🫠 This Week in Psychedelics

Welcome to Tricycle Day. We’re the shroom chocolate of newsletters. We pack a punch, but it’s wrapped up in a nice and tasty package for ya every time.

Here’s what we got this week.

• Harm reduction works 💖

• Australia legalizes psychedelic therapy 🦘

• MAPS needs cash 💵

• We microdosed Ayahuasca 💧

FROM OUR SPONSORS

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(And that’s before you’ve blasted off to hyperspace.)

See the Tepez Pharm difference.

RESEARCH

Hotline peer support helps psychedelic users avoid harm

It’s no secret that we’re believers in the future of psychedelic therapy. But let’s be real; most of us are just tripping at home with no professional supervision. (No, your cat doesn’t count, even if he’s clearly dimension hopping.)

These days, more and more people are experimenting with psychedelics, which comes with some risk. So a recent study sought to find out if Fireside Project’s Psychedelic Peer Support Line could actually help people having a difficult psychedelic experience get out of harm’s way.

Based on hundreds of anonymous caller surveys and thousands of call logs, the answer is a resounding ‘yes.’

• 😮‍💨 65.9% of callers said the peer support line helped them de-escalate psychological distress

• 🤕 29.3% said they may have otherwise been harmed

• 📱 12.5% said they would have had to call 911

• 🚑 10.8% said they dodged a trip to the emergency room

For most people, medical support won’t be within reach during a challenging trip—or in the integration period afterward. It’s reassuring to know that affordable (i.e. free) support is not only available but also effective at reducing harm.

So next time you’re spinning out, and it’s not a life-threatening emergency, you know what to do.

MICRODOSES

🧫 Germ theory: Scientists working on more sustainable production methods for psychedelics have now biosynthesized psilocybin, as well as DMT, 5-MeO-DMT, and bufotenine, using E. Coli bacteria.

⚡ Fast-acting relief: In GH Research’s Phase 1/2 trial of GH001, a vaporized formulation of 5-MeO-DMT, 7 out of 8 patients were in remission from depression seven days after treatment.

🗣 A real clusterf*ck: Lobe Sciences has initiated a Phase 1 study of L-130, its proprietary stabilized form of psilocin, for the treatment of chronic cluster headaches.

🙅 Can’t touch this: The authors of a new paper on the challenges of informed consent in psychedelic therapy recommend therapists warn patients of “the possibility of feeling closer or more familiar to clinicians” and the “vulnerability to abuse.”

POLICY

Australia is the first country to let patients be prescribed psychedelics

What do walkabouts, freakishly large spiders, and psychedelic-assisted therapy have in common? They’re all harrowing experiences that are, nonetheless, legal in Australia.

On Saturday, July 1, Australia became the first country in the world to allow doctors to prescribe MDMA and psilocybin to their patients with PTSD and treatment-resistant depression.

Australia’s medicines regulator, the Therapeutic Goods Administration (TGA), announced the change in February. Ever since, there’s been some concern from more cautious public health experts that regulators are jumping the gun. They think:

• 🔍 The evidence isn’t there (yet): We need more research before psychedelics move to clinical practice.

• 🧑‍⚕️ Doctors aren’t ready: Overeager, undertrained providers could flood the space.

• 💸 Treatment will be unaffordable: A course of treatment is expected to cost between $15,000 and $25,000 AUD (or roughly $10k-$17k USD).

• 📝 We won’t learn from mistakes: Formal oversight of training, treatment, and outcomes will be minimal or misguided.

On the other hand, it probably won’t be as chaotic as doomsayers are warning. That’s because docs will have to jump through plenty of hoops to give psychedelics to their patients.

Only registered psychiatrists who have obtained approval from a research ethics committee and regulatory authorization from the TGA will be allowed to prescribe them. (No one is approved yet, as applications only opened on July 1.)

Even then, patients can only trip in supervised clinical settings. (Sorry, no take-home doses. 🥲) And to state the obvious, MDMA and psilocybin are still illegal in Australia outside this limited medical context.

Despite all the caveats, it’s still a huge moment for psychedelics and people suffering from difficult-to-treat mental health conditions worldwide. As Australia blazes the trail, the rest of us will be watching. 👀

MICRODOSES

🇺🇸 Presidential platforms: US President Joe Biden is apparently “very open minded” about the benefits of psychedelic therapy. Meanwhile, Robert F. Kennedy, Jr. has vowed to legalize psychedelics and cannabis if elected to the White House in 2024.

🪖 Defending the defenders: Bipartisan congressional lawmakers have added several provisions to a must-pass defense bill called the National Defense Authorization Act, which would expand access to medical cannabis and psychedelics for military veterans.

🇨🇦 Oh, Canada: The Canadian government is investing $3 million through the Canadian Institutes of Health Research to support three clinical trials that will study the benefits of psilocybin-assisted psychotherapy.

🌿 Cali sober: The California State Assembly’s Public Safety Committee has approved a Senate-passed bill to legalize the possession and facilitated use of some psychedelics. Next, it heads to the full Assembly for a vote.

💝 A gift from the heart: New Jersey senators have introduced the Psilocybin Behavioral Health Access and Services Act, which would establish an advisory board and legalize the possession, home cultivation, and gifting of psilocybin mushrooms between adults.

BUSINESS

MAPS is selling shares to get MDMA over the finish line

Anyone got $85 million lying around? ... Anyone? 🦗

That’s how much MAPS (that’s the Multidisciplinary Association for Psychedelic Studies) wants to raise through a private stock offering, just to stay afloat until MDMA is approved.

Even after throwing the largest psychedelic conference in history, they’re still strapped for cash. Why? Because developing and commercializing a drug is expensive AF.

MAPS is the organization that’s spent the last 9 years conducting (and paying for) clinical trials of MDMA-assisted therapy for PTSD. The FDA granted the drug “breakthrough” designation in 2017, but the regulatory process is still dragging on. Most experts predict MDMA will receive FDA approval within 12 months, but MAPS needs a cash lifeline to survive that long.

Until now, they’ve managed to keep the lights on through charitable donations and unconventional funding methods. Rick Doblin, founder of MAPS, has been careful to avoid any investor relationship that could compromise the mission of his nonprofit and public benefit corporation.

Don’t get it twisted; this is not financial advice. But if when the FDA does approve MDMA, MAPS will probably expand to international markets and get MDMA approved to treat other conditions, too. An investor in the deal says that would take the company from a $200 million valuation today to over $1 billion. 😳

MICRODOSES

🙏 Sankyo very much: Psychedelic biotech startup, Psylo, has entered a sponsored research agreement with global pharma company, Daiichi Sankyo, to help develop its pipeline of psychiatric medicines.

🤮 Not that kind of purge: Filament Health has agreed to license its proprietary botanical psilocybin drug candidate, PEX010, exclusively to NeoLumina Bioscience. Together, they plan to commercialize the drug for the treatment of eating disorders.

🚗 BetterLife is a highway: BetterLife Pharma’s patent application covering BETR-001, a non-hallucinogenic LSD derivative with neuroplasticity properties, has been put on the fast track.

💉 No patent, no problem: PharmaTher has partnered with Vitruvias Therapeutics to bring a generic form of ketamine called KETARX™️ to market. This week, they kicked off the abbreviated new drug application process with the FDA.

Ayahuasca Microdose Tincture — You’ve heard of microdosing mushrooms and LSD. But what about the grandmother plant medicine, Ayahuasca? This dual-extracted tincture provides all the therapeutic benefits of Banisteriopsis caapi, aka the soul vine, without the hallucinogenic effects of DMT. (It also happens to be 100% legal in all 50 states.)

Try a bottle, and see why users report feeling calm, at peace, and “unf*ckablewith.” Use code TRICYCLE10 for 10% off your order.

Thank You Life Launch Party — It’s not every day that you get to rub (virtual) shoulders with some of the biggest names in psychedelics and music. But today is a special day, my dear Cyclists, because Thank You Life is inviting you—yes, you—to their free launch party this Monday, July 10. Pull up for the private performances from East Forest, Porangui, and more, and stay for the enlightening talks from some true pioneers of psychedelic therapy.

Psychedelic Summit Replays — Science nerds, rejoice! The fine folks at UC Davis have released all the recordings from this year’s inaugural Psychedelic Summit. Whet your appetite with Dr. David Lubarsky’s opening address, and if you’re feeling inspired, catch the deep dives on topics ranging from microdosing to neuroplasticity and psilocybin therapy.

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.