Magic mushroom therapy takes on gambling addiction
NCT ID NCT07391332
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Nantes University Hospital
Nantes, France
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