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

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Diagnostic test: Virtual Reality-based cue exposure paradigm

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10115
    • Psychiatric University Hospital Charité at St. Hedwig Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with AUD treated in inpatient or outpatient psychiatric clinic

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Alva Lütt, Dr. med., Psychiatrische Universitätsklinik der Charité im St. Hedwig Krankenhaus, 10115 Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2023
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: May 6, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 23, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism
• Other Study ID Numbers: EA1/190/22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No