NCT02710331进行中（未招募）1 期
Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Substudy III
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from Baseline: Road Tracking Error
研究概览
简要总结
The overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.
详细描述
To study the effects of ethanol clamped at BAC 0.04% (equivalent to consuming approximately 2 drinks over 1 hour) and oral Dronabinol (10 mg capsule) on driving.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females 21 to 55 years of age (extremes included).
- •Exposed to cannabis at least once.
- •Exposed to alcohol at least once.
- •Able to provide informed consent.
排除标准
- •Cannabis naïve
- •Alcohol naïve
- •Positive pregnancy screen
- •Hearing deficits
- •Sesame oil allergy
研究组 & 干预措施
Active THC and Placebo Ethanol
Experimental
干预措施: Active Dronabinol (Drug)
Active THC and Placebo Ethanol
Experimental
干预措施: Placebo (Drug)
Active THC and Active Ethanol
Experimental
干预措施: Active Dronabinol (Drug)
Active THC and Active Ethanol
Experimental
干预措施: Active Ethanol (Drug)
Placebo THC and Active Ethanol
Experimental
干预措施: Placebo (Drug)
Placebo THC and Active Ethanol
Experimental
干预措施: Active Ethanol (Drug)
Placebo THC and Placebo Ethanol
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline: Road Tracking Error
时间窗: baseline, +100, +210 mins after start of dronabinol administration
次要结局
- Change from Baseline: Biphasic Alcohol Effects Scale (BAES)(baseline, +60, +90, +210, +360 mins after start of dronabinol administration)
- Change from Baseline: Visual Analog Scale (VAS)(baseline, +60, +90, +210, +360 mins after start of dronabinol administration)
- Change from Baseline: Cognitive Test Battery(baseline, +120 mins after start of dronabinol administration)
- Change from Baseline: Willingness to Drive Scale(baseline, +60, +90, +210, +360 mins after start of dronabinol administration)
- Change from Baseline: Number of Joints Scale(baseline, +60, +90, +210, +360 mins after start of dronabinol administration)
- Change from Baseline: Number of Drinks Scale(baseline, +60, +90, +210, +360 mins after start of dronabinol administration)
研究者
Deepak C. D'Souza
Professor of Psychiatry
Yale University
研究点 (2)
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