🫠 This Week in Psychedelics

PRESENTED BY SCHOOL OF PSYCHEDELICS 🤝

Welcome to Tricycle Day. We’re the psychedelics newsletter that keeps it real. By “it” we mean your inbox, and by “real” we mean way more interesting than a 20% off sale at a store you forgot existed. 🛒

Here’s what we got this week.

• The first FDA-approved whole mushroom trial 🍄

• Delix’s 5-MeO-DMT-based neuroplastogen 🧠

• Australian VA funds psychedelic therapy 🎖️

• Mushroom coloring pages for Cyclists 🖍️

FROM OUR SPONSORS

Any one of you can build a fulfilling career in psychedelics.

You don’t need a special degree to support people’s growth and healing. You don’t even have to handle medicine.

See, the journey is the awakening, but integration is the commitment to change. That takes work, which is where you come in.

In our masterclass yesterday, we shared a replicable method for psychedelic integration that you can learn and build a practice around.

The replay won't be up forever, so catch it while you can. (And stick around for a surprise at the end.)

Watch the replay.

MICRODOSES

🔬 Research

Obsessed (in a good way): Across 13 studies, psilocybin consistently reduced symptoms of obsessive-compulsive disorder.
Phew: Serious adverse events in psilocybin clinical trials are extremely rare.
Pain, pain, go away: Low-dose ketamine infusions are safe and significantly effective for patients with chronic pain, according to a large real-world study.
What were we saying? MDMA use is associated with memory dysfunction, possibly due to grey matter thinning.
Get paid to share: UT Austin researchers are seeking participants who’ve had a psychedelic-induced creative insight they applied to to their work. You’ll get $15 for completing the survey.

🏛️ Policy

Will they or won’t they: Nine months into Trump’s second term, psychedelic reform hangs in the balance.
Get out of the gas station: The Missouri Department of Health and Senior Services issued a warning about the health risks of 7-OH, an isolate from the kratom plant.
Wellness washing: Meanwhile, researchers are concerned that psilocybin, cannabis, and kratom products are being marketed as wellness products rather than drugs.
Drug bust: The Manhattan DA announced the sentencing of five people involved in selling $7 million of MDMA, ketamine, and other substances.
Baltic vacation, anyone? Following in Germany and the Czech Republic’s footsteps, Estonia may be the next EU country to legalize psychedelic therapy.

📈 Business

It’s go time: Based on a meeting with the FDA, Compass Pathways has accelerated its launch timeline by 9-12 months. That means COMP360 psilocybin could be approved as early as late 2026.
Tailor-made medicine: Compass Pathways has also partnered with NeuroKaire to develop more precise, personalized depression treatments.
A+ aftercare: MIRA Pharmaceuticals picked chemotherapy-induced neuropathic pain as the lead indication for Ketamir-2, its oral ketamine analog.
Follow the money: Psychedelic Alpha updated its Psychedelic Federal Lobbying Tracker with Q3 data.
Sunday school: The Archdiocese of San Francisco is running an online course on psychedelics and the Catholic response.

🫠 Just for fun

Stars, they’re just like us: Judd Apatow saw Jesus on ayahuasca, and Miguel says he loves psychedelics.
Trip report: The first woman in New Zealand to take clinically prescribed psilocybin shared her experience.
Pairs well with adaptogens: Has ketamine gone full Goop?
Meme of the week: When you drop acid with your friend…

THE PEAK EXPERIENCE

Nature’s medicine

Daily reminder that “psilocybin” isn’t just the scientific word for mushrooms.

It’s the name of one molecule, present in some mushrooms, that produces a psychedelic effect in humans.

So when someone claims they ate 3 grams of psilocybin, you can hit ‘em with an “ackshualllly” (… or watch them dissolve into pure consciousness if they really did ingest that much 4-phosphoryloxy-N,N-dimethyltryptamine).

Reason we bring this up is, we’re finally getting the first FDA-approved clinical trial of whole P. cubensis mushrooms, rather than isolated or synthetic psilocybin.

In April, we told you FDA cleared Arizona’s $5 million plan. Now, with the help of research company Alira Health, the Scottsdale Research Institute is ready to start dosing patients by December. Here’s what’s happening.

• ❤️ No placebo group: The FDA and IRB agreed it would be unethical to randomize severe PTSD patients at risk for suicide to a placebo.

• 🧑‍🧑‍🧒‍🧒 24 participants: In another first, the FDA approved administering the medicine in groups. 8 firefighters, 8 police officers, and 8 military vets will trip together in their respective cohorts.

• ⚖️ 4.32 grams: That's the precise amount of whole “Jedi Mind F*ck” mushrooms equivalent to 30mg of psilocybin.

• 📝 Hundreds on the waitlist: But strict Phase 1 criteria disqualify most applicants.

So why the fixation on whole mushrooms? First off, psilocybin isn’t the only compound at play. These fungi contain alkaloids and tryptamines that researchers believe work together synergistically. The entourage effect, if you will.

Second, whole mushrooms are what's actually being used in the real world, whether in Oregon and Colorado's regulated programs or elsewhere. This study finally brings the research in line with reality.

SRI is screening qualified candidates this month. But Dr. Sue Sisley tells us her real goal is to qualify for Phase 2 and eventually provide access under Right to Try laws for people with life-threatening illness.

The Force is strong with this one. 🫠 

AFTERGLOW

Don’t call it a magic pill

Good news for people who like options. (Bad news for evangelists who insist you need to trip to feel better.) Delix Therapeutics just dropped surprisingly solid Phase 1b results for zalsupindole (DLX-001), its non-hallucinogenic 5-MeO-DMT analog. Yep, participants’ depression scores plummeted, and nope, not a single sacred geometry sighting was reported.

Digging into the numbers, 18 patients with major depression saw their MADRS scores drop 12 points (roughly 50%) by day 8, and benefits lasted through day 36. Interestingly, patients got pretty much the same results whether they took the pill daily for 7 days or just twice all week. The FDA was impressed enough to greenlight a Phase 2 trial with at-home self-administration.

Earlier preclinical work showed zalsupindole promotes dendritic spine growth comparable to ketamine and psilocybin, without the trip. If these so-called “neuroplastogens” pan out, they sidestep psychedelic therapy's logistical hurdles (i.e., specially trained therapists, dedicated facilities, many-hour sessions). That's the theory, anyway. Do we still call it the “God molecule” if you don’t get to meet God tho? Asking for a friend.

Stepping up, down under

Australia is now one of the first countries to put government money behind psychedelic therapy for veterans. The Department of Veterans' Affairs just announced it will fund MDMA and psilocybin-assisted therapy for vets with PTSD and treatment-resistant depression, respectively. Mind Medicine Australia called it “a major endorsement.” We call it putting your money where your mouth is.

The Aussies have been ahead of the curve since July 2023, when the Therapeutic Goods Administration approved MDMA and psilocybin for prescription by authorized psychiatrists. But cost has been a massive barrier ever since. Treatments run around AU$30,000 (roughly US$20,000). Cool, so it's legal... for people who can afford a down payment on a house. Now, eligible veterans can actually get treatment without selling a kidney.

It's one thing for a government to legalize psychedelic therapy. It’s quite another to pay for it. This is what it looks like when policymakers go beyond acknowledging the science and commit resources to accessibility. Meanwhile, the U.S. VA just started funding psychedelic research in 2024 (for the first time since the 1960s). There’s still time to catch up, guys.

CYCLISTS’ PICKS

• 🖍️ Relaxing activity: Our friends at Whimzy Woodz illustrated a mini printable coloring book for Cyclists of all ages. This five-page download was designed to inspire play, introspection, and joy. (Microdosing optional.)

• 🧘 Trip sitting course: Zendo Project’s next Sitting and Integration Training (SIT) cohort kicks off this weekend. Take 10% off tuition with code TRICYCLE10.

• 📕 Safety manual: Gv Freeman’s handbook, Healing With Psychedelics, builds on Timothy Leary’s famous “set and setting” concept with a new model called the Psychedelic Safety Wheel.

• 🤝 Networking event: The Psychedelic Professionals Networking Club has its next gathering on Nov 20. Rub (virtual) shoulders with industry insiders and spark up your next collab. Grab a ticket for $5 with code TRICYCLE.

UNTIL NEXT TIME

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

ONE CYCLIST’S REVIEW

Forwarded this email? Subscribe here.

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.