Craving Assessment in Patients With Alcohol Use Disorder Using Virtual Reality Exposure (CRAVE)

Charité University Medicine Berlin

Status: Completed

Conditions: Alcohol Use Disorder

Treatments: Diagnostic Test: Virtual Reality-based cue exposure paradigm

Study type: Observational

Funder types: Other

Identifiers

NCT05861843

EA1/190/22

Details and patient eligibility

About

Alcohol use disorder (AUD) is a burdensome clinical disorder with high relapse rates. Virtual Reality (VR)-based therapeutic and diagnostic approaches have received increasing attention in the treatment of AUD but evidence on the induction of craving via VR scenarios is still needed. Craving for alcohol is associated with psychological and physiological responses. This single-arm clinical study will be conducted including n=60 patients with AUD. Using a head-mounted display (HMD), patients will be confronted with three different VR scenarios (neutral vs. two target situations) while heart rate, heart rate variability (HRV), pupillometry and electrodermal activity (EDA) will be measured continuously. Subjective craving levels will be assessed pre-/during/post-exposure to each VR scenario.

Enrollment: 61 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, confirmed 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 affective disorder or substantial cognitive impairment
• serious illnesses influencing brain-/heart-function with influence on physiological study parameters.
• acute suicidality (or acute endangerment of others)
• concurrent pharmacological treatment targeting AUD (i.e. benzodiazepines) or craving (i.e. acamprosate, disulfiram, naltrexone, nalmefene) and further medication significantly influencing heart frequency.