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

Alcohol Use Disorder Clinical Trial

— CRAVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05861843
• Other study ID #: EA1/190/22
• Status: Recruiting
• Start date: September 23, 2023
• Est. completion date: June 2024

Study information

• Verified date: November 2023
• Source: Charite University, Berlin, Germany
• Contact: Alva Lütt, Dr. med.
• Phone: +49 30 2311 2904
• Email: alva.luett[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

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

Locations

Country	Name	City	State
Germany	Psychiatric University Hospital Charité at St. Hedwig Hospital	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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