NCT06386003

Psilocybin-Assisted Cognitive Processing Therapy for Chronic PTSD

Psilocybin-Assisted Massed Cognitive Processing Therapy for Chronic Posttraumatic Stress Disorder: An Open-label Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label trial evaluating feasibility, tolerability, safety and efficacy of psilocybin assisted cognitive processing therapy for chronic Posttraumatic Stress Disorder (PTSD).

Detailed description

Current front-line treatments for Posttraumatic stress disorder (PTSD) are ineffective for up to half of patients, with serious medical and societal consequences. It is imperative to improve the efficacy of front-line treatment options, such as cognitive processing therapy (CPT). CPT is an effective treatment for PTSD, including when delivered intensively (i.e., multiple sessions over 7 days). However, a substantial proportion of patients continue to meet criteria for PTSD or have residual PTSD symptoms post-treatment. Psilocybin-assisted CPT may be a potential solution, as preliminary evidence supports the potential of psilocybin to alleviate symptoms of PTSD. Fifteen participants will receive a single dose of psilocybin 25mg combined with 12 sessions of massed CPT, and 2 psychotherapy sessions related to psilocybin over 7 days. Participants will complete clinician-administered scales, self-reported mental health questionnaires, and use a wearable device. After the 1-week interventional period, participants will enter a 12-weeks follow-up period.

Conditions

• Post Traumatic Stress Disorder
• PTSD
• Chronic PTSD

Interventions

Type	Name	Description
DRUG	Psilocybin	Participants will receive a single dose of psilocybin 25mg combined with 12 sessions of massed CPT, and 2 psychotherapy sessions related to psilocybin over 7 days.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2024-04-26
• Last updated: 2026-01-30

Locations

1 site across 1 country: Canada