🫠 This Week in Psychedelics

Welcome to Tricycle Day. We’re the DMT entity of newsletters. We flash before your eyes, and you wake up with a massive download of new knowledge. 👽

Here’s what we got this week:

• Coming soon: a better picture of your brain 🧠

• Scholars tutor the FDA on regulating psychs 🧑‍🎓

• Can you pay my (psychedelic therapy) bills? 🎶

• Learn the secrets of microdosing 🍄

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RESEARCH

Psychedelic clinical trials are getting a hardware upgrade

If you want to know what psychedelics are doing to someone’s brain, it’s helpful to have an unobstructed view into their skull. Thanks to a new business deal, clinical trial researchers are about to have a clearer picture than ever.

Clerkenwell Health, a company that helps drug developers run clinical trials, has partnered with MYndspan, a med-tech company, to use MYndspan’s cutting-edge brain scanners at their research facility.

Here’s what’s special about this collab.

• Clerkenwell is a big deal in psychedelic R&D. They opened Europe’s first commercial psychedelic clinical trials facility in London last year. Their clients include biotech companies like Mindset Pharma, PharmAla Biotech, Octarine Bio, and Psyence.

• The brain scans are crisp. MYndspan’s scanners use magnetoencephalography (MEG) to record the magnetic fields emitted by neurons. This technique provides a more complete visual of brain activity and function, so scientists can understand how psychedelics are improving neurological conditions.

• It’s a first. MEG scanners have never been made available for commercial clinical trials before. And psychedelic researchers are getting first dibs.

Next, we should put one of these scanners into every home in America. If men could actually prove what’s on their mind, their wives’ fears would finally be put to rest.

MICRODOSES

🐁 Mouse models: Mydecine released preclinical data for its short-acting MDMA analog, MYC-006. If the drug works as well in humans, psychedelic therapy could become a lot less costly and time consuming.

🤣 Laughing My Ego Off: Nitrous oxide, aka laughing gas, produces brain activity patterns similar to ketamine and LSD, which suggests a common underlying biology for altered states of consciousness.

🥃 On the wagon: Clairvoyant Therapeutics is sponsoring a Phase 2b clinical trial of psilocybin therapy for alcohol use disorder. They’re enrolling participants now.

👁️ Expanded awareness: LSD increases entropy (disordered activity) in regions of the brain responsible for processing vision and sensory information. That’s what a computer says, at least.

POLICY

Academics weigh in on psychedelic regulation

With MDMA and psilocybin both on the FDA’s fast-track, there’s no denying it… Psychedelic medicine is coming.

But that doesn’t mean it’s going to be easy. The FDA has their work cut out for them, and scholars from Harvard Law and Baylor College of Medicine won’t let them forget it.

Experts from these schools got together and published a paper in Science outlining 3 challenges the FDA will have to overcome. They also proposed some solutions. We’re reserving our judgment (for the most part), but you can always reply and let us know you feel! ✍️ 

Challenge #1: Everyone knows set and setting are important. That’s the whole premise of psychedelic-assisted therapy. But the FDA only knows how to regulate drugs, not the conditions under which they’re used.

💡 Solution: The FDA should release Risk Evaluation and Mitigation Strategies (REMS) for psychedelics. REMS are drug safety protocols for medications with dicey risk profiles. But in this case, a similar approach could be used to control the therapeutic context.

Challenge #2: The state-by-state legalization model we’re headed down won’t help the FDA collect the efficacy and safety data they need to approve psychedelic medicines.

💡 Solution: The federal and state governments should… collaborate. Okay, this one feels like a throwaway. Like when your boss asks you to find more synergies. 🙄

Challenge #3: The FDA is used to reviewing synthetic drugs. They fit nicely into the scientific method because they’re isolated and dosed with precision. But natural psychedelics, aka plant medicine, come with much more variability. Not to mention the entourage effects.

💡 Solution: The government should welcome creative study design. We need to fund trials that will create an approval pathway for naturally occurring psychedelics.

So there ya have it. 3 challenges, 2.5 solutions, and 1 major takeaway:

You can make it all the way to the top of the federal government, and you’ll still have teachers telling you what to do. 🤷

MICRODOSES

⛰️ Colorado lawmakers have passed a bill in the Senate and House to regulate legal psychedelics. The measure now heads back to the Senate for concurrence and then, potentially, to the governor’s desk.

🏞️ Minnesota lawmakers voted to create a Psychedelic Medicine Task Force as part of new omnibus health bill that passed in the House.

🦘 Australia, the first country to legalize psychedelic medicine, is unlikely to subsidize psychedelic-assisted therapy right away. That means patients will have to pay $20-30k out of pocket.

BUSINESS

Psychedelic-assisted therapy gets a billing code

Healthcare in America may be flawed, but at least we know the rules of the game.

Yesterday, Compass Pathways and MAPS announced a major step forward in the integration of psychedelic medicine into the US healthcare system. The American Medical Association (AMA) has approved a CPT 3 billing code for psychedelic therapy.

Current Procedural Terminology (CPT) codes are a widely used system used to document and bill for medical services. They’re a pain in the ass for doctors, but they’re also an essential piece of the puzzle for patients to receive appropriate and necessary care.

Without billing codes, it would be much harder for doctors to get paid. Insurance companies and government programs, such as Medicare and Medicaid, require billing codes to process claims and reimburse providers. These codes are also used to track healthcare utilization, monitor costs, and inform policy decisions.

In other words, without a billing code for psychedelic therapy, it doesn’t matter how many breakthrough therapies the FDA approves. No one trips if docs don’t collect. 🤌 

Meanwhile, underground facilitators everywhere:

MICRODOSES

📦 Key deliverables: Mindbloom is providing the management consulting firm, SHIFT, with discounted at-home ketamine therapy as an employee benefit.

🚨 Red alert: Red Light Holland and NUBU Pharmaceuticals have co-authored a report to educate lawmakers and physicians in Australasia about the benefits of microdosing.

🫣 No trip, no problem: Mindset Pharma has filed two international patent applications to cover a range of novel, non-hallucinogenic psychedelics.

📑 reMind me later… to read Psychedelic Alpha founder Josh Hardman’s free reports on the psychedelics industry and emerging non-medical markets.

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Unlock the Power of Microdosing — If you have questions about microdosing, this free webinar will answer them. It’s hosted by Microdosing Collective, a 501(c)(3) non-profit organization dedicated to promoting the legalization of microdosing natural medicines. Their panel of seasoned pros will demystify the practice and share proven techniques for maximizing its benefits.

It’s happening tomorrow (May 4), so register now for free.

Music for Psychedelic Therapy — In 2021, electronic musician/producer Jon Hopkins — not to be confused with the university, Johns Hopkins — released his album, Music for Psychedelic Therapy. (Johns Hopkins would totally do that, too.) Since then, Jon discovered that fans had been meditating to his music, so he remastered two of the tracks specifically for that purpose.

Stream the new tracks during your next meditation or deep work session. (We may or may not have written this newsletter to the sound of Tayos Caves.)

That’s all for today. Before you head off, don’t forget to share, rate, and review Tricycle Day below. Catch ya next time, Cyclists! ✌️

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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.