xenakis first emerged as an advocate for psychedelic therapy as co-founder of Reason for Hope, an organization that promotes legal reforms to support access to psychedelic medicine. A clinical psychiatrist who has advised the Chairman of the Joint Chiefs of Staff on the psychological health of military personnel, he has long been interested in innovative treatments for combat veterans suffering from post-traumatic stress disorder. His interest in psychedelic therapies stretches back to when he was a medical student at the Spring Grove Clinic in Maryland, where he was involved in research into LSD therapies during the first wave of investigations into psychedelics.
When Xenakis’ appointment was announced, APPA board member Darron Smith praised his “unique mix of executive leadership qualities developed during his decades of military, governmental, and private practice service, along with his unparalleled view into the patient-centric needs of the mental health industry…” Smith added that, “We have 100% confidence in his ability to shape the future of this industry and ensure all voices in the space are heard.”
Lucid News spoke with Xenakis in November about his new position and the role that he expects APPA will play as MDMA and psilocybin therapies move toward FDA approval. This interview has been edited for clarity and concision.
Lucid News: What is your vision for APPA?
Xenakis: As a practitioners association, APPA brings together clinicians of different disciplines. Psychiatrists, psychologists, social workers, advanced nurse practitioners, physician’s assistants, these are all licensed providers interested in and doing psychedelic assisted therapy. They’re either doing it now, because ketamine is approved, or they’re looking at what might be approved with MDMA and psilocybin. They want to be able to do that in a way that they feel most competent and confident, and that they’re doing the right thing for their patients. APPA is an organization of all these people, so that they can work together and collaborate, but also so that they can inform the process going forward.
Most important is that the practitioners have a seat at the table. That’s not what I think currently happens. In U.S. healthcare, there is a very strong influence of the payers, government agencies, and academics. All that’s valuable, there’s good reason for it. But there’s also a very important contribution to be made by the clinicians. Our point is to reinforce that, bring that for consideration in the most effective way possible.
APPA’s focus is on health care professionals with licenses who want to work directly with psychedelics. Does that mean only those who administer psychedelic substances, or does it include those who work therapeutically with clients before or after a session?
They all need to be part of the modalities. There’s a lot of groundwork that we’ve got to do, in terms of meeting the need. We’ll have to be creative in configuring clinics and systems. I don’t think that’s worked out yet.
As you know, many therapists are working underground without licensure. But they have many years of experience working with psychedelic medicines in a therapeutic context. Do they have a place in APPA?
There’s a vital place for these folks. First of all, they have tremendous clinical experience. And if we’re going to learn what the most effective treatments and therapies are, then we need to build on their experience. We have to bring them into the conversation.
How do you do that if the services they offer can get them arrested?
We have to consider how we make sure that they feel protected, that there’s confidentiality if they feel exposed. Our organization needs to be very disciplined about getting details and facts. I like to make sure that I’ve got as many of the facts as possible in my hand before we look at what we’re going to do or not do. So I think: How are these people exposed? What are they exposed to? How does the government think about it? They’ve got rich clinical experience and knowledge. How do we use their knowledge for training, use it to build a workforce? So there’s clearly a place for them.
Isn’t APPA membership restricted to people with licenses?
There might be some other way that we can bring non-licensed practitioners in. But how do they identify themselves in that way and not be exposed? I don’t know. I probably need to have a whole platoon of lawyers backing me up to figure out what to do here.
What is APPA’s timeline and specific goals?
The first step was the professional practice guidelines, which were published in July. We’re saying, this is now a legitimate, recognized professional practice, and here are the pillars of that practice. As the next step, there’s a set of projects that we’d like to kick off first quarter of the next calendar year , looking at core competencies, best practices, and moving towards developing clinical practice guidelines. What works when a patient, or subject, sits with a practitioner or clinician? What are the actions that occur there? What do we know about the setting? What do we understand are the responsibilities and obligations of the practitioners? What do we know about what the subjects, or patients, are looking for? How do we use the tools which are becoming available, to help patients understand what is going on?
We will have working groups and conferences to identify and develop best practices, core competencies, and clinical practice guidelines for each of the modalities: ketamine, MDMA, and psilocybin. And then publish them, socialize them, so people understand what these treatments are. Who are the candidates for these treatments? How do we know that we’re doing it right? And we have to make sure that we understand where the harms or risks are. Any treatment that’s potent can also have adverse effects. Otherwise, it’s a placebo. Let’s acknowledge that we have very potent treatments, and make sure we know who the right candidates are for these treatments.
The amount of research you suggest sounds vast.
Well, it’s the practice of medicine. That’s why it’s a practice, we keep learning. We should keep learning if we want this to grow. We want to work closely with the people doing research and development, because we should be learning more every day.
I suppose that most of the research to date has focused on the substances themselves, rather than the effects of different therapeutic approaches. Are you saying that, in parallel with research into the substances, there should also be more research into the therapeutic modalities?
That’s exactly right. We see it as a four act play. Act one involves the pharmaceutical manufacturers, working with the FDA to say that these substances have efficacy. Act two is looking at the clinical setting and asking, how do practitioners apply these medicines in a therapeutic setting? That’s where clinicians come into play, but it’s not typical of this kind of research. Understanding the effectiveness of therapy and clinical practice has not been substantially funded in the past 30 to 40 years. So we’re saying, let’s make sure that we bring in the voice of the practitioners. We want to lead these kinds of projects.
Would these studies include underground practitioners?
We have people who have been in this field for decades. From their practice they can tell you: this kind of patient seems to do better with this particular use of certain medicines, in a certain setting. A lot of knowledge is there. We can now methodically, conscientiously pull from that knowledge
What’s act three?
It’s looking at the mental health need. We have 100,000 deaths from opioids, 50,000 to 60,000 suicides. Let’s map that out so we understand where the need is and act from knowing that need. And act four is configuring the services so they are available where the need is. Not just for the people who can afford it. Not just for people who happen to live in the right location.
Does that mean APPA would recommend certain kinds of therapeutic practices over others, and set standards for the field?
We would be saying: here’s the state of the art, and what we’ve learned from practitioners and the research.
Does APPA have a position on whether a practitioner should have their own psychedelic experience?
We don’t have a position yet. I grew up when psychoanalysis was dominant. To be a good psychoanalyst, one had to go through a training analysis. In fact, in my child psychology training program, they had us in therapy, as well. That a good therapist has experienced the therapy and knows what it feels like is an old, old idea.
APPA’s guidelines include an emphasis on informed consent and the patient’s right to refuse touch. Is APPA considering enforcement mechanisms against practitioners who cross those boundaries?
I think we’ve got to go back and explore those ethical guidelines and further develop them before we come out with recommendations about enforcement or oversight. We need to look at what informed consent is. Clearly, if a person is feeling the effects of the medications, they may have an unexpected reaction, and it may be that some kind of touching is what’s most comforting or helpful. That’s details to be worked out. I recently heard of an instance when, fortunately, a therapist had videotaped a session of a person who had been traumatized. The subject felt that she had been inappropriately touched by the therapist. In fact, nothing had happened. We could see that from the video. But it was a replay of the trauma. So we’ve got some homework to do here before we talk about what might or might not work.
Do you anticipate that APPA would be an enforcement vehicle?
Oh no. That’s going to be left to licensing boards and the states. But they do need guidance.
You said that APPA should have a seat at the table when decisions are being made about psychedelic therapies. How would that work?
For example, as the FDA approves MDMA and psilocybin, and thinks about risk evaluation and mitigation strategy, practitioners would inform what that REMS looks like. We would convene practitioners and say, this is the most solid way of providing these treatments. We would publish these recommendations in accepted journals. When the American Psychiatric Association forms a committee about psychedelics, we would send delegates to that. When the American Psychological Association prepares to endorse a guidance, we would say, “Here’s recommendations about what that guidance should be.”
Obviously the field is extremely active, and there are many differing and strongly held opinions about the topics APPA will address. What process will you have for soliciting information and diverse perspectives?
We’re going to formalize a process. The membership is a constellation of working groups. And we’ll bring members together in face-to-face conferences, which include a process of bringing in the wider audience of experts, so they can contribute and feel like they’re part of this broader experience.
When will this schedule for meetings and opportunities for participation be announced?
We’re targeting first quarter of the calendar year. We announce when we think we have the funding. We’re now going out and soliciting funding.
It’s been a challenging environment to raise capital recently, especially for projects that push toward new frontiers.
We’re at an inflection point, or as my teacher Thomas Kuhn would say, a paradigm shift.
You studied with the author of The Structure of Scientific Revolutions?
He was my advisor in college. He’s embedded in my head. So, what we have to do is respect that transformation, because we’re at that inflection point. There’s no clear path, each of us see a different path to move towards a better way to provide mental health. So you face all the challenges of building your team, reaching consensus, and particularly in this case, getting funding, support and legitimacy.
On a more personal note, how do your friends from the military see your position with APPA? What kind of response are you getting from them?
It’s mixed. You know, there are those who have had contact with service members who they’ve watched fall by the wayside. They feel bad for them, and they also feel desperate about getting treatments available. There’s a shared sentiment there. But there’s also a group of people who think this is incredibly impractical. You know, these medicines were illegitimate and illegal for many years. Why would a former military senior officer dabble in anything that could potentially tarnish a reputation? Because we in the military, even up until now, think that any drug use is really detrimental. And it’s not what we should be like as military leaders. So it’s a very mixed feeling. I think there’s also a group that feel it’s a heavy lift, that this is a really hard task, and legitimately wonder if we can accomplish what we’re setting out to accomplish in a practical way.
Are you ever surprised by who shows up from your military life in support of what you’re doing?
Yes, I’m encouraged by it. My colleagues are people I liked working with. Their attention and time was with the frontline, those army soldiers. You know, they said, Steve, you’re doing what we all did before. You’re there to help those soldiers who really need it, and we respect that. I like that, it’s supportive and encouraging.
They see APPA as a continuation of the leadership you offered during your military service.
Particularly as senior leaders, our obligation is to our fellow service members – to do everything we can to protect them, and then to care for them afterwards. All this fits with what’s been most important in my professional life.