Craving Assessment in Patients With Alcohol Use Disorder Using Virtual Reality Exposure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- change in psychophysiological craving levels (heart rate variability) elicited by alcohol-associated cues
研究概览
简要总结
Alcohol use disorder (AUD) is a burdensome clinical disorder with high relapse rates. Virtual Reality (VR)-based therapeutic and diagnostic approaches have received increasing attention in the treatment of AUD but evidence on the induction of craving via VR scenarios is still needed. Craving for alcohol is associated with psychological and physiological responses. This single-arm clinical study will be conducted including n=60 patients with AUD. Using a head-mounted display (HMD), patients will be confronted with three different VR scenarios (neutral vs. two target situations) while heart rate, heart rate variability (HRV), pupillometry and electrodermal activity (EDA) will be measured continuously. Subjective craving levels will be assessed pre-/during/post-exposure to each VR scenario.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: 18-65 years
- •diagnosis of alcohol dependence according to ICD-10 (F10.2)
- •completed in-patient withdrawal treatment during the last 3 months
- •history of alcohol craving, confirmed via craving questionnaires
- •able to provide written informed consent
排除标准
- •substance dependence other than alcohol and nicotine
- •current alcohol intoxication (randomly tested via 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 on-going consumption of alcohol
- •severe neuropsychiatric disorder, e.g. schizophrenia spectrum disorders, bipolar affective disorder or substantial cognitive impairment
- •serious illnesses influencing brain-/heart-function with influence on physiological study parameters.
- •acute suicidality (or acute endangerment of others)
- •concurrent pharmacological treatment targeting AUD (i.e. benzodiazepines) or craving (i.e. acamprosate, disulfiram, naltrexone, nalmefene) and further medication significantly influencing heart frequency.
结局指标
主要结局
change in psychophysiological craving levels (heart rate variability) elicited by alcohol-associated cues
时间窗: 20-30 min VR exposure
Changes in craving levels measured continuously by heart rate variability (ms) during VR-exposure to alcohol-associated cues compared to neutral cues.
change in subjective craving levels elicited by alcohol-associated cues
时间窗: 20-30 min VR exposure
Changes in craving levels measured by subjective parameters (visual analogue scale = VAS, scale 0-100) before, during and after VR-exposure to alcohol-associated cues compared to neutral cues
change in psychophysiological craving levels (heart rate) elicited by alcohol-associated cues
时间窗: 20-30 min VR exposure
Changes in craving levels measured continuously by heart rate (bpm = beats per minute) during VR-exposure to alcohol-associated cues compared to neutral cues.
change in psychophysiological craving levels (electrodermal activity) elicited by alcohol-associated cues
时间窗: 20-30 min VR exposure
Changes in craving levels measured continuously by electrodermal activity (micro-Siemens) during VR-exposure to alcohol-associated cues compared to neutral cues.
change in psychophysiological craving levels elicited by alcohol-associated cues
时间窗: 20-30 min VR exposure
Changes in craving levels measured continuously by pupillometry (pupil dilation in mm) during VR-exposure to alcohol-associated cues compared to neutral cues.
次要结局
- development of subjective craving levels post-exposure(3 hours after VR-exposure)
- context-related change in craving levels(20-30 minutes VR Exposure)
研究者
Alva Lütt
Dr. med. Alva Lütt, MD
Charite University, Berlin, Germany