Psilocybin-assisted therapy for ongoing symptoms after concussion
A Randomized Double-blinded Controlled Trial for the Treatment of Persisting Symptoms After Concussion With Psilocybin-assisted Therapy: A Safety and Feasibility Trial
This study will see if a single higher dose of psilocybin combined with Acceptance and Commitment Therapy helps adults (18–65) with persistent post-concussion symptoms reduce their symptom burden compared to a very low-dose control.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT06615908 on ClinicalTrials.gov |
What this trial studies
This phase 1 randomized controlled trial will enroll 40 adults with persisting symptoms after concussion and randomize them to a high-dose (25 mg) or low-dose (1 mg) psilocybin arm delivered alongside Acceptance and Commitment Therapy (ACT). Participants complete preparation sessions, a single psilocybin administration visit, five weekly ACT sessions, and outcome assessments at 1 week, 4 weeks, 3 months, and 6 months post-dosing. The primary outcome is change in symptom burden measured by the Rivermead Post-Concussion Symptoms Questionnaire (RPQ); secondary outcomes include headache, dizziness, mood, anxiety, PTSD symptoms, cognitive flexibility, emotional regulation, and quality of life. Safety (adverse events up to 6 months) and feasibility (recruitment, enrollment, and adherence) will also be tracked.
Who should consider this trial
Good fit: Ideal candidates are adults 18–65 with an ICD-10 diagnosis of persisting symptoms after concussion lasting 3 months to 5 years, an RPQ score ≥13 with at least three symptoms rated ≥3, limited lifetime use of serotonergic hallucinogens, and the ability to attend in-person visits.
Not a fit: Patients with recent moderate-to-severe non-nicotine substance use disorder, a lifetime diagnosis of schizophrenia or bipolar disorder (or a first/second-degree relative with these), active suicidal ideation within the past year, current pregnancy or breastfeeding, significant ECG or lab abnormalities, or inability to attend the Calgary site are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could reduce persistent post-concussion symptoms and improve patients' daily functioning and quality of life.
How similar studies have performed: Psilocybin-assisted therapy has shown promising results in clinical trials for depression and PTSD, but its application to persistent post-concussion symptoms is largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Individuals of all sexes, gender identities, and ethnicities * Ages 18 to 65 years at the time of screening * Diagnosis of concussion based on the 2024 ACRM criteria * Meet ICD-10 criteria for PSaC for at least 3-months to a maximum of 5 years * Have an overall RPQ score ≥ 13 with 3 or more symptoms scored ≥3 * Limited lifetime use of serotonergic hallucinogens * Ability to read/write English An individual who meets any of the following criteria will be excluded from participation in this study: * Severe or moderate substance use disorder other than nicotine in past 6 months * Lifetime diagnosis of schizophrenia or bipolar disorders (or first or second-degree relative) * Active suicidal ideation or serious attempt within the past 1 year. * Current pregnancy or nursing, trying to become pregnant * Any notable abnormality on ECG or routine medical blood laboratory test * Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia * Epilepsy with a history of seizures * Current or recent (within 12 weeks) participation in a clinical trial * Cognitive impairment (SLUMS score \<20) * Suffered a moderate/severe TBI at least once in lifetime * Any other circumstances that, in the opinion of the investigators, compromises participant safety
Where this trial is running
Calgary, Alberta
- University of Calgary — Calgary, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Chantel T Debert, MD MSc FRCPC — University of Calgary
- Study coordinator: Chantel T Debert, MD MSc FRCPC
- Email: cdebert@ucalgary.ca
- Phone: (403) 944-4500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.