🫠 This Week in Psychedelics

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Here’s what we got this week.

• Tripping up the corporate ladder 🪜

• The FDA’s warning on ketamine ⚠️

• Novartis takes an L 👎

• A journal for integration 📓

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RESEARCH

Your boss must be trippin’

Pop quiz: What do Steve Jobs, Bill Gates, and Elon Musk have in common?

Aside from being obscenely wealthy, they’ve all spoken openly about their positive experiences with psychedelics. (And they’ve probably inspired many copycats, too.)

Naturally, when a billionaire tech mogul admits to using controlled substances, the media jumps all over it. These are the kinds of headlines they drool over. But it begs the question—has the reported trend of psychedelic use among business leaders been exaggerated?

So recently, a team of researchers decided to set the record straight. They turned to the National Survey on Drug Use and Health (NSDUH), a swath of data from 2006 to 2014, to analyze 168,000 gainfully employed adults and their self-reported LSD use.

They found that while LSD use increased across the board, it did so at a significantly faster clip among managers.

• 📈 Non-managers had a modest 0.02% yearly increase in LSD use

• 🚀 Managers had a much greater 0.07% yearly increase

• 🔃 The flippening: In 2006, LSD was more popular among non-managers, but by 2014, the bosses were out-tripping their direct reports.

To explain the shift, the study couldn’t turn up any changes in perception of risk. So the trend has probably been driven by an increasing recognition of—or at least curiosity around—LSD’s potential benefits for leadership. “Think different,” indeed. 💡

MICRODOSES

🤍 Net-zero trauma: Patients showed zero symptoms of PTSD one month after a macrodose of synthetic psilocybin in Halucenex’s Phase 2 clinical trial.

🔧 Tweaking the system: Filament Health is approved to run a Phase 2 trial of its botanical psilocybin for the treatment of methamphetamine use disorder.

🍷 Aged like a fine wine shroom? The older you get, the less likely you are to have an intensely challenging mushroom trip.

🙈 Guilt trip: While most participants in a recent study described their trip as positive, over two thirds experienced feelings of shame or guilt.

🎒 Back to school: Harvard is launching a new Study of Psychedelics in Society and Culture. A $16 million gift will support an endowed professorship and research across the university.

🫠 It’s personal: Research sheds light on how different personality traits can affect the psychedelic experience, and vice versa.

🕊️ R.I.P.: Legendary psychedelic research pioneer, Roland Griffiths, has taken the ultimate trip.

POLICY

FDA sounds the alarm on ketamine

Ketamine—you’re doing it wrong. At least that’s what the FDA says.

This week, the agency issued a warning letter to American patients and providers about the risks of ketamine. They’ve noticed the uptick in its use for mental health conditions, and they think it’s gotten out of hand.

The letter spells out three related but separate concerns.

• 🫠 Off-label use: With the exception of esketamine (Spravato), no ketamine product has been FDA approved for any psychiatric condition. It’s an anesthetic. Yet docs are prescribing it for depression, anxiety, PTSD, etc.

• 💊 Compounded drugs: Medications that are specially prepared by a pharmacy for a specific patient’s needs aren’t reviewed by the FDA, either. And that’s how most mental health patients are getting their ketamine.

• 🧑‍💻 Telemedicine: While some clinics administer ketamine on site with therapists present, there are also online companies shipping ketamine directly to patients’ homes. Without medical supervision, the risks are higher.

And what are those risks? According to the FDA, we’re talking potential abuse, psychiatric events, respiratory and cardiovascular issues, and urinary tract problems that can lead to incontinence. 😬

All that said, the FDA regulates drugs, not the practice of medicine. So they can send all the warnings they want, but ultimately it’s not up to them to decide what scripts doctors write.

MICRODOSES

💊 Get your refills: The DEA has yet again extended the temporary rules that allow telehealth ketamine prescriptions.

🥇 The Maine event: Portland has become the first city in Maine to decriminalize psychedelics.

📕 A Return to Love: New-age author and presidential candidate Marianne Williamson wants to legalize psychedelic-assisted therapy and cover the costs with a universal healthcare system.

🌿 Kratom nation: Federal lawmakers have introduced a bill that would regulate kratom products.

🇲🇽 Medicina natural: A Mexican senator wants to legalize psilocybin to solve the country’s mental health crisis.

BUSINESS

Novartis kills next-gen ketamine research

Yeah, yeah. It’s easy to hate on Big Pharma.

At the same time, it’s hard to imagine a future for psychedelic medicine—in our healthcare system, at least—that doesn’t involve the Pfizers and Mercks of the world. They’re the ones with the billions it takes to push drug development over the finish line.

That’s why, this week, we’re pouring one out for Novartis. The Swiss pharma giant had to pull the plug on a clinical trial for a new ketamine-like drug it had been testing for major depressive disorder. Safe to say, the results weren’t looking good.

Now, if you’re 100% anti-pharma, then here’s the schadenfreude you came for. Just three years ago, Novartis paid $210 million for this molecule when they purchased Cadent Therapeutics, the biotech firm that created it.

But you can’t blame Novartis for going all in. The investigational drug, MIJ821, works by binding to NMDA receptors in the brain. That puts it in the same class as ketamine, PCP (angel dust), and nitrous oxide (laughing gas).

And they’re not ready to scrap MIJ821 entirely, either. It’s still got one more shot in a separate trial for treatment-resistant depression.

The reality is, even if MIJ821 fails again, Novartis won’t flinch. $210 million is practically pennies in the bucket for them. The psychedelic biotech sector, on the other hand—well, that’s another story. Because every time pharma gets burned, they’re less likely to come back to the fire.

MICRODOSES

🤝 Done deal: Cybin shareholders approved the company’s acquisition of Small Pharma.

💷 Pound it: Mydecine is now trading in the UK on the AQSE Growth Market.

❌ No excuse for abuse: A Canadian psychiatrist has lost her medical license after sexually assaulting a patient during MDMA-assisted therapy.

🌵A thorny approval: Peyote startup Lophos Pharmaceuticals has obtained a license from Health Canada to produce, sell, and transport mescaline.

💼 Need a job? MAPS is officially hiring marketers for the commercial rollout of MDMA-assisted therapy, anticipated in 2024.

Microdosing and Integration Journals — If you’ve ever tried journaling after a trip and found yourself staring at a blank page, well, you’re not alone. Wakeful Travel has put together two psychedelic journals—one for microdosing and another for deep inner travel—to help you reflect, process, and embody your insights. Yep, they’ve got coloring pages, but feel no pressure to stay inside the lines. Use code TRICYCLEDAY for 10% off.

Fireside Chat with Julie Holland, MD — Wonder what it would be like to be a fly on the wall at a psychedelic clinical trial? On October 26, Dr. Julie Holland will be sharing stories and insights from her time as a medical advisor to MAPS, throughout its research on MDMA for PTSD. It’s free to attend this live virtual event, but the host, Thank You Life, will be accepting donations to support its mission to eliminate financial barriers to psychedelic therapy.

Descending the Mountain — A zen master, a neuroscientist, and a mushroom walk into a bar… but instead of a corny punchline, you get an enchanting documentary. Find out what happens when lifelong meditators experience psilocybin for the first time at the end of 5-day retreat in the Swiss mountains. Stream it on Apple TV, Prime Video, or Vimeo.

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.