Psilocybin-Assisted Massed Cognitive Processing Therapy for Chronic Posttraumatic Stress Disorder: An Open-label Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Meet Diagnostic and Statistical Manual-5th edition (DSM-5) criteria for current PTSD with a duration of 6 months or longer assessed by study psychiatrist;
• Have a Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score of 50 or higher, indicating moderate to severe PTSD symptoms;
• Are willing to refrain from taking any psychiatric medications during the study period.
Locations
Other Locations
Canada
St. Michael's Hospital, Unity Health Toronto
RECRUITING
Toronto
Contact Information
Primary
Venkat Bhat
Venkat.Bhat@unityhealth.to
416-360-4000
Time Frame
Start Date: 2026-06
Estimated Completion Date: 2027-01
Participants
Target number of participants: 15
Treatments
Experimental: Experimental
Single dose of psilocybin 25mg + Massed cognitive processing therapy
Related Therapeutic Areas
Sponsors
Collaborators: University of Ottawa, Toronto Metropolitan University
Leads: Unity Health Toronto