Placebo Controlled Pilot Study of Dutasteride for the Reduction of Alcohol Use in Male Drinkers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Change Number of Standard Drinks Per Week.
研究概览
简要总结
The purpose of this study is to evaluate whether dutasteride is safe and effective for reducing alcohol use in male drinkers who want to stop or reduce their drinking. The investigators hypothesize that at a dosage of 1mg/day, dutasteride will be well tolerated and that, compared to placebo treatment, dutasteride will result in a greater reduction in the amount of alcohol consumed per week. The study sample size is of a pilot scale and is designed to provide additional support for the study hypothesis and provide an estimate of likely effect sizes in order to design a more definitive study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male outpatients age 18 to 65 years
- •Have an average weekly ethanol consumption of >24 standard drinks
- •Be able to read English at the 8th grade or higher level and show no evidence of significant cognitive impairment
- •Be willing to nominate an individual who will know the patient's whereabouts in order to facilitate follow up during the study
- •Be willing to provide signed, informed consent to participate in the study (including a willingness to reduce drinking to non-hazardous levels)
排除标准
- •Have a current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation
- •Have a serious psychiatric illness (e.g., schizophrenia, bipolar disorder, severe or psychotic major depression, organic mood or mental disorders, current eating disorder symptoms, or substantial suicide or violence risk) on the basis of history or psychiatric examination
- •Have a current diagnosis of drug dependence (other than nicotine or alcohol dependence)
- •Have a current diagnosis of alcohol dependence who on clinical examination by a physician, are deemed to be too severely alcohol dependent to permit them to participate in a placebo-controlled pilot study
- •Have a history of hypersensitivity to dutasteride
- •Current or past 4 month use of finasteride (Propecia), dutasteride (Avodart) or testosterone
- •Are currently taking psychotropics other than a single antidepressant with stable dose for at least 4 weeks or a non-benzodiazepine sleep medication
- •Are considered by the investigators to be an unsuitable candidate for receipt of an investigational drug
研究组 & 干预措施
dutasteride
dutasteride (1 mg oral daily dose) for 8-week treatment period
干预措施: Dutasteride (Drug)
Placebo
placebo daily for 8-week treatment period
干预措施: Placebo (Drug)
结局指标
主要结局
Change Number of Standard Drinks Per Week.
时间窗: Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)
Change in Average Standard Drinks (14 gr ethanol) per week: last 2 weeks of treatment (wk 7-8) minus baseline average drinking average from baseline 90 day drinking history
次要结局
- Change in Standard Drinks Per Week - Moderation by Genetic Variation(Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment))
研究者
Jonathan Covault
Professor of Psychiatry
UConn Health