This randomised, quadruple-blind, placebo-controlled trial (n=40) will evaluate the safety, feasibility, and efficacy of psilocybin-assisted therapy in adults aged 18–65 with persistent post-concussion symptoms (PPCS). Participants will receive either a high dose (25mg) or a low dose (1mg) of psilocybin and undergo 5–6 weekly sessions of BrainACT, an adapted form of Acceptance and Commitment Therapy (ACT) for individuals with acquired brain injury.
The study, conducted by the University of Calgary, aims to determine the safety of psilocybin through adverse event monitoring and feasibility through recruitment, adherence, and retention rates.
Efficacy will be assessed by measuring changes in PPCS burden using the Rivermead Post-Concussion Symptoms Questionnaire (RPQ) at 1 week, 4 weeks, 3 months, and 6 months post-dosing. Secondary outcomes include assessments of headache, dizziness, mood, anxiety, post-traumatic stress, cognitive flexibility, emotional regulation, and quality of life. The trial is expected to begin in October 2024 and conclude in March 2027.
Trial Details
Trial Number
Sponsors & Collaborators
University of CalgaryThe University of Calgary, located in Alberta, Canada, is a comprehensive academic and research institution.