大麻对饮酒的影响
大麻对酒精消费的影响：整合实验室和生态瞬时评估方法
This study employs a repeated measures experimental design to examine the effect of THC-dominant dose of cannabis and CBD-dominant dose of cannabis, relative to placebo, on subsequent drinking in an alcohol choice task in which participants choose either to drink or receive monetary reinforcement for drinks not consumed. Cannabis will be administered simultaneously with an alcohol-priming dose or alcohol placebo.
The study will enroll up to 350 nontreatment-seeking heavy episodic alcohol drinkers who use cannabis weekly.
研究概览
地位
详细说明
This study employs a repeated measures experimental design to examine the effect of THC-dominant (9.53% THC and 0.09% CBD) dose of cannabis and CBD-dominant (0.35% THC and 11.27% CBD) dose of cannabis, relative to placebo, on subsequent drinking in an alcohol choice task in which participants choose either to drink or receive monetary reinforcement for drinks not consumed. Cannabis will be administered simultaneously with an alcohol-priming dose or alcohol placebo. The study will enroll up to 350 nontreatment-seeking heavy episodic alcohol drinkers who use cannabis weekly to obtain the final sample of 200 with complete data. Participants will be tested at a baseline session, during three experimental sessions, and then during a subsequent 4-week period in the natural environment using a smart-phone application. Findings have important implications for cannabis regulatory science and alcohol use disorder treatment by addressing the relative impact of specific cannabinoids as well as contextual risk in cannabis-alcohol co-use.
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Jane Metrik, PhD
- 电话号码：401-863-6650
- 邮箱：Jane_Metrik@brown.edu
学习地点
-
-
Rhode Island
-
Providence、Rhode Island、美国、02912
- 招聘中
- Brown University
-
接触：
- Jane Metrik, PhD
- 电话号码：401-863-6650
- 邮箱：Jane_Metrik@brown.edu
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 21 to 50
- English-speaking
- cannabis smoking in past two months
- heavy drinking in past two months
- in good physical health and weighing < 250 lbs
- zero breath alcohol at each visit
Exclusion Criteria:
- positive pregnancy test
- nursing
- positive urine toxicology screen for drugs other than cannabis
- interest to quit or receive treatment for cannabis or alcohol use
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：THC-dominant cannabis dose
367 mg of cannabis plant material with 9.53% THC and 0.09% CBD and 217 mg of placebo cannabis plant material will be mixed and smoked in a handheld pipe |
Drink containing 0.3 g/kg of alcohol Placebo beverage contains only juice and a negligible trace of alcohol for masking |
|
实验性的：CBD-dominant cannabis dose
367 mg of cannabis plant material with 11.27% CBD and 0.35% THC and 217 mg of placebo cannabis plant material will be mixed and smoked in a handheld pipe |
Drink containing 0.3 g/kg of alcohol Placebo beverage contains only juice and a negligible trace of alcohol for masking |
|
安慰剂比较：Placebo
584 mg of cannabis plant material will be smoked in a handheld pipe |
Drink containing 0.3 g/kg of alcohol Placebo beverage contains only juice and a negligible trace of alcohol for masking |
|
实验性的：Alcohol priming dose
Alcohol: 0.3 g/kg. Alcohol priming drink is designed to raise blood alcohol levels to 0.03 g/dl and be consumed in 5 minutes. The drink is mixed using 80-proof liquor and juice. Participants are randomized to receive either the experimental alcohol priming dose or alcohol placebo. |
Smoked cannabis with 9.53% THC and 0.09% CBD Smoked cannabis with 0.35% THC and 11.27% CBD Smoked placebo cannabis plant material |
|
安慰剂比较：Alcohol placebo dose
Placebo beverage contains only juice and a negligible trace of alcohol for masking. The weight and sex-adjusted volume of alcohol and non-alcohol containing beverages will be equal. Participants are randomized to receive either the experimental alcohol priming dose or alcohol placebo. |
Smoked cannabis with 9.53% THC and 0.09% CBD Smoked cannabis with 0.35% THC and 11.27% CBD Smoked placebo cannabis plant material |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
ml of alcohol consumed
大体时间：post-smoking during two-hours of the alcohol choice task
|
ml of alcohol consumed during the alcohol choice task |
post-smoking during two-hours of the alcohol choice task
|
合作者和调查者
调查人员
- 首席研究员：Jane Metrik, PhD、Brown University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.