šŸ«  This Week in Psychedelics

[5-min read] AI-powered psychedelic company is approved to launch human trials.

Welcome to Tricycle Day. Weā€™re the psychedelics newsletter that likes altered states but loves altered traits. This email is dedicated to all our Cyclists putting in the work to show up better today than yesterday. šŸ’Ŗ

šŸ’† Psychedelic therapists, coaches, and facilitators: People need your help. Desperately. The problem is, they donā€™t know you exist.

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Hereā€™s what we got this week.

  • Engineering new states of consciousness with AI šŸ¤–

  • Two psilocybin biotechs join forces šŸ¤

  • FDA takes heat for MDMA fumble šŸ¤¬

  • Eat this to make your dreams more vivid šŸŒŒ

FROM OUR SPONSORS
Revitalist

One book can change your life.

Especially when that book posits a new theory for how the brain works and completely reimagines the way we measure mental health.

Inflamed isnā€™t another pop psychedelics book, recycling the same ideas youā€™ve heard a million times. Itā€™s a manual for your mind.

Kathryn Walker, a mental health nurse practitioner and CEO of Revitalist, wrote it for anyone whoā€™s tired of struggling. One reader said it quite literally saved his life.

For a limited time, sheā€™s offering it to Tricycle Day readers at no cost.

MICRODOSES
šŸ”¬ Research

Mystical doesnā€™t do it justice: Thereā€™s more to the psychedelic experience than oceanic boundlessness. Itā€™s time for a new measuring stick.
Whatā€™d you expect? A new study combed through 200 peopleā€™s LSD trips to find what predicted a positive or challenging experience.
Canā€™t scare me: Researchers have a new explanation for how psychedelics turn off the fear response.
The verdict is in: A review of the scientific literature shows psychedelics are safe and well tolerated.
Fire kasina: This advanced meditation practice reliably produces psychedelic experiences.
Volunteers wanted: Participate in research on psilocybin as a treatment for fibromyalgia.

šŸ›ļø Policy

Psychedelics will be yuuuge: Donald Trump has thoughts on psychedelic and cannabis policy.
Royal court: The ā€œketamine queenā€ and one doctor implicated in Matthew Perryā€™s death will go to trial, while the other defendants will plead guilty.
Safety first: Drug testing isnā€™t as common at festivals as it could be, due to an often misunderstood federal law.
Post-mortem: MAPS hosted a discussion with experts after the FDAā€™s public meeting on PTSD treatments (more coverage below).

šŸ“ˆ Business

Fresh blood: Lykos Therapeutics has a new interim CEO.
Staking claims: Awakn is trying to patent a new class of psychedelic compounds, while Clearmind and SciSparc filed a patent for an MDMA combo treatment.
The root problem: The iboga retreat industry is burrowing deeper underground after another death.
De-real deal: This clinic specializes in helping people recover from extended bad trips.
Weā€™d like to thank the academy: Entries are now open for the first Psychedelics Design Awards.

šŸ«  Just for fun

For the fun guys and gals: 7 mushroom festivals you should know about.
Tune in: Musicians are driving the psychedelic therapy revolution.
Not cordyceps: The same fungus that turns house flies into zombies may be the basis for new psychotropic drugs.
Meme of the week: Psychedelic therapists watching their clients overcome traumaā€¦

THE PEAK EXPERIENCE

Now weā€™re cooking with gas

Weā€™ve all heard the line. Go ahead. Say it with us:

ā€œThe medicine may not give you what you want, but it always gives you what you need.ā€

Thereā€™s definitely some wisdom in there. But hear us outā€¦ what if thatā€™s a cop out? And really, we just need more precise tools to get where we wanna go?

Thatā€™s the basic idea that Mindstate Design Labs is running with. Instead of leaving the psychedelic experience up to natureā€™s whim, theyā€™re using AI to engineer new and specific altered states of consciousness.

Now this all might sound like sci-fi, but itā€™s about to get very real. Because the FDA and European Medicines Agency (EMA) just gave Mindstate the thumbs up to start human trials. Letā€™s break it down.

  • šŸ§Ŗ Base ingredient: Their first clinical candidate is MSD-001, aka 5-MeO-MiPTā€”a psychedelic so mild, they're calling it "psychedelic tofu."

  • šŸ¤Œ Season to taste: The plan is to combine MSD-001 with other compounds (or probes) to dial in specific effects and mental states. (Because tofuā€™s pretty bland without sauce.)

  • šŸ¤– The cookbook: Where does AI come in? Identifying the ā€œprobes.ā€ Mindstateā€™s platform analyzed 70,000+ trip reports and a huge biochemical data dump to see what would pair best.

Mindstate's CEO, Dillan DiNardo, says this mission is bigger than drugs. He wants to ā€œgo beyond psychedelicsā€ to crack the code of consciousness itself. Only then can we have precision therapies for everything from depression to stuttering.

With Phase 1 trials on the horizon, guess weā€™ll find out soon if heā€™s on the right track. Fingers crossed there are no disasters in the kitchen lab. After all, even tofuā€™s dangerous if you're allergic to soy. šŸ« 

AFTERGLOW
You are mine now. You belong to me.

Mushroom merger

Uh-oh, the psychedelic biotechs are consolidating power. Psyence Biomedical just inked a deal to acquire Clairvoyant Therapeutics for the low, low price of $500k in shares, with the potential for another half milly in cash down the road. What's got them so excited? A synthetic psilocybin treatment for Alcohol Use Disorder (AUD) that's already knee-deep in a Phase 2b trial.

This acquisition isn't so much about gobbling up a competitor. It's a strategic move that could expand Psyenceā€™s portfolio and fast-track them from shroom startup to commercial player. With Clairvoyant's AUD treatment complementing Psyence's own nature-derived psilocybin for cancer-related adjustment disorder, they're positioning themselves as the Swiss Army knife of psychedelic therapy.

But let's not get too far ahead of ourselves. The sector's still nursing a hangover from the FDA's recent MDMA rejection. Still, with 50 million at-risk drinkers around the world, and previous studies showing psilocybin's promise in AUD, Psyence might just be onto something. And if their whole plan goes sideways? Hey, at least mushrooms still grow in the woods (/in your closet). šŸ¤«

FDA gets an earful

The FDA just hosted a public roast meeting on PTSD treatments, and let's just say the suggestion box is smoking. Emotions were (justifiably) running high after the FDAā€™s recent rejection of MDMA-assisted therapy. About 4% of men and 10% of women will face PTSD in their lifetimes, yet here we are, still stuck with same old ineffective choices. So on Friday, everyone from academic researchers to salty vets showed up to give the feds a piece of their mind.

The FDA's Dr. Bernard Fischer tried to play it cool, pointing to the 447 psychedelic clinical trials in motion. But the crowd wasn't buying it. Johns Hopkins' Dr. Neşe Devenot demanded higher standards, while veteran Jon Lubecky basically told the FDA to get a move on already. Meanwhile, Denver's Ashley Troxell showed up championing full psilocybin descheduling. Because why stop at medical use when our cognitive libertyā€™s at stake? (Preach.)

HHS's Dr. Leith States tried to smooth over the MDMA setback, saying, "We all feel some type of way." Yeah, no kidding, doc. Just ask Amy Emerson, who stepped down as Lykos's CEO this week after laying off 75% of the companyā€™s staff. But enough about them. We want to know what you think, Cyclists.

āœļø Reply and let us know: If youā€™d had the floor, what would you have told the FDA about PTSD treatments?

Best answer wins a Tricycle Day t-shirt.

CYCLISTSā€™ PICKS
UNTIL NEXT TIME

Thatā€™s all for today, Cyclists! Whenever youā€™re ready, hereā€™s how we can help.

ONE CYCLISTā€™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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