"ALCO-VR": Virtual Reality Cue Exposure Therapy for the Treatment of Alcohol Use Disorder

NCT04858061 | Completed

• 1 other identifier: 2016I078
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Alcohol-related stimuli emerge as high-risk cues for individuals diagnosed with alcohol use disorder (AUD). Relapse after treatment remains a challenge in AUD. Alcohol craving and anxiety are factors contributing to relapse, even after completion of treatment. The current study aims to test the efficacy of a Virtual Reality Cue-Exposure Therapy (VR-CET) patients diagnosed with severe AUD, who made several failed attempts to cease alcohol drinking. It is expected that VR-CET is more efficient in reducing AUD symptomatology and preventing relapses than treatment-as-usual (TAU). 80 participants will be randomly assigned to experimental or control group. The experimental group will receive treatment-as-usual supplemented with 6 sessions of virtual reality cue-exposure therapy (TAU + VR-CET) over the course of five weeks. VR-CET booster sessions consist of exposure to preferred alcoholic beverages and alcohol-related contexts in a VR environment. Throughout the six VR-CET sessions, momentary anxiety and alcohol craving levels will be assessed. The control group will receive only treatment-as-usual (TAU).

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (3)

• Change in Craving based on AUDIT

  Change in Craving levels using the Alcohol Use Disorders Identification Test (AUDIT), with scores ranging from 0 to 40. Higher scores reflect higher levels of craving

  pre-assessment

• Change in Craving based on MACS

  Change in Craving levels using the Multidimensional Alcohol Craving Scale (MACS), with scores ranging from 0 to 60. Higher scores reflect higher levels of craving

  at pre-assessment and after 3 weeks

• Change in Anxiety

  Change in Anxiety levels using the State-Trait Anxiety Inventory (STAI), with scores ranging from 0 to 60. Higher scores reflect higher levels of anxiety

  at pre-assessment and after 3 weeks

Other Outcomes (2)

• Craving levels during exposure sessions

  Up to 50 minutes. Baseline (prior to beginning the session), every 20 seconds during the virtual reality session, and at the end of the session

• Anxiety levels during exposure sessions

  Up to 50 minutes. Baseline (prior to beginning the session), every 20 seconds during the virtual reality session, and at the end of the session

Study Arms (2)

Treatment-as-usual supplemented with virtual reality cue-exposure therapy

EXPERIMENTAL

Treatment-as-usual supplemented with virtual reality cue-exposure therapy (TAU + VR-CET).

Behavioral: Virtual Reality Cue Exposure Therapy

Treatment-as-usual

ACTIVE COMPARATOR

Only treatment-as-usual (TAU)

Behavioral: Treatment-as-usual

Interventions

Virtual Reality Cue Exposure Therapy BEHAVIORAL

Exposure to alcohol-related cues within virtual environments

Treatment-as-usual supplemented with virtual reality cue-exposure therapy

Treatment-as-usual BEHAVIORAL

Pharmacotherapy and psychotherapy

Treatment-as-usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with moderate (4-5 diagnostic criteria) or severe (6 or more diagnostic criteria) AUD according to DSM-5
• Minimum 3 days abstinence before initial evaluation

You may not qualify if:

• severe cognitive impairment that could interfere with comprehension and completion of the task
• severe psychopathology (e.g. major depression, schizophrenia, dementia)
• opiate addiction
• epilepsy
• severe visual impairments
• pregnancy

Sponsors & Collaborators

• University of Barcelona: lead
• Hospital Clinic of Barcelona: collaborator
• Ministry of Health, Spain: collaborator
• Ministry of Education and Vocational Training, Spain: collaborator

Study Sites (1)

Universitat de Barcelona

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• José Gutiérrez Maldonado, Prof. Dr.

  University of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 26, 2021
• Study Start: September 15, 2018
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: December 8, 2023

Record last verified: 2023-12

Locations

ES (1)