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

Completed

• Conditions: Alcohol Use Disorder

• Registration Number: NCT05861843
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-24
• Study First Submitted QC: 2023-05-06
• Study First Posted: 2023-05-17
• Study Start: 2023-09-23
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-23
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in psychophysiological craving levels (heart rate variability) elicited by alcohol-associated cues	20-30 min VR exposure	Changes in craving levels measured continuously by heart rate variability (ms) during VR-exposure to alcohol-associated cues compared to neutral cues.
change in subjective craving levels elicited by alcohol-associated cues	20-30 min VR exposure	Changes in craving levels measured by subjective parameters (visual analogue scale = VAS, scale 0-100) before, during and after VR-exposure to alcohol-associated cues compared to neutral cues
change in psychophysiological craving levels (heart rate) elicited by alcohol-associated cues	20-30 min VR exposure	Changes in craving levels measured continuously by heart rate (bpm = beats per minute) during VR-exposure to alcohol-associated cues compared to neutral cues.
change in psychophysiological craving levels (electrodermal activity) elicited by alcohol-associated cues	20-30 min VR exposure	Changes in craving levels measured continuously by electrodermal activity (micro-Siemens) during VR-exposure to alcohol-associated cues compared to neutral cues.
change in psychophysiological craving levels elicited by alcohol-associated cues	20-30 min VR exposure	Changes in craving levels measured continuously by pupillometry (pupil dilation in mm) during VR-exposure to alcohol-associated cues compared to neutral cues.

Secondary Outcome Measures

Name	Time	Method
development of subjective craving levels post-exposure	3 hours after VR-exposure	changes of subjective craving (VAS) over the following 3 hours after VR-exposure
context-related change in craving levels	20-30 minutes VR Exposure	changes in subjective and objective craving levels compared between the two VR-scenarios bar vs. living room

Trial Locations

Locations (1)

Psychiatric University Hospital Charité at St. Hedwig Hospital; 🇩🇪 Berlin, Germany