Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06104176

Effectiveness of Virtual Reality Therapy in Alcohol Use Disorder Study

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-01-08

156

Participants Needed

1

Research Sites

139 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Intro: Virtual reality exposure therapy (VRET) has been widely assessed in several mental disorders, including substances use disorders. In the case of alcohol use disorder (AUD), published studies focus mainly on craving interventions: eliciting, triggering, reduction or extinction, with promising result. However, data Virtual reality exposure therapy effect on reduction of alcohol consumption or abstinence remains scarce. Hypothesis/Objective: The investigators hypothesis that VRET associated to cognitive behaviors therapy (CBT) will be more effective than CBT alone on the reduction in the cumulative number of standard drinks (vs) of alcohol intakes at 8 months after inclusion. The second objective is the assess its effectiveness on reported craving also at 8 months. Method: The investigators plane to recruit 156 subjects aged 18 and over, with AUD according to DSM V criteria, abstinent for at least 15 days. Non-inclusion criteria are: AUD relapse, pregnancy or breastfeeding (for women), decompensated comorbid mental disorder, severe cognitive impairment, epilepsy or history of photo paroxysmal EEG responses, balance disorders, recent stroke less than 3 months old, current nausea/vomiting, claustrophobia, severe visual impairment, and medium or high myopia (beyond -3.5 diopters). The study recruitment and sitting will be on 4 addiction day hospitals, and the follow up period will be of 8 months. All subjects will have 4 sessions of group CBT (one per week) during the first month following their inclusion, and then randomly assigned (ratio 1:1) to VRET group or individual CBT group. Subjects will undergo 4 additional sessions of VRET or individual CBT (one per week) during the second month. Afterwards, all included subjects will be followed monthly for 6 months (Months 2 to 8 after inclusion). Timeline Follow-Back (TLFB) is used for the reporting of the number of alcohol standard drinks intakes, and the Transaddiction Craving Triggers Questionnaire (TCTQ) for craving assessment.

CONDITIONS

Official Title

Effectiveness of Virtual Reality Therapy in Alcohol Use Disorder Study

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 or over, and under 80 on the date of inclusion
  • Diagnosed with Alcohol Use Disorder according to DSM-V criteria
  • Abstinent from alcohol for at least 15 days
  • Able to speak, understand, and read French
  • Signed an informed consent
  • Affiliated with the French health insurance scheme
Not Eligible

You will not qualify if you...

  • Under major legal protection or deprived of liberty by judicial or administrative decision
  • Pregnant or breastfeeding women
  • Decompensated psychiatric disorders such as psychotic, mood, or anxiety disorders
  • Alcohol Use Disorder relapse
  • Severe cognitive impairment (MOCA score 10 or less)
  • Visual impairment
  • Contraindications to virtual reality exposure including photosensitive epilepsy, balance disorders, recent stroke less than 3 months old, current nausea/vomiting, claustrophobia, medium or high myopia beyond -3.5 diopters
  • Wearing pacemaker, implanted defibrillator, or implanted hearing aids
  • Participation in another trial or in exclusion period following previous research
  • Not affiliated to the French health insurance scheme and receiving State Medical Aid

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hôpital Albert Chenevier

Créteil, Île-de-France Region, France, 94000

Actively Recruiting

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Research Team

E

El-Hadi ZERDAZI, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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