Alberta regulates psychedelic-assisted therapy, Phase 3 psilocybin clinical trials, LSD paper retracted, and what Biden’s marijuana pardons mean for psychedelics
Alberta regulates psychedelic-assisted therapy, Phase 3 psilocybin clinical trials, LSD paper retracted, and what Biden’s marijuana pardons mean for psychedelics
Plus: Do psychedelics improve mental health? It might depend on your race.
Happy Friday, and welcome back to The Microdose.
Alberta becomes first Canadian province to regulate psychedelic-assisted therapy
Last week, officials in the Canadian province of Alberta announced plans to regulate psychedelic-assisted therapy. CBC detailed the new regulations:
Alberta's new regulations would require medical directors to apply for a license before treating patients with psychedelics for mental health disorders. A psychiatrist would have to oversee any treatment, according to the regulations taking effect in January 2023. Health professionals could not charge money for the drugs, and a qualified professional must only give patients the drug at a medical facility – unless the person is in palliative care.
Over the last few years, the main access points to psychedelic-assisted therapy in Canada have been through participation in clinical trials, which have limited enrollment, or by receiving an official exemption from Health Canada’s health minister. Earlier this year, the agency introduced a new program allowing patients to apply for access to psychedelic-assisted therapy through their physicians. Over the summer, patients sued the Canadian government demanding greater access to psychedelics. (That case is still in process.)
Do psychedelics improve mental health? It might depend on your race
Both clinical trials and correlational studies suggest psychedelics could help treat mental health issues. A new study, published this week in Scientific Reports, replicates those results, finding that MDMA and psilocybin use were associated with lower psychological distress and suicidality — but not for people who are Black, Indigenous, and/or multiracial.
Harvard psychologists Grant M. Jones and Matthew K. Nock used data from the National Survey on Drug Use and Health, a yearly survey that asked over 484,000 people about their psychological health and drug use between 2008 and 2019. In their analysis, they found that for white participants, MDMA and psilocybin use had strong correlations with lower likelihood of participants reporting psychological distress over the month before they participated in the survey, and suicidal ideation or suicidal planning over the previous year. Reports from Hispanic and Asian participants suggest weaker links between psychedelics and mental health; those who used psilocybin were significantly less likely to report distress over the previous month, and Hispanic participants who used MDMA were less likely to report suicidal ideation over the previous year. But for Black, Indigenous, and multiracial participants, neither psilocybin nor MDMA use did not significantly correlate with positive mental health effects.
Jones and Nock caution readers against drawing conclusions about causality from these results; correlational studies like this one can’t explain the cause of these mental health outcomes. “We cannot infer that MDMA use and psilocybin use decrease distress and suicidality within White participants, nor that these substances fail to do so for Black, Indigenous, and Multiracial participants,” they write.
Still, the authors go on to argue that their results suggest that race and ethnicity play some role in the link between psychedelic use and mental health, and that other researchers should consider that when designing studies. Both set (people’s mindset going into a psychedelic experience) and setting (the environment in which the experience occurs) affect the outcomes of drug experiences and psychedelics’ efficacy. “Unfortunately, in the American ‘setting,’ racism, prejudice, and discrimination are deep-rooted features of the minority experience and may thus negatively impact the minority psychedelic experience,” the authors write. Settings in clinical trials and treatment environments have been largely designed and administered by white clinicians and therapists, and the authors write that researchers should consider including “culturally-tailored” psychedelic treatment.
There has never been a more exciting – or bewildering – time in the world of psychedelics. Don’t miss a beat.
A free newsletter from the U.C. Berkeley Center for the Science of Psychedelics
LSD paper retracted
The 2020s have seen an explosion in the number of psychedelics-related academic papers published. That explosion has coincided with a larger discussion in the sciences about the replicability of research, and academic journals’ tendency to favor papers with splashy findings. This week, watchdog publication Retraction Watch reported on the retraction of a 2020 paper about LSD’s effects in the brain, which was originally published in Scientific Reports.
The study was retracted after University of Amsterdam graduate student Paul Lodder tried and failed to replicate the results reported in the paper. Lodder says he reached out to Rubén Herzog, the study’s lead author and a Ph.D. student at the University of Valparaíso in Chile, who shared details about the model that was used in the paper. (Lodder’s co-authors included fellow Valparaíso researcher Rodrigo Cofre, University of Buenos Aires researchers Yonatan Sanz Perl and Enzo Tagliazucchi, University of Cambridge’s Pedro A.M. Mediano, and Imperial College London researchers Fernando E. Rosas and Robin Carhart-Harris.)
Lodder followed the methods described by the authors, but ended up with different results. He wrote to Herzog again, hoping he could help identify the issue. Herzog then sent Lodder the original code he used to run the study, which produced the same results the team originally reported in their paper. After looking more closely, Lodder identified an error in the code.
“Rubén’s handling of the situation has been a display of extreme academic integrity from beginning to end,” Lodder wrote in a follow-up Retraction Watch post detailing his experience. “In a more general sense, however, I’m disappointed in how little emphasis there seems to be in academia (and by journals) on the reproducibility of computational results.” In an ideal world, study co-authors and paper reviewers would understand the code well enough and have enough time to double-check their colleagues’ work before publication.
What Biden’s marijuana pardons mean for psychedelics
Last week, President Biden pardoned all U.S. citizens and permanent residents who have been charged or convicted with simple marijuana possession by federal or District of Columbia officials. Biden’s proclamation specifically mentions a few laws, including the Controlled Substances Act, and specifically mentions that the proclamation pardons “only the offense of simple possession of marijuana in violation of Federal law” (or District of Columbia laws), “and not any other offenses related to marijuana or other controlled substances.” So, what might this pardon mean for psychedelics?
In a new issue of On Drugs, attorney Shane Pennington argues that Biden’s proclamation is a game-changer for all scheduled drugs. He focuses on an item Biden mentions in a statement about his pardon:
I am asking the Secretary of Health and Human Services and the Attorney General to initiate the administrative process to review expeditiously how marijuana is scheduled under federal law. Federal law currently classifies marijuana in Schedule I of the Controlled Substances Act, the classification meant for the most dangerous substances. This is the same schedule as for heroin and LSD, and even higher than the classification of fentanyl and methamphetamine – the drugs that are driving our overdose epidemic.
Pennington’s post states that the process of rescheduling marijuana would require reinterpretation of whether marijuana is, indeed, a Schedule I drug, meaning a drug that has “no currently accepted medical use in treatment in the United States.” If marijuana is found to have medical use and is rescheduled, that could lead to rescheduling of other drugs, including psychedelics. “In short, virtually any administrative process that permits cannabis to escape Schedule I will permit—or at least open the door for—other substances to escape Schedule I as well,” Pennington writes.
Compass’s first ever Phase 3 psilocybin clinical trials
On Wednesday, psychedelics company Compass announced plans for Phase 3 clinical trials studying psilocybin’s efficacy in treating treatment-resistant depression. This is the first Phase 3 clinical trial for psilocybin, which brings the drug one step closer to potential approval from the U.S. Food and Drug Administration.
A quick refresher on clinical trial phases: there are four phases a drug moves through, each can last a few months to a few years. Phase 1 trials test just a few dozen people to assess a drug’s general safety and to explore what dosages to use. Phase 2 trials study involve a few hundred people to investigate how effective the drug is in treating a particular disease or illness, and its potential side effects. Phase 3 involves hundreds or thousands more participants to further assess efficacy and safety by closely monitoring adverse reactions. (Often, drug companies apply for FDA approval after Phase 3.) Finally, in Phase 4 trials, researchers study several thousand additional participants to collect even more data on safety and efficacy of drugs. Most Phase 4 trials are conducted after a treatment is approved for use by the FDA.
Compass says their Phase 3 program is set to begin before the new year, and it will include nearly 1,000 participants. Based on the timing of these trials, Psychedelic Alpha estimates any potential approvals wouldn’t happen until 2025:
Forbes profiles Bob Parsons, the billionaire founder of GoDaddy and a major psychedelics funder and advocate.
In a new series, Lucid News explores the intersection of psychedelics and religion. The first installment explores the Santo Daime church and its role in shaping U.S. psychedelic policy.
The Bend Bulletin published an op-ed written by Bridget Knight, a psychiatric nurse practitioner serving on the Oregon Psilocybin Services Rules Advisory Committee. In her piece, Knight raises concerns about what she calls “very limited training requirements” for practitioners.
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.
If you know anyone who might like the latest on psychedelics in their inbox, feel free to forward this to them, or click below.
Got tips? Email us at themicrodose@berkeley.edu.
"But for Black, Indigenous, and multiracial participants, neither psilocybin nor MDMA use did not significantly correlate with positive mental health effects." (??? Uhhhh...I do not quite understand...)
"marijuana is, indeed, a Schedule I drug, meaning a drug that has “no currently accepted medical use in treatment in the United States.” This is untrue. THC was approved by the FDA in 1985. The drug Marinol is made of synthetic THC and was approved for nausea from chemo and radiation and to stimulate appetite in people with anorexia nervosa. Cannabis as a Schedule 1 drug is political not scientific. Other compounds found in cannabis such as CBD are approved all over the world.