šŸ«  This Week in Psychedelics

[5-min read] FDA says Amanita muscaria is not authorized as a food ingredient.

Welcome to Tricycle Day. If youā€™re still deciding on a new yearā€™s resolution, how about this? ā€œOpen, read, and click every issue of Tricycle Day.ā€ Simple, achievable, beautiful really. The gymā€™s too crowded in January anyway. šŸ˜

Hereā€™s what we got this week.

  • MindMedā€™s Phase 3 LSD trial, sans therapy šŸ§Ŗ

  • FDA cracks down on Amanita muscaria šŸ„

  • A 2-hour DMT trip you can control šŸŽ›ļø

  • Tell your psychedelic story šŸ“¢

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MICRODOSES
šŸ”¬ Research

Love on the spectrum: Researchers are exploring whether psychedelics can help people with autism.
Choose wisely: A meta-analysis of studies identified which psychedelics are most effective for depression and anxiety in people with terminal illnesses.
I see you: Psilocybin improves emotional empathy in people with depression.
Astrocytes! Researchers found a new explanation for ketamineā€™s rapid antidepressant effects.
Take five: If youā€™ve ever microdosed, fill out this survey to help shed light on the effects of integration practices on outcomes.

šŸ›ļø Policy

Pressureā€™s on: Rep. Dan Crenshaw is calling on the FDA to finalize its guidance on psychedelic clinical trials.
As one door closesā€¦ New Jerseyā€™s psilocybin therapy bill may be too ā€œcontroversialā€ to pass this year.
Another opens: Nevada lawmakers are recommending the state create its own regulated access model for psychedelic therapy.
Show time: Applications are open for Colorado natural medicine licenses. (And hereā€™s what to expect from psychedelic healing centers in 2025.)
Reform rewind: Read a roundup of psychedelic policy wins and losses in 2024.

šŸ“ˆ Business

Back in the market: Psyence has regained compliance with Nasdaq and is now raising $2 million.
Speaking of Nasdaq: MindMed has been added to its Biotechnology Index.
Exit strategy: Awakn Life Sciences is getting acquired by Graft Polymer PLC.
Coca goes clinical: Magdalena Biosciences is importing Peruvian coca leaf to Canada for mental health research.
On your honor: ASKP3 launched a pledge program to provide ketamine practitioners with basic guidelines and standards.

šŸ«  Just for fun

Do you speak emoji? Drug dealers have moved on to social media.
Monkey see, monkey do: A brave chemist just released the first step-by-step video on how to synthesize LSD.
Mainstream media: NY Times published pieces on psychedelics for brain injury and end-of-life care.
Even more mainstream media: Craig Robinson (from The Office) will play the villain in an upcoming psychedelic comedy called Toad.
Meme(s) of the week: A highlight reel of our most popular memes of 2024ā€¦

THE PEAK EXPERIENCE
Drop the "-assisted therapy." Just psychedelics. It's cleaner.

No frills, no pills, just tabs

Everyone's talking about psychedelic-assisted therapy these days.

Ok, not everyone obviously. But in the psychedelic echo chamber research community, the combo of medicine with talk therapy is practically gospel at this point.

Like PB&J (or mushrooms and lemon juice?), itā€™s just understood they work better togetherā€¦ which is why purists are gonna feel some type of way about this news.

MindMed just launched the first-ever Phase 3 clinical trial of LSD, andā€”you guessed itā€”they're bucking the psychotherapy trend.

Here's what makes this trial a big deal. Ya know, aside from getting us one step closer to an FDA-approved psychedelic medicine for anxiety.

  • šŸ’Š Keep it simple, stupid: No therapy, no prep, no integration. MindMedā€™s out to prove the drug works on its own.

  • šŸš€ Accelerated review: The FDA already gave MM120 (their special LSD tablet) breakthrough status based on strong Phase 2 results.

  • šŸ‘„ Big sample: Thereā€™ll be 200 participants across 20 U.S. sites (which is a lot for psychedelic research).

Essentially, the company's betting that psychedelics don't need all the extras to work. Instead of therapists, they've got "dosing session monitors" who basically just check vital signs and help you adjust the music while youā€™re tripping your face off.

Sure, it's still an all-day affair. LSD is LSD after all. But without the intensive therapy that's become standard in most psychedelic trials, maybe the FDA will have an easier time judging the data and giving their thumbs up.

Then again, if MindMedā€™s so confident in their strategy, you gotta wonder why the CEO and other insiders have been trimming their positions latelyā€¦

Maybe theyā€™re just having acid flashbacks to the bear market. šŸ« 

AFTERGLOW
When the FDA takes away your favorite mushroom

Amanita minute to process this

The FDA just dropped the hammer on Marioā€™s favorite mushroom. After a string of hospitalizations and sketchy lab results, the agency has declared Amanita muscaria and its compounds off-limits in food products. That means a whole crop of dubious (yet legal) gummies and chocolates flooding convenience storesā€”and some legitimate products, tooā€”are officially on notice.

You might recall that last year, Prophet Premium Blends had to recall their Diamond Shruumz products after people started getting sick. Like, really sick. But whether Amanita is to blame is up for debate. Lab tests found not just muscimol (one of the mushroomā€™s active compounds) but also forms of synthetic psilocybin, prescription drugs, and other undisclosed substances. Lesson learned: when you buy ā€œadultā€ candy from a gas station, you might get more than you bargained for.

The real question is whether this ban will stick. The FDA has a pretty spotty track record enforcing similar rules around CBD and Delta-9 THC products. And since Amanita muscaria doesnā€™t contain any controlled substances, no oneā€™s calling in the DEA for backup. Maybe they should've eaten a power-up mushroom before picking this fight.

DMT on cruise control

Swiss researchers just challenged everything we thought we knew about DMT. Instead of the classic 10-minute blastoff to hyperspace, they gave 22 healthy volunteers continuous IV infusions for two whole hours. And it turns out that when you drip-feed the spirit molecule, you get a much smoother ride. It might even be the key to fine-tuning the psychedelic experience.

Whatā€™s especially fun about this study is the participants got to adjust their own dose. Yup, after testing four different infusion rates, researchers let volunteers turn the knobs on their own DMT levels. Most people cranked it up pretty high (who wouldnā€™t?). But they still avoided the anxiety and overwhelm that often accompany heroic doses. The key? Starting low and controlling the intensity. Apparently meeting the machine elves feels a lot less scary when you can ghost ā€˜em at any time.

But hereā€™s the catch. The body starts building tolerance almost immediately. Even as DMT levels in the blood kept climbing, the subjective effects plateaued or even dropped after about 30 minutes. Guess you can't just put infinity on an IV drip.

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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