California psychedelics bill headed to Gov Newsom and proposed ballot initiative will cost $6.6 billion over 30 years; New clinical trial results move MAPS one step closer to FDA approval for MDMA

Australian psychedelics leaders surveyed on the rollout of legal therapeutic MDMA and psilocybin, Canadian peyote company goes public, and UK Committee reviews country’s drug policies

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.

The State of Psychedelics: California psychedelics bill heads to governor. Plus, proposed ballot initiative will cost CA $6.6 billion over 30 years

The California legislature has passed Senate Bill 58, which makes it state-legal for people over 21 to possess, prepare, grow, gather, gift and transport mescaline (excepting peyote), DMT, ibogaine, psilocin, and psilocybin. Selling drugs would still be illegal in the state. The Assembly voted last Thursday 21-14 to pass the bill, which was introduced by state senator Scott Wiener. Wiener introduced a similar bill in 2021, but it was gutted in committee last summer. The newly passed bill now heads to governor Gavin Newsom.

Meanwhile, the state’s Legislative Analyst’s Office released their review of the TREAT California Act, a proposed ballot initiative that would designate $5 billion in state bond sales to fund a new state institute to oversee psychedelics research, infrastructure, and delivery. The state determined that the initiative would cost $6.6 billion over the next 30 years.

New clinical trial results move MAPS one step closer to FDA approval for MDMA

Yesterday, Nature Medicine published results from MAPP2, MAPS’s second phase 3 clinical trial investigating the efficacy of MDMA-assisted therapy in treating PTSD. The study’s methods and results were similar to MAPP1, MAPS’s first phase 3 trial, the results of which were published in 2021. MAPP2 included around 100 participants who participated in three experimental sessions alongside therapy sessions over three months. In those experimental sessions, roughly half were given MDMA, while the other half received a placebo. Researchers assessed participants’ PTSD severity using a measure called CAPS-5. Those who received MDMA-assisted therapy had significantly lower CAPS scores after treatment than they did before treatment. By the end of the study, 71% of participants no longer met clinical diagnostic criteria for having PTSD. That’s similar to results from MAPP1 which found that 67% of participants who received MDMA-assisted therapy in that study were also considered to be in remission from PTSD. It seems therapy may have had some overall effect on outcomes as well; 21% of participants in the MAPP2 placebo group also met remission criteria, and 32% in MAPP1. 

One element included in MAPP2 that was not present in MAPP1 was an assessment of the study’s blinding. In an effort to reduce bias, clinical trials are often designed so that researchers and participants are “blind” to which participants have been assigned to an experimental versus control condition, but psychedelics’ strong subjective effects usually make it quite obvious who’s in which condition. MAPP2 asked participants which condition they thought they were in, and the vast majority guessed correctly: 94% of people given MDMA believed they had received the drug, and 75% of participants in the placebo group believed they had not received MDMA. This suggests that attempts to blind the study may have been ineffective.

For years, MAPS has been working towards receiving FDA approval for MDMA to treat PTSD, and the organization’s public benefit corporation says they expect to submit a New Drug Application to the agency “later this year.”

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Australian psychedelics leaders surveyed on country’s therapeutic MDMA and psilocybin rollout

Two months ago, Australia became the first country in the world to allow specially licensed psychiatrists to prescribe psilocybin and MDMA as medicine. On July 1, the country’s Therapeutic Goods Administration opened applications for psychiatrists seeking authorization to prescribe psilocybin for treatment-resistant depression and MDMA for PTSD. The last few months have seen a mix of concern, skepticism, and excitement from Australia psychedelics advocates, clinicians, and researchers. In a new paper published in Public Health Research and Practice this week, Monash University researchers interviewed four politicians and nine others from various stakeholder groups, including advocates and healthcare providers. 

All interviewees expressed concerns about the quality of evidence for psychedelics’ clinical use. Some pointed to common methodological flaws in studies of psychedelics with human participants, including small sample sizes and a lack of adequate blinding practices. Interviewees told the article’s authors that better research should be the basis of all messaging about psychedelics, and that stronger research in conjunction with human stories about the need for mental health intervention could combat some of the lingering stigma in the country around use of psychedelics. 

Canadian peyote company goes public

Last week, a Canadian company called Lophos began trading on the Canadian Securities Exchange, with shares debuting at $0.15 a share. The company’s CEO told Vice that Lophos is the only publicly-traded Canadian company that aims to legally grow and sell peyote. In the United States, peyote is federally illegal except for ceremonial use by the Native American Church. In Canada, growing and consuming the cactus itself is not illegal, though extracting mescaline from it is. 

Peyote can take up to a decade to grow into a mature cactus, but Lophos claims they will accelerate peyote cultivation to “as low as 3 years.” Lophos also hopes to conduct clinical trials with mescaline in the future. Images from a Lophos slidedeck posted by psychedelic patent attorney Graham Pechenik in 2022 suggest the company is working towards creating “peyote-based health and wellness products,” including microdose capsules and other “potentially patentable Peyote product delivery methods including transdermal patches, sublingual stripes, and extended-release technologies.”

UK Committee reviews country’s drug policies

The United Kingdom’s Home Affairs Committee released a report in which members of parliament made recommendations to the UK Government on reforming the country’s Misuse of Drugs Act, which went into effect in 1971. In the report, the committee suggested drug policy changes, which included supporting safe consumption facilities and establishing a national drug checking service in which people can anonymously have their drugs tested for adulterants like fentanyl. 

The Home Affairs Committee’s report also addresses psychedelics directly, citing testimony by psychedelics researchers David Nutt and Joanna Neill that “Schedule 1 licensing requirements place bureaucratic and costly burdens on researchers and medical professionals.” Such barriers slow research as well as impede the UK from developing a psychedelics industry, which could “undermine innovations in medical treatment and undermine the UK as a global leader in science and medicine,” according to the report.

• In his newsletter Ecstatic Integration, Jules Evans writes about Canadian psychedelic figure David Harder’s role in the industry and allegations from clients who say Harder raped them during tantric massage sessions and provided inadequate support during psilocybin sessions. 

• The New York Times profiles rapper Sean Combs, who says his “toad venom” trips were a life-changing part of “remaking himself” and returning to the music scene.

• Wired UK talks to entrepreneurs and employees embracing the “workplace shroom boom.”

• According to People, former Saturday Night Live comedian Pete Davidson opened a recent stand-up set with a bit about his daily, four-year-long ketamine habit and his most recent stint in rehab.

• Robert Forte, the man who claims he introduced microdosing godfather James Fadiman to the concept of microdosing, isn’t a fan of the practice. "Microdosing is reframing psychedelics to serve the mainstream values of consumers,” he tells writer Reilly Capps in Rooster Magazine. 

• On Thursday, the U.S. Office for Human Research Protections, a part of the Department of Health and Human Services, held a day-long workshop on the ethical and practical considerations of psychedelics research. You can see slides from the workshop here.

Correction: In our September 8 issue, we included an item about a study investigating teenagers’ attitudes towards receiving MDMA-assisted therapy, as well as attitudes from their parents and clinicians. We initially wrote that the researchers also administered MDMA to the teenagers. While researchers are planning to administer MDMA to young people, they have not yet done so. The post has been corrected, and we regret the error. 

You’re all caught up! Have a great weekend. We’ll be back in your inbox on Monday with a new issue of 5 Questions. 

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