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

Study Overview
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Brief Summary
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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.

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

Conditions
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Alcohol Use Disorder

Intervention / Treatment
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* Diagnostic Test: Virtual Reality-based cue exposure paradigm


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Virtual Reality-based cue exposure paradigm|Virtual Reality (VR) cue exposure to alcohol-associated cues using head-mounted displays (HMD)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in subjective craving levels elicited by alcohol-associated cues | 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 | 20-30 min VR exposure | 
| change in psychophysiological craving levels (heart rate) elicited by alcohol-associated cues | Changes in craving levels measured continuously by heart rate (bpm = beats per minute) during VR-exposure to alcohol-associated cues compared to neutral cues. | 20-30 min VR exposure | 
| change in psychophysiological craving levels (heart rate variability) elicited by alcohol-associated cues | Changes in craving levels measured continuously by heart rate variability (ms) during VR-exposure to alcohol-associated cues compared to neutral cues. | 20-30 min VR exposure | 
| change in psychophysiological craving levels (electrodermal activity) elicited by alcohol-associated cues | Changes in craving levels measured continuously by electrodermal activity (micro-Siemens) during VR-exposure to alcohol-associated cues compared to neutral cues. | 20-30 min VR exposure | 
| change in psychophysiological craving levels elicited by alcohol-associated cues | Changes in craving levels measured continuously by pupillometry (pupil dilation in mm) during VR-exposure to alcohol-associated cues compared to neutral cues. | 20-30 min VR exposure | 

Secondary Outcome Measures

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