Psilocybin-assisted psychotherapy for gambling disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 pilot randomized feasibility study evaluating psilocybin-assisted psychotherapy for gambling disorder. Participants will receive high-dose (25 mg or 40 mg as appropriate) or low-dose (1 mg) psilocybin alongside psychotherapy, with feasibility measured by retention through the protocol. The study will also collect preliminary efficacy signals and explore clinical factors linked to the intensity of the psychedelic experience, which may relate to therapeutic effect. Safety and tolerability of the combined treatment will be monitored. Eligible participants are adults with a DSM-5 gambling disorder, able to complete self-report measures, and willing to engage in treatment and additional assessments in a French-language setting at Nantes University Hospital.

Why it matters

Who can join: the full rules

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

Where it's running

• Nantes University Hospital
  Nantes, France Recruiting

Study contacts

• Study coordinator: Benoit SCHRECK
• Email: benoit.schreck@chu-nantes.fr
• Phone: +33.2.40.84.76.20

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.