Treatment of Persistent Post-concussive Symptoms With Psilocybin Assisted Therapy (PatACT)

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.

Topic Safety Traumatic Brain Injury
Compound Psilocybin Placebo
Country Canada
Visit trial
Status Not yet recruiting
Results Published No
Start date 30 October 2024
End date 30 March 2027
Phase Phase I
Design Blinded
Type Interventional
Generation First
Participants 40
Sex All
Age 18- 65
Therapy Yes

Trial Details

The goal of this randomized controlled trial is to evaluate the safety, feasibility, and efficacy of psilocybin assisted therapy as an intervention to reduce symptom burden in adult patients (aged 18-65) with persistent post-concussion symptoms (PPCS). This trail will test the following 2 aims: AIM 1 : To test the safety and feasibility of an active psilocybin-assisted psychotherapy to an active control for patients with PPCS AIM 2: To evaluate the efficacy of an active psilocybin-assisted psychotherapy compared to an active control as a treatment for PPCS Participants will be asked to: Complete a 2 part screening process Attend a baseline assessment Complete a psychoeducation preparation session(s) Attend psilocybin administration session (receive high dose [25mg] or low dose psilocybin [1mg]) Complete 5-6 weekly sessions of BrainACT Repeat outcome measures at 1-week, 4 weeks, 3 months, and 6 months post-psilocybin administration (online only at 6 months).

Trial Number NCT06615908

Sponsors & Collaborators

University of Calgary
The University of Calgary, located in Alberta, Canada, is a comprehensive academic and research institution.

Data attribution

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