Psilocybin-assisted therapy for ongoing symptoms after concussion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.