🫠 This Week in Psychedelics

Welcome to Tricycle Day. We’re the psychedelics newsletter that won’t let a tough news cycle ruin our mood. Our happiness just ain’t that cheap. (Hey, did the microdose just kick in?)

Here’s what we got this week.

• Why the FDA rejected Lykos’s MDMA application 🚮

• A new use case for ketamine 🐴

• Canada opens its first psychedelic research center ⚗️

• Know your dose before you trip 🧑‍🔬

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MICRODOSES

🔬 Research

Follow your gut: The gut microbiome affects how psychedelics work in the brain.
All inclusive: Even people with psychosis, who are normally excluded from the research, can benefit from psychedelics.
End both stigmas: Psilocybin-assisted group therapy helped patients overcome HIV-related shame.
Sober up: Awakn Life Sciences screened the first participant in its Phase 3 trial of IV ketamine for alcohol use disorder.
Filmmakers: atai shared preliminary results from its Phase 1b trial of oral DMT.
Moms on mushrooms: Complete USF’s survey on maternal psilocybin experiences for a chance to win $100.

🏛️ Policy

Decrim nature: Olympia, WA has decriminalized entheogenic plants and fungi, with unanimous approval no less.
All in favor: Two Massachusetts cities have endorsed the state’s ballot measure to decriminalize psychedelics and legalize psychedelic therapy.
School’s in session: The success of Colorado’s natural medicine program hinges on educating the public.
Okay, we’re listening: The DEA says Mira Pharmaceuticals’ ketamine analog is not a controlled substance.
Sacred responsibility: Religious leaders want psychedelic churches to uphold higher ethical standards.

📈 Business

Not to worry: MindMed is raising another $75 million to continue developing its LSD drug for anxiety.
Resilience medicine: The psychedelic sector is holding up surprisingly well against this week’s news.
IP freely: Filament Health scooped 20 new patents in Australia, Canada, and the US.
Building an empire: Psychedelic REIT, Healing Realty Trust, has added clinics in three states to its portfolio.
(Morally?) bankrupt: The ayahuasca church responsible for a 22-year-old’s death won’t pay the $15 million they owe.
Calling it now: The future of psychedelics is CPG.

🫠 Just for fun

Counterculture counterfactual: Were overzealous artists to blame for the shutdown of psychedelic research in 1970?
A taste of the afterlife: End-of-life patients are finding solace in mushrooms.
Color outside the lines: A few tips on creating your own trippy art.
Meme of the week: Being reckless with the medicine might look like…

THE PEAK EXPERIENCE

So close, yet so far

Deep breaths, Cyclists. This isn’t the news most of you were hoping for, but we know you can handle it.

MDMA-assisted therapy for PTSD won’t be legalized any time soon.

In a matter of months, it’s gone from "breakthrough therapy" darling to the FDA's problem child. Now we have the official ruling, and it’s no bueno for Lykos Therapeutics… or sadly, the millions of traumatized Americans who were hoping for a new treatment option.

The vibe shift started in April when ICER dropped its infamous report. Then an FDA advisory committee gave their thumbs down in June. Now, the FDA has slapped Lykos with a Complete Response Letter (basically, a "thanks, but no thanks" note). Here's the tea.

• 🧪 Expectancy bias: The FDA thinks participants with prior MDMA experience might have skewed the results. (Plus, there’s no obvious solution to the “functional unblinding” issue.)

• 🛋️ Therapy tangle: They’re also questioning how much of the benefit comes from the MDMA vs the therapy. (FDA regulates drugs—not the practice of medicine—so the “psychedelic-assisted” model never fit neatly into their box.)

• 🚩 Trial tribulations: Whispers of unreported adverse events and even participant abuse have raised lots of eyebrows.

• 🥅 Moving goalposts: Despite signing off on Lykos's trial design previously, the FDA now wants another Phase 3 study.

• ⏳ Delay, not defeat: Lykos is asking the FDA for a do-over. But if they have to run another trial, it’ll take years and cost millions.

Adding insult to injury, a prominent journal just retracted three papers related to Lykos's MDMA therapy research. Kick ‘em while they’re down, why don’t ya?

But here's the silver lining. Other psychedelic therapies in the pipeline might actually benefit from Lykos's stumble. Drug developers now know exactly where the FDA's bar is set.

The show must go on. In the meantime, well… Viva la underground? 🫠

AFTERGLOW

What can’t ketamine do?

Ketamine, you never cease to impress. First, you overcame that old horse-tranquilizer narrative. Now, as a psychedelic therapy, you’re still reinventing yourself. A new study suggests that ketamine can do more than treat mood disorders. It also turns us into social butterflies with a penchant for helping others. Perfect timing, too—since MDMA’s been shoved aside, we need a new legal “entactogen.” (Too soon?)

In their 68-person study, researchers found that ketamine significantly increased the likelihood of participants reporting pleasure from social interactions, compared to the placebo group. They felt more joy spending time with family, seeing smiling faces, and helping others. Don’t call it a drug high, either. Because those warm and fuzzy feels stuck around for a full week post-infusion.

That’s not all. In another experiment that sounds like a tiny, furry version of the Trolley Problem, ketamine-treated rats were more likely to forgo treats to protect their cage-mates from electric shocks. Just like the humans, their empathy boost lasted up to six days after treatment. So if you're feeling antisocial or disconnected, maybe consider ketamine therapy. Just don't blame us when you volunteer to help your neighbor move.

In the Great White North

Shoutout to our Canadian Cyclists. While we Americans have been dizzying ourselves tracking state-by-state psychedelic reform, you've been quietly cultivating a research powerhouse. Now Kingston, Ontario is ready to make waves in psychedelic science, with Queen's University and Providence Care Hospital opening Canada's first dedicated psychedelic research center—err, centre—last week.

The new Centre for Psychedelics Health and Research isn't just focusing on mental health. They're casting a wide net, exploring psilocybin, LSD, and ketamine for substance use disorders, chronic pain, and palliative care. For example, one of their first studies, which looked at psilocybin for alcohol use disorder, is wrapping up now. Some participants went from crushing 15-20 drinks per day to just one per week.

While the new digs are being outfitted for more robust trials, the centre plans to host community workshops to battle the stigma around psychedelics. Later, they’ll train psychedelic-assisted therapists, too. With four studies in the pipeline, including one on microdosing, it seems they’re just getting started. Now, be honest. Who here had Kingston becoming Canada's psychedelic capital on their 2024 bingo card?

CYCLISTS’ PICKS

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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.