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

NCT ID: NCT05861843

Last Updated: 2024-08-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 61 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-23
• Study Completion Date: 2024-06-30

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.

Conditions

Alcohol Use Disorder

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Virtual Reality-based cue exposure paradigm

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

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Alva Lütt

Dr. med. Alva Lütt, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alva Lütt, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Psychiatrische Universitätsklinik der Charité im St. Hedwig Krankenhaus, 10115 Berlin, Germany

Locations

Psychiatric University Hospital Charité at St. Hedwig Hospital

Berlin, , Germany

Countries

Germany

References

Lutt A, Tsamitros N, Wolbers T, Rosenthal A, Brocker AL, Schoneck R, Bermpohl F, Heinz A, Beck A, Gutwinski S. An explorative single-arm clinical study to assess craving in patients with alcohol use disorder using Virtual Reality exposure (CRAVE)-study protocol. BMC Psychiatry. 2023 Nov 14;23(1):839. doi: 10.1186/s12888-023-05346-y.

Reference Type: DERIVED

PMID: 37964300 (View on PubMed)

Other Identifiers

EA1/190/22

Identifier Type: -

Identifier Source: org_study_id