Clinical trial NCT05861843: Craving Assessment in Patients With Alcohol Use Disorder Using Virtual Reality Exposure
Official title: Craving Assessment in Patients With Alcohol Use Disorder Using Virtual Reality Exposure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcohol Use Disorder
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with AUD treated in inpatient or outpatient psychiatric clinic

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: change in subjective craving levels elicited by alcohol-associated cues
timeFrame: 20-30 min VR exposure
measure: change in psychophysiological craving levels (heart rate) elicited by alcohol-associated cues
timeFrame: 20-30 min VR exposure
measure: change in psychophysiological craving levels (heart rate variability) elicited by alcohol-associated cues
timeFrame: 20-30 min VR exposure
measure: change in psychophysiological craving levels (electrodermal activity) elicited by alcohol-associated cues
timeFrame: 20-30 min VR exposure
measure: change in psychophysiological craving levels elicited by alcohol-associated cues
timeFrame: 20-30 min VR exposure
Secondary outcomes:
measure: context-related change in craving levels
timeFrame: 20-30 minutes VR Exposure
measure: development of subjective craving levels post-exposure
timeFrame: 3 hours after VR-exposure
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Psychiatric University Hospital Charité at St. Hedwig Hospital
Study officials:
affiliation: Psychiatrische Universitätsklinik der Charité im St. Hedwig Krankenhaus, 10115 Berlin, Germany
name: Alva Lütt, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: