Skip to main content
OpenTrials
Completed

NCT Number: NCT05861843

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Psychiatric University Hospital Charité at St. Hedwig Hospital

Berlin, 10115, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Reality-based cue exposure paradigm

Diagnostic Test

Virtual Reality (VR) cue exposure to alcohol-associated cues using head-mounted displays (HMD)

Primary outcomes

  1. change in subjective craving levels elicited by alcohol-associated cues

    Time frame: 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

  2. change in psychophysiological craving levels (heart rate) elicited by alcohol-associated cues

    Time frame: 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.

  3. change in psychophysiological craving levels (heart rate variability) elicited by alcohol-associated cues

    Time frame: 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.

  4. change in psychophysiological craving levels (electrodermal activity) elicited by alcohol-associated cues

    Time frame: 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.

  5. change in psychophysiological craving levels elicited by alcohol-associated cues

    Time frame: 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 outcomes

  1. context-related change in craving levels

    Time frame: 20-30 minutes VR Exposure

    changes in subjective and objective craving levels compared between the two VR-scenarios bar vs. living room

  2. development of subjective craving levels post-exposure

    Time frame: 3 hours after VR-exposure

    changes of subjective craving (VAS) over the following 3 hours after VR-exposure

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Acronym: CRAVE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 17, 2023
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.