🫠 This Week in Psychedelics

[4-min read] Congress sets a deadline for the VA's MDMA implementation plan.

Welcome to Tricycle Day. We’re only 3 months away from the anticipated approval of MDMA. That’s the same number of wheels on a tricycle. Coincidence? We think not! 🤨

Here’s what we got this week.

  • Congress tells VA to pick up the pace 🏃 

  • Do SSRIs and 5-MeO-DMT mix? 🧐

  • Compass taps another delivery partner 🧭

  • A summer party for fun guys and gals 🪩

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MICRODOSES
🔬 Research

Twitching with excitement: Psychedelic therapy may unlock treatment of functional seizures.
Secure the bag: The NIH is offering $8.4 million to fund research on psychedelics for chronic pain.
Borderline results: People with personality disorders may benefit from psychedelics after all.
World domination next: Lykos has completed its European Phase 2 trial of MDMA-assisted therapy for PTSD.
Hype machine: Will the psychedelics’ outsized antidepressant effects stand the test of time?

🏛️ Policy

Technically not a psychedelic but… the DEA is making moves to reschedule cannabis.
Get out your red pen: The latest draft rules for Colorado’s psilocybin program are here.
California, here we come: CA’s bill to legalize psychedelic service centers passed in another committee.
You win this round, fentanyl: Missouri lawmakers nixed the plan to put $10 million in opioid settlement funds toward psilocybin research.
Nitpickers: The DEA says “Right to Try” laws don’t apply to controlled substances.
Fair and balanced: MDMA therapy proponents push back on ICER’s critical report.

📈 Business

Psilocon Valley: Why do tech bros love talking about microdosing so much?
More molly: PharmAla raised $750k to scale up manufacturing of its MDMA-like drugs.
Watch out, Cuisinart: Hypha Labs (not to be confused with Hyphae Labs) claims to have developed a countertop device that can grow mushrooms in a week.
Special Access: Alberta is leading the way in Canada for psychedelic health care.
Discovery Sessions: Underground pioneers and outlaw chemists shared the stage in SF.

🫠 Just for fun

My Roman Empire: Archaelogists confirm Ancient Romans were tripping on seeds.
Bro-deo: Ketamine bros are giving psychedelics a bad rap.
One more reason to condemn Hitler: It’s the Nazis’ fault LSD has been stigmatized for years.
Meme of the week: How my friends who’ve never tried psychedelics introduce me

THE PEAK EXPERIENCE
Waiting for the health care system to embrace psychedelics

Congress’s patience is wearing thin

Yes, we need research on psychedelics. More data is always welcome.

But at what point does waiting for extra evidence become a form of procrastination?

Considering MDMA-assisted therapy is on track for approval by this August, maybe we should be thinking more about rolling this thing out than running another study.

That’s what a bipartisan group of 9 members of Congress think, at least. They just signed an open letter to the VA, essentially saying it’s time to sh💩t or get off the pot.

Okay, they were a bit more diplomatic than that. They are politicians after all.

The gist of their argument is this:

The FDA could approve MDMA for PTSD as early as this summer. If the VA isn’t prepared to facilitate psychedelic-assisted therapies when they become available, then veterans will have to go elsewhere to seek treatment.

That’s a problem because the VA is (supposed to be) uniquely qualified to provide mental health care to veterans. Their providers have specialized knowledge in treating military and combat trauma that others may not. Plus, there’s the whole issue of cost and access.

So, the lawmakers are asking the VA to put together an implementation plan by July 1. They want specifics on:

  • 🏥 Care model. How will vets actually receive this therapy?

  • 📍 Locations and availability. Where can they get it?

  • 🫰 Infrastructure needs. What resources does the VA need to make it happen?

  • 🧑‍⚕️ Staff training. How quickly can they get their providers up to speed?

  • 📊 Evaluation plan. How will they track outcomes and costs?

It’s great that VA is funding its own psychedelic studies for the first time since the 60s. But let’s not forget the purpose of this research.

There are lives at stake here. Pressure’s on. 🫠

AFTERGLOW
Why don't we have both?

Myth busting contraindications

Here’s the twisted irony about psychedelic medicine. The people who could benefit the most often have an extra painful hoop to jump through—getting off their current medication. But does it have to be that way? Beckley Psytech wants to find out. They just dosed the first participant in a study to see if 5-MeO-DMT is safe and effective for people taking SSRIs.

Usually, psychedelic studies require participants to taper off their conventional meds first. There are a couple reasons for this: 1) to isolate the effects of the psychedelic, and 2) to avoid potential drug interactions. (For instance, serotonin syndrome is no bueno.) Since Beckley has already shown that 5-MeO works on treatment-resistant depression, that just leaves the combination effects to be tested.

Being depressed is hard enough. If we can skip the discomfort of drug withdrawal, wouldn’t it be better to go straight for the transformative healing? Fingers crossed, because dumping SSRIs would be a whole lot easier if the depression were already wiped out.

Can’t go on a Journey without a Compass

If the VA is taking the Thumb-Twiddle Approach™️ to launching MDMA, then Compass Pathways is doing the exact opposite for psilocybin. (They’re the makers of COMP360, a proprietary form of psilocybin that the FDA called a “breakthrough therapy.”) As of this week, Compass has lined up not one, not two, but three collaborations to ensure COMP360 is rolled out smoothly and at scale once approved.

Their newest partner is Journey Clinical, a platform and network of 2,000+ licensed therapists focused on psychedelics in the US. Together, they’ll research and develop models for care delivery, reimbursement, and provider training around COMP360. In January, Compass announced similar partnerships with Greenbrook TMS and Hackensack Meridian Health.

Even on the most optimistic timeline, we shouldn’t expect COMP360 to be approved until late 2025. In other words, Compass is not F’ing around. Say all you want about these drug development companies. But at least they know it’s gonna take more than clinical trials to integrate psychedelics into the Western health care system.

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.

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