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Effectiveness of Virtual Reality Therapy in Alcohol Use Disorder Study

RecruitingNAAges 18 Years - 80 YearsAllAssistance Publique - Hôpitaux de Paris
NCT06104176 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, abstin

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📋 Eligibility rules (as published)
Inclusion Criteria: * Aged 18 or over, and under 80 on the date of inclusion * Fulfilling Alcohol use disorder according to the DSM-V criteria (American Psychiatric Association, 2013); * In alcohol abstinence for at least 15 days; * Be able to speak, understand and read French; * Signed an informed consent * Affiliated to the French health insurance scheme Exclusion Criteria: * • Major under legal protection measure, or deprived of liberty by judicial or administrative decision; * Pregnant or breastfeeding women; * Decompensated psychiatric disoreder (psychotic disorders, mood disorders and anxiety disorders); * Alcohol use disorder relapse * Severe cognitive impairment as defined by a score of 10 or less at the Montreal Cognitive Assessment (MOCA) (Nasreddine et al., 2005) * Visual impairment * Contraindications to virtual reality exposure: a history of photosensitive epilepsy, response, balance disorders, recent stroke less than 3 months old, current nausea/vomiting, claustrophobia, and medium or high myopia (beyond -3.5 diopters) * Patients wearing one of the following medical devices (due to the risk of interference of the virtual reality headset with them): pacemaker, implanted defibrillator, or implanted hearing aids (non-implanted prostheses are not contraindicated if the patient agrees to remove them during virtual reality exposure) * Participation in another trial or being in the exclusion period following previous research involving humans, if applicable * Patients not affiliated to the French health insurance scheme and receiving the State Medical Aid
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What it tests

  • CBT in group
  • Virtual reality exposure
  • individual CBT
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Where

1 site
Hôpital Albert Chenevier
Créteil, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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