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
- 4
- 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.
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