Magic mushroom therapy takes on gambling addiction

NCT ID NCT07391332

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This pilot study will test whether psilocybin (the active ingredient in magic mushrooms) combined with psychotherapy can help people with gambling disorder. Thirty adults will receive either a high dose (25-40 mg) or a very low dose (1 mg) of psilocybin during therapy sessions. The main goal is to see if the study is feasible and acceptable, not yet to prove it works.

What this could mean

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

Active substance
psilocybin (a psychedelic drug)
What this could lead to
If successful, this could point toward a new treatment option for gambling disorder using psychedelic-assisted therapy.
What could go wrong
This is a very small pilot study (30 people) testing feasibility, not effectiveness. It may not show clear benefits, and psilocybin can cause intense psychological experiences and temporary distress.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Jan 2029

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 years and older

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.

Inclusion Criteria: * Men and women aged 18 years or older * With a confirmed diagnosis of current gambling disorder (diagnostic criteria according to DSM-5), regardless of severity. * Able to complete self-assessment questionnaires * Willing to start addiction treatment, or for whom treatment already undertaken is not sufficient * Willing to undergo a blood test and ECG * Written and oral comprehension of French * Having signed an informed consent form before any procedure under study * Affiliated with a French social security system * Women of childbearing age with a negative pregnancy test and highly effective contraception (according to version 1.2 of March 2024 of the CTCG recommendations in Appendix 7) * Men of childbearing age using effective contraception (according to version 1.2 of March 2024 of the CTCG recommendations). * Negative result on urinary toxicology screening * In the case of psychotropic treatment (excluding nicotine replacement therapy): stabilization of dosage or initiation for more than 1 month. Exclusion Criteria: * Medical conditions that would prevent safe participation in the trial (epilepsy, significantly impaired liver function (TP\<50%), significantly impaired kidney function (GFR\<90 mL/min), coronary artery disease, history of arrhythmia, heart failure, uncontrolled hypertension, history of stroke, severe asthma, hyperthyroidism, narrow-angle glaucoma, symptomatic prostatic hypertrophy, or bladder neck obstruction). * Serious ECG abnormalities (including QTc prolongation = corrected QT) * Current or past psychotic or bipolar disorder * Other unstable psychiatric disorder * Family history (first-degree relatives) of psychotic disorder or type 1 bipolar disorder * Current high risk of suicide (according to the MINI 5.0 suicide risk module) * History of hallucinogen use disorder or any use in the past year * Current alcohol use disorder with a history of withdrawal symptoms * Extreme thinness (BMI \< 16.5) or obesity (BMI \> 30) * Major cognitive impairment (Mini-Mental State Examination score \< 26) * Allergy or hypersensitivity to psilocybin or any of the excipients contained in the investigational drug * Taking UGT1A9, UGT1A10, ALDH, or ADH inhibitors * Pregnancy or breastfeeding * Current protective measures (guardianship and legal protection) * Participation in another interventional research protocol involving another psychotherapeutic or pharmacological intervention that may have an impact on clinical progression

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Conditions

The condition(s) this trial relates to.

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 places running it

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

  2. 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 ↗

  3. 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

  • Nantes University Hospital

    Nantes, France

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