Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Sub-Study I
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
- 1
- 主要终点
- 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 oral ethanol (a target BAC of ~0.04 g/dl; equivalent to consuming approximately 2 drinks over 1 hour) and vaporized THC (4 mg of THC dissolved in an ethanolic solution; equivalent to smoking approximately 1/4 of a marijuana cigarette, or "joint") 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).
- •Occasional current cannabis users.
- •Experience with drinking 2 or more standard drinks of alcohol at least once in lifetime.
- •Able to provide informed consent.
排除标准
- •Cannabis naïve.
- •Alcohol naïve.
- •Positive pregnancy screen
- •Hearing deficits.
研究组 & 干预措施
Placebo THC and Placebo Ethanol
干预措施: Placebo (Drug)
Active THC and Active Ethanol
干预措施: Active inhaled delta-9-THC (Drug)
Active THC and Placebo Ethanol
干预措施: Active inhaled delta-9-THC (Drug)
Active THC and Placebo Ethanol
干预措施: Placebo (Drug)
Active THC and Active Ethanol
干预措施: Active Oral Ethanol (Drug)
Placebo THC and Active Ethanol
干预措施: Placebo (Drug)
Placebo THC and Active Ethanol
干预措施: Active Oral Ethanol (Drug)
结局指标
主要结局
Road Tracking Error
时间窗: baseline, +20, +50, +120, +180 mins after start of alcohol administration
次要结局
- Willingness to Drive Scale(baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration)
- Biphasic Alcohol Effects Scale (BAES)(baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration)
- Visual Analog Scale (VAS)(baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration)
- Cognitive Test Battery(+40 mins after start of alcohol administration)
- Number of Joints Scale(baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration)
- Number of Drinks Scale(baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration)
研究者
Deepak C. D'Souza
Professor of Psychiatry
Yale University