Development of a Valid Test Battery for Assessing Driving Ability When Influenced by Drugs.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Standard deviation of lateral position on road (SDLP)
研究概览
简要总结
The purpose of the validation study is to develop a valid test battery for assessing driving ability in a driving simulator when influenced by drugs. Ethanol has known, well-documented and well-characterized effects on driving behaviour and accident risk, and will be used to assess the simulator test scenarios' sensitivity to drug effects. Once the test scenarios have been refined and their ability to predict driving accident risk have been validated, we plan to use the simulator to assess driving ability under the influence of different drugs suspected to produce driving impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy, caucasian males aged 25-50 years in possession of a valid driver's license for the last 5 years.
- •Recreational alcohol drinkers without alcohol dependence or abuse, no traffic-related convictions or alcohol-influenced behavioural disturbances.
- •1 or 0 points on the modified Apfel scale for predicting post-operative nausea/vomiting (non-smoker, previously experienced nausea/vomiting post-operatively, previously experienced motion sickness)
排除标准
- •Females (risk of teratogenicity)
- •Non-caucasian ethnicity (possibility of deviant ethanol metabolism)
- •Previous strong reactions such as nausea, fainting etc. during blood sampling
- •Previous abnormal reactions to ethanol
- •Previous convictions related to drug intoxication
- •Previous excessive drug use
- •Regular use of prescription drugs
- •Two points or more according to the modified Apfel criteria
研究组 & 干预措施
BAC 0.5
BAC level 0.5 g/dL (drink + placebo pill)
干预措施: Ethanol (Drug)
BAC 1.0
BAC level 1.0 g/dL (drink + placebo pill)
干预措施: Ethanol (Drug)
placebo
BAC level 0,0 g/dL (placebo drink+ placebo pill)
干预措施: Placebo drink (Other)
结局指标
主要结局
Standard deviation of lateral position on road (SDLP)
时间窗: Instantly (while the subject is inebriated)
次要结局
未报告次要终点