Laboratory and Field Validation of a Wrist-Worn Alcohol Monitor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Transdermal Alcohol Concentration (TAC)
研究概览
简要总结
This study will validate a wrist-worn alcohol monitor (BACtrack Skyn) in both laboratory and real-life settings.
详细描述
The overarching goal of this research program is to improve alcohol intervention and eventually related clinical outcomes (e.g., liver function) among HIV+ drinkers through biosensor-assisted intervention. Research shows HIV infection can influence alcohol metabolism (i.e., higher blood alcohol levels), so it's necessary to validate the new alcohol biosensor in HIV+ drinkers rather than in general population. The primary goal of this project, as a step toward the development and evaluation of a biosensor-assisted alcohol intervention, is to validate the newly available wrist worn transdermal alcohol biosensor (BACtrack Skyn). The two specific aims are: (1) To assess validity and reliability of the Skyn biosensor using fixed-dose lab administration of alcohol through comparison with laboratory grade breathalyzer, and (2) To validate Skyn biosensor in daily life using a 2-week ecological momentary assessment (EMA) to compare self-reported drinking and the Skyn derived transdermal alcohol concentration (TAC) readings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HIV+ consumers of alcohol; self-reported ≥ 5 days with at least 1 alcoholic drink, and ≥1days with at least 3 drinks
- •HIV- consumers of alcohol; self-reported ≥ 5 days with at least 1 alcoholic drink, and ≥1days with at least 3 drinks
排除标准
- •non-drinkers
- •recent addiction treatment or treatment seeking
- •urine positive for illegal drugs except THC (not applicable to those who are only invited to do field test);
- •past & current alcohol withdrawal
- •severe alcohol use disorder (DSM-5)
- •meeting criteria for current nicotine dependence (not applicable to field only participants) or current substance use disorder (excluding mild cannabis use disorder and mild/moderate alcohol use disorder)
- •medical conditions (other than HIV) contraindicating alcohol
- •pregnancy/breastfeeding in women
- •psychosis or other severe psychiatric conditions.
研究组 & 干预措施
All participants (HIV+ and HIV- drinkers)
All participants were planned to complete the BACtrack Skyn biosensor in two lab sessions, and wear the Skyn biosensor for two weeks in the field. However, due to COVID, not all participants were able to complete the lab sessions.
干预措施: Skyn Monitor Lab Session 1 (Device)
All participants (HIV+ and HIV- drinkers)
All participants were planned to complete the BACtrack Skyn biosensor in two lab sessions, and wear the Skyn biosensor for two weeks in the field. However, due to COVID, not all participants were able to complete the lab sessions.
干预措施: Skyn Monitor Field Test with EMA App (Device)
All participants (HIV+ and HIV- drinkers)
All participants were planned to complete the BACtrack Skyn biosensor in two lab sessions, and wear the Skyn biosensor for two weeks in the field. However, due to COVID, not all participants were able to complete the lab sessions.
干预措施: Skyn Monitor Lab Session 2 (Device)
结局指标
主要结局
Transdermal Alcohol Concentration (TAC)
时间窗: 2 weeks
Here we reported mean and SD of peak TAC in the laboratory sessions and in the field test.
次要结局
未报告次要终点