The New Mexico protocol is a community-informed, group psilocybin-assisted therapy study for PTSD led by a University of New Mexico team, conducted under an FDA IND. It is a phase I, open-label feasibility-implementation trial that uses whole psilocybin mushrooms formulated as chocolate rather than synthetic psilocybin.
Design: six cohorts of six participants, including veterans or first responders and female survivors of sexual violence. Each cohort completes two dosing sessions with chocolates containing 20 mg and 30 mg psilocybin, plus preparatory and integration group meetings and some individual therapy. Sessions include peer facilitators with relevant lived experience to support acceptability and potential scalability.
Primary endpoints focus on safety and feasibility of the group format. PTSD outcomes are tracked with CAPS-5 (clinician-administered) and PCL-5 (self-report). This protocol reports methods, not treatment results.
As of April 2026 the team had funding, FDA IND clearance, local ethics approval, and a ClinicalTrials.gov registration, with screening planned to start in May 2026. For a concise overview, see this summary of the New Mexico protocol.
Hope this clarifies the essentials.