VR-CE: Virtual reality cue exposure (VR-CE) using visual (neutral vs. alcohol-related VR scenarios) and olfactory (no odor vs. alcohol-related odor) stimuli conditions.
Study summary
Alcohol use disorder (AUD) is a prevalent and burdensome clinical condition with high relapse rates. A central risk factor for relapse is craving for alcohol-often accompanied by an attentional bias toward alcohol-related stimuli-which can be evoked by both real-world and virtual stimuli 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 craving and attentional bias in patients with AUD.
The goal of this prospective experimental single-arm clinical study, with a 2 (visual stimuli: neutral vs. alcohol-related VR scenarios) × 2 (olfactory stimuli: no odor vs. alcohol-related odor) within-subjects factorial design, is to determine how visual and olfactory stimuli contribute to the outcomes during a multimodal VR-CE in patients with AUD.
The main question is whether VR-CE with concurrent visual and olfactory alcohol-related stimuli induces a greater increase in craving and attentional bias from baseline than exposure to a single modality (visual or olfactory), as assessed by subjective and psychophysiological measures in patients with AUD.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* age between 18-65 years
* diagnosis of alcohol dependence according to ICD-10 (F10.2)
* complete inpatient detoxification within the last three months
* history of alcohol craving
* capacity to provide written informed consent
Exclusion Criteria:
* substance dependences other than alcohol or nicotine
* current alcohol intoxication (tested by random breath-alcohol measurements)
* alcohol abstinence less than 7 days or on-going alcohol consumption
* severe neuropsychiatric disorder (e.g. schizophrenia-spectrum disorder, bipolar affective disorder or substantial cognitive impairment)
* severe medical conditions affecting brain or heart function that could influence the parameters under investigation
* acute suicidality or risk of harm to others
* current pharmacological treatment for alcohol dependence (e.g., benzodiazepines) or for craving (e.g., acamprosate, disulfiram, naltrexone, nalmefene)
* other medications that may have a significant influence on heart rate
* sinusitis, self-reported problems with smell, or lack of normosmia, assessed both subjectively and objectively
* limited ability to understand the study information, the consent form or the study procedures and principles
Primary outcome measure(s)
Self-reported craving (VAS-C) — Day 1, at minute 0:30, 2:30 and 4:30 during both VR baseline sessions and each VR-CE condition. Self-reported craving will be assessed using the visual analogue scale (VAS-C; range 0-10, higher score indicates higher levels of craving) during the 2 (visual) × 2 (olfactory) virtual reality cue exposure (VR-CE) conditions.
Trial sites (1)
Facility
City
Region
Status
Psychiatric University Hospital Charité at St. Hedwig Hospital, Berlin, Berlin 10115
Berlin
State of Berlin
More Charite University, Berlin, Germany trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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