NCT03632408Unknown1 期
The Effect of Alcohol Hangover and Night-time Zopiclone on Next-morning Spatial Perception in Healthy Young Volunteers
Petri Vainio2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2018年9月最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Driving error rate
研究概览
简要总结
Hangover after recreational alcohol use, residual effect of zopiclone and placebo compared in terms of spatial perception, psychomotor tests and simulated driving ability. Three recording visits plus screening included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Alcohol not masked Zopiclone and placebo capsulated, identical in weight and appearance Third party generated code only available to pharmacy and in case of emergency
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •weight >45 kg
- •likely to experience and predict alcohol hangover within the next five weeks
- •no childbearing potential of negative pregnancy test at screening
- •a valid driving license
排除标准
- •breastfeeding
- •infection with HCV, HBV or HIV
- •a medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
- •suspected or current drug or alcohol abuse
结局指标
主要结局
Driving error rate
时间窗: Day 1
Driving error rate
Number of erroneous responses to peripheral visual stimuli during driving
时间窗: Day 1
Number of erroneous responses to peripheral visual stimuli during driving
次要结局
- drug concentration(Day 1)
- digit symbol substitution(Day 1)
研究者
Petri Vainio
Assistant professor
Turku University Hospital
研究点 (2)
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