A Closed-Circuit Track Trial to Assess Risk, Impairment and Performance from Alcohol in Healthy Participants
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 24
- 主要终点
- AARC: Standard deviation of lateral position (SDLP)[Standard deviation of lateral position (SDLP) measures the amount of lateral deviation or weaving of the vehicle within the driving lane. SDLP is measured using GPS-enabled external cameras that track the vehicle's position within the lane, providing precise data on how much the vehicle moves laterally while driving. Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose, and 1.5-hour post-dose.<br>];Primary for METEC Only: Frequency of lane excursions during driving.[Lane excursions are instances where the vehicle crosses the centre lane marking or drifts out of its lane without a clear or intentional reason (such as making a turn). These events are recorded both visually by the driving instructor and confirmed through video analysis of the driving footage captured during the sessions. Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose, and 1.5-hour post-dose.]
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 21 Years 至 No limit（—）
- 性别
- All
入选标准
- •History of alcohol consumption in a single drinking session to an estimated BAC of 0.05% without adverse reaction (more than 2 standard drinks for females or 3 standard drinks for males in a single session).-Weigh less than 100 kg.-Possess a current and unrestricted Victorian driver’s licence.-Oral fluid negative for all illicit drugs on the morning of test sessions
排除标准
- •Use of cannabis more than once per week.-An AUDIT-C score greater than 12, indicating problematic drinking.-Use of any psychoactive medication that could impact driving.-Current diagnosis of any Axis 1 mental health or substance use disorder.-Taking any form of medication within one week of admission (except for certain routine medications like prophylactic antibiotics or contraceptive pills).-Moderate to severe current depression (BDI score of >=20).-Severe current anxiety (BAI score of >=16).-Participation in any other studies involving investigational or marketed products within 30 days prior to the screening visit.-Currently under administrative or legal supervision
结局指标
主要结局
AARC: Standard deviation of lateral position (SDLP)[Standard deviation of lateral position (SDLP) measures the amount of lateral deviation or weaving of the vehicle within the driving lane. SDLP is measured using GPS-enabled external cameras that track the vehicle's position within the lane, providing precise data on how much the vehicle moves laterally while driving. Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose, and 1.5-hour post-dose.<br>];Primary for METEC Only: Frequency of lane excursions during driving.[Lane excursions are instances where the vehicle crosses the centre lane marking or drifts out of its lane without a clear or intentional reason (such as making a turn). These events are recorded both visually by the driving instructor and confirmed through video analysis of the driving footage captured during the sessions. Assessed continuously during each driving session at baseline (pre-dose), at 0.5-hour post-dose, and 1.5-hour post-dose.]
次要结局
未报告次要终点