Effects of Tolcapone on Decision Making and Alcohol Intake Using a Laboratory Bar in Moderate to Heavy Social Drinkers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Number of Drinks Consumed in a Laboratory Bar Session
研究概览
简要总结
The purpose of this study is to determine the effects of tolcapone on decision making and alcohol intake using a laboratory bar (on-site alcohol self-administration) in alcohol drinkers.
详细描述
The study is a 7-session, double blind, placebo-controlled crossover study of the effects of tolcapone, the COMT inhibitor, on decision making and alcohol intake using a laboratory bar in moderate to heavy social alcohol drinkers. Subjects will be moderate to heavy social users of alcohol, defined as at least 10 standard drinks per week for women and at least 14 standard drinks per week for men. There will be one screening session followed by six additional visits including 2 laboratory bar sessions. On each study drug administration day, subjects will come in to the clinic for a medication dispensation visit and instructions on when and how to take the study drug for the remainder of the study. Study drug bottles will be equipped with MEMS caps to ensure compliance. After 5 days of drug administration, subjects will return to the clinic for a laboratory bar. This session will consist of administration of a standardized laboratory bar paradigm and a series of computerized and written decision-making tasks. Subjects will then be crossed over and complete the same series of study visits on the alternate study drug.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers who are 21-40 years of age
- •If female, 10 or more alcoholic drinks must be consumed weekly.
- •If male, 14 or more alcoholic drinks must be consumed weekly.
- •Meets DSM-V criteria for Alcohol Use Disorder (AUD).
- •If female, must be non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device [IUD], hormonal birth control, or barrier method).
- •Ability to read and speak English.
- •High school graduate.
- •Able and willing to provide an informed consent.
- •Able to understand and follow the instructions of the investigator, including the delayed discounting tasks. Residing within 5 miles of the study site.
排除标准
- •Positive urine drug screen (except marijuana).
- •Using cocaine, stimulants (other than nicotine and caffeine), amphetamines, hallucinogens, ecstasy, opiates, sedatives, pain pills, sleeping pills. or other psychoactive drugs within 2 weeks of the start of the study (except marijuana).
- •Marijuana use more than 3 times/week.
- •Current enrollment in an alcohol, or other drug treatment program or current legal problems relating to alcohol, or other drug use.
- •Currently trying to quit alcohol use.
- •History of major alcohol related complications within the preceding 2 years (liver failure/cirrhosis, pancreatitis, esophageal varices, etc.).
- •Two SGPT/ALT or SGOT/AST values greater than the upper limit of normal.
- •Unable to pass the Standard Field Sobriety Test in a sober state (BAC = 0.00).
- •BAC level >0.05% at the beginning of screening visit (within margin of error of detection).
- •Regular use of any of the drugs on the tolcapone contraindications list OR within 2 weeks of drug administration.
- •Severe low blood (< 90/50) pressure or uncontrolled high blood pressure (>160/100). Allergy or intolerance to tolcapone.
- •Subject has received an investigational drug within 30 days of the screening visit.
- •Subject is considered unsuitable for the study in the opinion of the investigator or clinician for any other reason (such as an Axis II personality disorder that makes the subject unable to comply with study instructions, per the Clinician's judgement.)
研究组 & 干预措施
Tolcapone First, then Placebo
Tolcapone arm first: 5 days of 100 mg tolcapone TID, followed by washout period, then 5 days of placebo TID
干预措施: Tolcapone (Drug)
Tolcapone First, then Placebo
Tolcapone arm first: 5 days of 100 mg tolcapone TID, followed by washout period, then 5 days of placebo TID
干预措施: Placebo (Drug)
Placebo First, then Tolcapone
Placebo arm first: 5 days placebo, followed by washout period, followed by 5 days of 100 mg tolcapone TID
干预措施: Tolcapone (Drug)
Placebo First, then Tolcapone
Placebo arm first: 5 days placebo, followed by washout period, followed by 5 days of 100 mg tolcapone TID
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Drinks Consumed in a Laboratory Bar Session
时间窗: A laboratory bar session is 1 hour long
Number of drinks consumed in a laboratory bar session (out of a maximum of 4 drinks available) following either placebo or tolcapone administration.
次要结局
未报告次要终点
研究者
Jennifer Mitchell
Associate Professor
University of California, San Francisco