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š« This Week in Psychedelics
[5-min read] AI-powered psychedelic company is approved to launch human trials.
Welcome to Tricycle Day. Weāre 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. šŖ
š Psychedelic therapists, coaches, and facilitators: People need your help. Desperately. The problem is, they donāt know you exist.
So letās change that. If youāve been dreaming of landing more clients and making a greater impact, hereās your opportunity to 10x your practice.
Hereās what we got this week.
Engineering new states of consciousness with AI š¤
Two psilocybin biotechs join forces š¤
FDA takes heat for MDMA fumble š¤¬
Eat this to make your dreams more vivid š
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MICRODOSES
š¬ Research
Mystical doesnāt do it justice: Thereās more to the psychedelic experience than oceanic boundlessness. Itās time for a new measuring stick.
Whatād you expect? A new study combed through 200 peopleās LSD trips to find what predicted a positive or challenging experience.
Canāt 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.
šļø Policy
Psychedelics will be yuuuge: Donald Trump has thoughts on psychedelic and cannabis policy.
Royal court: The āketamine queenā and one doctor implicated in Matthew Perryās death will go to trial, while the other defendants will plead guilty.
Safety first: Drug testing isnāt 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 FDAās public meeting on PTSD treatments (more coverage below).
š 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.
Weād like to thank the academy: Entries are now open for the first Psychedelics Design Awards.
š« 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 weāre cooking with gas
Weāve all heard the line. Go ahead. Say it with us:
āThe medicine may not give you what you want, but it always gives you what you need.ā
Thereās definitely some wisdom in there. But hear us outā¦ what if thatās a cop out? And really, we just need more precise tools to get where we wanna go?
Thatās the basic idea that Mindstate Design Labs is running with. Instead of leaving the psychedelic experience up to natureās whim, theyāre using AI to engineer new and specific altered states of consciousness.
Now this all might sound like sci-fi, but itās about to get very real. Because the FDA and European Medicines Agency (EMA) just gave Mindstate the thumbs up to start human trials. Letās break it down.
š§Ŗ Base ingredient: Their first clinical candidate is MSD-001, aka 5-MeO-MiPTāa psychedelic so mild, they're calling it "psychedelic tofu."
š¤ Season to taste: The plan is to combine MSD-001 with other compounds (or probes) to dial in specific effects and mental states. (Because tofuās pretty bland without sauce.)
š¤ The cookbook: Where does AI come in? Identifying the āprobes.ā Mindstateās 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 āgo 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 weāll find out soon if heās on the right track. Fingers crossed there are no disasters in the kitchen lab. After all, even tofuās dangerous if you're allergic to soy. š«
AFTERGLOW
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 Psyenceās 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). š¤«
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 FDAās 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. NeÅe 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 libertyās 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 companyās staff. But enough about them. We want to know what you think, Cyclists.
āļø Reply and let us know: If youād 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
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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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