Pilot Randomized Control Trial of Smartphone-enabled Breath Alcohol Monitoring on Perceived Fitness to Drive a Vehicle Among Intoxicated Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Participants' Perceived Fitness to Drive Measurement
研究概览
简要总结
The goal of this study is to conduct a laboratory-based pilot randomized control trial of smartphone-enabled breath alcohol monitoring on perceived fitness to drive a vehicle among intoxicated adults. The study team will enroll up to 30 adults aged > 21-44 who are frequent drinkers without dependence who drive more than four times per week to complete a standardized alcohol drinking protocol in a monitored setting collecting breathalyzer measurements. The protocol involves consuming three weight-based doses of alcohol with a target BAC of 0.10 and completing breathalyzer measurements every 20 minutes until a BAC of 0.03 is reached. The control group will complete a visual analog scale on their perceived fitness to drive and be blinded to their breath alcohol readings with the BACtrack Mobile Pro breathalyzer device, while the intervention group would do the same, but be shown their breath alcohol readings on the paired BACtrack smartphone application. The research team's previous research has validated the accuracy of the BACtrack Mobile Pro device to measure BAC within +/- 0.001 of police-grade breathalyzer and estimate BAC within +/- 0.01 of a blood test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 21-39 years old,
- •Less than 4 drinking days and less than 12 drinks per week on average in the past 2 months,
- •Have consumed at least 4 (women) or 5 (men) drinks on one occasion, in the past year without experiencing adverse effects
- •Have a valid photo ID
- •Willing and able to use a rideshare credit or septa token as transportation home from the study visit
- •Drives at least 2 days per week on average.
排除标准
- •Desire alcohol treatment now or received it in the past 6 months,
- •Have Alcohol use disorder per DSM-V criteria
- •Meet or have met criteria for a substance use disorder within the past 12 months per DSM V criteria
- •Have a prior psychiatric condition requiring hospitalization
- •Are non-English-speaking
- •Individuals who have a medical condition or who are taking medication which limits or prevents the consumption of alcohol
- •Are experiencing suicidal ideation
结局指标
主要结局
Participants' Perceived Fitness to Drive Measurement
时间窗: The duration of study visit, up to 8 hours
Participant's self rating on visual analog scale from 1-10 (1: Extremely Able to Drive; 10: Not at all Able to Drive) after Breath Alcohol Content Measurement was collected
次要结局
- Participants' Perceived Willingness to Drive Measurement(The duration of study visit, up to 8 hours)
研究者
M. Kit Delgado, MD
Assistant Professor of Emergency Medicine and Epidemiology
University of Pennsylvania