Treatment of Persisting Symptoms After Concussion With Psilocybin Assisted Therapy
Recruiting
Phase 1Interventional Study
Persisting Symptoms After Concussion
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
University of Calgary · Other
Who this trial is looking for
This trial is looking for adults aged 18 to 65 who have symptoms that persist after a concussion. Participants will take part in therapy sessions that include psilocybin treatment and complete follow-up assessments over several months.
Are You a Good Fit for This Trial?
Rules you outSevere substance use disorderSchizophreniaBipolar disorderSuicidal ideationPregnancyNursingInsulin-dependent diabetesEpilepsy
You may be able to join if
I am aged 18 to 65 years
I have been diagnosed with a concussion
I have symptoms for at least 3 months
I have a score of 13 or higher on the RPQ
I have limited use of hallucinogens
I can read and write in English
You may not be able to join if
I have had a substance use disorder in the past 6 months
I have been diagnosed with schizophrenia or bipolar disorder
I have had suicidal thoughts or attempts in the past year
I am currently pregnant or nursing
I have serious health issues shown in tests
I have insulin-dependent diabetes
I have epilepsy and a history of seizures
I have cognitive impairment
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 activ…
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).
Trial Locations
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Eligibility Criteria
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…
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
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