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NCT Number: NCT07391332

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

  1. Protocol completion rate

    Time frame: End of study (33 months)

    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.

Secondary outcomes

  1. Feasibility of recruitment and the proposed experimental protocol.

    Time frame: End of study (33 months)

    Goal of recruiting 30 participants within the planned inclusion period achieved

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

    Time frame: Month 1

    Self-reported acceptability by patients and caregivers

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

    Time frame: Month 1

    Changes in each arm, between baseline assessment (V0) and post-treatment assessment (V1) of personal self-efficacy (General Self-Efficacy Scale: GSES)

  4. 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 obtained post-administration, and the spirituality WHOQOL-SRPB at baseline

  5. 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 obtained post-administration, and the self-compassion score (Self-Compassion Scale: SCS)

  6. 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 obtained post-administration, and treatment expectations based on the Credibility/Expectancy Questionnaire (CEQ)

  7. 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 obtained post-administration, and the personal self-efficacy based on General Self-Efficacy Scale (GSES)

  8. 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 obtained post-administration, and average dose of psilocybin administered during the two sessions

  9. 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

    Correlation between the intensity of the psychedelic experience, measured by the Mystical Experience Questionnaire (MEQ-30) score obtained post-administration, and the measurement of blind maintenance.

  10. Clinical global impression of severity (Clinical Global Impression-Severity: CGI-S)

    Time frame: Month 1

    Changes between baseline assessment (Visit 0) and post-treatment assessment (Visit 1) of clinical global impression of severity (Clinical Global Impression-Severity: CGI-S)

  11. Self-Compassion Scale (SCS)

    Time frame: Month 1

    Changes between baseline assessment (Visit 0) and post-treatment assessment (Visit 1) of Self-Compassion Scale (SCS)

  12. Spirituality assessment (World Health Organization Quality of Life Spirituality, Religiousness and Personal Beliefs Instrument: WHOQOL-SRPB)

    Time frame: Month 1

    Changes between baseline assessment (Visit 0) and post-treatment assessment (Visit 1) of World Health Organization Quality of Life Spirituality, Religiousness and Personal Beliefs Instrument (WHOQOL-SRPB)

  13. Analysis of daily diary

    Time frame: Month 1

    Changes between baseline assessment (Visit 0) and post-treatment assessment (Visit 1) of gambling behavior using daily diary.

  14. Heart rate

    Time frame: Month 1

    Average scores in each arm of heart rate assessed during administration sessions

  15. Blood pressure

    Time frame: Month 1

    Average scores in each arm of blood pressure assessed during administration sessions

  16. Expected acute effects assessment

    Time frame: Month 1

    Average scores in each arm of expected acute effects (17-item behavior and mood observation grid), assessed during administration sessions

  17. Assessment of Adverse Effects

    Time frame: Month 3

    Assessment of AEs (excluding expected acute effects), assessed during administration sessions in particular, but also throughout the duration of participation in the study;

  18. Mini International Neuropsychiatric Interview (MINI 5.0)

    Time frame: Month 3

    Average scores in each arm of an increase in the level of suicide risk assessed by the Mini International Neuropsychiatric Interview (MINI 5.0)

  19. Clinical Global Impression-Efficacy Index: CGI-IE

    Time frame: Month 3

    Average scores in each arm of the therapeutic index (Clinical Global Impression-Efficacy Index: CGI-IE) and clinical improvement (Clinical Global Impression-Improvement: CGI-I), assessed at post-treatment evaluation.

Study contacts

Contact information is provided by the study sponsor or research team.

Benoit SCHRECK

CONTACT

[email protected]

+33.2.40.84.76.20

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: PASSENGER

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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