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

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05861843

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Alcohol use disorder (AUD) is a burdensome clinical disorder with high relapse rates. Craving for alcohol is a major predictor for relapse and is associated with psychological and physiological responses. 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. This single-arm monocentric 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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Use Disorder	Diagnostic Test: Virtual Reality-based cue exposure paradigm

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Outcome Measures

Primary Outcome Measures

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 (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 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

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alva Lütt, Dr. med. Alva Lütt, MD, Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT05861843

Other Study ID Numbers:

EA1/190/22

First Posted:

May 17, 2023

Last Update Posted:

May 17, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alcoholism

Alcohol Drinking

Study Results

No Results Posted as of May 17, 2023