NCT02164422已完成2 期
Does Guanfacine Attenuate Stress-Induced Drinking?
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
- 70
- 试验地点
- 1
- 主要终点
- mL Per 15 Minutes
研究概览
简要总结
Evaluating the effect of guanfacine on alcohol consumption. The investigators hypothesize that guanfacine versus placebo will decrease the amount of alcohol consumption (mls consumed) during the 2-hour self-administration period across two laboratory sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 21-65
- •Able to read and write English
- •Meets Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for current (past 6 months) alcohol abuse or alcohol dependence
排除标准
- •Participants with any significant current medical conditions, seizures, delirium or hallucinations, or other unstable medical conditions including HIV
- •Current DSM-IV abuse or dependence on substances, other than alcohol abuse, alcohol dependence, or nicotine dependence
- •Women who are pregnant or nursing
- •Suicidal, homicidal or evidence of current (past 6-month) mental illness
- •Meet DSM-IV criteria for current (past-6 month) attention deficit hyperactivity disorder (ADHD)
- •Specific exclusions for administration of guanfacine not already specified include: EKG evidence at baseline screening of any clinically significant conduction abnormalities or arrhythmias; known intolerance for guanfacine or any alpha blocker; history of fainting, syncopal attacks, heart failure or myocardial infarction, or impaired liver as indicated by aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 3x normal or renal function (estimated creatinine clearance <60 cc/min); treatment with any antihypertensive drug or any alpha-adrenergic blocker; use of any central nervous system (CNS) depressant (e.g., phenothiazines, barbiturates, benzodiazepines)
- •Subjects likely to exhibit clinically significant alcohol withdrawal during the study.
- •Individuals who are seeking treatment for drinking
研究组 & 干预措施
Guanfacine 3mg/day
Experimental
Guanfacine 3mg/day
干预措施: Guanfacine 3mg/day (Drug)
Guanfacine 1.5mg/day
Experimental
Guanfacine 1.5mg/day
干预措施: Guanfacine 1.5mg/day (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
mL Per 15 Minutes
时间窗: 2 hour self administration period during lab sessions held on days 22 and 25
mL per 15 minutes during 2-hour ad-lib drinking period
次要结局
未报告次要终点
研究者
Sherry McKee
Professor of Psychiatry
Yale University
研究点 (1)
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