RecruitingPhase 1

Treatment of Persisting Symptoms After Concussion With Psilocybin Assisted Therapy

NCT06615908 · PatACT · University of Calgary

Recruiting

Status

Accepting participants

Phase 1

Phase

Target enrolment

Study sites

Outside the US

What it is testing

Summary

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).

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Measured over Throughout study completion, an average of 6 months
Study protocol efficacy
Measured over Throughout study completion, an average of 6 months
Study protocol feasibility
Measured over Screening, enrolment, intervention, and participation up to study end point (6-months)

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years

Ages

All

Sex

Not accepted

Healthy volunteers

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

1 study site

Facility	City	Region	Country
University of Calgary	Calgary	Alberta	Canada

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06615908 on ClinicalTrials.gov →

Last updated in the registry 2025-12-30. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Psilocybin

All 4 trials from University of Calgary →