Recruiting
Phase 1

Psilocybin Assisted Therapy

Sponsor:

University of Calgary

Code:

NCT06615908

Conditions

Persisting Symptoms After Concussion

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Psilocybin

Study Details

Brief 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).

Conditions

Persisting Symptoms After Concussion

Study ID

NCT06615908

Start date

May 27, 2025

Status verified date

Sep, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: High dose (25mg)

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

active comparator: Low dose (1mg)

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

Interventions

Psilocybin

See treatment arm description.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Chantel T Debert, MD MSc FRCPC

(403) 944-4500cdebert@ucalgary.ca

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Contacts

Chantel T Debert, MD MSc FRCPC CSCN

(403) 944-4500cdebert@ucalgary.ca

Christina Campbell, MSc

403-944-8649PATACTstudy@ucalgary.ca

More Information

Sponsor

University of Calgary

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • Psychotherapy
  • Psilocybin
  • Concussion
  • Mild Traumatic Brain Injury
  • Acceptance and Commitment Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2026-09-09.