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临床试验/NCT02983773
NCT02983773已完成2 期

Marijuana's Impact on Alcohol Motivation and Consumption

Brown University2 个研究点 分布在 1 个国家目标入组 157 人开始时间: 2017年1月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
157
试验地点
2
主要终点
change in alcohol craving

研究概览

简要总结

This laboratory study will employ a repeated measures experimental design to examine the effect of high (7.2% THC) and moderate (3.1% THC) dose of marijuana, relative to placebo, on alcohol craving and on behavioral economic measure of alcohol demand after exposure to alcohol cues, and on subsequent drinking in an alcohol choice task in which participants choose either to drink or receive monetary reinforcement for drinks not consume. The study will recruit 173 non-treatment seeking heavy episodic alcohol drinkers who smoke marijuana at least twice weekly.

详细描述

This laboratory study will employ a repeated measures experimental design to examine the effect of high (7.2% THC) and moderate (3.1% THC) dose of marijuana, relative to placebo, on alcohol craving and on behavioral economic measure of alcohol demand after exposure to alcohol cues, and on subsequent drinking in an alcohol choice task in which participants choose either to drink or receive monetary reinforcement for drinks not consumed. Moderators of the marijuana's effects on alcohol-related dependent variables will be tested: DSM5 alcohol use disorder severity, affective vulnerability, trait impulsivity, and working memory functioning. Several empirically-determined mechanisms that may explain why marijuana may increase risk of alcohol relapse and help maintain heavy drinking will be tested as mediators of marijuana's effects on alcohol. The study will recruit 173 non-treatment seeking heavy episodic alcohol drinkers who smoke marijuana at least twice weekly to obtain the final sample of 150 with complete data (15% of attrition). Participants will be tested at a baseline session and during three experimental sessions. Investigators will collect blood samples for analysis of cannabinoid plasma levels and to examine marijuana-induced changes in hormones and other biomarkers potentially related to appetite, inflammation and stress. Collection of these biomarkers would allow for a greater understanding about the mechanisms whereby marijuana may acutely increase alcohol motivation and use. The findings will inform researchers and clinicians about how marijuana acutely increases alcohol craving and consumption. The strategy of this proposal is to use the most comprehensive controlled test characterizing marijuana's putative effects on alcohol.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 44 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 21 to 44
  • English-speaking
  • marijuana smoking in past month
  • report of current heavy episodic (binge) drinking
  • in good physical health and weighing < 250 lbs
  • zero breath alcohol at each visit

排除标准

  • history of seizures
  • smoking >20 tobacco cigarettes per day
  • positive pregnancy test
  • positive urine toxicology screen for drugs other than cannabis
  • interest to quit or receive treatment for marijuana or alcohol use
  • meeting criteria for a current affective disorder (depression, or mania, panic disorder, and having psychotic symptoms as assessed by the SCID)

研究组 & 干预措施

3.1% THC

Experimental

1 marijuana cigarette (3.1% THC)

干预措施: THC 3.1% (Drug)

7.2% THC

Experimental

1 marijuana cigarette (7.2% THC)

干预措施: THC 7.2% (Drug)

Placebo

Placebo Comparator

Placebo marijuana cigarette

干预措施: Placebo (Drug)

结局指标

主要结局

change in alcohol craving

时间窗: T1: pre-smoking (-45 minutes) and post smoking at 20 (T2), 55 (T3), and 70 (T4) minutes for a total of two hours during the experimental session

Alcohol Craving Questionnaire-Short Form-Revised (ACQ-SF-R)

Alcohol Craving

时间窗: T0: pre-smoking (-45 minutes) and post smoking at 12 mins (T1), 47 mins (T2), and 58 mins (T3), 116 mins (T4), 178 mins (T5) during the experimental session

Alcohol Craving Questionnaire-Short Form-Revised (ACQ-SF-R) is a 12-item state measure of alcohol craving in the current moment (i.e., right now), scored on a 7-point Likert scale, from (1) strongly disagree to (7) strongly agree, with higher scores indicating greater craving. Scores on this measure are averaged to yield a total craving score.

次要结局

  • change in alcohol demand measured with Alcohol Purchase Task-State Version (APT-SV)(T1: pre-smoking (-45 minutes) and post smoking at 55 (T2) and 70 (T3) minutes for a total of two hours during the experimental session)
  • number of alcohol beverages consumed(post-smoking during two-hour alcohol choice task during the experimental session)
  • Percent of Total Available Alcohol Consumed(post-smoking during two-hour alcohol choice task during the experimental session)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jane Metrik

Associate Professor (research)

Brown University

研究点 (2)

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