FLUOXETINE FOR RELAPSE PREVENTION OF ALCOHOLISM

该项目旨在研究5-羟色胺摄取的作用。 抑制作为一种预防复发的药物治疗 酗酒。在先前动物和人体研究的基础上，氟西汀， 一种特殊的5-羟色胺摄取抑制剂，似乎是一种潜在的有用的 治疗剂，在维持酒精依赖戒断中的作用 人。酒精中毒的成功治疗显然是巨大的 健康和社会利益对个人和社会都是一种 完整的。假设是5-羟色胺摄取抑制会降低 饮酒的欲望。这项研究将专门检查 氟西汀是一种有效的短期药理辅助治疗药物 酗酒。一项随机的安慰剂对照临床试验将是 对200名最近戒酒的人进行了调查，他们将 服用60毫克氟西汀或安慰剂，疗程8周。这个 大多数重新饮酒的酒精依赖者是在 戒毒后的头几个月。因此，药理作用(AS 以及其他)治疗可能在这期间产生最大的影响 时间段。研究人群将包括相当数量的 妇女和少数民族(非裔美国人)。所有科目将同时进行 参加强化门诊治疗，包括三次就诊 每周接受呼气测定仪监测、咨询和团体治疗， 六个月的期限。受试者将完成关于酒精的日常日记 消费额将在每周的研究访问中收集，用于 首先是两个月，然后是两个半月、三个月和六个月。其他 禁欲的合规措施将在研究访问中确定， 并将包括尿液酒精和药物筛查、实验室测试(AST、 ALT、GGT、MCV)和来自抵押品的自我报告的验证。 服药依从性将用药片确认 计数和血清氟西汀和去氟西汀水平。主要结果 将先验地建立端点，并将包括 禁欲受试者在1个月和2个月时分组。其他分析将 包括禁欲天数、复发天数和代孕天数 对饮酒行为的测量，如实验室测试和社交 稳定性。将进行意向治疗分析，并在 只要不确定该群体的身份，就可以进行分析。这 这项研究将为氟西汀作为 预防复发的一种药物疗法。

This project is designed to examine the role of serotonin uptake inhibition as a pharmacologic treatment for the prevention of relapse to alcoholism. On the basis of prior animal and human studies, fluoxetine, a specific serotonin uptake inhibitor, appears to be a potentially useful therapeutic agent, in the maintenance of abstinence in alcohol dependent persons. The successful treatment of alcoholism is clearly of enormous health and social benefit both to the individual, and to society as a whole. The hypothesis is that serotonin uptake inhibition decreases the desire to consume alcohol. This study will specifically examine whether fluoxetine is a useful short term pharmacologic adjunct in the treatment of alcoholism. A randomized placebo controlled clinical trial will be conducted in 200 recently abstinent alcohol dependent persons, who will receive 60 mg of fluoxetine or placebo for a duration of eight weeks. The majority of alcohol dependent persons who relapse to drinking do so during the first few month following detoxification. Therefore pharmacologic (as well as other) treatment is likely to have greatest impact during this time period. The study population will include significant numbers of women and minorities (African-Americans). All subjects will concurrently be enrolled in intensive outpatient treatment which includes three visits per week with breathalyzer monitoring, counseling and group therapy, for a duration of six months. Subjects will complete daily diaries on alcohol consumption which will be collected at research visits weekly for the first two months, and then at two and a half, three and six months. Other compliance measures for abstinence will be determined at research visits, and will include urine alcohol and drug screens, laboratory tests (AST, ALT, GGT, MCV), and corrobration of self report from a collateral. Compliance with the taking of medication will be confirmed with pill counts and serum fluoxetine and norfluoxetine levels. Primary outcome endpoints will be established a priori and will include the proportion of abstinent subjects by group at one, and two months. Other analyses will include number of days of abstinence, days to relapse, and surrogate measures of drinking behavior such as laboratory tests and social stability. An intention to treat analysis will be conducted, and interim analyses will be allowed provided that the group are not identified. This study will provide important information on the utility of fluoxetine as a term pharmacologic treatment for relapse prevention.