🫠 This Week in Psychedelics

Welcome to Tricycle Day. This newsletter has more neuroplasticity than a Krang action figure. (Only the real G’s remember.)

Here’s what we got this week.

• The psychoplastogen man 🧠

• Gov’t dolla$, dolla$ for addiction research 🤑

• A win for compassionate access in Canada 🍄

• Rules of thumb for tripping solo 🧑‍🚀

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RESEARCH

Delix Therapeutics is approved for its first human trial

Another day, another clinical trial, amirite?

WRONG. This isn’t a throwaway study, Cyclists. This week’s approval of a Phase 1 clinical trial for Delix Therapeutics is major because it marks a turning point for a real MVP of psychedelic research. Meet David.

David E. Olson is a professor and researcher at UC Davis. There he runs a lab focused on a class of molecules called “psychoplastogens,” which promote neuroplasticity. He’s made some important contributions to our understanding of how psychedelics work, neurologically speaking. (We covered a recent breakthrough from his lab back in February.)

Now with Delix, Olson is going commercial. On top of his teaching job, he’s moonlighting as Co-founder and Chief Innovation Officer of the drug development company, which already secured a $70 million Series A funding round. But who’s counting?

David and his lab rats made two key discoveries in 2018 that laid the groundwork for Delix.

• Psychedelics are psychoplastogens: Drugs like LSD, MDMA, and ibogaine can regrow damaged cortical neurons (cells in the outer layer of the brain)

• Tripping (may be fun, but it) isn’t necessary: The hallucinogenic effects of these compounds can be decoupled from their effects on neuronal growth

From that point on, Olson Lab set out to create an extensive library of non-hallucinogenic psychoplastogens that could target a broad range of diseases — everything from treatment-resistant depression to addiction, PTSD, cognitive impairment, neurodegeneration and more.

Now after expanding on the lab’s work for years, Delix Therapeutics is finally taking its lead candidate, DLX-001, to human trials.

Personally, we think psychedelic visuals are a feature, not a bug. But we’ll let it slide, Dave. Good work. 👏

MICRODOSES

🧫 Hoffman’s forgotten child: LSD wasn’t the only thing that came out of Albert Hofmann’s lab. A new study suggests that his non-hallucinogenic creation, 2-Br-LSD, offers a potential treatment for depression and anxiety.

🤤 Please, please me: University of Colorado is taking a unique approach to their clinical trial of psilocybin for treatment-resistant depression. The study will focus on measuring anhedonia, or the inability to feel excitement of pleasure from activities.

🎤 Whoa, we’re halfway there: MindMed hit a noteworthy milestone in its Phase 2b trial of MM-120 (their proprietary form of LSD) for Generalized Anxiety Disorder. Over 50% of participants have been enrolled and dosed.

✅ Checking the boxes: The University of Washington is researching how psilocybin-assisted therapy could help treat depression and anxiety in military veterans and first-responders with PTSD and alcohol use disorders. The study was mandated under a new Washington state law.

💪 What doesn’t kill you… According to a survey of 2,000+ Canadians, the top motivations for using psychedelics were fun, self-exploration, general well-being, and personal growth. Of those who’d had a challenging experience, over half believed “some good” came from it after-the-fact. Next, the survey goes global.

POLICY

A federal agency is funding $1.5 million into psychedelics for addiction

Still stewing over your second place finish at the grade school science fair? Here’s your shot at redemption, kids.

The National Institute on Drug Abuse (NIDA), a federal agency underneath the NIH, just published three notices of funding opportunities (NOFOs) for psychedelic research projects. They’re calling for applicants who think they can improve our understanding of how psychedelics help people overcome addiction.

Two of the NOFOs are for clinical research, meaning on human subjects.

• NIDA’s asking: What are the neurological changes that bring about the cognitive, emotional, and behavioral shifts we see with psychedelics?

• And they want receipts: So applicants better be prepared to use “neuroimaging and behavioral analytic tools” to prove psychedelics are responsible for those changes.

The last NOFO is for non-clinical research.

• NIDA’s asking: What are the mechanisms of action of psychedelics when it comes to treating substance use disorders?

• It’s complicated: We already know the so-called “classic psychedelics” activate serotonin receptors, but is that all? These compounds can be pretty “promiscuous” with their interactions, so there might be other molecular pathways at play.

NIDA is ready to give out four awards totaling $1.5 million this coming year. So which of you Cyclists is going after that cheddar? We know you mofos have NOFO FOMO.

MICRODOSES

💸 Grants on grants: A North Carolina House committee approved the Breakthrough Therapies Research/Advisory Act, which would support $5.4 million in grants for research into psilocybin and MDMA.

🎖️ Tactical offensive: In a hearing ahead of the Fiscal Year 2024 defense policy bill markup, members of US Congress pressed the House Armed Services Committee to research psychedelics as a potential treatment for PTSD.

🕵️ Tax evasion: An expert panel advised entrepreneurs venturing into Oregon’s regulated psilocybin market on how to navigate the IRS’s Section 280E, which restricts businesses “trafficking in controlled substances” from deducting expenses on their taxes.

BUSINESS

TheraPsil struck a deal to advance psilocybin access throughout Canada

In case you needed another reason America Junior Canada is better than the US…

Ever since January 5, 2022, Canadian doctors have been able to request psilocybin for their patients via Health Canada’s Special Access Program (SAP).

Sure, there are some extra hoops to jump through, but Canadians in need actually have a legal path to psilocybin therapy. Getting this far has been a hard-fought battle by orgs like TheraPsil, a non-profit that advocates for compassionate access, especially for people experiencing end-of-life distress.

This week, TheraPsil chalked up another W. See, they’d already rolled out a registry called Project Solace that streamlines the process for patients and providers to take advantage of the SAP. Because we all know how government programs can be.

But there’s still one missing piece: the psilocybin itself. 🧩

Well, not anymore. TheraPsil has partnered with Lucy Scientific Discovery to introduce a suite of natural psilocybin products into the Canadian market under the SAP. Now everyone wins.

• Patients get relief through psilocybin-assisted therapy

• Health Canada collects data on the effectiveness and safety of psilocybin therapy

• Lucy builds brand recognition ahead of broader, maybe even global, adoption

Hold my maple syrup. We’re moving to Canada. 🍁

MICRODOSES

🧑‍🌾 Fair trade: Filament Health, a drug development company focused on naturally sourced psychedelics, has completed its first import of iboga root from Gabon to Canada. The company has committed to equitable profit sharing under the Nagoya Protocol.

🍄 Go Pro: Enveric Biosciences received a Notice of Allowance from the USPTO for a patent application involving EB-373, their novel psilocin prodrug being developed to treat anxiety.

👼 With you ‘til the end: A new non-profit wants to improve the end-of-life experience with psychedelics. Aptly named End of Life Psychedelic Care will offer online classes, death doula trainings, and group integration sessions for families making peace with mortality.

🥵 Okay for now: Ketamine telehealth clinics may live to see another day. After proposing a rule in March that would have restricted mail-order prescriptions, the DEA has issued an extension of more favorable COVID telemedicine policies through November 2023.

🌿 All-time high: More U.S. employees are testing positive for cannabis than they have in 25 years, according to a workplace drug screening report of over 6 million tests. Just wait ‘til they look into mushrooms.

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Enter the Portal with East Forest — Headed to Denver next month for Psychedelic Science? First of all, you better hit us up for a meet n’ greet. Secondly, we got you the hookup for Enter the Portal, a special “ceremony concert” with East Forest, courtesy of our friends at Mission Club. Public ticket prices jump to $100 next week, but this friends and family link locks you in at $65. (You can thank us at that meet n’ greet.)

Btw, if you still need a ticket to PS2023 itself, register with code TD10 to take 10% off.

Thank You Life — I’m gonna go out on a limb here... When you saw the prices at Oregon’s first psilocybin center, your jaw dropped and your eyes popped. Well, you’re not alone.

Thank You Life is a 501(c)(3) nonprofit dedicated to helping people overcome the financial barriers to psychedelic therapy. If you’re feeling inspired to join their mission, you can donate to their scholarship fund and help bring life-saving treatment to more people.

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.