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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Psychotherapy assisted by high-dose psilocybin (25mg or 40mg where appropriate)Experimental treatment 1 intervention
Group B: Psychotherapy assisted by low-dose psilocybin (1 mg)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
End of study (33 months)

Secondary outcomes

1

Feasibility of recruitment and the proposed experimental protocol.

Goal of recruiting 30 participants within the planned inclusion period achieved

Time frame
End of study (33 months)
2

Assessement of the acceptability of the proposed experimental treatment by patients and caregivers.

Self-reported acceptability by patients and caregivers

Time frame
Month 1
3

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)

Time frame
Month 1
4

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

Time frame
Month 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nantes University Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: