Pregabalin Treatment of Alcohol Use Disorder.

项目摘要 尽管在药理学和行为干预方面取得了实质性进展， 酒精使用障碍仍然是美国的一个重大公共卫生问题， 治疗设备方面仍然存在差距。从概念上讲，酒精使用的理想药物疗法 当给予积极饮酒的患者时，这种疾病是安全的， 适度戒酒，并促进减少酒精摄入量。目前无药物治疗 酒精使用障碍符合这些标准，因此代表了一个重要的未满足的公共卫生需求。 普瑞巴林是一种加巴喷丁类化合物，在治疗酒精戒断症状方面的疗效证据有限， 以及作为复发预防剂的有效性的有限证据。我们的研究人员进行了一项试点研究（n=15）， 一个研究小组发现，普瑞巴林的剂量高达600毫克，每天是安全的，可行的， 酒精使用障碍的耐受治疗。拟议的研究旨在建立在这些结果和评估 加巴喷丁作为酒精使用障碍潜在的抗干渴剂。普瑞巴林已被证明是一种良好的- 具有低滥用倾向的耐受性药物，从而使其理想地用于门诊设置。的 拟议的试点项目是研究普瑞巴林对参与者有害饮酒行为的影响， 有酒精使用障碍的主动饮酒门诊患者。受试者在研究期间将积极饮酒 入组，并在整个研究期间测量使用模式相对于基线的变化。具体目标 是为了确定普瑞巴林治疗是否会显着减少有害的酒精消费相比， 安慰剂主要结果测量将是重度饮酒日（定义为任何一天）的比例 其中标准饮料的数量为男性至少5杯，女性至少4杯 通过时间轴跟踪方法。拟定项目为8周随机双盲安慰剂- 评价普瑞巴林治疗酒精使用障碍50例疗效的前瞻性对照试验 门诊病人所有参与者将接受每周一次的支持性行为治疗， 饮酒，鼓励参加12步会议，并促进研究药物的依从性。的 一个拟议的研究项目将是第一个研究普瑞巴林作为一种治疗积极饮酒 门诊病人，这将是巨大的临床效用，如果被证明是有效的。

Project Summary Despite substantial advances in the development of pharmacological and behavioral interventions, alcohol use disorder continues to be a significant public health problem in the United States, and significant gaps in the treatment armamentarium remain. Conceptually, the ideal pharmacotherapy for alcohol use disorder would be safe when administered to actively drinking patients, provide protection against mild-to- moderate alcohol withdrawal, and promote reductions in alcohol intake. No current pharmacotherapy for alcohol use disorder meets these criteria and thus represents an important unmet public health need. Pregabalin is a gabapentinoid with limited evidence of efficacy in treating the symptoms of alcohol withdrawal, as well as limited evidence of efficacy as a relapse prevention agent. A pilot study (n=15) conducted by our research group found pregabalin in doses up to 600 mg daily to be a safe, feasible, and generally well tolerated treatment for alcohol use disorder. The proposed study aims to build on these results and evaluate gabapentin as a potential antidipsotropic agent for alcohol use disorder. Pregabalin has proven to be a well- tolerated medication with a low abuse liability, thereby making it ideal for use in the outpatient setting. The proposed pilot project is to study the effects of pregabalin on the participants’ harmful drinking behavior in actively drinking outpatients with alcohol use disorder. Participants will be actively drinking alcohol at study entry, and the change in use pattern from baseline is measured throughout the study period. The specific aim is to determine if pregabalin treatment will significantly reduce harmful alcohol consumption as compared to placebo. The primary outcome measure will be the proportion of the heavy drinking days (defined as any day where the number of standard drinks was at least 5 for men and at least 4 for women) per week as measured by the timeline followback method. The proposed project is an 8-week randomized double-blind placebo- controlled pilot trial to evaluate the efficacy of pregabalin in the treatment of alcohol use disorder in 50 outpatients. All participants will receive weekly supportive behavioral treatment that promotes reductions in alcohol use, encourages 12-step meeting attendance, and facilitates compliance with study medication. The proposed research project would be the first study of pregabalin as a treatment for actively drinking outpatients, which would be of great clinical utility if proven to be effective.