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New Rules for Psychedelic Therapy Programs

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Last year, Oregon became the first state in the nation to provide state-regulated access to supervised services involving mind-altering magic mushrooms — raising the likelihood of introducing psilocybin to many Oregonians who have never experienced psychedelics before.

“There are no measures of best practices because the field is so new,” said Todd Korthuis, M.D., M.P.H., professor of medicine (general internal medicine and geriatrics) in the School of Medicine at Oregon Health & Science University.

Now, a new publication from OHSU and other institutions for the first time establishes a series of practices gleaned from experienced psilocybin facilitators to ensure the safety and effectiveness of psilocybin services offered to the general public.

The study published Tuesday in the Journal of Psychopharmacology.

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Researchers recruited 36 highly seasoned psilocybin experts with experience facilitating psilocybin within clinical trials, in ceremonial settings and in traditional indigenous practices. Together, the experts identified measures they believed to represent best practices. Researchers used a method known as the Delphi approach to arrive at consensus; the approach uses several rounds of information-gathering among a group of experts to identify conclusions.

The study generated 22 key measures of high-quality services, including the most important service delivery processes, safety indicators and client outcomes.

As other states and localities join Oregon and Colorado in legalizing psychedelics, the new publication provides the first set of core measures to monitor for safety, quality and effectiveness. Because Oregon’s program is the first of its kind, there are no established standards for measuring the safety or effectiveness of these services.

“It ultimately gives policymakers and program managers a harmonized set of measures they can use to say how safe and effective these services are in the community,” said Korthuis, the study’s senior author.

In Oregon and Colorado, voters approved the use of psilocybin in supervised settings for people 21 and older.

Other states may choose to authorize the use of psilocybin and other psychedelics in the context of medical therapy. Psychedelics have been tested experimentally in clinical trials for treatment of mental health conditions, including the use of psilocybin to treat depression and alcohol use disorder, or the use of MDMA, colloquially known as Ecstasy or Molly, for treatment of post-traumatic stress disorder. But it’s unclear how the safety and benefits observed in carefully controlled experiments translate to widespread state-approved community access.

New tools for emerging psychedelic services industry

Researchers used a methodology common in assessing various types of medical interventions.

“Even though the use of psilocybin in Oregon is happening outside of the health care system, it clearly may affect people’s health whether they’re seeking it for that reason or not,” said Korthuis, who also heads addiction medicine at OHSU. “It’s crucial that policymakers and the public have a way to understand the effects of these policies.”

The study identified core process and outcome measures ranging from the obvious to the eye-opening.

Among the 22 measures, for example, experts in the study recommended facilitators prepare for the session by asking about boundaries and preferences around touch, as some clients may express a desire for human touch, such as holding their hand, to help them navigate the experience.

Among the outcome measures, clients should rate the overall benefits and harms of the experience, and facilitators should complete a safety checklist documenting items such as whether the client left before the session was complete or required referral for medical attention.

The safety checklist and other measures provide important tools for the brand-new psychedelic services industry. The results of this study will help researchers, policymakers and service providers decide what data to collect in order to monitor their programs. By using the same set of measures, all state-level programs can be easily compared and combined, to get an overall picture of safety and success.

Reference: Korthuis PT, Hoffman K, Wilson-Poe AR, et al. Developing the Open Psychedelic Evaluation Nexus consensus measures for assessment of supervised psilocybin services: An e-Delphi study. J Psychopharmacol. 2024:02698811241257839. doi: 10.1177/02698811241257839

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