Phase 2: testing Psychotherapy assisted by high-dose psilocybin (25mg or 40mg where appropriate) for Gambling Disorder
The PASSENGER project aims to conduct a pilot feasibility study of the implementation of a randomly assigned 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.
Official registry: https://clinicaltrials.gov/study/NCT07391332 · Nantes University Hospital · enrollment listed as 30
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Psychotherapy assisted by high-dose psilocybin (25mg or 40mg where appropriate), or Psychotherapy assisted by low-dose psilocybin (1 mg). The registry lists allocation as randomized. The PASSENGER project aims to conduct a pilot feasibility study of the implementation of a randomly assigned clinical trial on psilocybin-assisted psychotherapy for the treatment of gambling disorder.
They plan to enroll about 30 people at Nantes. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER : a Pilot Study
Interventions: Psychotherapy assisted by high-dose psilocybin (25mg or 40mg where appropriate), Psychotherapy assisted by low-dose psilocybin (1 mg)
Primary outcome (registry wording): Protocol completion rate
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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
- Affiliated with a French social security system
Who the registry excludes
- 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
Public study contact (from the registry)
Benoit SCHRECK
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Nantes University Hospital — Nantes, France (recruiting)
FAQ about this NCT record
Is NCT07391332 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07391332?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07391332?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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