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Magic mushroom therapy could ease persistent concussion symptoms

NCT ID NCT06615908

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 2 times

Summary

This study tests whether psilocybin (the active ingredient in magic mushrooms) combined with talk therapy can safely reduce symptoms in adults with persisting symptoms after concussion. Forty participants will receive either a high or low dose of psilocybin, plus weekly therapy sessions. The main goals are to check safety, feasibility, and whether symptoms improve over six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
psilocybin (the active ingredient in magic mushrooms)
What this could lead to
If it works, this could point toward a new treatment option for people with long-lasting concussion symptoms.
What could go wrong
This is a very early phase 1 trial with only 40 participants, so results may not apply widely. Psilocybin can cause temporary psychological distress, and the low-dose control group may also show effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

Brain Concussion

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Calgary

    RECRUITING

    Calgary, Alberta, T2N 2T9, Canada

    Contact Email: •••••@•••••

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