Sertraline Pharmacotherapy for Alcoholism Subtypes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Number of Days on Which Subjects Drank
研究概览
简要总结
The purpose of this study is to determine whether Sertraline, compared to placebo, is effective in the treatment of alcohol dependence as a function of the subtype of alcoholic patient being treated. This involved administering sertraline (to a maximum of 200 mg/day) or an inactive placebo for a 14-week treatment period.
详细描述
In an effort to broaden the options for pharmacotherapy of alcoholism, this study will examine the effects of sertraline, a selective serotonin reuptake inhibitor (SSRI), for the treatment of alcohol dependence. The study is based on evidence that, although SSRI therapy is not appropriate for all alcoholics, there exists a substantial subgroup of alcoholics for whom SSRIs appear to exert a clinically important effect. Sertraline is among the most widely prescribed psychotropic medications in the world. Consequently, this study will examine the safety and efficacy of sertraline, the mechanism and duration of those effects and the best method for subtyping alcoholics to identify individuals for whom the medication is most likely to produce a clinically important reduction in drinking behavior.
The study employs a parallel-group, prospective design in which randomization is balanced on patient subtype (early-onset/late-onset) and other relevant pretreatment measures with an approximately equal number of subjects assigned to treatment with sertraline (to a maximum of 200 mg/day) or placebo. The study will include a 14-week treatment period; because the 2 weeks are for medication taper, efficacy will be evaluated over the first 12 treatment weeks. A total of 160 early-onset or late-onset alcoholics will be randomized. Daily process measures of positive and negative events, global perceived stress, mood, desire to drink, and drinking frequency and intensity, collected using interactive voice response technology, will provide insight into the mechanisms by which sertraline may exert its effects. Coping-skills training will be provided weekly for the first 6 weeks, then every other week for the last 8 weeks of the study. A 6-month post-treatment follow-up period will evaluate the duration of medication effects. This study will also examine the relation between genotypes at a number of relevant loci and both risk of alcohol dependence and response to sertraline treatment.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current episode (i.e., in the preceding month) of alcohol dependence defined by Diagnostic and Statistical Manual of Mental Disorders 4th ed (DSM-IV) criteria
- •18-65 years of age
- •Abstinent from alcohol for a period of at least 3 days prior to baseline research assessment
- •Able to read English and complete study evaluations
- •Male, or if female, without active reproductive potential
- •Participants will have signed informed consent
排除标准
- •Currently meets criteria for dependence on a psychoactive substance other than alcohol and nicotine
- •Regular use of psychoactive drugs including anxiolytics and antidepressants
- •Current use of disulfiram or naltrexone
- •Current major depression or psychosis (or other severe psychiatric disability e.g., suicidality, current mania)
- •Significant underlying medical conditions such as hepatic, cerebral, renal, thyroid, or cardiac pathology, which in the opinion of the evaluating physician would preclude the patient from study adherence or be of potential harm to the subject
研究组 & 干预措施
1
Oral sertraline, cognitive-behavioral counseling to maintain abstinence from alcohol
干预措施: Sertraline (Drug)
2
Placebo, cognitive-behavioral counseling to maintain abstinence from alcohol
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Days on Which Subjects Drank
时间窗: 12-week treatment period
Obtained using daily interactive voice response data augmented by Timeline Followback data. Missing days were treated as drinking days.
次要结局
- Number of Days of Heavy Drinking (Defined as Days on Which Women Drank >= 4 Drinks and Men Drank >= 5 Drinks)(12-week treatment period)
- Change in the Level of Alcohol-related Problems(12-week treatment period compared with baseline value)