MindMed launches first Phase III LSD trial; A new psychedelic mushroom species?; No tripping outdoors in Denver
Plus: Can psilocybin increase empathy in depressed people? and Naropa spins out psychedelic training program
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.
MindMed launches first phase III LSD trial
This week, psychedelics company Mind Medicine announced it has begun the first Phase III clinical trials for MM120, the company’s formulation of LSD, which comes in the form of an oral tablet. In March of this year, the U.S. Food and Drug Administration granted MM120 a breakthrough therapy designation to treat generalized anxiety disorder.
The trial will take place across 20 sites in the U.S, and 200 participants will receive either MM120 or a placebo. Researchers will assess whether LSD leads to a reduction in anxiety symptoms within the first 12 weeks of the study; after that, there will be a 40-week open label phase of the study in which some of those participants will be eligible to continue receiving LSD treatment.
Perhaps the most noteworthy thing about MindMed’s methodology is that unlike most previous psychedelic clinical trials, participants in MM120 trials do not receive psychotherapy. “We want to isolate the stand-alone effects of our investigational drug,” MindMed’s chief medical officer Daniel R. Karlin told The Microdose. Instead, he says participants will be introduced to a clinician before their dosing session who will serve as a “dosing session monitor” (DSM); during the session, a second monitor will observe via video. “During the dosing session, the DSM’s goal is to be unintrusive to the participant’s experience but must provide occasional safety-related checks such as monitoring vital signs at the protocol-specified time points,” Karlin says. “The DSMs passively observe the participant in silence and are available if a participant needs food, a beverage, to use the bathroom or change lighting or music or assistance for comfort.”
MindMed has previously released results for its phase IIB study using MM120, reporting that people with generalized anxiety disorder who received a dose of MM120 showed lower scores on an anxiety scale than those who received a placebo, with 65 percent of participants who took LSD showing a significant decrease. The results have not yet been published in a peer reviewed journal.
A new psychedelic mushroom species?
Biologists in Zimbabwe, South Africa, and the U.S. have identified a new psychedelic mushroom species. In a paper uploaded to bioRxiv, a site that hosts pre-prints, or scientific papers that have not yet been peer-reviewed, the researchers describe what they believe is a new species that they’ve proposed calling Psilocybe ochraceocentrata. The species is a relative of Psilocybe cubensis, which is arguably the best-known psychedelic mushroom species and cultivated widely throughout the world. There are more than 100 known Psilocybe species, which can be found in temperate areas of every continent besides Antarctica.
P. ochraceocentrata appears nearly identical to other Psilocybe species, which may be why it has remained unidentified until now. (In fact, in their paper, the researchers say that 4 of 5 Psilocybe natalensis samples they collected appear to actually be P. ochraceocentrata.) The researchers compared the genetics of the two mushrooms and found they were, in fact, different — and based on their shared genetics, they estimate that the mushrooms shared a common ancestor roughly 1.5 million years ago.
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No tripping outdoors in Denver
Last week, the Natural Medicine Work Group, convened by the city of Denver’s Department of Excise and Licenses, made recommendations to the city about what rules to adopt as the state prepares to launch its Natural Medicine program on December 31. While some cities such as Colorado Springs and Fountain have proposed stricter restrictions on where or when psilocybin businesses can operate, the Denver work group did not make such recommendations.
However, the work group has suggested the city prohibit sessions in the outdoors and that the city require service centers to pay an annual fee, likely between $200 and $500, in addition to state licensure fees. The group will draft the new ordinance in coming weeks, and the city council will vote on it in early 2025.
Can psilocybin increase empathy in depressed people?
After a psychedelic trip, many people report feeling more open to others and connected to the world. Depression, on the other hand, often makes people withdrawn and isolated. Empathy, a form of social cognition, can be impaired in people with depression, but previous studies surveying the general population suggest psilocybin can increase it. In a new paper published in Molecular Psychiatry, Swiss and German researchers put those pieces together, positing that psilocybin could boost empathy and help people with depression.
This study was the first to examine how psilocybin can alter measures of empathy in depressed people, rather than a general population. Researchers recruited 51 people experiencing depression and randomly assigned them to receive either a dose of psilocybin or a placebo alongside 4 weeks of psychological support. They measured participants’ empathy through a standard questionnaire, which asks people to give a 1-5 agreement rating in response to questions like “I find it easy to bond with people who have radically different values or lifestyles from my own,” and “The success or happiness of others often makes me feel envious.” Participants completed the questionnaire once before their dosing session, and then 2 days, a week, and 2 weeks afterward.
Overall, the researchers report that people who received psilocybin showed more improvement in their empathy scores compared to the placebo group, and that those results persisted over the two weeks after their dosing session. However, there was no correlation between increased empathy and improvement in depression symptoms over the course of the study. As a result, the researchers write, “our findings do not allow the conclusion that improvement in empathy is a key psychological mechanism of psilocybin which drives the reduction of depressive psychopathology.”
Naropa spins out psychedelic training program
Earlier this month, Boulder-based Naropa University cancelled its psilocybin facilitator training program, which was beginning a new cohort in January. The university’s president told Boulder Weekly that the school’s insurer “decided that they were not comfortable with the training happening through the university,” and that the university was exploring ways to offer the course through a different entity.
This week, Naropa announced that its Center for Psychedelic Studies would be separated from the rest of the university and renamed the Memoru Center for Visionary Healing Arts. (Memoru means “to remember” in Esperanto, a language created in the 1880s with the vision of being a universal language.)
Naropa is partnering with psychedelic researchers and therapists to launch the program, which will include its psilocybin facilitator training program. Memoru will also be starting an Introduction to Psychedelic Ethics course. The Microdose reached out to Naropa’s president with questions about the university’s insurer, but did not receive a reply; it is not yet clear whether or how Memoru is insured.
The New York Times covers veterans with brain injuries interested in using psychedelics as well as people using psychedelics as part of their end-of-life care.
For Science, journalist Rachel Nuwer reports on a recent study suggesting psychedelics could improve mental health in people with autism.
The podcast Search Engine talks to former “anti-woke” podcaster Sarah Haider about how her ayahuasca trip sapped her of her will to participate in performing outrage online, and, ultimately, in podcasting altogether.
Is it a conflict of interest for psychedelics researchers to use psychedelics? For DoubleBlind, journalist Mattha Busby talks with researchers, who say they believe their first-hand experiences with the drugs have made them better researchers.
Psychedelics advocates are hopeful they have an ally in Robert F. Kennedy, Jr., president-elect Donald Trump’s nomination for Secretary of Health and Human Services. But will the Senate confirm him? The Washington Post is tracking senators’ allegiances.
DoubleBlind put together a list of the top 25 psychedelic rock albums.
You’re all caught up! And that’s it for the year. We’ll be back in your inbox the first week of 2025 with predictions for the new year from psychedelic journalists.
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