Clinical TrialPsilocybinPsilocybinNot yet recruiting

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

This Phase II, randomised, double-blind trial (n=30) will evaluate the feasibility and preliminary efficacy of psilocybin-assisted psychotherapy for individuals diagnosed with gambling disorder. Participants will be assigned to receive either high-dose psilocybin (25 mg or 40 mg, depending on response) or low-dose psilocybin (1 mg) in conjunction with psychotherapy. The primary outcome will be the protocol completion rate over a 33-month period. The study aims to assess the retention of participants throughout the trial and gather initial data on the therapeutic effects of psilocybin, as well as identify clinical factors influencing the intensity of the psychedelic experience. Participants must be aged 18 or older, have a confirmed diagnosis of gambling disorder, and meet various inclusion criteria, including the ability to complete self-assessment questionnaires and willingness to undergo medical tests. The trial is set to commence in April 2026 and is sponsored by Nantes University Hospital.

Target Enrollment
30 participants
Study Type
Phase II interventional
Design
Randomized, double Blind

Detailed Description

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.

Study Arms & Interventions

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

experimental

Interventions

  • Psilocybin

Psychotherapy assisted by low-dose psilocybin (1 mg)

active comparator

Interventions

  • Psilocybin

Participants

Ages
18 – ?
Sexes
All

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

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment30 participants
  • Timeline
    Start: 2026-04-01
    End: 2029-01-01
  • Compounds
    PsilocybinPsilocybin

Study Team

Sponsors & Collaborators

Locations

Nantes University Hospital — Nantes, France

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