FLUOXETINE FOR RELAPSE PREVENTION OF ALCOHOLISM

这个项目旨在研究血清素摄取的作用 抑制作为预防复发的药物治疗， 酒精中毒 基于先前的动物和人类研究，氟西汀， 一种特异性5-羟色胺摄取抑制剂，似乎是一种潜在的有用的 用于维持酒精依赖者戒酒的治疗剂 人士 酒精中毒的成功治疗， 对个人和社会都有好处， 整体 假设是5-羟色胺摄取抑制降低了 渴望饮酒。 本研究将具体探讨 氟西汀是一种有效的短期药物辅助治疗 酒精中毒 将进行一项随机安慰剂对照临床试验， 在200名最近戒酒的酒精依赖者中进行，他们将 接受60 mg氟西汀或安慰剂，持续8周。 的 大多数酒精依赖者复吸饮酒是在 戒毒后的头几个月 药理学（如 以及其他）治疗可能在此期间产生最大影响 时间段 研究人群将包括大量的 妇女和少数民族（非洲裔美国人）。 所有受试者将同时 参加强化门诊治疗，包括三次就诊 每周进行呼气测醉器监测、咨询和团体治疗， 为期六个月。 受试者将完成每日酒精日记 每周研究访视时收集的消耗量， 头两个月，然后两个半月，三个月和六个月。 其他 禁欲的依从性措施将在研究访视时确定， 并将包括尿液酒精和药物筛查，实验室检查（AST， ALT、GGT、MCV），并从旁系中证实自我报告。 服药依从性将通过药丸确认 计数和血清氟西汀和去甲氟西汀水平。 主要结局 终点将事先确定，并将包括 在一个月和两个月时按组进行禁欲受试者。 其他分析结果将 包括禁欲天数、复发天数和替代品 饮酒行为的措施，如实验室测试和社会 稳定 将进行意向治疗分析，并在中期 如果未确定该群体，则允许进行分析。 这 这项研究将提供关于氟西汀作为 预防复发的长期药物治疗。

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.