Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER : a Pilot Study
ConditionGambling Disorder
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNantes University Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Psychotherapy assisted by high-dose psilocybin (25mg or 40mg where appropriate)
- Psychotherapy assisted by low-dose psilocybin (1 mg)
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov