About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Single group
Treatments tested in this trial
VR-CE
DeviceVirtual reality cue exposure (VR-CE) using visual (neutral vs. alcohol-related VR scenarios) and olfactory (no odor vs. alcohol-related odor) stimuli conditions.
Treatment groups
Trial outcomes
Primary outcomes
Self-reported craving (VAS-C)
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.
Secondary outcomes
Psychophysiological craving index (heart rate variability, HRV)
For a multimodal craving measurement, heart rate variability (HRV) will be assessed as a psychophysiological craving index during both VR baseline sessions and each VR-CE condition.
Psychophysiological craving index (heart rate, HR)
For a multimodal craving measurement, heart rate (HR, in beats per minute (bpm)) will be assessed as a psychophysiological craving index during both VR baseline sessions and each VR-CE condition.
Psychophysiological craving index (electrodermal activity, EDA)
For a multimodal craving measurement, electrodermal activity (EDA, in microsiemens) will be assessed as a psychophysiological craving index during both VR baseline sessions and each VR-CE condition.
Psychophysiological craving index (respiratory rate, RR)
For a multimodal craving measurement, respiratory rate (RR) will be assessed as a psychophysiological craving index during both VR baseline sessions and each VR-CE condition.
Other outcomes
Sociodemographic variables
Sociodemographic variables will be assessed, e.g. age, gender, sex
AUD characteristics (AUDIT)
Alcohol use disorder (AUD) characteristics, such as AUD screening score (AUDIT, range: 0-40, higher score indicates greater likelihood of alcohol dependence) will be assessed.
AUD characteristics (ADS)
Alcohol use disorder (AUD) characteristics, such as addiction severity (Alcohol Dependence Scale, ADS, range: 1-47, higher score indicates greater alcohol dependance severity) will be assessed.
Self-reported trait craving before VR-CE (OCDS)
Self-reported trait craving prior to VR-CE will be assessed using the Obsessive Compulsive Drinking Scale (OCDS, range: 0-40, higher scores indicate higher craving).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: