This open-label trial (n=15) will evaluate the feasibility, tolerability, safety, and efficacy of psilocybin-assisted (25mg) cognitive processing therapy for chronic Posttraumatic Stress Disorder (PTSD).
Conducted by Unity Health Toronto, this study aims to improve front-line treatment options for PTSD, particularly for patients who do not respond well to existing therapies like cognitive processing therapy (CPT).
Participants meeting DSM-5 criteria for current PTSD will receive a single dose of psilocybin (25mg) combined with 12 sessions of massed CPT and two psychotherapy sessions related to psilocybin over a 7-day period.
The study will assess recruitment rate, withdrawal rate, adherence rate, and other parameters to gauge feasibility and tolerability. Additionally, various clinician-administered scales and self-reported mental health questionnaires will be used to evaluate treatment efficacy over a follow-up period of up to 16 weeks.
The study is set to begin in August 2024 and conclude in May 2025.
The trial protocol can be found here.
Trial Details
Trial Number