Presence and Relapse Rates in Patients With Alcohol Use Disorder Using Virtual Reality (PRE-VR)

Charité University Medicine Berlin

Status: Completed

Conditions: Alcohol Dependence

Treatments: Device: VR Cue-Exposure Therapy

Study type: Observational

Funder types: Other

Identifiers

NCT06333457

EA4/024/24

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

60 participants in 2 patient groups

VR group

Description:

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.

Treatment:

Device: VR Cue-Exposure Therapy

control group

Description:

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