NCT07506395

Group Psilocybin-Assisted Therapy for Post-Traumatic Stress Disorder

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University of New Mexico · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

This study is a community-informed, pragmatic, open-label, phase 1 clinical trial of group-format psilocybin-assisted therapy (GPAT) for individuals with post-traumatic stress disorder (PTSD). The primary objectives of this phase 1 study are to assess the safety and feasibility of (GPAT) for individuals with (PTSD) and to evaluate preliminary effects on PTSD severity.

Detailed description

This study is a community-informed, pragmatic, open-label, phase 1 clinical trial of group-format psilocybin-assisted therapy (GPAT) for individuals with post-traumatic stress disorder (PTSD). The primary objectives of this phase 1 study are to assess the safety and feasibility of (GPAT) for individuals with (PTSD) and to evaluate preliminary effects on PTSD severity. These will be assessed by the following outcome measures: * Proportion of participants completing the study protocol * Incidence of adverse events (AEs), serious adverse events (SAEs) and AEs of special interest using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 * Mean change in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and PTSD checklist for DSM-5 (PCL-5). The CAPS-5 and PCL-5 are based on the DSM-5 not the DSM-5-TR.

Conditions

• PTSD

Interventions

Type	Name	Description
DRUG	Psilocybin	Two group-format dosing sessions, scheduled 4 weeks apart, will be held at the ISUBI Center at UNM or a site outside of UNM with DEA approval for psilocybin storage

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-05-01
• Completion: 2028-05-01
• First posted: 2026-04-01
• Last updated: 2026-04-01

Regulatory

• FDA-regulated drug study