NCT07391332 Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER : a Pilot Study
| NCT ID | NCT07391332 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Nantes University Hospital |
| Condition | Gambling Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-10-08 |
| Primary Completion | 2029-07-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2026-10-08 with a primary completion date of 2029-07-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The PASSENGER project aims to conduct a pilot feasibility study of the implementation of a randomized clinical trial on psilocybin-assisted psychotherapy for the treatment of gambling disorder. Feasibility will be assessed by estimating the ability to retain participants until the end of the protocol. Other objectives of the study will be to generate preliminary efficacy data, identify clinical factors potentially associated with the intensity of the psychedelic experience (which determines the expected therapeutic effect), and conduct a preliminary assessment of the safety of the treatment under study.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07391332 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gambling Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07391332 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07391332 currently recruiting?
Yes, NCT07391332 is actively recruiting participants. Contact the research team at benoit.schreck@chu-nantes.fr for enrollment information.
Where is the NCT07391332 trial being conducted?
This trial is being conducted at Nantes, France.
Who is sponsoring the NCT07391332 clinical trial?
NCT07391332 is sponsored by Nantes University Hospital. The trial plans to enroll 30 participants.