Psilocybin-Assisted Cognitive Processing Therapy for Chronic PTSD

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.

Topic PTSD Safety
Compound Psilocybin
Country Canada
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 August 2024
End date 31 May 2025
Phase Phase II
Design Open
Type Interventional
Generation First
Participants 15
Sex All
Age 18- 65
Therapy Yes

Trial Details

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.

NCT Number NCT06386003

Data attribution

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