RAND Corporation report digs into U.S. psychedelic use; Yet another California psychedelics bill dies; The latest on Lykos and MDMA-assisted therapy
Plus: UN report reviews the “psychedelic renaissance” and LSD use associated with lower resilience
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.
RAND Corporation report digs into U.S. psychedelic use
The thinktank RAND Corporation released a report yesterday reviewing and analyzing the changing state of psychedelics policy. The most substantial contribution of the report is an overview of a survey conducted by RAND in December 2023 in which the organization polled a nationally representative group of over 3700 adults about their drug use. While nearly 86 percent of respondents said they’d drank alcohol in their lifetime and 56 percent said they’d used cannabis, just 12 percent said they’d tried psilocybin, and 12 percent said they’d tried LSD.
RAND also asked respondents about their use of substances in the previous year and month. According to responses, psilocybin was the most popular psychedelic, with 3 percent of respondents using it in the last year and just under 1 percent in the last month. Among those who reported using psilocybin in the last year, about half said they last used a microdose. Researchers also analyzed data from the U.S. Substance Abuse and Mental Health Services Administration’s National Survey on Drug Use and Health, and determined that compared with cannabis or other drugs, people who take psychedelics use the drugs much less frequently. The researchers conclude that more data should be collected on drug use to inform future policy changes.
The report also reviews recent policy changes in access to psychedelics. Currently, there are a range of approaches, such as companies conducting clinical trials to have psychedelics approved as medicines; the launch of regulated psilocybin programs in Colorado and Oregon; and state bills decriminalizing the possession and use of psychedelics. “Now is the time for federal policymakers to decide what they want these supply models to look like and to start taking action,” the RAND report authors write. “Or, if they prefer a patchwork of state policies—possibly including those that allow for commercial supply and promotion—they can do nothing and just watch the industry grow. If that happens, it can be difficult to make major changes to supply or regulations, but that will depend on the size and political power of the industry that has taken root.”
Yet another California psychedelics bill dies
On Tuesday, California’s Senate Bill 803 stalled in the State Assembly’s Committee on Health. Introduced in June, the bill would have allowed public health officers in San Francisco, San Diego, and Santa Cruz counties to “establish and operate psychedelic-assisted facilitation centers” only for veterans and first responders.
An analysis by the committee raises several policy concerns with the bill, including a lack of clarity in the program’s design. Public health officers, the document says, are “highly unlikely” to “have the background, experience, and capacity to single-handedly establish and operate an experimental pilot program.” The committee’s analysis also points out that this lack of capacity could be “especially concerning given that there is zero role for local or state government in establishing or overseeing the pilot programs in this bill.”
This rounds out the fourth legislative session in a row that California lawmakers have tried and failed to pass a psychedelics-related bill.
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The latest on Lykos and MDMA-assisted therapy
Yesterday, the Institute for Clinical and Economic Review (ICER), published a final evidence report assessing Lykos Therapeutics’ clinical trial results on MDMA-assisted therapy for treating PTSD. A draft version of the report concluded that the existing evidence is “insufficient,” as does the final version.
ICER also published policy recommendations should MDMA-assisted therapy be approved by the FDA. The group urges the FDA to create a risk evaluation and mitigation (REMS) strategy to track adverse events and to require certifications for providers of MDMA-assisted therapy, and notes that groups like the Veterans Affairs or professional societies should develop their own clinical practice guidelines.
In response, Lykos published a press release on Thursday saying they were “disappointed in the contents and overall findings of this report,” and that it “has requested time to discuss its concerns with ICER.” ICER has previously told The Microdose that Lykos was invited to participate in the organization’s months-long investigation and report-drafting process, but did not engage.
Some psychedelics advocates have harshly criticized ICER. The Heroic Hearts Project, a group that advocates for psychedelic treatment for veterans, published an open letter on its website detailing what it sees as the “underlying motives for the carefully coordinated, unscientific, anti-MDMA smear campaign.” In the letter the Heroic Hearts Project speculates that ICER’s “opposition to MDMA-AT is thus likely influenced by Big Pharma.” Evidence for such a claim was not provided and, in fact, ICER has been highly critical of large pharmaceutical companies’ pricing schemes, which has resulted in some large companies paying lobbying firms to undermine the impact of the non-profit’s analyses and reports.
UN report reviews the “psychedelic renaissance”
On Wednesday, the United Nations’ Office on Drug and Crime released its annual World Drug Report. The report, compiled by dozens of UN-affiliated researchers and scientists, offers data on drug use and analysis of drug markets and includes a section on developments related to psychedelics. It notes that there are currently more than a thousand registered clinical trials to study the effects of LSD, MDMA, psilocybin, and ketamine but that no country has authorized an open medical market for psychedelics.
The report mentions the June 4 Food and Drug Administration’s Advisory Committee meeting on Lykos Therapeutics’ New Drug Application for MDMA-assisted therapy and the concerns that were raised by the committee about bias in outcomes, how to protect against clients against potential abuse by facilitators, and the complications inherent in approving a drug that is administered together with psychotherapy, which the FDA does not regulate. “This highlights the complexity and constraints of a medical therapy that could eventually come out of experimentation and have the potential to open up parallel markets of psychedelics used for alleged medical benefits outside of a formal medically-approved context,” the report says.
It also mentions psychedelic use outside of state-regulated or medical spaces in contexts like psychedelic tourism and retreats or microdosing communities. People in these environments often engage with these substances to self-treat ailments or for spiritual pursuits. “The risk is that the perception of psychedelics as the ‘silver bullet’ for mental health disorders and overall mental or spiritual well-being, which is advocated for by a growing number of advocacy groups and commercial interests, will move faster than scientific evidence, opening up the market to unsupervised, ‘quasi-therapeutic’ or spiritual and recreational use before supervised therapeutic use, including adequate screening and facilitation, can be established.”
LSD use associated with lower resilience
Some previous studies have found that psychedelic use is associated with improved mood and increased psychological resilience, allowing people to better navigate hardship. But a new study published in PLOS One adds to a small but growing body of evidence suggesting that psychedelic use can also be associated with worse mood and lower resilience.
In the study, University of Konstanz researcher Benjamin Korman analyzed data from 5 million people experiencing job loss between 2008 and 2019 to see whether LSD use before job loss helped people cope with that stressful life event. The data came from the National Survey on Drug Use and Health, a U.S. survey that collects information on mental health, life circumstances, and substance use. From those 5 million people, Korman selected only those who had used LSD in the year before their job loss. (The data did not ask respondents when they’d last used other psychedelics, such as psilocybin, mescaline or DMT, so he excluded participants who reported using those drugs.)
Overall, he found that LSD use was associated with a higher likelihood of severe psychological distress. Those who had used LSD before losing their job were 1.6-1.7 times more likely to feel distressed than those who did not. Korman notes that other variables — like personality traits — could be driving the effect, and is clear that the “findings are not meant to contest classic psychedelics’ potential therapeutic use in clinical populations,” or the possibility that LSD could provide short-term boosts to mental health or resilience in other contexts.
The city of Olympia, Washington is considering a proposal to make the enforcement of laws related to the use or cultivation of entheogenic substances such as psilocybin and ayahuasca tea the city’s lowest law enforcement priority, and that no city funds be used in investigations, prosecution, or arrests related to “entheogens,” a term used to describe psychoactive substances similar to mescaline or psilocybin.
In DoubleBlind, journalist Webb Wright delves into the rise of 4-AcO-DMT, an unscheduled psychedelic drug that is marketed in products that “contain psychoactive mushrooms.” The drug itself is largely unstudied, Webb writes, and risks could also arise from other chemicals used in making this unregulated product.
Indigenous healers in Mexico have long used psilocybin mushrooms in ceremony. A new bill in the country might increase access to psilocybin, which “has created friction within Indigenous communities,” reports the Los Angeles Times.
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