Psilocybin for Post-Concussion Syndrome
(PatACT Trial)

Recruiting in Palo Alto (17 mi)

Chantel Debert | INTEGRATED CONCUSSION ...

Overseen byChantel T Debert, MD MSc FRCPC CSCN

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Calgary

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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 persistent post-concussion symptoms (PPCS). 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 PPCS AIM 2: To evaluate the efficacy of an active psilocybin-assisted psychotherapy compared to an active control as a treatment for PPCS 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 5-6 weekly sessions of BrainACT * Repeat outcome measures at 1-week, 4 weeks, 3 months, and 6 months post-psilocybin administration (online only at 6 months).

Research Team

Chantel T Debert, MD MSc FRCPC CSCN

Principal Investigator

University of Calgary

Eligibility Criteria

Adults aged 18-65 with persistent post-concussion symptoms can join this trial. They must complete a two-part screening, attend assessments and therapy sessions, and be available for follow-ups up to six months after treatment. Those with certain health conditions or who cannot commit to the study schedule are excluded.

Inclusion Criteria

I am between 18 and 65 years old.

I have rarely used drugs like LSD or magic mushrooms.

Ability to read/write English

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Exclusion Criteria

I or a close family member have been diagnosed with schizophrenia or bipolar disorder.

Active suicidal ideation or serious attempt within the past 1 year

Current or recent (within 12 weeks) participation in a clinical trial

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Treatment Details

Interventions

Psilocybin (Psychedelic Therapy)

Trial OverviewThe trial is testing psilocybin-assisted therapy's safety and effectiveness in treating long-lasting symptoms after a concussion. Participants will receive either a high dose (25mg) or low dose (1mg) of psilocybin during one session, followed by weekly psychotherapy sessions.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: High dose (25mg)Experimental Treatment1 Intervention

High Dose (25mg) PEX010 (Oral Psilocybin), 25mg; single dose (20 participants) administered 24hrs prior to first BrainACT session

Group II: Low dose (1mg)Active Control1 Intervention

Low Dose (1mg) PEX010 (Oral Psilocybin), 1mg; single dose (20 participants)administered 24hrs prior to first BrainACT session

Psilocybin is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Psilocybin for: