Combined Effects of Alcohol and Caffeine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Total beverage consumed
研究概览
简要总结
The purpose of this study is to investigate the effects of caffeine on the self-administration of alcohol. The study will also examine the combined effects of alcohol and caffeine on behavioral performance, participant ratings of behavioral performance, and self-reported subjective effects.
详细描述
The purpose of this study is to examine the effects of caffeine on alcohol self-administration. Volunteers will participate in 7 experimental sessions in which they will be given the opportunity to self-administer an alcohol + caffeine or alcohol + caffeine-placebo beverage. The first 6 sessions will involve exposure to the two beverage conditions in mixed order three times each (e.g., A, B, B, A, A, B). The seventh session will be a choice session in which the participant will make a single choice at the beginning of the session about which beverage they will consume that day. In addition to the primary outcomes of quantity of alcohol self-administered and beverage choice, three additional outcomes will be measured including: 1). indirect measures of reinforcing effects (e.g. subjective ratings of liking, well-being, take again); 2). an alcohol-sensitive behavioral measure; and 3). participant ratings of degree of behavioral impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Very light or moderate consumer of caffeine (either daily or non-daily).
- •Social drinker of alcohol.
- •Has experience in lifetime of heavy alcohol consumption.
- •Read, write, and speak English fluently.
排除标准
- •Serious and unstable illnesses including current hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease, uncontrolled hypertension, and congestive heart failure), endocrinologic, neurologic (including stroke, transient ischemic attack, subarachnoidal bleeding, brain tumor, encephalopathy, and meningitis), or hematologic disease.
- •Parkinson's disease, seizure disorder, or history of significant head trauma.
- •Current psychiatric illness
- •Pregnant or nursing women or women who are not using an effective means of birth control.
研究组 & 干预措施
Alcohol self-administration
All participants will participate in seven sessions. In three sessions, each participant will consume a beverage containing alcohol and caffeine. In three separate sessions, participants will consume a beverage containing alcohol and caffeine-placebo. In the final session, all participants may choose which beverage they consume. Participants and research assistants will be blinded to inclusion of caffeine/caffeine-placebo in beverage, but each beverage will be labeled for identification (e.g., A or B).
干预措施: Alcohol + Caffeine Beverage (Drug)
Alcohol self-administration
All participants will participate in seven sessions. In three sessions, each participant will consume a beverage containing alcohol and caffeine. In three separate sessions, participants will consume a beverage containing alcohol and caffeine-placebo. In the final session, all participants may choose which beverage they consume. Participants and research assistants will be blinded to inclusion of caffeine/caffeine-placebo in beverage, but each beverage will be labeled for identification (e.g., A or B).
干预措施: Alcohol + Caffeine-placebo (Drug)
结局指标
主要结局
Total beverage consumed
时间窗: Measured during 2.5 hour drinking period
The primary outcome measure is the total volume of beverage consumed during alcohol + caffeine sessions and alcohol + caffeine-placebo sessions.
次要结局
- Circular Lights Task(Approximately every 30 minutes of the 5.5 hour study period)
- The Biphasic Alcohol Effects Scale(Approximately every 30 minutes of the 5.5 hour study period)
- Subjective ratings 9-point likert scale(Approximately every 30 minutes during the 5.5 hour study period)
- Expired air breath alcohol measures(Approximately every 30 minutes during the 5.5 hour study period)
- Subjective ratings visual analogue scale(Approximately every 30 minutes during the 5.5 hour study period)
研究者
Roland Griffiths
Professor, Department of Psychiatry,
Johns Hopkins University