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Not yet recruiting NCT07391332

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

Phase II Interventional Gambling Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Psychotherapy assisted by high-dose psilocybin (25mg or 40mg where appropriate), Psychotherapy assisted by low-dose psilocybin (1 mg).
Who it may be relevant to
Registry conditions: Gambling Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Psychotherapy assisted by high-dose psilocybin (25mg or 40mg where appropriate)
    The first session of psilocybin PEX010 administration will use a moderately high dose of psilocybin, i.e., 25 mg. The dose may be increased to 40 mg during the second administration session in the experimental group, depending on the response during the previous session, as assessed by the Mystical Experience Questionnaire-30 (MEQ-30).
  • Drug Psychotherapy assisted by low-dose psilocybin (1 mg)
    The first session of psilocybin PEX010 administration will use a very low dose of 1 mg in the control group. During the second administration session, the dose will be maintained at 1 mg.

Primary outcome measures

  • Protocol completion rate [Time frame: End of study (33 months)]
Secondary outcome measures (12)
  • Feasibility of recruitment and the proposed experimental protocol. [Time frame: End of study (33 months)]
  • Assessement of the acceptability of the proposed experimental treatment by patients and caregivers. [Time frame: Month 1]
  • Assessment of personal self-efficacy (General Self-Efficacy Scale: GSES) [Time frame: Month 1]
  • Correlation between the intensity of the psychedelic experience, measured by the Mystical Experience Questionnaire (MEQ-30) score, and the WHOQOL-SRPB spirituality score [Time frame: Month 1]
  • Correlation between the intensity of the psychedelic experience, measured by the Mystical Experience Questionnaire (MEQ-30) score, and the Self-Compassion Scale [Time frame: Month 1]
  • Correlation between the intensity of the psychedelic experience, measured by the Mystical Experience Questionnaire (MEQ-30) score, and treatment expectations (Credibility/Expectancy Questionnaire: CEQ) [Time frame: Month 1]
  • Correlation between the intensity of the psychedelic experience, measured by the Mystical Experience Questionnaire (MEQ-30) score, and personal self-efficacy (General Self-Efficacy Scale: GSES) [Time frame: Month 1]
  • Correlation between the intensity of the psychedelic experience, measured by the Mystical Experience Questionnaire (MEQ-30) score, and average dose of psilocybin administered during the two sessions [Time frame: Month 1]
  • Correlation between the intensity of the psychedelic experience, measured by the Mystical Experience Questionnaire (MEQ-30) score, and measurement of blind maintenance [Time frame: Month 1]
  • Clinical global impression of severity (Clinical Global Impression-Severity: CGI-S) [Time frame: Month 1]
  • Self-Compassion Scale (SCS) [Time frame: Month 1]
  • Spirituality assessment (World Health Organization Quality of Life Spirituality, Religiousness and Personal Beliefs Instrument: WHOQOL-SRPB) [Time frame: Month 1]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

France · 1 center
  • Nantes University Hospital — Nantes

Identifiers

NCT: NCT07391332 · RC25_0105 · 2025-522743-18-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗