Status:
RECRUITING
Effectiveness of Virtual Reality Therapy in Alcohol Use Disorder Study
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Alcool Use Disorder
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 fo...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT06104176
Start Date
November 1 2023
End Date
July 1 2026
Last Update
January 8 2025
Active Locations (1)
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1
Hôpital Albert Chenevier
Créteil, Île-de-France Region, France, 94000