Presence and Relapse Rates in Patients With Alcohol Use Disorder Using Virtual Reality

NCT06333457 | Completed DMC

• 1 other identifier: EA4/024/24
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Investigation of the influence of the sense of presence during a Virtual Reality Cue-Exposure Therapy (VR-CET) with alcohol-associated cues on craving and relapse rates. Study group: abstinent patients (at least 18 years old) with a diagnosed alcohol dependence after completed inpatient withdrawal treatment in the the last 3 months. Primary hypothesis: the experience of presence during a virtual presentation of alcohol in alcohol-dependent patients is associated with levels of craving for alcohol during VR-CET.

Conditions

Alcohol Dependence

Outcome Measures

Primary Outcomes (3)

• Craving

  subjective craving for alcohol, measured with Visual Analogue Scales (VAS; 0 - 10 with higher scores indication higher craving levels)

  VR-group: 6 appointments/6 weeks. Every appointment pre, during (approx. 20 min VR exposure) and post VR exposure / control group: 6 appointments/6 weeks, measures once every appointment, both groups: follow up appointments after 6 weeks + after 12 weeks

• Craving

  subjective craving for alcohol, measured with Alcohol Urge Questionnaire (AUQ; scores ranging from 8-56, higher scores indicating higher craving levels)

  VR-group: 6 appointments/6 weeks. Every appointment pre and post VR exposure / control group: 6 appointments/6 weeks, measures once every appointment, both groups: follow up appointments after 6 weeks + after 12 weeks

• Craving

  subjective craving for alcohol, measured with Obsessive Compulsive Drinking Scale (OCDS, scores 0-56; higher scores indicating higher craving levels)

  VR-group: 6 appointments/6 weeks. Every appointment pre VR exposure / control group: 6 appointments/6 weeks, measures once every appointment, both groups: follow up appointments after 6 weeks + after 12 weeks

Secondary Outcomes (4)

• Relapse rates

  both groups: follow up appointment after 6 weeks, follow up appointment after 12 weeks

• Quality of Life

  both groups: assessment during appointment 1 and 6 and during follow up appointments after 6 and 12 weeks

• Motion Sickness

  VR group: pre and post VR exposure (6 appointments/6 weeks)

• Presence in VR

  VR group: post VR exposure (6 appointments/6 weeks)

Study Arms (2)

VR group

50 patients with diagnosed alcohol dependence (in-patients, patients in the outpatient department or day clinics) receiving VR Cue-Exposure Therapy (VR-CET) additional to the standard treatment.

Device: VR Cue-Exposure Therapy

control group

50 patients with diagnosed alcohol dependence (in-patients, patients in the outpatient department or day clinics) receiving standard treatment.

Interventions

VR Cue-Exposure Therapy DEVICE

Standard VR Cue Exposure Therapy (VR-CET) for the treatment of alcohol dependence

VR group

Eligibility Criteria

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

Study Population

Patients with alcohol dependence treated in the inpatient or outpatient psychiatric clinics or day clinics of the Psychiatric University Hospital Charité at St. Hedwig-Hospital/ Department of Psychiatry and Neurosciences Campus Charité Mitte/ Theodor-Wenzel Werk Berlin / Jüdisches Krankenhaus Berlin / Vivantes Auguste-Viktoria-Klinikum

You may qualify if:

• age: 18-65 years
• diagnosis of alcohol dependence according to ICD-10 (F10.2)
• completed in-patient withdrawal treatment during the last 3 months
• history of alcohol craving, confrmed via craving questionnaires
• able to provide written informed consent

You may not qualify if:

• substance dependence other than alcohol and nicotine
• current alcohol intoxication (randomly tested via measurement of breath alcohol concentration)
• unable to understand the study information, consent form or principles of the study
• abstinence for less than 7 days or on-going consumption of alcohol
• severe neuropsychiatric disorder, e.g., schizophrenia spectrum disorders, bipolar afective disorder or substantial cognitive impairment
• somatic diseases for which VR is associated with risks, e.g. photosensitive epilepsy
• acute suicidality or acute endangerment of others
• concurrent pharmacological treatment targeting AUD (i.e. benzodiazepines) or craving (i.e. acamprosate, disulfram, naltrexone, nalmefene)

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Psychiatric University Hospital Charité at St. Hedwig Hospital

Berlin, State of Berlin, 10115, Germany

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: March 27, 2024
• Study Start: April 1, 2024
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: January 21, 2026

Record last verified: 2025-10

Locations

DE (1)