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

Charité University Medicine Berlin

Status: Not yet enrolling

Conditions: Alcohol Dependence

Treatments: Device: VR Cue-Exposure Including Olfactory Cues

Study type: Observational

Funder types: Other

Identifiers

NCT07388693

EA1/269/24

Details and patient eligibility

About

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 cues are increasingly recognized as important for creating realistic, multisensory VR environments. However, no systematic investigation has yet examined how olfactory cues 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 cues into VR-CE.

In addition, this study not only examines the general feasibility of alcohol-related olfactory cues in VR-CE but also explores which specific alcohol-related olfactory cues prove to be feasible.

The investigators hypothesize that implementing olfactory cues 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.

Full description

Twenty patients with alcohol dependence (AD), treated in an inpatient or outpatient psychiatric clinic, will be included in the study. Participants will receive written and verbal information about the study and informed consent for participation will be obtained. A screening for eligibility will then be conducted. Sociodemographic data will be collected, and screening for harmful alcohol use (Alcohol Use Disorders Identification Test, AUDIT) and assessment of AD severity (Alcohol Dependence Scale, ADS) will be performed.

Participants will be exposed to two types of Virtual Reality (VR) scenarios combined with corresponding olfactory cues: a neutral VR scenario with neutral visual and olfactory cues (rose), and an alcohol-related VR scenario with alcohol-related visual and olfactory cues (beer, white wine, red wine, vodka, schnaps). The VR-CE protocol comprises one exposure to the neutral VR-CE followed by five alcohol-related VR-CEs. The five alcohol-related VR-CEs will be presented in a randomized order, each pairing a visual cue with the corresponding olfactory cue for a specific beverage.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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