A Phase 2 interventional study of Psychotherapy assisted by high-dose psilocybin (25mg or 40mg where appropriate) and Psychotherapy assisted by low-dose psilocybin (1 mg) in Gambling Disorder, sponsored by Nantes University Hospital. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Nantes University Hospital · Phase 2, Interventional, and Treatment
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.
158 studies on the registry are indexed under Gambling; 42 are open to participants now.
This study's planned enrollment of 30 is below the median of 66 across 128 interventional studies indexed under Gambling.
Browse Gambling studies →Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Psychotherapy assisted by high-dose psilocybin (25mg or 40mg where appropriate)
Drug: Psychotherapy assisted by low-dose psilocybin (1 mg)
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).
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.
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.
Time frame: End of study (33 months)
Feasibility of recruitment and the proposed experimental protocol.
Goal of recruiting 30 participants within the planned inclusion period achieved
Time frame: End of study (33 months)
Assessement of the acceptability of the proposed experimental treatment by patients and caregivers.
Self-reported acceptability by patients and caregivers
Time frame: Month 1
Assessment of personal self-efficacy (General Self-Efficacy Scale: GSES)
Changes in each arm, between baseline assessment (V0) and post-treatment assessment (V1) 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
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
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
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)
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)
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)
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)
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)
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
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
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
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.
Time frame: Month 1
Clinical global impression of severity (Clinical Global Impression-Severity: CGI-S)
Changes between baseline assessment (Visit 0) and post-treatment assessment (Visit 1) of clinical global impression of severity (Clinical Global Impression-Severity: CGI-S)
Time frame: Month 1
Self-Compassion Scale (SCS)
Changes between baseline assessment (Visit 0) and post-treatment assessment (Visit 1) of Self-Compassion Scale (SCS)
Time frame: Month 1
Spirituality assessment (World Health Organization Quality of Life Spirituality, Religiousness and Personal Beliefs Instrument: WHOQOL-SRPB)
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)
Time frame: Month 1
Analysis of daily diary
Changes between baseline assessment (Visit 0) and post-treatment assessment (Visit 1) of gambling behavior using daily diary.
Time frame: Month 1
Heart rate
Average scores in each arm of heart rate assessed during administration sessions
Time frame: Month 1
Blood pressure
Average scores in each arm of blood pressure assessed during administration sessions
Time frame: Month 1
Expected acute effects assessment
Average scores in each arm of expected acute effects (17-item behavior and mood observation grid), assessed during administration sessions
Time frame: Month 1
Assessment of Adverse Effects
Assessment of AEs (excluding expected acute effects), assessed during administration sessions in particular, but also throughout the duration of participation in the study;
Time frame: Month 3
Mini International Neuropsychiatric Interview (MINI 5.0)
Average scores in each arm of an increase in the level of suicide risk assessed by the Mini International Neuropsychiatric Interview (MINI 5.0)
Time frame: Month 3
Clinical Global Impression-Efficacy Index: CGI-IE
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.
Time frame: Month 3
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Jul 2029, 33 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 16, 2026: start Apr 2026 → Oct 2026, primary completion Jan 2029 → Jul 2029 and completion Jan 2029 → Jul 2029.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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