Topiramate Treatment of Alcohol Use Disorder in African Americans

1.目标(S)：尽管饮酒率和重度饮酒率低于 欧洲裔美国人(EA)、非裔美国人(AA)的比例明显高于 各种酒精相关疾病的死亡率，包括肝脏 肝硬变、意外和暴力。目前的提案旨在改善酒精含量 AA退伍军人的治疗，他们占退伍军人总数的12%。 2.研究设计：本研究为双臂随机对照研究，为期12周。 托吡酯与安慰剂用于降低频率的平行分组比较 减少酗酒天数，并增加160个戒酒者的禁酒天数 AUD患者。 3.方法论：指导方法的具体目标如下： 具体目的1.检测托吡酯(TOP)200 mg/d的降压效果 在非洲，酗酒和禁酒天数增加的频率- 美国(AA)酒精使用障碍(AUD)患者。我们假设， 就像在欧洲裔美国人(EA)一样，AA受试者收到最高的报告将会更少 酗酒天数(HDD)和戒酒天数比那些 安慰剂(解放军)。 这些分析利用所有患者提供的所有数据来估计模型 在大量饮酒和禁酒的日子里测试最大的效果。权力，为 对比将由最后六周的结果模式决定， 因此，功率估计是基于第7周到第12周的6周试用， 基准线和第6周之间的减损调整。基于我们的 之前的研究(Kranzler 2014)，我们预计前六年的留存率为92% 每组每周，在第6周结束时每组产生74个可用，以及 由于在最后六周内辍学而造成的额外4%的损失，以及受试者内部 相关系数约为0.6。Hedeker等人(1999)的方法表明，我们将 对于顶主效应大小d=0.40、0.43和0.46，具有80%的功率，对于- 在修正的阿尔法水平下，受试者的相关性分别为0.5、0.6和0.7 0.025。 4.影响/意义：该提案是创新的，因为它将侧重于行政审批 对于澳元，研究不足、服务不足的人群没有这样的数据 目前存在。鉴于澳元病的深远影响及其高患病率 在退伍军人中，基于证据的额外治疗可能会降低健康水平 不必要的急诊室就诊的护理费用和减少疾病的并发症 例如丙型肝炎和充血性心力衰竭。

1. Objective(s): Despite having lower rates of drinking and heavy drinking than European Americans (EAs), African Americans (AA) have significantly higher rates of mortality from a variety of alcohol-related conditions, including liver cirrhosis, accidents, and violence. The current proposal aims to improve alcohol treatment in AA Veterans, who comprise 12% of the Veteran population. 2. Research Design: The proposed study is a two-arm, randomized 12-week, parallel-groups comparison of topiramate versus placebo to reduce the frequency of heavy drinking days and increase the number of abstinent days in 160 AA patients with AUD. 3. Methodology: The following specific aim is used to direct the methods: Specific Aim 1. To test the efficacy of topiramate (TOP) 200 mg/day in reducing the frequency of heavy drinking and increasing abstinent days in African- American (AA) patients with alcohol use disorder (AUD). We hypothesize that, as in European-Americans (EAs), AA subjects receiving TOP will report fewer heavy drinking days (HDDs) and more abstinent days than those receiving placebo (PLA). The analyses make use of all data provided by all patients to estimate models to test the TOP effect on days of heavy drinking and abstinent days. Power for the contrasts will be determined by the patterns of outcomes in the final six weeks, so power estimates are based on weeks 7 through 12 as a 6-week trial, with adjustments for loss to attrition between baseline and week 6. Based on our prior study (Kranzler 2014), we anticipate 92% retention through the first six weeks for each group, yielding 74 available per group at the end of week 6, an additional 4% loss due to dropout across the final six weeks, and a within-subject correlation of about 0.6. The methods of Hedeker et al (1999) show that we will have 80% power for a TOP main effect size of d=0.40, 0.43, and 0.46, for within- subject correlations of 0.5, 0.6, and 0.7, respectively, at a corrected alpha level of 0.025. 4. Impact/Significance: The proposal is innovative in that it will focus on AAs with AUD, an understudied and underserved population for whom no such data currently exist. Given the far-reaching effects of AUD and its high prevalence among veterans, added evidence based treatments may realize reduced health care costs from unnecessary ED visits and reduced complications of illnesses such as hepatitis C and congestive heart failure.