Dutasteride Treatment for the Reduction of Heavy Drinking
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Heavy Drinking Days Per Week
研究概览
简要总结
This study will examine the safety and potential benefit of the medication dutasteride to help men reduce or stop drinking alcohol.
详细描述
Extensive preclinical studies indicate that neuroactive steroids medicate important effects of alcohol and support the examination of neuroactive steroid modulators as treatment options for alcohol use problems. Dutasteride, a widely prescribed medication for benign prostatic hypertrophy, blocks a key step in the production of neuroactive steroids and represents a promising candidate for treatment of alcohol use disorders. This study will use a 12-week randomized placebo controlled design to examine the safety and efficacy of dutasteride to reduce drinking among a sample of 160 men with hazardous levels of alcohol use. It will additionally examine the potential moderation of dutasteride treatment effects by a common missense polymorphism in a neuroactive steroid biosynthetic enzyme that we have previously reported to be associated with alcohol dependence. Identification of genetic predictors of medication response offers the potential for matching alcohol treatment medications with those most likely to respond.
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 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •an average weekly ethanol consumption of at least 24 standard drinks;
- •be able to read English at the 8th grade or higher level;
- •no evidence of significant cognitive impairment;
- •be willing to provide signed, informed consent to participate in the study (including a willingness to stop or reduce drinking to non-hazardous levels);
- •be willing to nominate an individual who will know the patient's whereabouts to facilitate follow up during the study
排除标准
- •history of significant alcohol withdrawal symptoms (e.g. substantial tremor, autonomic changes, perceptual distortions, seizures, delirium, or hallucinations);
- •current Diagnostic and Statistical Manual Version IV (DSM-IV) 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 study (e.g. evidence of serious adverse medical or psychiatric effects that are exacerbated by heavy drinking and would, for safety reasons, lead the physician to urge the patient to be totally abstinent and engage in an empirically supported treatment).
- •current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation,(we will not exclude patients with hypertension, diabetes mellitus, asthma or other common medical conditions, if these are adequately controlled and the patient has an ongoing relationship with a primary care provider)
- •serious psychiatric illness on the basis of history or psychiatric examination (i.e., schizophrenia, bipolar disorder, severe or psychotic major depression, organic mental disorder, current clinically significant eating disorder, or substantial suicide or violence risk);
- •current DSM-IV diagnosis of drug dependence (other than nicotine dependence);
- •currently taking psychotropics other than medication for depression/anxiety disorder (with stable dose for at least 4 weeks),medications for treatment of Attention Deficit/Hyperactivity Disorder (with stable dose for at least 4 weeks), a non-benzodiazepine sleep medication or a low dose of benzodiazepine equivalent to 2 mg clonazepam or lorazepam per day;
- •are considered by the investigators to be an unsuitable candidate for receipt of an investigational drug
研究组 & 干预措施
dutasteride
4 mg oral loading dose of dutasteride followed by 1 mg/day dutasteride for 12 weeks.
干预措施: Dutasteride (Drug)
Sugar Pill
Placebo pills prepared to appear the same as active medication and taken in the same number as active medication for 12 weeks.
干预措施: sugar pill (Drug)
结局指标
主要结局
Heavy Drinking Days Per Week
时间窗: 12-week treatment period
Number of days / study week with 5 or more drinks consumed
Drinks Per Week
时间窗: 12-week treatment period
Total number of drinks aggregated by week
Number of Participants With no Heavy Drinking Days
时间窗: Last 4 weeks of treatment
Number of participants with no heavy drinking days (days with 5 or more drinks) during the last 4 weeks of treatment.
Number of Participants With no Hazardous Drinking
时间窗: Last 4 weeks of treatment
Number of participants with no hazardous drinking (not more than 4 drinks on one day and not more than 14 drinks per week) during the last 4 weeks of treatment.
次要结局
- HDD/ Week by Treatment Group and AKR1C3*2 Genotype(12-week treatment period)
- Carbohydrate-deficient Transferrin(end of 12-week treatment vs. baseline)
研究者
Jonathan Covault
Professor of Psychiatry
UConn Health