Welcome to Tricycle Day. We’re the psychedelics newsletter that’s issuing our own executive order. We hereby demand one (1) deep breath and two (2) lowered shoulders, effective immediately. 😘

Here’s what we got this week.

  • Trump signs a psychedelics Executive Order ✍️

  • A new tool to track life changes after psychedelics 🦋

  • France approves IV ketamine for suicidal crisis 🇫🇷

  • Hear from 45+ experts on healing trauma 💔

| FEATURED EXPERIENCE |

We’re spotlighting select listings on Althea Experiences, our curated marketplace of legally operated psilocybin experiences.

This experience is an 8-week online Mindful Self-Compassion (MSC) course followed by an in-person group psilocybin journey in Portland. The program pairs one of the most research-backed compassion training frameworks with a guided psychedelic experience designed to deepen and solidify the work.

! MICRODOSES !

🔬 Research

Grave concerns: Psilocybin significantly reduces death anxiety in terminal patients, with effects lasting up to six months after a single dose.
Head twitch: A single dose of DMT matched esketamine's antidepressant effects in mice, with longer-lasting results and additional anti-anxiety benefits.
Ladies first: Psilocin appears to modulate certain emotional circuits in female brains only.
It’s not just the drug: In psychedelic clinical trials, facilitators account for 13.6% of variance in participants’ outcomes.
Don’t hate, integrate: Fill out this 10-minute survey to help researchers understand how post-psychedelic integration practices affect mental health outcomes.

🏛️ Policy

Jig is up: The FDA wrote to 2,200+ trial sponsors sitting on unfavorable results to remind them suppressing data is both unethical and illegal.
Oklahoma will be OK: Oklahoma's Inter-Tribal Council unanimously backed ibogaine the same day the state Senate committee advanced a bill supporting ibogaine trials.
The final boss: Colorado is one signature away from updating state law to recognize federally approved Schedule I drugs for prescription use.
Guided tour: Missouri advanced a bill that would let veterans and first responders enrolled in a study access psilocybin with a facilitator.
Unmute yourself: Oregon Psilocybin Services is hosting two virtual sessions on May 6 and 8 to solicit public feedback.

📈 Business

Both/and: Althea's Niko Skievaski explains why state psilocybin programs, not just biotech, will benefit from this week’s Executive Order. (More on that below.)
Up and to the right: Spravato hit $468M in Q1, up 46% year over year. Jefferies predicts annual sales will eventually hit $5B.
Ready to roll: Compass Pathways and Osmind are teaming up to prepare independent clinics for psilocybin and other psychedelic treatments.
Anxiously waiting: Definium Therapeutics expects Phase 3 topline results soon. Its LSD formulation would be the first new anxiety treatment approved since 2007.
Journeyer beware: Nearly 90% of psychedelic retreats require participants to stop antidepressants before attending, often without medical supervision.

🫠 Just for fun

Happy Bicycle Day: The Smithsonian tells the 83-year-old tale of Albert Hofmann taking LSD and pedaling home on April 19.
Veritas: This Harvard Law professor says a psychedelic experience and a university education have the same purpose: the pursuit of truth.
Brick by brick: LEGO is finally releasing a mushroom set.
Meme of the week: Remind me again why the NFL is ok with this but not with psychedelics…

! THE PEAK EXPERIENCE !

Sent from my iPhone

Hear that sound, Cyclists?

That’s Richard Nixon rolling in his grave.

After 56 years of drug prohibition, America now has a president who accepts that psychedelics might not be pure evil. All it took was decades of advocacy and *checks notes* a well-timed text from Joe Rogan.

(Man, whoever’s running this simulation is on some good sh💩t.)

On Saturday morning, Trump signed an Executive Order that directs the U.S. government to accelerate psychedelic research and access.

Now, this isn’t instant legalization. But it’s still a yuuuge deal with serious implications. Let’s break it down.

  • 🎟️ Golden tickets: FDA will issue 3 priority vouchers to psychedelic breakthrough therapy candidates this week, which would cut NDA review down to 50 days. (We know Compass was considered for the first batch, so surely they’re in the running.)

  • 🏁 On your mark, get set… FDA Commissioner Marty Makary also announced IND clearance for ibogaine, meaning clinical trials can finally begin on U.S. soil.

  • 💗 Compassionate use: FDA and DEA must open a pathway for patients with life-threatening conditions to access psychedelics before approval. (The Controlled Substances Act can’t keep overruling the Right to Try Act.)

  • 🍲 All in the pot: HHS, FDA, and VA are directed to pool data from ~30 psychedelic studies already underway at VA sites, and funnel the evidence into the approval pipeline.

  • 🫰 Cha-ching: ARPA-H will match at least $50M in state-level research funding. Texas’s ibogaine initiative is the obvious beneficiary, but states like Oregon, Colorado, and New Mexico could see some of those federal dollars flow into their programs, too.

It’s all very exciting, we know. But Trump's marijuana EO (signed in December) still hasn't fully materialized, and the agencies that need to move on this aren’t exactly known for their sense of urgency.

Still, midterms are coming. Rogan had been publicly souring on Trump before firing off that text, and was standing right behind him when he signed it.

So if there's anything we've learned from this saga, it's the absurd power of influencers that realpolitik can actually make change happen. 🫠

! AFTERGLOW !

Rate your rebirth

We all know a guy who drank ayahuasca and came back a new person. Quit their job, got a divorce, started a podcast about breathwork and butt-sunning. (Oh, that’s just our social circle?) Well, now science can quantify this phenomenon. The P-MLCQ is a new questionnaire that tracks major life changes after a psychedelic experience across ten domains.

Researchers from UMich gave the P-MLCQ to 581 adults and found that 83% reported at least one major life change, and 94% rated those changes positively. Goals and values topped the list at 54% each, followed by spirituality (49%), social activities (37%), diet/eating habits (34%), occupation (32%), hobbies (29%), and political views (15%). The average participant reported 3+ of these MLC’s. Makes sense since, you know, everything is connected.

For what it’s worth, study participants were mostly recruited at Entheofest. (That’s like asking people at Coachella if they enjoy music.) The tool, though, seems genuinely useful. Clinical trials typically don’t measure any of this stuff, so the P-MLCQ could help capture the full picture of what psychedelics do. Now give it to a group of people who didn't already name their cat Terence.

Oui need this

Leave it to the French to show us American exceptionalists up. They took all of August off, had a three-hour lunch, and still became the first country in the world to approve IV racemic ketamine for adults in severe suicidal crisis. Touché.

The approval comes with guardrails, of course. It’s for hospital use only and requires a psychiatrist's prescription, three-year re-evaluation, and pharmacovigilance reporting. But the risk/benefit was too good to ignore. The data show a single IV infusion can reduce suicidal ideation within hours, with benefits lasting days or weeks. Ketamine doesn’t work for everyone (~10% of patients see no effect at all), but when someone is at risk of taking their own life, every second counts.

Meanwhile, the closest (FDA-approved) thing we have in the U.S. is Spravato, an intranasal form of esketamine that was cleared for major depression with suicidal thoughts back in 2020. Trouble is, Spravato’s restricted distribution system makes it impractical in a psychiatric emergency. France, to their credit, noticed that the generic form works and said… pourquoi pas? Honestly, we’re shook they even identified a psychiatric emergency in a country with universal healthcare, fresh croissants, and a 35-hour work week.

! CYCLISTS’ PICKS !
  • ❤️‍🩹 Summit: In May, Heart Mind Institute is hosting a free 7-day summit with 45+ trauma experts. They’ll cover how emotional wounds from the past affect your life today, and how to heal them in grounded, practical ways.

  • 🍿 Documentary: A new indie psilocybin doc just dropped on Apple TV. Journeys wraps interviews on end-of-life care, childhood trauma, and ethical practice in artistic visuals.

  • 🎙️ Stand up: Part deux of Shane Mauss’s hilarious TRIPS comedy set is now streaming. Vulture called it the first special they could see being performed at the Las Vegas Sphere.

  • 👵 Event: Author Abbie Rosner is giving a free talk on her forthcoming book, Psychedelics and Counterculture of Aging, and the broader topic of meaning-making and personal growth later in life.

! UNTIL NEXT TIME !

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

🍄 Experience psilocybin
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🧑‍💻 Power your licensed psilocybin business
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🫂 Join our professional community
Apply for Practice Expansion, our private platform where psychedelic facilitators connect, learn, and build their practices together.

👕 Shop merch
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! ONE CYCLIST’S REVIEW !

So, how was your tricycle ride?

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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.

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