RecruitingPhase 1NCT06615908

Treatment of Persisting Symptoms After Concussion With Psilocybin Assisted Therapy

A Randomized Double-blinded Controlled Trial for the Treatment of Persisting Symptoms After Concussion With Psilocybin-assisted Therapy: A Safety and Feasibility Trial


Sponsor

University of Calgary

Enrollment

40 participants

Start Date

May 27, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Psilocybin for people with persisting symptoms after concussion. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPsilocybin

See treatment arm description.


Locations(1)

University of Calgary

Calgary, Alberta, Canada

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NCT06615908