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

NCT07391332 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: RC25_01052025-522743-18-00
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gambling Disorder

Outcome Measures

Primary Outcomes (1)

• Protocol completion rate

  Proportion of randomized participants who completed all scheduled visits and procedures, including all PAP sessions/control sessions and follow-up assessments until the end of study participation.

  End of study (33 months)

Secondary Outcomes (19)

• Feasibility of recruitment and the proposed experimental protocol.

  End of study (33 months)

• Assessement of the acceptability of the proposed experimental treatment by patients and caregivers.

  Month 1

• Assessment of personal self-efficacy (General Self-Efficacy Scale: GSES)

  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

  Month 1

• Correlation between the intensity of the psychedelic experience, measured by the Mystical Experience Questionnaire (MEQ-30) score, and the Self-Compassion Scale

  Month 1

Study Arms (2)

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

EXPERIMENTAL

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

Psychotherapy assisted by low-dose psilocybin (1 mg)

ACTIVE COMPARATOR

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

Interventions

Psychotherapy assisted by low-dose psilocybin (1 mg) DRUG

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.

Psychotherapy assisted by low-dose psilocybin (1 mg)

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

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).

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify 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).
• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, France

Location

MeSH Terms

Conditions

Gambling

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Risk-Taking; Behavior; Disruptive, Impulse Control, and Conduct Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Central Study Contacts

Benoit SCHRECK

CONTACT

+33.2.40.84.76.20; benoit.schreck@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 5, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)