🫠 This Week in Psychedelics

[5-min read] Ketamine company receives one of nine FDA Commissioner's National Priority Vouchers.

PRESENTED BY SCHOOL OF PSYCHEDELICS 🤝

Welcome to Tricycle Day. We’re the psychedelics newsletter that doesn’t depend on a complex supply chain. You’ll never pay tariffs or taxes on these emails. But hey, if you feel like leaving a tip, a simple reply and thumbs up goes a long way. 👍

Here’s what we got this week.

  • Ketamine company gets FDA priority voucher 🎟️

  • Ibogaine gets its own assessment scale 👁️

  • Catholic Church pays for psilocybin therapy ⛪️

  • Break free from self-limiting behaviors ⛓️‍💥

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MICRODOSES
🔬 Research

Trip down memory lane: Psychedelics strengthen the brain circuits for memory. This mechanism may play a role in their therapeutic effects.
Love drugs: A review of 19 studies linked psychedelic use to positive intimacy-related outcomes, including relationship satisfaction, connectedness, and empathy.
Take a chill pill: Psilocybin modulates the HPA axis, which regulates the body’s stress response.
Reality check: In two double-blind, placebo-controlled trials, microdosing psilocybin did not improve cognitive performance or mood.
Expect the unexpected: A study comparing intravenous ketamine to active placebo found no significant difference. Depression scores dropped in both groups.

🏛️ Policy

Listen to her: A former narcotics prosecutor argues New York should legalize psilocybin therapy.
Live free or die: New Hampshire lawmakers pre-filed two bills that would allow the therapeutic use of psilocybin. They also want to participate in a multi-state consortium for ibogaine clinical trials.
Breakthrough in the bayou: Members of Louisiana’s psychedelics task force spoke at the state capitol about the potential to help veterans dealing with mental health issues.
Doom and bloom: A wrongful-death lawsuit has been filed against the direct-to-consumer ketamine provider, Mindbloom.

📈 Business

Out of the red: Cybin raised $175 million to repay the company’s unsecured debt.
Musical chairs: BetterLife Pharma, which is developing a non-hallucinogenic form of LSD for headache disorders, appointed Cybin’s former CEO as a corporate advisor.
Key hire: Clearmind Medicine has completed enrollment for the first cohort of its Phase 1/2a alcohol use disorder trial. They also named a new Chief of Global Impact.
Team effort: The Chief Science Officer at Filament Health believes acknowledging the entourage effect could lead to better psilocybin-based drugs.
Fair pay: Paul Stamets’ company earned an official living wage certification.

🫠 Just for fun

Think different: One of Apple’s early computing pioneers was a secret evangelist for 5-MeO-DMT.
Moms on mushrooms: Women’s Health explores why more midlife women are using psychedelics.
It’s the little things: Even in a stressed-out world, you can rebuild the capacity for joy.
Now you can fly: Experts explain how to start lucid dreaming.
Meme of the week: Underground facilitators messaging clients on their phones

THE PEAK EXPERIENCE
When the FDA selects the medicine that could save your life to prioritize

American ketamine

Nothing says “we take your health seriously” quite like the federal government handing out golden tickets to pharmaceutical companies.

Very Wonka of them. Anyhow.

Last Thursday, the FDA announced nine lucky recipients of its new Commissioner's National Priority Voucher pilot program. What that means is these companies get to skip the line for drug approval and get a decision in 1-2 months, instead of the usual eternity 10-12.

And nestled among cancer and rare disease treatments is a company called Phlow, charged with establishing a US-based ketamine supply chain.

Here's the deal.

  • 🌏 The problem: Most of the world's ketamine comes from China and India, and diversion to the illegal market has created global shortages for the past decade.

  • 🇺🇸 The mission: Phlow wants to build a domestic manufacturing pipeline for ketamine to restore “America's pharmaceutical sovereignty.” (‘Murica, F yeah)

  • 🤑 The cash: They landed $37 million in Series C funding this summer to get to work.

  • 🥲 The catch: The FDA voucher is specifically for ketamine as a general anesthetic, not for mental health treatments.

So we’re clear, Phlow isn't creating new ketamine therapies. They're a supply chain company, not a drug developer. After Phlow makes the raw materials, other companies turn them into treatments.

But a stable domestic ketamine supply is good for everyone. That includes hospitals, clinicians, patients, and yes, the mental health field that's been using it off-label for years.

And for what it’s worth, the FDA’s decision has already strengthened the conviction of some companies working on novel ketamine-based therapies. After all, you can't innovate with a medicine you can't get your hands on.

Maybe now we’ll finally get a version that tastes like snozzberries. 🫠

AFTERGLOW
Ibogaine making me witness the suffering of all my ancestors in 4k

What gets measured gets managed

If you can’t optimize your medicine-induced dream state, then what’s the point really? Thank goodness for psychedelic science. This month, researchers published a 70-item Ibogaine Experience Scale (IES), giving clinics and researchers a proper tool to collect (and quantify) what makes an ibogaine journey so distinctively ibogaine-y.

Yes, we have the Mystical Experience Questionnaire for classic psychedelics. But its prompts about unity and sacredness don’t quite capture the ibogaine vibe. The new IES includes gems like: “Did you see scenes of violence among humans (e.g., wars, dead bodies, torture, rape, murder)?”, “Did you see visions of indigenous tribes?”, and “Did you hear the sound of buzzing or vibrating?”. Jeez, they make it sound like watching the history of human suffering from the perspective of a refrigerator.

Before publishing the scale, the authors tested it on nearly 500 people at Ambio Life Sciences and whittled 144 questions down to 70 that nail ibogaine's oneiric (or dream-like) quality. As we’ve covered, ibogaine is having a moment. If we're going to understand how it works, we need data on the full range of subjective experiences. Shoot, maybe these “visions of futuristic technologies” people are having can even tell us where we’re headed next.

Divine intervention

Holy… The Catholic Church just paid for a sexual abuse survivor to trip on mushrooms in Oregon. Chuck Lovett, 63, was molested by a priest as a child. Decades later, his Pennsylvania diocese offered him $10,000 for therapy. After months of persistence, he convinced them to put up six grand for a legal psilocybin retreat instead, making him possibly the first abuse victim to get Church funding for psychedelic therapy.

The accountability is remarkable, even before you consider how conservative Christians have often viewed psychedelics (that is, somewhere between hippie nonsense and gateway to hell). Yet research increasingly shows psilocybin's potential for treating complex trauma, especially the kind of shame, dissociation, and trust violations that come with sexual abuse. Even religious leaders themselves have had life-changing mushroom journeys.

For thousands of clergy abuse survivors still seeking healing, this story offers hope. Just know, the diocese made it clear this was a “one-time exception” and they still prioritize “traditional counseling.” Still, one exception can become precedent. And as far as we know, hell hasn’t even frozen over yet.

CYCLISTS’ PICKS

FROM OUR SPONSORS

🎧 Podcast: This must-listen Secret Wilderness episode cuts right to the heart of psychedelic therapy. No spoilers, but steel yourself for a gut-wrenching account of loss and the search for answers.

  • 🧠 7-Day Summit: Heart Mind Institute’s next summit is all about rewiring your brain to overcome self-limiting behaviors, like procrastination, people pleasing, and chronic comparison. You even get implementation support.

  • 🧑‍💻 Event: The PhilaDelic Fall Forum is a one-day conference, featuring a keynote by ibogaine advocate, W. Bryan Hubbard. Virtual tickets run $33, but Cyclists get in free with our link.

  • 🎥 Documentary: The critically acclaimed ibogaine documentary, In Waves and War, premieres on Netflix on Nov 3. You can save it to your queue now.

  • 📱 Instagram account: @psychedelicarchives (run by a fellow Cyclist!) regularly posts the most delightful finds from psychedelic history and culture.

UNTIL NEXT TIME

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

📣 Promote your brand to 80k psychedelic enthusiasts.
Sponsor Tricycle Day.

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😎 Style yourself out in our iconic merch.
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ONE CYCLIST’S REVIEW
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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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