Gambling DisorderPhase 2PASSENGERNCT07391332
Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER : a Pilot Study
A Phase 2 study testing Psychotherapy assisted by high-dose psilocybin (25mg or 40mg where appropriate) and Psychotherapy assisted by low-dose psilocybin (1 mg) in people with Gambling Disorder, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gambling Disorder
- What is being tested?
- Psychotherapy assisted by high-dose psilocybin (25mg or 40mg where appropriate) and Psychotherapy assisted by low-dose psilocybin (1 mg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 8 Oct 2026to 8 Jul 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Nantes University Hospital
Nantes
Benoit SCHRECK, +33.2.40.84.76.20, benoit.schreck@chu-nantes.fr
About this 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.
- Conditions
- Gambling Disorder
- Being tested
- Psychotherapy assisted by high-dose psilocybin (25mg or 40mg where appropriate), Psychotherapy assisted by low-dose psilocybin (1 mg)
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Psychotherapy assisted by high-dose psilocybin (25mg or 40mg where appropriate) | Experimental | Not described Receives: Drug: Psychotherapy assisted by high-dose psilocybin (25mg or 40mg where appropriate) |
| Psychotherapy assisted by low-dose psilocybin (1 mg) | Active comparator | Not described Receives: Drug: Psychotherapy assisted by low-dose psilocybin (1 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of study (33 months)
Secondary outcomes (19)
Feasibility of recruitment and the proposed experimental protocol.
Goal of recruiting 30 participants within the planned inclusion period achieved
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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)
Measured: Month 1
Self-Compassion Scale (SCS)
Changes between baseline assessment (Visit 0) and post-treatment assessment (Visit 1) of Self-Compassion Scale (SCS)
Measured: 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)
Measured: Month 1
Analysis of daily diary
Changes between baseline assessment (Visit 0) and post-treatment assessment (Visit 1) of gambling behavior using daily diary.
Measured: Month 1
Heart rate
Average scores in each arm of heart rate assessed during administration sessions
Measured: Month 1
Blood pressure
Average scores in each arm of blood pressure assessed during administration sessions
Measured: 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
Measured: 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;
Measured: 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)
Measured: 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.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start8 Oct 2026
- Primary completion8 Jul 2029 (estimated)
- Study completion8 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gambling DisorderStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391332
- Sponsor's protocol ID
- RC25_0105
- Other IDs
- 2025-522743-18-00, 2025
- Acronym
- PASSENGER
- Status last verified
- Oct 2026
- First submitted
- 22 Jan 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER : a Pilot Study
- ClinicalTrials.gov ID
- NCT07391332
- Acronym / sponsor ID
- PASSENGER / RC25_0105
- Conditions
- Gambling Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 8 Oct 2026 (actual)
- Primary completion
- 8 Jul 2029 (estimated)
- Study completion
- 8 Jul 2029 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 high-dose psilocybin (25mg or 40mg where appropriate) |
| 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. | Drug | Psychotherapy assisted by low-dose psilocybin (1 mg) |
Primary outcome
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.
19 secondary outcomes
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
Analysis of daily diary
Time frame: Month 1
Heart rate
Time frame: Month 1
Blood pressure
Time frame: Month 1
Expected acute effects assessment
Time frame: Month 1
Assessment of Adverse Effects
Time frame: Month 3
Mini International Neuropsychiatric Interview (MINI 5.0)
Time frame: Month 3
Clinical Global Impression-Efficacy Index: CGI-IE
Time frame: Month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psychotherapy assisted by high-dose psilocybin (25mg or 40mg where appropriate) and Psychotherapy assisted by low-dose psilocybin (1 mg) in people with Gambling Disorder, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benoit SCHRECK (+33.2.40.84.76.20, benoit.schreck@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protocol completion rate (time frame: End of study (33 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.