🫠 This Week in Psychedelics

Welcome to Tricycle Day. We’re the psychedelics newsletter that kinda likes the sound of its own horn. (Tooooot tooooooot.) 📯

Here’s what we got this week.

There are more legal psilocybin options now than ever before.

Which is great! Until you’re trying to pick one. So before you get stuck in analysis paralysis, let us help.

Althea can personally match you to a facilitator, center, or curated experience that’s right up your alley.

You just fill out a quick form, then hop on a 30-minute call with one of our care navigators. They’ll ask about your goals, answer any questions you have, then connect you directly with one of many vetted and licensed providers in our network.

Whatever you’re bringing, there’s a facilitator for you.

Bloody brilliant: Psilocybin produced significant improvements in depression, in its first publicly-funded randomized controlled trial in the UK.
Never better: Researchers are pushing to include well-being, beyond the usual symptom effects, as a primary endpoint in psychedelic trials.
That one missing piece: Psilocybin shows promise as a treatment for phantom limb pain.
Heart warming: For patients undergoing MDMA-assisted therapy for PTSD, a positive-mood experience may be more important than a full-blown mystical experience.
Bred to trip: Scientists engineered a new genetic line of mice specifically for testing the effects of psychedelic drugs.

Well endowed: The Arizona Department of Health Services issued a $5 million grant to Barrow Neurological Institute to run an ibogaine trial.
So it begins: Louisiana’s psychedelic pilot program, which was funded by opioid settlement money, launched this month.
Domino effect: Groups in Palm Springs, CA and Pierce County, WA are considering decriminalization of certain psychedelics.
Dropping the hammer: The governor of North Dakota issued an executive order banning kratom and called a legislative session to put the ban into state law.

Ripe for the picking: Analysts predict these three psychedelic companies could be the next pharma acquisition targets.
Mark your calendars: Compass Pathways posted Q2 financial results and suggested the commercial launch of COMP360 will come in the first half of 2027.
Huh? Clearmind Medicine is acquiring a majority stake in a company that develops (not psychedelic compounds but) wireless charging solutions for electric vehicles.
Banking on relief: Ceruvia Lifesciences raised $8 million to continue developing its non-hallucinogenic LSD analog for cluster headaches.

YouTube university: Meet the outlaw chemist teaching people how to make LSD and DMT.
Hiding in plain sight: After finding hundreds of geometric earthworks, archaeologists now think they’d underestimated the size of this Amazonian civilization.
Humble origins: We may owe our very existence to an ancient poop explosion.
As it should: This music festival is trying to make drug use safer.
Meme of the week: When you’re tripping in nature and the mushrooms start giving you instructions…

Every Wednesday, we faithfully report the psychedelic news.

This time, we made the news. (Granted we’re the editors. Deal with it.)

For the past two years, Althea (Tricycle Day’s parent co) has logged every psychedelic journey, from screening through integration, across its Oregon and Colorado network. Those data just became the largest real-world look at regulated psilocybin services ever published, in partnership with CU Anschutz.

So yeah, we’re taking the day off from being unbiased to brag a little.

Here's the tl;dr from 2,363 legal sessions.

You might expect messy, real-world results to pale in comparison to carefully controlled clinical trials. But au contraire, these numbers are arguably stronger on paper than what's come out of the synthetic psilocybin pipeline. (Now, these are two-week results, so a future paper will need to dig into durability.)

Beyond the headline figures, though, a couple things strike us. First, more isn’t necessarily better. With all due apologies to Mr. McKenna, doses above 30mg didn't outperform doses below that bar.

Second, and maybe more interesting, is what happened with people on SSRIs. They needed a larger dose on average (34mg vs 28mg), and even then, their mystical experience scores came in lower than everyone else's. But their depression and anxiety improvements were statistically the same as non-SSRI users.

Not knocking on the mystical. We get down with oceanic boundlessness as much as the next marine biologist seeker.

But it appears dissolving into the universe isn’t the only way to heal. 🫠

The VA launched a new clinical trial this week to suss out whether psilocybin can help veterans with treatment-resistant depression, including those with comorbid PTSD. The trial, called PIVOT, is a partnership with Compass Pathways, which is donating its synthetic psilocybin formulation and training the investigators who'll run it.

The study will enroll vets across five VA sites in Alabama, Oregon, Pennsylvania, and Washington, and the protocol includes two dosing sessions, spaced four weeks apart. PIVOT may be the VA's highest-profile psilocybin clinical trial to date, but it’s hardly the agency’s first rodeo. The VA announced a big study of MDMA for PTSD and alcohol use disorder in May, and by its own count now has 20 active psychedelic trials running.

Not to jinx it, but it seems like that VA-HHS memo we covered last month is panning out. (Recall that it promised to fast-track this sort of research.) FDA approval for psilocybin is probably coming soon anyway, but “probably” and “soon” aren’t exactly music to your ears as a veteran out of options. Trials like this one are a shortcut to access. Just gotta get randomized into the right arm.

Cue up “Eye of the Tiger,” boys. This is the redemption arc we’ve been waiting for. Resilient Pharmaceuticals (the company fka Lykos Therapeutics and, before that, MAPS PBC) has resubmitted its New Drug Application for MDMA for PTSD. While we haven’t heard a peep from Resilient itself, MAPS (the nonprofit that incubated it) confirmed the news this week.

Interestingly, Resilient filed the NDA without a new Phase 3 trial, the very (expensive) thing the FDA's 2024 rejection complete response letter seemed to call for. And MAPS founder Rick Doblin is feeling vindicated. In his words, the agency wasn't saying no back in 2024, just “not yet.” If MDMA does clear the finish line, don't be surprised if you see it marketed as RYSANSO, a name Psychedelic Alpha has been floating as the likely brand.

It’s very possible that Resilient was waiting for the FDA's final guidance on psychedelic drug trials, just published a few weeks ago, to pull the trigger. Rick D’s optimism aside, the FDA hasn't actually said (publicly, at least) that this resubmission will fly without new data. Wishful thinking? Perhaps. Or maybe Resilient knows something we don’t. Scratch that. They definitely know plenty we don’t.

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.