This Week in Psychedelics
[6-min read] Psychedelics bill passes the California Senate.
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Alright, enough dilly dallying. Here’s what we got this week.
How ketamine stops depression 💥
Is California going Cali sober? 🌿
The company ready to pounce on MDMA’s approval 💊
Gone foragin’ 🍄
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The top stories in psychedelic research, policy, and business
Ketamine reverses depression by boosting neuroplasticity
For all the talk of psychedelics in mental health, ketamine is still the only treatment that’s actually legal in the US outside of clinical trials. This week, we found out how it works.
A new study in Nature confirmed that changes in neuroplasticity may be at the root of ketamine’s therapeutic effects on depression.
Hold up, Tricycle Day. Didn’t we already know that? Sorta… but not exactly.
Previous research helped establish that theory, yes. But so far, it’s all been in animal models. This is the first placebo-controlled study in humans to look at the relationship between markers of neuroplasticity and treatment response to ketamine.
Researchers gave 98 patients, who’d failed on at least one traditional depression treatment, an intravenous infusion of ketamine. Then they looked at specific areas of the brain known to be affected by the disease and measured local changes in neuroplasticity. Finally, they compared the brain images with standard depression rating scores.
Bada-bing, bada-boom. The results showed that increased neuroplasticity was linked to improved depression scores.
We may share ~90% of our DNA with rodents (and 100% of our hopes and dreams), but at the end of the day, mice ≠ humans. Translating animal neuroscience findings into people helps us confirm what really works in practice.
We all just want to be the best versions of ourselves, right?
💑 Do you feel me? Terran Biosciences performed the first comprehensive salt and polymorph screens of MDMA, resulting in a handful of new “empathogens” — compounds that increase feelings of empathy.
🐭 Pinky and the brain: A study in mice models found that 5-MeO-DMT produced short-lasting experiences with long-lasting benefits. Even though the acute effects were brief compared to psilocybin, the rewiring of neural connections persisted.
🙋 I volunteer as tribute: The first human volunteers have been dosed with CYB004, Cybin’s proprietary DMT infusion being developed for Generalized Anxiety Disorder.
🏃 Going the distance: More than half of patients who took a single dose of COMP360 (Compass Pathways’ psilocybin) were still in remission from depression 18 months later. The open-label trial, led by Sunstone Therapies, may be the longest clinical study of psilocybin therapy ever conducted.
California legalization bill passes the Senate
If you want to go Cali Sober in California, you have to break the law to do so. But that could all change soon. 🤞
This week, a bill that would decriminalize 5 naturally occurring psychedelics passed the state Senate. If it’s signed into law, adults 21+ will be allowed to have limited amounts of psilocybin, psilocin, DMT, ibogaine, and mescaline for personal and facilitated use.
The bill, SB 58, has had a checkered past, and its future is far from certain. So far, proponents have already made some concessions to appease naysayers and keep the momentum.
No synthetics. Sorry, MDMA and LSD. We’ll come back around for ya.
No peyote. Yes, it’s natural, but it’s also at risk of over-harvesting. We wouldn’t do our Indigenous brothers and sisters dirty like that.
No use on school campuses. Because college freshmen generally don’t pay much attention to age restrictions on mind-altering substances.
Quantity limits in line with personal use. Well, that’s kinda subjective if you ask us.
If it survives the Assembly, the last stop is Governor Gavin Newsom’s desk for sign-off (or veto). It’ll be a tricky decision for him, since everyone knows he’s got his eyes set on the presidency.
Look, we don’t endorse political candidates here, but let’s just say… we’re not not gonna vote for Newsom if he campaigns on a platform of making psychedelics free for everyone.
We’re only going to the rally if he wears the robe.
🪨 Colorado governor Jared Polis signed a bill into law, solidifying a regulatory framework for legal psychedelics in the state.
🏞️ Minnesota governor Tim Walz signed two large health policy bills into law with provisions on harm reduction and psychedelics to prepare the state for possible legalization.
🎰 Nevada Senate has passed a bill that would create a Psychedelic Medicines Working Group charged with developing a plan for regulated therapeutic access.
🇬🇧 United Kingdom: The UK Parliament held a debate about rescheduling psilocybin for medical use. Voices from both sides of the aisle expressed their frustration with the government’s slow pace of policy reform.
🇪🇺 Europe: Members of the European Parliament (MEPs) from Portugal, Finland, and more announced the launch of an Action Group for Medical Use of Psychedelics. The group hopes to make the EU a global leader in psychedelic regulation.
Numinus gears up for MDMA approval
Businesses can boom or bust at an inflection point. And in the psychedelics industry, there’s probably no greater inflection point ahead than the FDA approval of MDMA-assisted therapy, expected in 2024.
Expanding the Numinus Network: They’ve locked in their first “practitioner partner” and are courting more. Network partners are essentially franchisees who get to run their own clinics with Numinus’s backing and resources.
Trimming the fat: They’ve cut costs ruthlessly and are prioritizing revenue-generating activities, so they don’t burn all their cash before showtime. (We’ve seen that movie before.)
Cozying up to payers: Now that the AMA has approved a billing code for psychedelic-assisted therapy, they’re confident they can fall back on their existing payer relationships to get patients’ medical expenses reimbursed.
Training an army of practitioners: Numinus is already offering classes and certifications to professionals who want to offer ketamine, MDMA, and psilocybin-assisted therapy.
If the Great Ketamine Clinic Collapse of 2023™️ is any indication, psychedelic therapy is a brutal business. But it’s also a massive opportunity for whoever can execute.
And we all know, just being first isn’t enough to win.
No spoilers. 🙈
🥊 The plot thickens: FCM Holdings, the group of rogue MindMed shareholders who’ve repeatedly criticized the company’s leadership, apparently struck a nerve. MindMed put out a report from an independent third party, validating their R&D strategy.
💩 Bowel movement: Tryp Therapeutics has submitted an Investigational New Drug (IND) application to the FDA for its phase 2a clinical trial of psilocybin-assisted therapy for adults with IBS.
🧐 Putting you on notice… that Small Pharma has secured 5 Notices of Allowance and 5 new grants for various patents since February. The company expects 3 more patents to be granted by the end of this month.
🃏 Stack the deck: Incannex Healthcare has added three renowned psychedelics researchers, including two from Johns Hopkins, to the advisory board of its subsidiary, Clarion Clinics Group.
Hot takes from around the web
Our favorite opportunities for mind expansion
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Have a Good Trip Benefit Concert — ICYMI, Psychedelic Science 2023, the biggest psychedelics conference in the world, is coming up next month in Denver. But even if you’re not the business event type, you’re invited to the unofficial afterparty, which will include a full set from The Flaming Lips, comedy acts from Eric Andre and Reggie Watts, and other multi-sensory surprises.
A portion of proceeds goes to support MAPS and their efforts to advance psychedelic medicine. Tickets are on sale now.
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.