🫠 Psychonaut POV

Welcome to Tricycle Day. We're the psychedelics newsletter that’s learning to let go of what we can’t control. Like whether you read past this sentence. 🫣

Paul Thielking used to sit with dying cancer patients. But recently, he’s been busy supervising hundreds of psychedelic dosing sessions across 20+ clinical trials. Don’t call it a career pivot, now. Paul says death and psychedelic journeys have plenty in common.

We asked Paul what he’s learned running research for the leading psychedelic drug developers, where he’s changed his mind about the role of therapy, and what dying teaches you that psychiatry doesn't.

Look, you don't need an excuse to go to Aspen.

But if you did, a two-day psychedelic symposium would be a pretty good one.

The Aspen Psychedelic Symposium returns June 6-7 with panels on ibogaine for Parkinson's, Indigenous medicine protection, Medicaid coverage for psychedelic therapy, and much more.

If you’ve been cycling with us for a while, you’ll recognize plenty of the speakers. Consider this your chance to meet belly-to-belly with some of our most influential Psychonaut POV guests.

Oh, and those mountain views aren’t half bad, either.

I'm a psychiatrist who’s also trained in hospice and palliative medicine. For most of my career I was clinically focused at the University of Utah, where I built a program at the cancer center supporting people who were struggling with depression, anxiety, and existential distress.

Around 2018 or 2019, I started getting interested in psychedelic medicine. Some impactful studies on psilocybin and cancer patients had been published, and there was a growing resurgence of interest in the medical community. I had an opportunity to run a study at Utah for cancer patients with depression, using psilocybin in a group format. That study helped me see the power and impact that just one psychedelic session can have for people who are genuinely struggling with depression, anxiety, and existential distress. It convinced me this was what I wanted to focus on next.

In 2021, I joined what was then a startup called Novamind as Chief Scientific Officer. Novamind had recently acquired a small network of mental health clinics in Utah and a fledgling research operation called Cedar Clinical Research. Through some early connections with Usona, we got in at the tail end of their Phase 2 study of psilocybin and depression, and that was the start of Cedar becoming a reliable site for pharmaceutical companies trying to get psychedelic drugs through the FDA.

Novamind was later acquired by Numinus, and Cedar Clinical Research continues to operate under that umbrella. Four years later, we've run 20 Phase 2 or Phase 3 psychedelic studies across a whole range of indications, including depression, generalized anxiety disorder, and PTSD. At this point, I've personally supervised over 250 dosing sessions.

Funding is the first and most obvious difference. Academic psychedelic research has historically struggled to access federal money, so you're either relying on philanthropy or you're a place like Johns Hopkins that’s secured significant funding to build a whole program. When you're running a pharmaceutically sponsored trial, the drug company pays you.

The other big difference is independence. In academic research, I can write my own protocol and explore what I find interesting. When I ran the group psilocybin study at Utah, I was genuinely curious about how the group format compared to individual work and whether it could help scale access. That's a real-world question worth asking. But it's not a question a pharmaceutical company is particularly interested in right now. What they’re wondering is if the drug is efficacious and safe. That's what the FDA is evaluating.

When I'm running a sponsored trial, my job is to follow the protocol with as much fidelity as possible and generate clean, high-quality data. What's the same, regardless of which world you're in, is the commitment to good science and the safety and wellbeing of research participants. That doesn't change.

One of the clearer trends is a movement away from formalized psychotherapy as part of the trial protocol. Companies are increasingly recognizing that the FDA is narrowly focused on whether the drug works and whether it's safe. They're not set up to evaluate psychotherapy, and the more you layer that in, the more complicated the regulatory picture gets. I think Lykos ran into some version of that challenge at their FDA hearing. They had a psychotherapy-heavy protocol, and there are real plusses and minuses to that approach.

What's interesting is that these trials still have someone in the room; they're just not calling it therapy anymore. The framing has shifted toward what you might call general, non-specific support. Whether that's a meaningful clinical distinction or a regulatory workaround probably depends on who you ask.

One of the bigger learning curves for our team has been figuring out the role of the therapist. When you're sitting with someone during a session, there are constant opportunities to intervene. But in a clinical trial context, you have to hold back your natural therapeutic instincts. Being in a researcher role rather than a therapist role is a significant shift, and some people take to it more easily than others.

It's also challenged my own assumptions. I came in with a bias that pairing therapy with a session would always produce the best outcomes. I'm keeping that as an open question more and more now. We've had plenty of examples where people had genuinely profound, life-changing experiences with minimal intervention from anyone on the team.

What I notice is that people coming into training are eager to know how they can actually apply what they're learning. For most of them, the realistic options right now are fairly limited, unless you're working with ketamine or you're in Oregon or Colorado. One pathway that's opening up is getting involved in clinical research, since more trials are running and sites need trained facilitators. We've talked internally about whether we should be teaching trainees more explicitly about how to get into clinical trials work and what that mindset shift actually requires.

Personally, I chose to stay “above ground,” and that can sometimes feel like a tedious and onerous process. I understand why people look for other ways in. But these are powerful medicines, and there are a lot of vulnerable people who haven't been helped by the current system and genuinely need new options. There are gifted, well-intentioned healers doing good work in less regulated settings, but there are also people in those settings taking advantage of desperate people. That risk is real, and I think anyone coming into this field needs to sit with it.

Post-approval, clinicians will have more freedom than the trials suggest. Once these drugs get approved, practitioners will be able to bring their own therapeutic style and area of expertise into how they work with these medicines. Nobody will be locked into one specific approach.

There's quite a range in how the end-of-life journey unfolds for people. I saw everything from patients who could not tolerate facing their own mortality to people who genuinely let go, surrendered to the process, and found real growth and deepened relationships in their final days. One case that still sticks with me was a person who needed to be sedated over the last weeks of their life because they were so overwhelmed by fear and panic they simply could not face it.

What I see in psychedelic work is something similar. The more you try to control the experience, hold on, manage and manipulate it, the more likely it is to go badly. The more you can “trust, let go, and be open,” the more likely something meaningful happens. That’s a phrase Bill Richards coined, and it's the one I keep coming back to. As a mantra, it gets you a long way with psychedelic medicines, and a long way at the end of life, too.

That tightening up you see at the deathbed is exactly what you see in the dosing room when things go wrong. But if you can set up a safe container, establish a deep sense of trust, and get out of the way, the medicine does its work. Without that container, things are more at risk of going off the rails. I hear stories about that almost every day from people coming to our trials after prior experiences where those conditions weren't in place. In the research context, genuinely bad experiences are very rare.

Participate in a clinical trial at Cedar Clinical Research, or explore Numinus’s accredited psychedelic therapy training programs. Cyclists get 10% off all courses with code ALTHEA10.

That’s all for today, Cyclists! Whenever you’re ready, here’s how we can help.

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DISCLAIMER: This newsletter is for educational and informational purposes only and is not intended as a substitute for professional medical advice. The use, possession, and distribution of psychedelic drugs are illegal in most countries and may result in criminal prosecution.