Treatment of Persisting Symptoms After Concussion With Psilocybin Assisted Therapy
NCT ID: NCT06615908
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
40 participants
INTERVENTIONAL
2025-05-27
2027-03-30
Brief Summary
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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).
Detailed Description
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This trail will test the following 2 aims:
AIM 1 : To test the safety and feasibility of an active/high dose (25mg) psilocybin-assisted psychotherapy to an active control (1mg) for adults with PSaC. Safety will be determined through the reporting of adverse events and response following psilocybin for each participant up to 6-months. Feasibility will be determined through recruitment, enrollment, and adherence rates.
AIM 2: To evaluate the efficacy of an active/high dose (25mg) psilocybin-assisted psychotherapy compared to an active control (1mg) as a treatment for PPCS at 1-week, 4 weeks, 3 months, and 6 months post-psilocybin administration. The primary efficacy outcome will be the change in PSaC burden (RPQ).
The secondary efficacy outcomes will include measures of headache, dizziness, mood, anxiety, post-traumatic stress, cognitive flexibility, emotional regulation, and quality of life.
A total of 40 male and female patients between the ages of 18-65 with a diagnosis of mild traumatic brain injury (American College of Rehabilitation Medicine 2023 criteria) who meet criteria for persisting symptoms after concussion (ICD-10) within 3 months to 5 years will be recruited from Calgary brain injury clinics and the community.
All patients will undergo a thorough, 2-part screening procedure. Eligible participants will be randomly allocated 1:1 to either the high dose (20 participants) or low dose (20 participants) psilocybin groups. All participants will be asked to attend a baseline session consisting of clinical and behavioural outcome measures, followed by a pre-dosing psychoeducation session. Following the single dosing session, participants will complete 5 weekly ACT sessions. Outcome measure assessments will be repeated at 1-week, 4 weeks, 3 months, and 6 months post-dosing.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
The pharmacy administering the psilocybin will be responsible for maintaining the master randomization code list and only the technician preparing the samples will have access to the envelopes and code list.
When a new study ID is generated, the technician is to verify the randomization and prepare the participant's study intervention accordingly. Unblinding will only occur once the entire study is completed, and the database has been locked.
The trials active intervention and comparator will be provided by the manufactures and will be identical in shape, colour, and weight.
Study Groups
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High dose (25mg)
High Dose (25mg) PEX010 (Oral Psilocybin), 25mg; single dose (20 participants) administered 24hrs prior to first ACT session
Psilocybin
See treatment arm description.
Low dose (1mg)
Low Dose (1mg) PEX010 (Oral Psilocybin), 1mg; single dose (20 participants)administered 24hrs prior to first ACT session
Psilocybin
See treatment arm description.
Interventions
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Psilocybin
See treatment arm description.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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University of British Columbia
OTHER
University of Calgary
OTHER
Responsible Party
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Principal Investigators
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Chantel T Debert, MD MSc FRCPC
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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University of Calgary
Calgary, Alberta, Canada
Countries
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Central Contacts
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Facility Contacts
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Chantel T Debert, MD MSc FRCPC CSCN
Role: primary
Christina Campbell, MSc
Role: backup
Other Identifiers
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REB24-0334
Identifier Type: -
Identifier Source: org_study_id