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Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER : a pilot study
EU CTIS ID: 2025-522743-18-00
What this study is testing
Assess the feasibility of conducting a randomized clinical trial on psychedelic-assisted psychotherapy for the treatment of gambling disorder, estimating the ability to retain participants until the end of the protocol.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Men and women aged 18 or over
- Negative result in urinary toxicology screening
- 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 with effective contraception (according to version 1.2 of March 2024 of the CTCG recommendations in Appendix 7).
- If taking psychotropic medication (excluding nicotine replacement therapy): dosage stabilized or treatment started more than one month ago.
- In whom the current diagnosis of gambling disorder has been confirmed (diagnostic criteria according to DSM-5), regardless of the level of severity
You likely can't join if
- 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).
- Family history (first-degree relatives) of psychotic disorder or type 1 bipolar disorder
- High current suicide risk (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)
See the full eligibility criteria
- Men and women aged 18 or over
- Negative result in urinary toxicology screening
- 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 with effective contraception (according to version 1.2 of March 2024 of the CTCG recommendations in Appendix 7).
- If taking psychotropic medication (excluding nicotine replacement therapy): dosage stabilized or treatment started more than one month ago.
- In whom the current diagnosis of gambling disorder has been confirmed (diagnostic criteria according to DSM-5), regardless of the level of severity
- Able to complete self-assessment questionnaires
- Volunteers willing to start addiction treatment, or for whom the treatment already undertaken is not sufficient
- Agreeing to a blood test and an electrocardiogram
- Written and oral comprehension of French
- Having signed an informed consent form prior to any procedure under consideration
- Affiliated with a French social security system
- 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).
- Family history (first-degree relatives) of psychotic disorder or type 1 bipolar disorder
- High current suicide risk (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)
- Taking inhibitors of UGT1A9, UGT1A10, ALDH, and ADH
- Major cognitive impairment (Mini-Mental State Examination score < 26)
- Knewn allergy or hypersensitivity to psilocybin or any of the excipients contained in the experimental drug
- Pregnancy or breastfeeding
- Current protective measure (guardianship and judicial protection)
- Participation in another interventional research protocol involving another psychotherapeutic or pharmacological intervention that may have an impact on clinical progression
- Serious ECG abnormalities (including prolongation of the QTc interval = corrected QT)
- Current or past psychotic or bipolar disorder
- Other unstable psychiatric disorder
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.