Efficacy and Safety of Baclofen for Alcohol Dependence

描述（由申请人提供）：每年超过1000亿美元的生产力损失和酒精相关的犯罪活动，伤害，事故和疾病的酒精依赖成本强调了为酒精障碍提供有效治疗的必要性。鉴于现有药物数量少且有效性有限，测试新型药物是酒精治疗的一项特别重要的策略。最近，GABAB受体激动剂巴氯芬引起了人们的关注，因为临床前药理学和行为数据表明，它可以改变导致饮酒的神经生物学因素。此外，试点临床试验也取得了积极成果。为了确定巴氯芬是否确实是一种有前途的酒精依赖药物，重要的是要扩大临床试验数据库，采用随机，双盲，安慰剂对照的方法。评估巴氯芬在酒精依赖者中的耐受性也很重要。这项拟议中的研究将收集这两个目标的数据，并将代表美国第一个巴氯芬酒精依赖的安慰剂对照试验。该研究将探讨为期12周的30 mg/d巴氯芬联合行为疗法治疗酒精依赖患者的有效性和耐受性。一些研究还发现，巴氯芬减少自我报告的焦虑和渴望;因此，拟议的研究将评估巴氯芬减少这些症状的能力。

DESCRIPTION (provided by applicant): The more than $100 billon annual cost of alcohol dependence in lost productivity and alcohol-related criminal activities, injuries, accidents, and diseases underscores the need to provide effective treatments for alcohol disorders. Testing novel pharmacologic agents represents an especially important strategy for alcohol treatment, given the small number and limited effectiveness of existing medications . Recently, the GABAB receptor agonist baclofen has drawn attention because preclinical pharmacologic and behavioral data indicate that it modifies neurobiological factors contributing to alcohol consumption. Moreover, pilot clinical trials have been positive. To determine whether baclofen is, indeed, a promising pharmacotherapeutic agent for alcohol dependence, it is important to expand the clinical trial database using randomized, double-blind, placebo-controlled methods. Assessment of the tolerability of baclofen in alcohol-dependent individuals is also important. The proposed study will gather data toward both of these goals and will represent the first placebo-controlled trial of baclofen for alcohol dependence in the United States. The study will explore the efficacy and tolerability of a 12-week regimen of 30 mg/d baclofen in conjunction with behavioral therapy for reducing heavy drinking in alcohol-dependent individuals. Several studies also have found that baclofen reduces self-reported anxiety and craving; thus, the proposed study will assess baclofen's ability to reduce these symptoms as well.