Psilocybin Research and Implementation Study for Mental health and substance use (PRISM) - The rapid shift in public perception of psychedelics, coupled with the expansion of their use and policy reform across the United States, has created a unique opportunity to assess the real- world impacts of psychedelic use. Over 7,000 people in Oregon have received legal, supervised psilocybin experiences. Similar services are set to begin in Colorado in 2025, and nine other states are currently considering psychedelic services legislation. Although early phase trials suggest psilocybin may be safe and effective for treating some mental health and substance use disorders (e.g., tobacco use), it is not known whether these effects extend to community- based settings with less standardized screening and counseling support. There is an urgent need to assess the safety of these programs and their impact on substance use, before more voters and policymakers are asked to consider their merits and drawbacks. The Psilocybin Research and Implementation study for Substance use and Mental health (PRISM) study is designed to fill this gap by enrolling a cohort of individuals who use substances and receive Oregon’s state-regulated psilocybin services and comparing them to a group of people who would access these services, if they were available. Using 12 months of rigorous longitudinal surveys and qualitative interviews, PRISM will detect potential safety risks and benefits of regulated psilocybin services and identify specific substances and subpopulations that may be responsive to psilocybin’s effects. The study has three Aims: 1) Assess the impact of state- regulated psilocybin services on safety events in people who use substances, 2) Assess the impact of state-regulated psilocybin services on substance use, and 3) Elicit stakeholder views of the impact of state-regulated psilocybin services on long-term safety and changes in substance use. The PRISM study seeks to generate rigorous real-world evidence that can effectively guide state and federal decision-making. The timing of this work is critical, given the rapid expansion of psychedelic policy reform across the United States. The findings will help shape policies that maximize potential benefits of psilocybin services while minimizing risks, offering a scientifically grounded framework for public health strategies, harm reduction efforts, and future psychedelic regulations.
