Microdosing might boost mood and mental health, preparing for off-label use of psychedelics, and terminally ill patients likely to take DEA to court — again

Plus: Federal agencies weigh in on psychedelics and The State of Psychedelics

Happy Friday, and welcome back to The Microdose. Here’s the news of the week:

Microdosing might boost mood and mental health. While many people swear by microdosing, scientific evidence on the practice’s effectiveness is still scarce. One study we reported on in February concluded that the effects of microdosing were negligible; another, published by a team led by University of British Columbia psychologist Joseph Rootman, found that people who microdose report lower levels of anxiety and depression than non-microdosers. 

Last week, Rootman and colleagues published a new paper examining the mental health and mood of microdosers over the course of a month. (Several of the authors also worked on the Rootman et al. 2021 paper, and some participants’ data in this new study was also used in the group’s 2021 paper.) The researchers asked both microdosers and non-microdosers to fill out surveys about their mood and mental state and to complete tasks to measure cognitive abilities like spatial memory and mental processing speed. Participants went through this process twice: once at the beginning of the study and again a month later.

The researchers found that compared with non-microdosers, microdosers had small improvements in their mood and mental health. The usual caveats to observational studies like this are relevant here. First, it’s unclear that microdosing itself is driving these differences between groups. Second, because the researchers did not administer the microdoses themselves, they could not know the purity or quantity of the drug participants were taking, and whether that affected results. The authors also note other idiosyncratic details about the study, like the fact that the app they used to collect data was only available on iOS, meaning participants were all Apple users. 

Preparing for off-label use of psychedelics. Between Oregon’s plans to rollout psilocybin services in 2023 and the U.S. Food and Drug Administration’s designation of MDMA and psilocybin as “breakthrough therapies,” people in the U.S. could soon have new ways to legally access psychedelic drugs. Anna Wexler and Dominic Sisti, medical ethicists at the University of Pennsylvania, argue in JAMA that we should be prepared for these drugs to be used off-label as well. “History has shown that clinics will likely overhype the use of the drugs and advertise that psychedelics can effectively treat certain indications even in the absence of scientific evidence,” they write, “which is especially ethically concerning for vulnerable populations who may be paying significant costs out of pocket.” 

Wexler and Sisti also raise concerns about practitioners having the necessary credentials, and about the varied protocols and dosing practices when these drugs are  prescribed off-label. “Regulators, policymakers, and health authorities must carefully examine and create guardrails for the promotion and off-label use of psychedelics,” they conclude. 

There has never been a more exciting – or bewildering – time in the world of psychedelics. Don’t miss a beat.

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Terminally ill patients seeking psilocybin therapy will likely take DEA to court — again. For nearly two years, a group of terminally ill patients have been trying to gain access to psilocybin-assisted therapy under federal Right to Try laws, but their case has been ensnared in federal bureaucracy. Patients’ lawyers wrote to the U.S. Drug Enforcement Administration seeking guidance, and in 2021, the DEA replied by stating that Right to Try laws do not exempt drugs like psilocybin from their Schedule I status, and that the DEA could not grant an exemption to the patients’ physician, Dr. Aggarwal, unless he registered as a researcher. Soon after, the patients and their doctor sued the DEA, but a federal appeals court dismissed their suit in January 2022, stating that the court did not have jurisdiction to rule on the case. Ten days later, Kathryn Tucker, the patients’ attorney in this suit against the DEA, asked the DEA for a “final decision” on their case. 

On June 28, Tucker and her clients received a reply from the DEA, restating their 2021 reply — that Right to Try laws don’t exempt drugs like psilocybin from their scheduled status. “DEA finds no basis for reconsideration of its February 12, 2021 letter because the legal and factual considerations remain unchanged,” an agency administrator wrote. 

“It appears to be the agency doubling down on a decision that no access pursuant to Right To Try would be granted,” Tucker told The Microdose. She’s asked the DEA to confirm whether this June 28 letter constitutes a final decision from the agency. “If we do not hear from DEA by the July 20 deadline we have advised we will understand that to mean that the June 28 letter is final agency action and we will return to court,” she says. “We will seek expedited review, because of the urgency presented by the inexorable progression of terminal illness faced by Dr. Aggarwal’s patients.” (To learn more about this case, read The Microdose’s 5 Questions for Erinn Baldeschwiler, one of the patients in this case.)

Federal agencies weigh in on psychedelics.

In May, The Microdose reported on a letter that U.S. Senators Brian Schatz (D-Hawaii) and Cory Booker (D-New Jersey) wrote to the director of the National Institutes of Health (NIH) and the commissioner of the Federal Drug Administration, requesting more information about federal funding for psychedelic research, regulatory barriers to conducting such research, and gaps in current knowledge. Last week, Marijuana Moment obtained a four-page letter that two NIH directors sent in reply. The directors reported that the NIH is currently funding over $34 million in psychedelics research studies, and say that future work on psychedelics needs to address a lack of participant diversity in clinical trials. While the letter doesn’t offer much detail, the fact that it exists at all indicates the institutes’ continued willingness to support psychedelics-related research. 

In January, The Microdose reported on the Drug Enforcement Administration’s proposal to add five previously unscheduled psychedelic tryptamines to the list of Schedule I drugs. On Wednesday, the agency posted a notice that it will hold a hearing on the issue at DEA Headquarters on August 22. After its January proposal announcement, the agency accepted comments from the public for a month; their notice said they “received 589 comments and multiple requests for a hearing.” If the DEA proposal to schedule the tryptamines is finalized, these substances would be more difficult for researchers to access and study.

The State of Psychedelics

Last Friday, Maryland’s Senate Bill 709 became law. The bill passed in April, and it establishes a fund to study the effectiveness of “alternative therapies” — which includes MDMA, psilocybin, and ketamine — for patients with PTSD and traumatic brain injuries. The fund includes $1 million, and the Department of Veterans Affairs, Johns Hopkins, the University of Maryland, Walter Reed National Military Medical Center, Sheppard Pratt hospital, and mental health advocacy group BrainFutures are all listed as consultants on the project.

Last year, California senator Scott Wiener introduced Senate Bill 519, a bill that would make it legal to possess or give away — but not sell — drugs including psilocybin, DMT, ibogaine, LSD, and MDMA. In August 2021, Wiener paused the bill’s advancement, tweeting that he’d spend the next year “continuing to build support in the Assembly.” This week, Psychedelic Alpha pointed out that SB 519 appears to be back in play; it’s scheduled for a hearing before the California Assembly Appropriations Committee on August 3.

• The Journal of Neurochemistry’s entire July issue is dedicated to “Psychedelics and Neurochemistry.”

Charles Nichols @lab_nichols

The Special Topics issue of the Journal of Neurochemistry on Psychedelics that my father and I co-edited is officially published! Thank you to all the contributors! #psychedelics #neurochemistry #neuroscience onlinelibrary.wiley.com/toc/14714159/2…

• POLITICO interviews Imperial College London’s psychedelic researcher David Nutt about the future of psychedelics. 

• Chacruna Institute co-founder Bia Labate and anthropologist Kevin Feeney published a piece on Chacruna’s website about the issues surrounding decriminalization movements and peyote.

• Willamette Week reports that Dutch psilocybin company Red Light Holland and Canadian cannabis company Halo Collective have dissolved a partnership they began in Oregon in November 2020, shortly after the state’s Measure 109 passed.

• The Denver Post reports on activists’ efforts to decriminalize psilocybin mushrooms in Boulder.

You’re all caught up! Have a great weekend. Stay tuned on Monday for a new issue of 5 Questions.

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