🫠 This Week in Psychedelics

Welcome to Tricycle Day. Yeah, a psychedelic conference with over ten thousand attendees is cool. But there are almost twice as many of you Cyclists getting this newsletter every week. 🫡

Here’s what we got today.

• Ketamine in the real world 💉

• FDA guidance on psychedelic research 🔬

• The largest psychedelic gathering ever 🎊

• Gummies for stress, focus, and sleep 🍄

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RESEARCH

Real-world study shows ketamine beats traditional antidepressants

Feeling low? Here’s some science that could turn a whole generation of frowns upside down.

A new study, based on actual patients in real-world clinics, found that ketamine infusion therapy was effective against depression, anxiety, and suicidal ideation.

When we say “real world,” we’re making a distinction from the gold standard in scientific studies—the randomized controlled trial (RCT). But RCTs aren’t perfect, you know. For instance, you can’t always tell how a more diverse population will respond in the clinic, or how results will translate over the long term. Real-world studies fill in those gaps.

So here we have the largest real-world study on ketamine therapy yet. And it generated some pretty staggering results.

• 70% of patients got relief from suicidal ideation after treatment

• More than 50% of patients had improved depression or anxiety symptoms

• 25% of patients saw complete remission

• Patients still responded up to a year after starting treatment. (Symptoms return for up to 33% of people on traditional antidepressants.)

The study was sponsored by Osmind, a health tech company that maintains an electronic health record (EHR) system for psychiatrists. Crazy to think that without access to the data from the clinics they included in their analysis, we may never have known…

MICRODOSES

🪄 Passing the baton: Psychedelic elder Roland Griffiths, who faces a terminal cancer diagnosis, has stepped down as Director of the Johns Hopkins Center for Psychedelic & Consciousness Research. Dr. Frederick Barrett now assumes the role.

🖕 F**k cancer, together: A new study showed that psilocybin-assisted group therapy was safe, feasible, and potentially effective in managing cancer-related depression.

🫣 No trip, no problem: The first healthy volunteers have been safely dosed in Delix Therapeutics’ Phase 1 trial of DLX-001, a non-hallucinogenic, MDMA and 5-MeO-DMT inspired psychoplastogen. The compound was well tolerated and showed “no psychotomimetic effects.”

🟢 Go on then: Mindset Pharma has received regulatory and ethics approval to kick off a Phase 2 study of MSP-1014, its novel psilocin prodrug for major depressive disorder (MDD).

POLICY

FDA releases guidance on psychedelic clinical trials

At least 224 psychedelic studies are live or recruiting participants today. It’s about time the FDA wised up and realized this isn’t a passing trend.

This week, the FDA (they’re the regulatory agency that oversees drug applications and approvals in the US) issued its first draft guidance on psychedelics.

Now, they don’t weigh in on every drug category, but given the growing interest, therapeutic potential, and unique challenges in studying psychedelics, the FDA is offering their two cents.

The draft guidance touches on several steps in the drug development process.

• 🧑‍⚕️ Trial conduct: e.g., researchers should explain if, how, and why psychotherapy will be used alongside the drug

• 📊 Data collection: e.g., they should also monitor and assess drug abuse potential

• 🐁 Subject safety: e.g., new psychedelics should be studied in animal models before humans

• 📝 New drug applications: e.g., applications should include a proposal on how the drug should be rescheduled (under the Controlled Substances Act)

At the end of the day, the FDA’s goal is to help scientists design trials that treat participants ethically, meet standards of integrity, and produce reliable results. And to their credit, the FDA doesn’t pretend to be perfect. They’re encouraging the public to review their draft and send feedback over the next 60 days.

So far, we have one comment… It’s kinda weird that there’s not a single word on what to do if when you meet a mischievous machine elf in hyperspace, no?

MICRODOSES

🏇 Hold your horses: That $42 million Kentucky promised to put toward ibogaine research? It’s not a done deal. The Kentucky Opioid Abatement Advisory Commission will hold two public hearings this summer to discuss if the program should be funded and consider alternatives.

🙌 Let my people go: Colorado Gov. Jared Polis says he wants state lawmakers to give him the power to issue pardons to Coloradans who’ve been busted for crimes related to psychedelics.

🗳️ They’re right, you know: According to a recent poll, 60% of Americans think psychedelics should be legal in regulated, therapeutic settings. And almost half believe personal use should be decriminalized.

BUSINESS

MAPS throws the biggest psychedelic conference ever

What comes to mind if we tell you we just attended the largest psychedelic gathering in history?

Last week, more than 12,000 attendees and 500 speakers descended on Denver, Colorado for Psychedelic Science 2023, a massive 5-day conference dedicated to the power, promise, and potential of psychedelics.

The conference was hosted by the Multidisciplinary Association for Psychedelic Studies (MAPS), the organization spearheading the effort to get MDMA approved as a treatment for PTSD.

But despite MAPS’ interest in the commercial side of psychedelic medicine, the conference took a more all-encompassing approach. There were exhibitors, talks, and panels on everything from policy reform to community impact and religious use.

Industry leaders and community elders shared the stage stages with celebrities, who in some cases “came out of the psychedelic closet” for the first time to voice their support for the movement. People like:

• 🏈 New York Jets quarterback Aaron Rodgers

• 🏛️ Colorado Gov. Jared Polis and former Texas Gov. Rick Perry

• 🧑‍🎤 Musical artists Melissa Etheridge and Jaden Smith

• 🥬 Cofounder of Whole Foods John Mackey

Of course, the event wouldn’t have been complete without an appearance (or several) from Rick Doblin himself, founder of MAPS. During his closing address, the energy of the auditorium took a swift and sobering turn as indigenous activists stormed the stage in protest.

Just goes to show that, as far as the psychedelic movement has come, there’s still plenty of tension outside and within our little bubble. 🫧

MICRODOSES

💸 Billionaires doing billionaire things: New York Mets owner Steve Cohen has pledged $5 million to help push MDMA over the FDA’s finish line. Meanwhile, TOMS Shoes founder Blake Mycoskie just donated $100 million for psychedelic research.

🚗 Stellaaaaaa! Now defunct ketamine clinic brand Field Trip Health has found a new home in Stella, a neuropsychiatric treatment center business that just purchased the company’s US assets.

✨ Teamwork makes the trip work: The National Institute on Drug Abuse (NIDA) has agreed to provide supplemental data to beef up MAPS’ new drug application for MDMA.

🪙 Pay your tithe: Soul Tribes, a 508(c)(1)(a) faith-based organization, is raising money via the world’s first tax-exempt psychedelic bond offering.

🗺️ On the map: Numinus Wellness has struck a strategic partnership deal with HealingMaps, a search site for psychedelic-assisted therapists, to drive awareness and referrals to Numinus Network clinics.

🏳️ Failed coup: MindMed shareholders elected all of the company's proposed board members, much to the chagrin of FCM Holdings, who’d hoped to gain control of the company.

HempLucid Mushroom Gummies — Improve your sleep, boost your focus, or relieve your stress with these yummy gummies, which combine cannabinoids like THC and CBN with functional mushrooms like Reishi, Lion’s Mane, and Cordyceps.

We tried ‘em, and they work. But why not see for yourself? If you don’t feel the difference, they’ll refund your purchase, no questions asked. Use code TRICYCLE10 for 10% off your order.

Fireside Project — Difficult trip? We’ve all been there. Fireside Project’s Psychedelic Peer Support Line provides emotional support during and after psychedelic experiences. Their staff are rigorously trained, always compassionate, and never judgmental. Save their number in your phone, so you can text or call for real-time support when time doesn’t seem real.

The Science of MDMA & Its Therapeutic Uses — Andrew Huberman, everyone’s favorite hunky neuroscientist, is back with a new installment in his psychedelic 101 series. Last time, he covered psilocybin. In this episode, he’s onto MDMA, which he’ll point out isn’t a true psychedelic after all. Pop in your headphones for a lesson on MDMA’s fascinating history, unique effects, and pivotal role in the renaissance of psychedelic medicine.

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.