Validation of Alcohol Level Identification Using DRIVESC
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Proportion of Enrolled Participants who Complete all Scheduled Activities
研究概览
简要总结
This pilot study will evaluate the feasibility and acceptability of using a commercially available DRIVESC fitness-to-drive measurement tool to detect alcohol-induced impairment in healthy adult participants. The investigators hypothesize that DRIVESC can detect measurable changes in driving-related cognitive and motor performance across blood alcohol concentrations up to the U.S. per se legal limit of 0.08% g/210L ethanol. The study will enroll healthy adults aged 18-64 years (including both dosed and zero-alcohol arms) participating in the Wisconsin Breath Alcohol Examiner Specialist course, with each participant completing two study visits over two days.
详细描述
A total of 18-22 participants will be enrolled in this single-site partial crossover pilot study. Under the auspices of the Wisconsin Basic Breath Examiner Specialist training, participants will be dosed with alcohol on the first, second, or neither day of the three-day training.
This study design includes 6 double-alcohol-negative participants who will complete two days of alcohol-negative study tasks. The investigators will consider enrolling 12 alcohol-positive participants a success but are aiming to enroll 16 alcohol-positive participants. Alcohol-positive participants will complete two days of study tasks where one day is alcohol-negative and the other day is alcohol-positive. The order of positive-negative and negative-positive will be balanced. This range allows for flexibility in this feasibility study as study activities are scheduled in coordination with and around Chemical Testing Section training activities to minimize disruption to their educational tasks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants will be included in this study if they are trainees, observers, or instructors in the Wisconsin Basic Breath Examiner Specialist training program
- •Meet the age requirements for their assigned study arm (18 years or older for non-drinking, 21 years or older for drinking), and
- •Are able to provide informed consent.
排除标准
- •Participants will be excluded from this study if they are unable to provide informed consent
- •Do not meet the age requirements for their assigned study arm, or
- •Are determined to be not suitable for participation due to other reasons at the discretion of the study team.
结局指标
主要结局
Proportion of Enrolled Participants who Complete all Scheduled Activities
时间窗: through day 2
Data will be recorded as completed vs not completed measurements or timepoints for each participant session.
次要结局
- Within-Participant Change in DRIVESC Composite Score from Day 1 to Day 2: Non-Drinking Arm(through day 2)