🫠 This Week in Psychedelics

Welcome to Tricycle Day. If you want to go fast, go alone. If you want to go far, go with a stash of mushrooms to keep things interesting. (It’s our newsletter; we make the proverbs, k?)

Here’s what we got this week.

• The FDA meets on psychedelics 🧑‍🔬

• Is Arizona the new Oregon? 🍄

• MAPS and Numinus cozy up 🤝

• Mushroom mocktails 🍸

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MICRODOSES

🔬 Research

Allied forces: The patient-therapist connection predicts outcomes in MDMA-assisted therapy.
Sane in the membrane: LSD increases neural complexity (a proxy measure for consciousness) at low doses, but even high doses of THC won’t.
Face off: Researchers compared psilocybin vs esketamine for treatment-resistant depression.
Time is an illusion, man: Studies suggest microdosing LSD is safe and produces changes in sleep, cognition, and perception of pain and time.

🏛️ Policy

Do they eat them though? The amount of magic mushrooms seized by law enforcement has more than tripled 2017.
Hawaiian munch: A new bill in Hawaii would allow people to receive psilocybin therapy with a doctor’s approval.
Better ration that: A Missouri bill that would allow vets in palliative care to access up to 150 mg of psilocybin annually.
No contest: California’s Assembly unanimously approved a bill to create a workgroup tasked with designing a legal psychedelic therapy model. Meanwhile, a new bill cuts straight to the chase.
Put on your lab coats: An Indiana Senate committee passed a bill that would make psilocybin research easier.

📈 Business

SPACs are back: Psyence went public via SPAC and is now trading on the NASDAQ stock exchange.
Just as nature intended: The FDA has accepted Filament’s investigational new drug application for its botanical psilocybin product for substance abuse disorders.
We’re jammin’: Magic mushroom therapy retreats are booming in Jamaica.
Reality check: A cash crunch is catching up to overhyped psychedelic biotechs.
Wild, wild west: Ketamine health clinics are making up the rules as they go.

🫠 Just for fun

Managing up: Would you take psychedelics with your boss?
Fantasy league: Michael Bublé was tripping on shrooms at the NHL All-Star Game.
Support line bling: Applications are due Feb 29 to join Fireside’s volunteer team.
Meme of the week: When you trip with a friend…

THE PEAK EXPERIENCE

FDA pulls back the curtain

It’s tempting to think of the FDA as some shadowy cabal making perverse decisions about your health behind closed doors. Let’s face it—it feels good to have a bad guy, and who better than the feds?

While there’s a kernel of truth to most conspiracy theories, the reality is almost always more complex. To the FDA’s credit, they’ve recognized psychedelics for the breakthrough therapies they are, and they’ve been having discussions about them right out in the open.

Case in point: the FDA’s nonprofit arm hosted a free, two-day public forum on “Advancing Psychedelic Clinical Trial Design” this week. Here are our key takeaways.

• 📈 There’s been a giant spike in psychedelic drug filings. From 2000 to 2017, psychedelics accounted for a measly 0-4% of investigational new drug applications for psychiatry. By 2021, that number had skyrocketed to 16%.

• 🤔 Assessing the effectiveness of psychedelic therapies is… well, complicated. There are so many unusual variables—patient expectations, set and setting, the patient-practitioner relationship, and blinding challenges, to name a few—that it’s difficult to design a fair study. 

• 👮 The FDA does NOT regulate the practice of medicine. It’s rare for the FDA to consider a drug tied to psychotherapy. They can’t (and shouldn’t) tell therapists how to do their jobs. And yet, the quality of that therapy clearly plays a major role in patient outcomes.

Though the event was focused on clinical trials, the discussions raised important questions about how psychedelic medicine will be rolled out in the real world.

For instance, there were some not-so-subtle suggestions that the FDA might publish Risk Evaluation Mitigation Strategies (REMS) as a way to manage the looming safety concerns.

Come to think of it, the speakers talked a lot about hypersuggestibility and vulnerability under psychedelics. Guess the feds have their own worries about shadowy figures abusing their power. 🫠

AFTERGLOW

Arizona’s on the Oregon Trail

As of today, Oregon is still the only place in the US where you can have a legal, state-sanctioned (and pretty dang expensive) magic mushroom trip. But other states are watching and waiting for their moment to hop on the bandwagon. This week, lawmakers from Arizona introduced a bill that would legalize psilocybin service centers under a similar model.

The legislation, which has bipartisan support, would empower Arizona’s Department of Human Services (DHS) to license psilocybin-assisted therapy centers and facilitators. It would also create an Arizona Psilocybin Advisory Board, responsible for designing training criteria and keeping the state honest as the psilocybin program comes to life.

If the bill passes, the DHS will need to start accepting applications for psilocybin centers by Jan 1, 2026. Wish we could say this option were coming sooner, but hey, at least that leaves time to figure out how to drive costs down. Otherwise, we might die of dysentery sticker shock all over again.

MAPS seeds a delivery network

ICYBT (in case you’ve been trippin’), MDMA is on track for medical approval as early as this year. That’s a huge accomplishment for MAPS and its for-profit, Lykos, no doubt about it. But make no mistake—they’re far from the finish line. If MAPS really wants to bring MDMA-assisted therapy to the masses, they’ll need a network of providers ready to zap away the world’s PTSD, one session at a time.

Knowing that, this news story makes a whole lot more sense: Numinus, a psychedelic-assisted therapy clinic and training business, just announced a $6 million fundraising deal. One of the investors on the term sheet? You guessed it—MAPS. (Btw, we interviewed Numinus’s Chief Clinical Officer last year. Read the Q&A here.)

In some ways, this partnership is totally expected. Back in June, Numinus applied to run a clinical trial where therapists-in-training could experience MDMA themselves, using MAPS’ protocol, to become better stewards of the medicine. MAPS’ choice to bankroll the operation feels like the logical next step. Net-zero trauma, here we come.

CYCLISTS’ PICKS

UNTIL NEXT TIME

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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.