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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Feasibility of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure — Day 1, after each Virtual Reality Cue Exposure (VR-CE): questions regarding olfactory stimuli identification, olfactory perception of intensity, realism and congruence Day 1, after completion of all VR-CEs and assessments: dropout Questions regarding olfactory stimuli identification, olfactory perception of intensity (0=imperceptible-100=intensely perceptible), realism (0=unrealistic-100=realistic) and congruence with visual stimuli (0=incongruous-100=congruous), higher scores reflect higher feasibility; dropout
Tolerability of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure — Day 1, before the start of the Virtual Reality Cue Exposures (VR-CE): SAM, PANAS, FMS, SSQ Day 1, after each VR-CE: questions regarding tolerability, SAM, FMS Day 1, after completion of all VR-CEs: SAM, PANAS, FMS, SSQ Questions regarding tolerability of the technology and olfactory stimuli (0=unpleasant-100=pleasant), higher scores reflect higher tolerability Emotional side effects: Self-Assessment Manikin (SAM; valence, arousal and dominance, range -8 to 8 in steps of 2; -8=happy/tense/submissive feeling, 0=neither happy/tense/submissive nor unhappy/calm/submissive, 8=unhappy/calm/submissive) and Positive and Negative Affect Schedule (PANAS; positive affect: range 10-50, higher score reflects higher levels of positive affect; negative affect: range 10-50, lower score reflects lower levels of negative affect) Physical side effects (cybersickness): Fast Motion Sickness Scale (FMS; range 0-20, higher score reflects higher levels of cybersickness) and Simulator Sickness Questionnaire (SSQ; total score, range 0-48, higher score reflects more sickness; nausea factor, 0-27 range, higher score reflects more nausea; oculomotor factor, range 0-21, higher score reflects more oculomotor problems)
Acceptability of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure — Day 1, after each VR-CE: question regarding technical functionality Day 1, after completion of all VR-CEs: UEQ, semi-structured interview Question regarding technical functionality User experience: User Experience Questionnaire (UEQ; pragmatic quality, hedonic quality and overall scale: range -3 to +3, -3=most negative, 0=neutral, +3=most positive answer) Semi-structured interview including overall impression, perceived usefulness of the integration of olfactory stimuli into Virtual Reality Cue Exposure (VR-CE), perceived willingness to use, open-ended feedback
Trial sites (1)
Facility
City
Region
Status
Psychiatric University Hospital Charité at St. Hedwig Hospital
Berlin
State of Berlin
Recruiting
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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