Welcome to Tricycle Day. We’re the psychedelics newsletter that faced the risk of rejection when we sent you this email. Shoot us a ❤️ to boost our confidence, would ya?

Here’s what we got this week.

  • Adverse outcome rates for 5 psychedelics 🥴

  • FDA wants your ibogaine study design tips 📝

  • MAHA Summit features psychedelic sponsors 💰

  • Come integrate with us 🫂

| FROM OUR PARTNERS |
Althea

When we launched Tricycle Day in 2023, all we could offer was information. That was… well, a good start.

These days, we actually help people take psychedelics. Pretty cool evolution, if you ask us.

The reason that’s possible is that Tricycle Day is part of Althea, the first legal psilocybin marketplace in the country.

(Yes, such a thing exists, and no, you don’t need a doctor’s prescription to do a mushroom journey.)

If you’re curious about working with psychedelics safely and intentionally, we can help make that happen.

This Week in Psychedelics
! MICRODOSES !

🔬 Research

Everybody’s doing it: Nearly 14 million Americans used at least one of 13 psychedelic substances in the past year. Psilocybin was the most common.
Party animals: Psilocybin increased social exploration in a mouse model of OCD.
DIY dissociation: Ketamine users outside clinical settings saw the same mood benefits as supervised patients, but they also reported more long-term hallucinations.
Word salad: Scientists have begun mapping the language people use to describe their trips to specific psychedelic drugs and neurotransmitter receptors.
Monkey mind: Talking to yourself on psilocybin may be a good sign in alcohol use disorder treatment.

🏛️ Policy

All in favor: Portland, OR has designated personal use and sharing of naturally occurring psychedelics its lowest law enforcement priority.
Common ground: A bipartisan caucus’s new report summarizes various stakeholders’ views on how psychedelic therapy can be integrated into U.S. healthcare.
A second opinion: Clinician advocates are challenging one of the proposed rules for New Mexico’s psilocybin program, arguing it would lock out qualifying patients.
Don’t get it twisted: This law professor wants you to know that even though three states have legalized psilocybin therapy, the FDA is still undecided.
Phew: Canada tightened up its controlled substances regulations on Oct 1, but eligible patients can still access psilocybin and MDMA with the right paperwork.

📈 Business

Mushroom math: (At least) one advocate has concerns about the economic viability of New Mexico’s psilocybin program.
Power couple: MAPS and Psychedelic Therapy Alliance are teaming up to support access to practitioner training that prioritizes the inner-directed therapy model.
Thunder down under: Emyria opened its first clinic in Sydney, expanding its footprint across Australia. (See previous coverage.)
Heaven sent: St. Joseph’s Healthcare received two philanthropic gifts totaling $2 million to support its psychedelic research center.

🫠 Just for fun

‘Bout time: Psychedelics have brought mysticism into modern medicine.
Karmic debt: Alex Grey, arguably the world’s most famous psychedelic artist, admitted to doing something horrific that we’d rather not describe ourselves.
Now for something lighter: Ayahuasca golf retreats are apparently a thing.
Jolly good show: BBC ran a piece on the rise of psychedelic therapy.
Meme of the week: Me hearing out my protector parts on four grams of mushrooms…

! THE PEAK EXPERIENCE !
I like men who take risks

Calculated risks

We're big fans of psychedelics around here. You might’ve noticed.

But cherrypicking research that supports our narrative wouldn't be fair to anyone. We’re all adults here. You deserve to know the risks.

Anything less would be like taking someone skydiving without mentioning that the parachute might not open. Or feeding pizza to someone who's only ever eaten broccoli and soylent. There's no putting that genie back in the bottle… that cheesy, cheesy, delicious genie.

So, this week we’re sharing some less hypey news. A new study surveyed 1,964 U.S. adults about their health after using psilocybin, LSD, MDMA, ibogaine, or 5-MeO-DMT. Here’s what it found.

  • 🎢 Bumpy rides: Most recent users reported at least one of 13 adverse effects. The rates were 76% for psilocybin, 81% for MDMA, 84% for LSD, 93% for 5-MeO-DMT, and 95% for ibogaine.

  • 💔 Heartbreakers: About half of ibogaine and 5-MeO-DMT users reported heart palpitations or chest pain. Thoughts of death or suicide came up for 59% of ibogaine users.

  • 🩺 The doctor is in: 74% of ibogaine users sought healthcare for problems they blamed on the drug, compared with 16% of psilocybin users.

  • 🏔️ No joke: Ibogaine and 5-MeO-DMT users were the most likely to prepare, use under supervision, and integrate afterward. And they still fared worst.

For what it’s worth, psilocybin had the best numbers all around. Only 4.7% of users said their mental health got worse, while 51% said it got better. With ibogaine, those odds were practically a coin flip (35% worse, 37% better).

Of course, these outcomes were self-reported and self-attributed, so the study can't prove the drugs caused them. The ibogaine and 5-MeO samples were also small.

So, bottom line… should you jump? That’s your call.

But if you do, we recommend a parachute, err, a weighted blanket and some tissues. 🫠

! AFTERGLOW !
When the FDA posts its third Federal Register notice on psychedelics this year

Ibo-gaining momentum

Speaking of ibogaine, the federal government is gearing up to fund clinical trials in opioid use disorder and PTSD. But before it does, the FDA wants to run its game plan by the public. Yesterday, the agency released a formal request for information sketching out how it’s thinking about running these early-phase studies. (Tl;dr: very cautiously.)

Participants would be dosed one at a time in a room equipped for cardiac emergencies, starting at no more than 10 mg/kg and moving to higher doses only after a safety review. Only people who have the enzymes to metabolize ibogaine quickly could enroll, and they'd have to stop medications like SSRIs and opioid agonists first. After that would come 12 months of cognitive follow-up, given the neurotoxicity seen in animal studies.

This whole idea traces back to President Trump's April executive order, which specifically called out ibogaine and directed agencies to sh*t or get off the pot speed up psychedelic research. (Since then, the FDA has separately cleared a trial of noribogaine, ibogaine's main metabolite.) Comments on the proposed trial design are open till Nov 20 if you think you have a better idea.

MAHA musings

Last week, the Make America Healthy Again crowd gathered in DC for its second annual MAHA Summit, and once again, psychedelics got ample airtime. Never mind that some of that attention was paid for (up to $300k a pop, according to Bloomberg). Two of the three companies on the first panel, Compass Pathways and Definium Therapeutics, were listed as sponsors, although exactly how much they spent is anyone’s guess.

Joined by Helus Pharma's CEO and moderated by HHS “psychedelics czar” Matt Zorn, the panel pulled no punches on SSRIs and then pitched psychedelics as the upgrade. Later, HHS senior advisor Calley Means promised to fast-track psychedelic research (we’ve heard that one before), and Cheryl Hines, who happens to be married to Larry David RFK Jr., announced an upcoming MAHA symposium where psychedelics will be the sole focus.

The other standout message from the Trio of CEOs™️ was to keep psychedelics in the clinic. Definium's Rob Barrow said none of them want this stuff “spilling outside of medicine.” Gulp. Someone oughta tell Oregon, Colorado, and the 11 million Americans who used psilocybin last year. Hard to imagine some of ‘em weren’t right there in the room.

! CYCLISTS’ PICKS !
  • 🫂 Integration circle: Althea's free monthly integration circle meets next Tuesday, Oct 13. Come for 90 minutes of small-group sharing and processing, no matter where or when your last journey happened.

  • 🕯️ Workshop: On Oct 12, End of Life Psychedelic Care invites you to practice your own death. The Dying Rehearsal will draw on yoga to mimic a ketamine journey. (It’ll be recorded for those who’d rather perish in private.)

  • 🎪 Conference: “Bulletproof” biohacker Dave Asprey has revived Beyond Wonderland as a three-day psychedelic science and consciousness tech expo in Austin on Oct 12–14. Speakers include Rick Doblin and Paul Stamets.

  • 🍿 Film screening: Prophet of Ecstasy, a documentary about the ex-priest credited with nicknaming MDMA, opens at NYC's Cinema Village on Oct 17. Rick Doblin, who is apparently everywhere this month, will join a post-show panel.

! UNTIL NEXT TIME !

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

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! ONE CYCLIST’S REVIEW !
Feeling euphoric

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.

Keep pedaling, Cyclists. And enjoy the ride.

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