Colorado municipalities consider opting out of psilocybin services; Is MDMA an empathogen, an entactogen, or connectogen?; and recent brain imaging results made a splash, but what do they mean?
Plus: Oregon public listening sessions and early lessons from the MDMA approval process
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.
Colorado municipalities consider opting out of psilocybin services
When Oregon became the first U.S. state to launch a state-regulated psilocybin program, the ballot initiative that established that program allowed municipalities to opt out. As a result, dozens of cities and 27 counties asked voters to weigh in on the psilocybin program in the November 2022 election, and most of those municipalities voted to enact bans.
Meanwhile, in Colorado, voters in the November 2022 election passed Proposition 122, a ballot initiative that directed the state to start a regulated psilocybin program similar to Oregon’s — but that initiative didn’t allow municipalities to opt out. Now, with the state set to start issuing licenses for its psilocybin program in early 2025, The Denver Post reports that some municipalities, including the 80,000-person town of Castle Rock, are considering a functional opt out by adopting strict limits on psilocybin center locations and restricting hours of operation. Other towns, like Parker, CO, have already adopted statutes that severely restrict possible sites for psilocybin businesses.
At a recent council meeting, Castle Rock’s mayor said he was wary of the town being a “guinea pig” for new treatments, but that he didn’t want to shut down “businesses that are legitimately going to open in Castle Rock and legitimately help people.” According to the Douglas County News-Press, the town council will likely vote on the issue in September.
Is MDMA an empathogen, an entactogen, or connectogen?
Though MDMA is often listed among other psychedelics, some researchers have posited that it would be more accurate to refer to the drug as an empathogen or entactogen for its ability to generate connection and empathy. A new paper published in the Journal of Psychopharmacology traces the history of these two terms and argues that perhaps MDMA would best be described as a connectogen.
The authors, University of Basel psychopharmacologists Kurt Stocker and Matthias Liechti, describe how this debate has been circulating in psychedelics circles since the early 1980s, when psychologist Ralph Metzner proposed the term “empathogen” at a conference, pointing to how MDMA can“generate a profound state of empathy for self and other.” A few years later, chemist David Nichols proposed the term “entactogen” instead, writing in a 1986 scientific journal article that MDMA does “more than simply generate empathy,” and also that “people invariably dislike hearing the word ‘pathogen,’ which clearly stands out when empathogen is pronounced.” The Latin root tactus, which means to touch, together with Greek roots en (inside) and gen (to produce), could create “the connotation of producing a touching within.” Metzner, in turn, wrote years later that “entactogen” is “kind of a meaningless term: ‘touching within’ doesn’t really tell you anything about this class of drugs, and it certainly doesn’t distinguish them from psychedelics or entheogens.”
Currently, both terms are still commonly used, sometimes even interchangeably. But, the authors write, “the use of two basic names for the same class of substances would only make sense if one could not identify an underlying principle for the two psychological phenomena that these terms stand for.” And, they argue, the most important principle of MDMA seems to be, time and again, a feeling of connection. That connection can extend within — the idea entactogen tried to encapsulate — as well as outwardly, as the term empathogen indicates.
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Recent brain imaging results made a splash, but what do they actually mean?
Two weeks ago, Nature published a study that measured the brain activity of seven adults while on psilocybin and weeks to months after the psilocybin experience. We covered it, as did dozens of other publications, including The New York Times, NPR, and CNN. “There is much to like about this new study,” writes Leiden University cognitive psychologist Michiel van Elk in a new op-ed in The Conversation. But van Elk cautions against drawing too many conclusions from the study’s results. “At first sight, the changes in brain patterns seem impressive, but it is not immediately clear what these fancy brain images exactly entail.”
For one, he says, the study included a very small number of healthy volunteers, whose brain activity might look different from people who have mental health issues that might be treated with psilocybin-assisted therapy. It’s also unclear how much these effects could be driven by placebo and expectation effects, as the authors did not report participants’ beliefs or expectations about psilocybin, nor their guesses about whether they received a drug or placebo. Researchers also mentioned they measured long-lasting changes in participant well-being but did not report the results from the questionnaire they used to track this. This type of subjective, self-reported data is important, van Elk writes. He encourages the field to “open the black box of neuroscience” and instead, look at participants’ self-reported data to “clarify what the changes in neural connectivity reflect.”
Oregon public listening sessions
Earlier this month, Oregon Psilocybin Services, the agency that manages the state’s psilocybin program, held a series of public listening sessions. This week, the team released a document summarizing the feedback it received in these sessions, along with answers to participants’ questions.
New rulemaking sessions will be held in August, during which advisory committees will discuss themes such as the possibility of including back-up facilitators as well as emotional support people like family members during sessions. The agency also answered questions about requirements for licensed premises that may reflect locations Oregonians are considering for service centers, like whether residences or backyards can be connected to a licensed service center, and whether churches can be licensed.
Early lessons from the MDMA approval process
With the U.S. Food and Drug Administration just days away from when the agency said it would announce a decision on whether to approve Lykos’s new drug application using MDMA-assisted therapy to treat PTSD, the company announced on Thursday that it is launching “new initiatives and measures of additional oversight” in the event the drug is approved. The plan includes an independent advisory board that will advise the company on training and medical ethics, and working with health facilities and universities including Emory, Sheppard Pratt, and Hackensack Meridian Health to roll out the treatment.
Ahead of the FDA’s decision, others in the field are already thinking about what the psychedelics industry and the larger medical establishment can learn from the drug approval process thus far. In a STAT op-ed, former National Institute of Mental Health director Thomas Insel said he wasn’t surprised that an FDA advisory committee did not recommend approval of Lykos’s new drug application for MDMA in June. The FDA doesn’t regulate psychotherapy, so Lykos’s data — which suggests a combination of MDMA with psychotherapy could help decrease PTSD symptoms — introduces a curve ball to the agency. But, he writes, “I believe this new drug application could serve as a wake-up call for new regulatory processes that would view psychological treatments as key facilitators rather than as confounders of behavioral change.”
In another op-ed published In JAMA, legal scholar Mason Marks writes that if the FDA rejects Lykos’s new drug application for MDMA-assisted therapy, “it could discourage future regulatory submissions for drug-therapy combinations.” Marks also speculates that an approval may not be overwhelmingly positive news for the industry either, writing that MDMA’s approval “might do little to prompt drug-therapy submissions, given the advisory committee’s controversial votes.” Marks also suggests that given the advisory committee’s concerns about Lykos’s study designs and participant pool, psychedelics researchers should follow FDA guidance when possible, collect data on abuse-related adverse effects, and ensure that participants with previous experience with psychedelics are not overrepresented in trials.
PRX and the UC Berkeley Center for the Science of Psychedelics are launching a new podcast called Altered States, which explores “what science can tell us about psychedelics and what psychedelics can tell us about ourselves.” The show is hosted by science journalist Arielle Duhaime-Ross. Listen wherever you get your podcasts.
For DoubleBlind, drugs journalist Michelle Lhooq writes about captagon, a new stimulant popular in the Persian Gulf party scene. The stimulant, first manufactured by a German pharmaceutical company in the 1960s, has been called the “Jihad drug” for its use among extremist fighters. In April, President Biden signed The Illicit Captagon Trafficking Suppression Act, “signaling the US’s heightened concerns that Captagon may reach American shores,” Lhooq writes.
Pennsylvania’s Attorney General’s office announced that they arrested a couple who were running a large underground psychedelics manufacturing lab out of their home, which, they allege, produced DMT, psilocybin, and marijuana products. According to a press release, police confiscated 1,500 grams of DMT; for reference, the U.S. Government’s quota for DMT produced for research purposes in 2024 was 3,000 grams, much of which went to animals and not humans.
Vox podcast Today, Explained is releasing a three-part series about the history and future of MDMA, reported and produced by Ferriss-UC Berkeley Psychedelic Journalism fellow Haleema Shah.
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