NCT07391332

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-01-01
• Completion: 2029-01-01
• First posted: 2026-02-05
• Last updated: 2026-02-05

Locations

1 site across 1 country: France