OHSU-led federally funded initiative to evaluate state-regulated psilocybin services

A NIDA-funded implementation research initiative led by Oregon Health & Science University (OHSU) is evaluating the impact of state-regulated psilocybin services delivered in community settings.

A five-year, $3.3 million award from the National Institute on Drug Abuse (NIDA) is supporting a study of how supervised psilocybin services operate outside traditional research clinics. It frames the evaluation around comparing outcomes among people who want to reduce intoxicating substance use with and without psilocybin services, including potential safety risks and benefits.

The report names multiple participating investigators and organizations, including co-principal investigators Adie Rae, Todd Korthuis, and Ryan Cook, and describes their work as part of the Oregon Psychedelic Evaluation Nexus (OPEN) partnership. It situates the initiative in Oregon’s state-authorized psilocybin service program, which began permitting supervised services for adults under state regulation, and it also mentions Colorado as having subsequently adopted a similar legal approach. The work is framed around characterizing legal, state-regulated psychedelic services as delivered through community-based service provision under state oversight.

According to OHSU, the evaluation plans to enroll people who access supervised psilocybin services in Oregon and compare them with people who want to reduce use of intoxicating substances but do not access psilocybin services. The planned sample size is described with a recruitment target of at least 1,600 participants, and the report also notes preliminary data already gathered from more than 300 clients of Oregon psilocybin service providers who agreed to participate. Participants are described as completing a baseline survey followed by six subsequent surveys and interviews over 12 months after an initial psilocybin session, emphasizing longitudinal follow-up in routine community delivery rather than a single timepoint assessment.

Planned outcome tracking includes monitoring potential safety risks and challenging experiences in broad terms, alongside substance-use outcomes that include alcohol, nicotine, and other substances over time. It also describes plans to assess service delivery using a published set of 22 key measures of high-quality psilocybin services and notes that the project builds on prior OHSU work that specified 22 measures of high-quality psilocybin services, presented as a structured way to describe and assess service quality and fidelity in the field.

In the report’s framing, the initiative pairs safety and substance-use follow-up with measurement intended to characterize state-regulated psilocybin services as they are delivered.

Key Takeaways:

• A NIDA-supported, OHSU-led, multi-year effort is evaluating state-regulated psilocybin services delivered in community settings, with stated emphasis on safety, effectiveness, and substance-use outcomes.
• The planned design includes enrollment of people accessing Oregon services and a comparator group not accessing services, with longitudinal follow-up using repeated surveys and interviews as described.
• Planned measurements span safety monitoring, substance-use outcomes, and implementation outcomes (including access, fidelity, and equity), and the initiative is described as building on a previously published 22-measure framework for service quality.