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For this crowd, Rick Doblin hardly needs an introduction. His nonprofit, MAPS, has been tugging psychedelics out of the underground for the past 40 years. But things got a little hairy this year when the org’s for-profit arm spun out as Lykos Therapeutics to try to commercialize MDMA-assisted therapy.

We spoke to Rick about the original vision for MAPS, what went wrong (and what needs to happen next) with Lykos and the FDA, and his biggest concerns for the future of psychedelic medicine.

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Why did you found MAPS almost 40 years ago? Was there a specific moment or experience that set the wheels in motion?

When I learned about MDMA in 1982, it was both a drug called Adam used in underground therapy and a recreational drug called ecstasy. I knew the backlash was inevitable, with the escalation of the drug war during the Reagan era. I saw that moment as an opportunity to get politically involved.

On a personal note, the first time I took MDMA with my girlfriend, we were able to navigate complex emotions and arrive at a profound understanding of our love for each other. There was something genuine and special about the experience. We were able to communicate so clearly and honestly, in a deeper and more open manner than ever before.

In 1983, I took over a nonprofit affiliated with Buckminster Fuller called Earth Metabolic Design Lab. I thought of MDMA and psychedelics as a source of alternative mental energy, and I believed a nonprofit could help move them into the culture. We had a hearing with the DEA and were winning in the court of public opinion with reputable people like Brother David Steindl-Rast, Rabbi Zalman Schachter, and Lester Grinspoon from Harvard Medical School. However, in 1985, the DEA criminalized MDMA on an emergency basis.

At that point, I realized I needed to start a new nonprofit psychedelic pharmaceutical company. Some members of the original nonprofit had been getting government grants or were in academic positions, which made them nervous to speak out against the drug war. To me, that was a non-negotiable. So I decided to create a new organization with a board of directors that would support my vision. That's what led to the creation of MAPS.

Since the FDA decided not to approve MDMA-assisted therapy in August, you've stepped down from the board of Lykos Therapeutics, MAPS' for-profit subsidiary. What do you think is the right next step for the company?

First off, Lykos isn't really a subsidiary anymore. MAPS only owns about 42% now. While we've got 10-to-1 voting shares and we appoint most of the board, we admittedly made a choice that hasn’t worked out well. We basically handed off all responsibility for managing Lykos to its own board, which has acted more independently than necessary.

I think the key failure Lykos made was thinking we'd evolved to a point where the controversy over psychedelics was essentially over—that this was now just a rational process. They thought all they had to do was present compelling data to the FDA, and the data would speak for itself. So Lykos adopted a "quiet period," which is something traditional pharma does while the FDA's reviewing a drug. But that strategy is disastrous when you're dealing with a substance that's already out in the culture.

During this quiet period, Lykos not only didn't respond to misinformation and critiques; they blocked me and MAPS from responding, too. We couldn't answer reasonable questions that had good answers. Culture really did matter in the end. Our critics weren't staying quiet, and this isn't some unknown drug. 22 million Americans have already used ecstasy or MDMA. You can't just ignore that context.

So what Lykos needs to do now is speak up. Tell the story of how the therapy was developed. Get out there and explain the study design process, address the critiques, and engage with the culture. They need to recognize that this isn't just about convincing the FDA; it's about convincing the public, the media, and even the FDA advisory committee members who seem to be more influenced by what they read in the Washington Post than in their briefing packages.

Most importantly, Lykos needs to ditch this idea of being a traditional pharma company and embrace being a drug-plus-therapy company. That's what makes MDMA-assisted therapy unique and effective, and that’s what will save the most lives.

What kind of work is MAPS focused on currently, separate from Lykos? Where are you putting your focus personally?

MAPS is going in a bunch of different directions now. We're speaking out, trying to tell the story that Lykos has been quiet about. We're also pushing forward with research around the world for compassionate, humanitarian purposes. We're interested in couples therapy research, which I think is one of the best uses of MDMA, even though it's not clearly a diagnosable disorder.

We're also advocating for drug policy reform. The FDA rejection just underscores how badly we need it. We're working on the natural plant medicines ballot initiative in Massachusetts for November. Over time, we'll need to change people's perceptions about natural versus synthetic drugs, but for now, that's where the votes are. We're doing a lot of public education, too. That's why you and I are talking now.

One of our big focuses is bringing the psychedelic community together. We're planning another Psychedelic Science conference for June 2025 in Colorado. Last year, we had 12,400 people, and we're hoping for even more this time. Thanks to Colorado’s natural medicine program, we'll be able to have legal experiential opportunities before and after the conference. As MAPS, we can be the convener. We host Psychedelic Science to help people share information, network, and move the entire industry forward.

Personally, I'm really interested in these global humanitarian projects. We're educating therapists abroad and looking at pilot studies in places like Bosnia, working with survivors of the Srebrenica massacre, and in Denmark with Syrian refugees. We've got projects brewing in Somaliland, Kenya, and the Middle East. I'd also love to do research on using MDMA to facilitate meditation. And then, there's our "Open Ibogaine" dream project. If we can get the research on ibogaine for substance use disorders fully funded with public money or by donors, it could go all the way through FDA approval with no patents and be made available as a generic from day one.

What risks do you see around the growing mainstream acceptance of psychedelics? What can we do to mitigate them?

I think the first risk is the pressure that will come from for-profit pharma companies and insurance companies to minimize the therapy and make it about the drug. We've already seen bogus press releases from companies claiming studies involved no psychotherapy when that wasn't true. Reducing it to "psychological support" is an attempt to lower costs by using non-therapist staff, so that they can sell more of the drug. Whether the results will be as strong is not clear.

Another concern is proper training of therapists. The therapists in our Phase 3 trials went through a rigorous training program that involved observing therapy sessions, learning the treatment manual, role playing, and receiving feedback from adherence raters. There was even an optional protocol for therapists to have their own MDMA-assisted therapy experience. I worry about companies cutting corners and going to market without fully trained therapists. The results might not be as good, and there could be more adverse events.

I also worry about capitalism and the pricing of psychedelic-assisted therapies. We want them covered by insurance so they’re not just for the wealthy. Traditional pharma sees other companies as competitors, but in psychedelics, we're building an ecosystem. It's about keeping humanity from going over a cliff, not just making money.

Much of our work at MAPS is meant to get ahead of these risks. But from the public, what we need is more open conversation. There will be cases where people don't get better or even get worse. Having more positive stories out there—a psychedelic “coming out," so to speak—can balance the inevitable negative ones. A backlash might still come from religious fundamentalists, so our challenge here is to help them see that psychedelic experiences can reinforce or even deepen their faith.

If you could go back in time and give your younger self one piece of advice related to your work with psychedelics, what would it be?

When I first started taking psychedelics at 17, I had the delusion that the more drugs you take, the faster you evolve. So I did my best with that approach and found myself completely unmoored and ungrounded. The advice I would give my younger self is to pay more attention to the integration process. It's not just about where the experience takes you, but how you bring it back and integrate it afterwards. You can't just keep tripping and tripping without integrating and expect automatic benefits.

Another thing is that I didn't know much about MDMA or MDA in my early days with psychedelics. I would've advised myself to try an LSD-MDMA combination or MDA, which has some properties of both, to make things a bit easier. My early experiences were mostly with LSD and psilocybin, which can be pretty challenging alone, though still extraordinarily valuable. When I discovered the powerful fear-muting effects of MDMA ten years later, it enabled me to process emotions I’d never been able to before.

Want more from Rick?

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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.