Informations générales (source: ClinicalTrials.gov)
Effectiveness of Virtual Reality Therapy in Alcohol Use Disorder Study : a Multicenter Randomized Trial. Original Title in French : étude de l'efficacité de la Réalité Virtuelle Dans le Traitement du Trouble de l'Usage d'Alcool : un Essai randomisé Multicentrique (e-Réva)
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
novembre 2023
juillet 2026
15 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CH DES QUATRE VILLES SITE SEVRES | ZERDAZI Mohamed El Hadi | 18/09/2025 17:35:01 | Contacter | ||
| HOPITAL GOUIN A CLICHY | ZERDAZI Mohamed El Hadi | 18/09/2025 17:35:02 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 18/09/2025 17:35:02 | Contacter | |||
| AP-HP - Hôpital Bichat | |||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | |||||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | |||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hôpital Albert Chenevier - 94000 - Créteil - Ile-De-France - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- • 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