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Recruiting NCT07388693

Feasibility of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure for Patients With Alcohol Dependence

Conditions: Alcohol Dependence

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Charite University, Berlin, Germany

Location: Psychiatric University Hospital Charité at St. Hedwig Hospital Berlin State of Berlin

Summary

Alcohol dependence (AD) is a prevalent and burdensome clinical condition with high relapse rates. A central risk factor for relapse is craving for alcohol, which can be evoked by both real-world and virtual cues in immersive Virtual Reality (VR). In addition to visual and auditory stimuli, olfactory stimuli are increasingly recognized as important for creating realistic, multisensory VR environments. However, no systematic investigation has yet examined how olfactory stimuli embedded in VR-based Cue Exposure (VR-CE) influence cue-elicited craving. As part of the OLFA-VR (Effects of Olfactory Stimuli in Virtual Reality Cue Exposure on Craving in Alcohol Dependence) research project, the present feasibility study aims to evaluate the feasibility, tolerability and acceptability of implementing olfactory stimuli into VR-CE. In addition, this study not only examines the general feasibility of alcohol-related olfactory stimuli in VR-CE but also explores which specific alcohol-related olfactory stimuli prove to be feasible. The investigators hypothesize that implementing olfactory stimuli into VR-CE will be feasible and tolerable for patients with AD, with no preventable serious side effects caused by VR-CE. The investigators also hypothesize that VR-CE will induce craving in most patients.

Eligibility Criteria

Inclusion Criteria: * age: 18-65 years * diagnosis of alcohol dependence according to ICD-10 (F10.2) * history of alcohol craving * able to provide written informed consent Exclusion Criteria: * hyposmia * dependence on substances other than alcohol and nicotine * current alcohol intoxication (randomly tested by 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 ongoing consumption of alcohol * severe neuropsychiatric disorder (e.g. schizophrenia spectrum disorders, bipolar affective disorder) or substantial cognitive impairment * serious illnesses affecting brain or heart function that influence physiological study parameters * acute suicidality (or acute endangerment of others) * concurrent pharmacological treatment targeting AUD (e.g. benzodiazepines) or craving (e.g. acamprosate, disulfiram, naltrexone, nalmefene) and further medication significantly influencing heart rate

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07388693). StuddyBuddy aggregates publicly available trial information.