Community engagement as a foundation for implementation research for group psilocybin assisted therapy in New Mexico

Informed by a community engagement process, we have developed a pragmatic, open-label, hybrid feasibility-implementation study of Group Psilocybin-Assisted Therapy (GPAT) for post-traumatic stress disorder (PTSD). As psychedelic-assisted therapies begin to enter the broader mental health arena, engaging communities in the design of research and care models is essential to ensuring that those most impacted have access to-and trust in-the treatments being developed. Guided by the principle of "nothing about us without us," the proposed study was designed from the outset to be community-informed and co-designed. We established a tripartite collaborative partnership among researchers from the University of New Mexico (UNM) Department of Family & Community Medicine (DFCM) and the UNM Office for Community Health (OCH), the Bernalillo County Health Equity Council, and the national Psychedelic Mental Health Access (PMHA) Alliance. The protocol for the FDA-approved study uses a group therapy model incorporating peer facilitators with shared affinity with the participant group. There will be six groups of six participants, including veterans/first responders and women survivors of sexual violence. The study is aligned with the New Mexico Therapeutic Psilocybin Program in its focus on access and equity, as well as the use of state-regulated whole psilocybin mushrooms rather than synthesized psilocybin. Each group will participate in two sessions using psilocybin mushroom-infused chocolates containing 20 mg and 30 mg of psilocybin, along with both group and individual therapy sessions. Outcomes will include safety and feasibility measures, as well as standard measures of PTSD, including the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and the PTSD Checklist for DSM-5 (PCL-5). An extended integration model provides longer-term support to participants both within and beyond the clinical trial. A barrier to scaling psychedelic-assisted therapy is understanding what it actually costs to deliver a safe, comprehensive model of care, particularly for populations facing structural barriers to access. The University of California, Berkeley Collaborative for the Economics of Psychedelics (CEP) will conduct a prospective micro-costing study in parallel with GPAT. The analysis will capture delivery costs for community engagement, the group psilocybin therapy model, and the post-clinical protocol extended integration program.

https://clinicaltrials.gov/study/NCT07506395.