Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER : a Pilot Study (NCT07391332) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER : a Pilot Study
France30 participantsStarted 2026-04-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 abnormal…