Acute and Residual Effects of Alcohol on Young Drivers' Performance of Driving Related Skills
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Psychomotor impairment (driving)
研究概览
简要总结
Given the known driving behavior of Driving Under the Influence of Alcohol and some of its parallel to driving under the influence of cannabis, this supplemental study aims to validate the sensitivity of the primary and secondary outcome measures employed in a cannabis and driving study currently in progress.
详细描述
This study will examine the effects of an intoxicating dose of alcohol on driving-related skills among young drivers using driving simulator technology.
This study is a double-blind, placebo-controlled mixed design study, including randomized between-subjects comparison of the effects of alcohol intoxication and both between- and within-subjects examination of acute and residual effects at approximately 24 and 48 hours following one-time alcohol administration.
Initial contact with potential participants will be made by telephone, where study personnel will conduct a telephone screen for eligibility. Those telephone screened as eligible will attend CAMH for an eligibility assessment. Enrolled participants will complete four sessions on consecutive days: a practice day, an alcohol administration day, and a 24-hour and 48-hour post-alcohol session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females aged 19 to
- •Reported consumption of at least 1 heavy drinking episode (according to NIAAA criteria of 5 drinks for males and 4 for females within an occasion) in the 6 months prior to eligibility assessment.
- •Held a valid class G or G2 Ontario driver's license (or equivalent from another jurisdiction) for at least 12 months.
- •Willing to abstain from alcohol use for the duration of the study, and for 48 hours prior to Session
- •Provides written and informed consent.
排除标准
- •Taking medications or have any medical condition for which alcohol is contraindicated
- •Is a regular user of medications that affect brain function (i.e., antidepressants, benzodiazepines, stimulants).
- •Diagnosis of severe medical or psychiatric conditions.
- •Meets criteria for current or lifetime Substance Use Disorders (DSM-IV) with the exception of nicotine.
- •Meets criteria for Alcohol Dependence (DSM-IV)
- •Is pregnant, is trying to become pregnant, or is currently breastfeeding.
- •Severe allergic reaction to citrus.
研究组 & 干预措施
Alcohol
Alcohol
干预措施: Alcohol (Drug)
Placebo
Tonic water
干预措施: Placebo (Drug)
结局指标
主要结局
Psychomotor impairment (driving)
时间窗: Approximate Time Frame: 30 minutes before, 30 minutes after, 24 and 48 hours after drinking
The driving simulator will objectively measure changes in driving behaviour after drinking alcohol.
次要结局
- Cognitive testing(Approximate Time Frame: 30 minutes before drinking, and 1, 24 and 48 hours post-drinking)
- Breath alcohol content (BAC)(Approximate Time Frame: 30 minutes before drinking, 5, 15, 30, minutes and 1, 2, 3, 24, and 48 hours post-drinking)
- Subjective alcohol effects(Approximate Time Frame: 30 minutes before drinking, 5, 15, 30 minutes and 1, 2, 3, 24 and 48 hours post-drinking)
研究者
Robert Mann
Senior Scientist
Centre for Addiction and Mental Health