BridgeMD
New treatment option for Persisting Symptoms After Concussion
Official title Treatment of Persisting Symptoms After Concussion With Psilocybin Assisted Therapy
ClinicalTrials.gov ID: NCT06615908
What this study is testing
What is Psilocybin?
Psilocybin is an investigational medicine, given as an once-weekly, being studied as a potential treatment for persisting symptoms after concussion.
Also referred to as magic mushrooms, PEX010.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
See the full 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 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
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.