Actively Recruiting
Treatment of Persisting Symptoms After Concussion With Psilocybin Assisted Therapy
Led by University of Calgary · Updated on 2025-12-30
40
Participants Needed
1
Research Sites
96 weeks
Total Duration
On this page
Sponsors
U
University of Calgary
Lead Sponsor
U
University of British Columbia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 persisting symptoms after concussion (PSaC). 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 PSaC. AIM 2: To evaluate the efficacy of an active psilocybin-assisted psychotherapy compared to an active control as a treatment for PSaC. 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 weekly sessions of Acceptance and commitment therapy (ACT) * Repeat outcome measures at 1-week, 4 weeks, 3 months, and 6 months post-psilocybin administration (online only at 6 months).
CONDITIONS
Official Title
Treatment of Persisting Symptoms After Concussion With Psilocybin Assisted Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 persisting symptoms after concussion for at least 3 months to a maximum of 5 years
- Have an overall Rivermead Post-Concussion Symptoms Questionnaire (RPQ) score of 13 or higher with 3 or more symptoms scored at 3 or above
- Limited lifetime use of serotonergic hallucinogens
- Ability to read and write English
You will not qualify if you...
- 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 with these disorders
- Active suicidal ideation or serious attempt within the past 1 year
- Current pregnancy, nursing, or trying to become pregnant
- Any notable abnormality on ECG or routine medical blood laboratory tests
- Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
- Epilepsy with a history of seizures
- Current or recent participation in a clinical trial within the past 12 weeks
- Cognitive impairment with a SLUMS score less than 20
- History of moderate or severe traumatic brain injury at least once in lifetime
- Any other circumstances that, in the opinion of the investigators, compromise participant safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Calgary
Calgary, Alberta, Canada, T2N 2T9
Actively Recruiting
Research Team
C
Chantel T Debert, MD MSc FRCPC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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