Beckley announces new results for 5-MeO-DMT drug; Updates on psychedelics and the Trump Administration; Data and lessons from Health Canada’s psilocybin access program
Plus: More psilocybin dispensary raids in Ontario, and Rats see trippy movement, too
Happy Friday and welcome back to The Microdose, an independent journalism newsletter brought to you by the U.C. Berkeley Center for the Science of Psychedelics.
Beckley announces Phase 2B results for 5-MeO-DMT drug, continues merger plans with atai
Last week, UK-based biotech company Beckley Psytech announced results from a Phase 2B clinical trial using BPL-003, the company’s formulation of 5-MeO-DMT, to treat treatment-resistant depression. In the study, nearly 200 participants received a single dose of BPL-003: either 12 mg, 8 mg, or a 0.3 mg, with the latter dose considered to be a pharmacologically inactive placebo. Researchers took baseline measures of participants’ scores on the MADRS, a standard depression questionnaire, and again the following day, the following week, four weeks later, and eight weeks later. The company reports that participants who received the largest dose showed, on average, an 11-point lower MADRS score four weeks after receiving BPL-003, while those in the placebo group showed only a 6-point reduction. MADRS scores of those who received 8 mg of BPL-003 were, on average, 12 points lower, similar to that of the 12-mg group, suggesting that the slightly smaller dose “may be sufficient to achieve therapeutic benefit,” the company’s release says.
Last month, drug company atai, which is backed by prominent investor Peter Thiel, announced its plans to merge with Beckley Psytech as long as this Phase 2B study reached certain pre-agreed success criteria. Thus far, atai has not responded to our request for more information about these criteria, but the company’s July 1 announcement said that the criteria have been met and that the companies will therefore continue the merger process.
Psychedelics advocates in high-ranking U.S. government roles
Several recent federal changes could affect efforts to get psychedelics approved by the Food and Drug Administration as medicines. First, in mid June, the U.S. Food and Drug Administration announced the launch of its “Commissioner’s National Priority Voucher” program, which will grant vouchers to companies for accelerated approval of drugs that address “national health priorities.” According to the FDA’s announcement, those priorities include “addressing a health crisis in the U.S.” and “addressing unmet public health needs,” and companies chosen for the vouchers will have new drugs reviewed in 1-2 months instead of the usual 10-12 months.
Around a week later, the FDA announced psychiatrist Mike Davis would become the leader of its Center of Drug Evaluation and Research, which reviews new drug applications. Davis was previously the chief medical officer at the Usona Institute, a nonprofit psychedelic research organization. And just days after that, Robert F. Kennedy Jr. attended a U.S. House Energy Committee hearing, in which he testified that psychedelics have a “tremendous advantage if given in a clinical setting,” and said the government was “working very hard” to make psychedelics available for treatment in the next 12 months.
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Data and lessons from Health Canada’s psilocybin access program
In 2022, Canada began allowing physicians to apply for access to psilocybin to treat patients through its Special Access Program (SAP). A paper recently published in Nature Mental Health reviews the program’s impact and current challenges to broader psilocybin access in Canada. The authors, Quebec-based pharmacists and psychiatrists, queried Health Canada for statistics about the program. They report that between its inception in January 2022 and the end of 2024, the program processed 436 requests, and around 70% were granted. Most requests were to treat depression or end-of-life distress, but other ailments included cluster headache, PTSD, and alcohol use disorder.
According to the authors’ analyses, rates of approval of physicians’ applications to SAP declined significantly in recent years, from an 82% approval rate in 2022 to 59% in 2024, despite the number of requests remaining similar. In addition, approvals to treat end-of-life distress had significantly higher approval rates than depression.
The authors point to issues with rolling out the program, such as regulatory complexity: applying for approval is time-consuming and requires detailed paperwork from medical professionals and patients. Additionally, there are “no widely accepted trainings, certifications or standardized accreditation processes for the provision of psychedelic therapies,” the authors write. A lack of standard psychedelic therapy training could also be bad for patients, they say; expertise is crucial for safety and efficacy.
Though Canada’s program is unique, it could be a model that is replicated elsewhere. “As interest in psychedelics grows across the globe, Canada’s SAP may offer critical insights for other jurisdictions exploring or implementing similar frameworks that more effectively balance the promise and real-world complexity of psychedelic therapies,” the authors conclude.
More psilocybin dispensary raids in Ontario
While some patients can receive psilocybin through Health Canada’s program, others are trying to purchase it illegally — and this week saw another string of law enforcement raids on Canadian dispensaries selling psilocybin mushrooms. On July 2 in Brantford, Ontario, around 100 kilometers from Toronto, local police seized over $29,000 CAD of psilocybin products from FunGuyz, according to the Brantford Expositor. For a time, the chain had 30 locations mostly in Ontario, and a spokesperson told the CBC last year that they’d been raided over 120 times.
The same day, local police raided another mushroom store called Shroomyz in Sudbury, Ontario, about 500 kilometers north of Brantford. According to the CBC, police seized $16,500 of psilocybin products and two employees were arrested on drug trafficking charges. Shroomyz is another psilocybin dispensary chain that is no stranger to raids. For years, Canadian police have been trying to shut down dispensaries like Shroomyz and FunGuyz, some dispensary owners say their businesses are an act of civil disobedience to protest outdated drug policy.
Rats see trippy movement, too
Distortions of visual perception are a common side effect of a psilocybin trip; people often report seeing static items moving, like walls pulsing or stationary shapes spinning. New research published in Biological Psychiatry Global Open Science suggests that rats also experience psychedelic-induced visual distortions. In their study, Czech researchers gave humans doses of psilocybin in capsule form and rats doses of injected psilocin, the psychoactive compound resulting from the body’s metabolism of psilocybin. They then asked participants to determine whether images were moving or still. Human participants reported their response via a computer program and also provided information about how intense their hallucinations were. As you might guess, people were more likely to report that still images were moving after taking psilocybin.
The researchers had to get more creative with the rodents, since they can’t directly report what they see. The six rats in this study were trained to discriminate static images from moving ones by receiving a cornball reward for correctly categorizing the stationary images. But after being dosed with psilocin, the rats gave far more incorrect answers, suggesting they were seeing movement in those static images.
Knowing that rats may also experience these visual distortions means they could be a model for better understanding human disorders like schizophrenia and Parkinson’s disease. “Given the high prevalence of visual hallucinations in various neurological and psychiatric conditions and the limited understanding of their underlying mechanisms, establishing reliable preclinical models is essential,” the authors conclude. “The rat model of hallucinations offers a valuable platform for investigating these phenomena and could contribute to the development and evaluation of novel treatments.”
Psychedelic Alpha’s Josh Hardman interviews former U.S. Senator from Arizona-turned-ibogaine advocate Kyrsten Sinema about the future of psychedelics and her role in the field. (“I am well known for having no drama. I do not engage in drama,” she told Hardman.)
Speaking of ibogaine advocacy, former Texas governor Rick Perry recently penned an op-ed for The Washington Post called “I’m dedicating my life to fighting for a psychedelic drug.”
For Audubon magazine, journalist Rachel Nuwer investigates how the demand for peyote ceremonies has led to poaching of protected eagles and trafficking of their feathers.
Some psychonauts are using AI chatbots like ChatGPT as their tripsitter and therapist, but many experts say that’s a bad idea, reports journalist Webb Wright for MIT Technology Review.
In DoubleBlind, Journalist Mattha Busby explores how an unlikely friendship between two psychonauts — researcher Leor Roseman and musician A$AP Rocky — spurred a hit song.
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