🫠 This Week in Psychedelics

Welcome to Tricycle Day. We’re not the first psychedelics newsletter, but that’s okay. As a wise second-grader once told us: first is the worst, second is the best, third is the one invited to the kool-aid acid test. 🧃

Here’s what we got this week.

• J&J submits ketamine spray for expanded approval 👃

• The dirty deets of Colarado’s natural medicine rules 🍄

• A new study on microdosing and info processing 🧠

• Get to know all the “parts” of yourself 📖 

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MICRODOSES

🔬 Research

Do the locomotion: Psychedelics may help with regaining motor function.
Axon, ax-off: Ibogaine up-regulates genes and proteins involved in remyelination, or the repair of neurons, after opioid use.
Beyond the clinical trial: Canadians who received compassionate access to psilocybin therapy saw real-world benefits.
Should’ve turned left at Albuquerque: University of New Mexico researchers are studying psilocybin in depression and postpartum depression.
Blastoff pills: Enveric Bioscience’s novel DMT-like drug appears to be orally bioavailable… in mice at least.

🏛️ Policy

Be sensible, won’t you? Students for Sensible Drug Policy is trying to block the DEA from classifying DOI and DOC as Schedule I drugs.
City vs state: As Frisco and Alamosa make way for natural medicine centers in Colorado, Lake Oswego voters may opt out of Oregon’s psilocybin program altogether.
If at first you don’t succeed… California’s (many) psychedelic therapy bills have all failed. Maybe it’s time for a different approach.
Shock and awe: Veterans planted another striking visual outside the White House to encourage the FDA to approve MDMA.
You can’t handle the truth: Combining psychotherapy with drugs works, but the FDA doesn’t get it.

📈 Business

Communication is key: Cybin’s CEO reflects on working with the FDA to shape their drug development programs.
To the moon: RBC Capital Markets sees a 210% upside on this psychedelic stock.
Sacred reciprocity: MycoMeditations is organizing a Hurricane Beryl relief fund for the area of Jamaica that hosts its psilocybin retreats.
Florida man… and Commissioner of Agriculture issued a stop-sale order for all Diamond Shruumz-branded products.
Mikeadelics: Mike Tyson is now selling his own magic mushroom grow kit.

🫠 Just for fun

Stargazing: How to camp safely with psychedelics.
Heavy drinkers: Alcoholics who’ve used ayahuasca in recovery are being shunned at AA meetings.
Bickering on the couch is out: Psychedelic-assisted couples therapy is in.
Meme of the week: When your health care provider won’t acknowledge the benefits of psychedelics…

THE PEAK EXPERIENCE

Spravato is going solo

Remember when we told you Spravato was speedrunning to $1 billion in annual sales?

Well, Johnson & Johnson isn't resting on its laurels. Now they're pushing to get their ketamine-based nasal spray in the hands of even more people.

J&J just submitted an application to the FDA for Spravato as a monotherapy for treatment-resistant depression (TRD). If approved, it would be the first standalone treatment—psychedelic or not—specifically for TRD.

Here's why Spravato could make history (again).

• 🚽 Flush away those pills: Today, Spravato can only be taken in combination with an oral antidepressant. This approval would allow patients to use it on its own.

• ⚡ No time to waste: The Phase 4 trial showed improvement in depressive symptoms as early as 24 hours post-dose. That's lightning fast compared to traditional antidepressants.

• 📊 The data looks good: Not only did patients improve rapidly, but the effects lasted at least 4 weeks. And while Spravato’s safety profile certainly isn’t spotless, the monotherapy study didn’t raise any new red flags.

Obviously, this move could be huge for TRD patients who've churned through multiple SSRIs to no avail. But it’d also be a major development for the psychedelic industry.

Remember, Spravato is already a blockbuster, on track to surpass a billy in sales this year. This expanded approval could send those numbers even higher, further validating psychedelic medicine in the eyes of investors.

Our take? This is the biggest solo breakout since Beyoncé left Destiny’s Child. No offense, Michelle—you’re Lexapro. We don’t make the rules. 🫠

AFTERGLOW

Play by the rules (or don’t, whatever)

Colorado's final draft rules for natural medicines are here. And yep, they're almost as complex as a mycelial network. The state's still aiming to launch licensing in early 2025, but first, they have to hash out details on everything from psilocybin candies to outdoor tripping. Don’t worry—we’ll spare you the 120-page doc and give you a quick rundown of the hot-button issues.

First, the rules establish two tiers of cultivation licenses: micro-cultivators can grow and store up to 750 grams of dried shrooms, while standard cultivators hit their limit at 5 kg. Meanwhile, manufacturers could score an "extraction endorsement" that would make chocolates and gummies fair game, but some folks are pushing back on products that could tempt kids. Testing requirements are no joke either, with mandated checks for tryptamines, contaminants, and even potency degradation every nine months.

Perhaps most inviting is the concept of outdoor "administration areas" at licensed healing centers. It is an objective fact our humble opinion that tripping in nature is superior to tripping in an office, so it’s nice to see regulators catching on. In the end, let’s hope Colorado can strike the right balance between safety and accessibility. We’re not saying rules were meant to be broken, but sometimes the only way to expand is to let go of control.

It’s all in your head

A new study just dropped that's making us rethink the whole microdosing game. Turns out, the effects of a tiny bit of acid might be more complicated than we thought. Go figure. Anyway, researchers dosed 53 volunteers with either 15 μg of LSD or a placebo over two weeks, then peered into their brains with fancy EEG tech. Here’s the trip report.

LSD did indeed light up participants' brains, reducing those sleepy slow-wave patterns (delta, theta, and alpha, to be specific) and ramping up the zippy ones (beta and gamma). It also sped up how quickly folks processed new information. But here's the kicker—these effects were most pronounced in people who had sluggish brains to begin with. If your neurons were already firing on all cylinders, the acid didn't do all that much.

What’s most exciting is that some of these brain changes stuck around for a week after the last dose. There’s been a lot of talk about psychedelics and neuroplasticity, but it’s still remarkable to see these effects show up with microdosing. Naturally, researchers are hyped about what this could mean for treating conditions like ADHD. Now, before you go microdosing your way into a productivity frenzy, please don’t forget: you’re a human being, not a human doing.

CYCLISTS’ 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.