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

Study acronym: PASSENGER
StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 6 months later Jan 1, 2029 → Jul 8, 2029
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Record History

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  1. Primary and study completion pushed from Jan 1, 2029 to Jul 8, 2029 Show 5 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of Apr 1, 2026 to Oct 8, 2026
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 1 of 19 entries
    • Site details revised
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT07391332
Lead Sponsor Nantes University Hospital
Conditions
(from sponsor)		 Gambling Disorder
Related terms Gambling
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov