Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER : a Pilot Study (PASSENGER)

Nantes University Hospital (NUH)

Status and phase

Begins enrollment in 1 month

Phase 2

Conditions

Gambling Disorder

Treatments

Drug: Psychotherapy assisted by high-dose psilocybin (25mg or 40mg where appropriate)

Drug: Psychotherapy assisted by low-dose psilocybin (1 mg)

Study type

Interventional

Funder types

Other

Identifiers

NCT07391332

2025-522743-18-00 (EU Trial (CTIS) Number)

RC25_0105

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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