Efficacy and Safety of Baclofen for Alcohol Dependence

描述(由申请人提供)：每年因酒精依赖造成的生产力损失和与酒精相关的犯罪活动、伤害、事故和疾病的成本超过1000亿美元，这突显了为酒精障碍提供有效治疗的必要性。鉴于现有药物的数量很少，疗效有限，测试新的药理药物对酒精治疗来说是一个特别重要的策略。最近，GABAB受体激动剂巴氯芬引起了人们的注意，因为临床前的药理学和行为学数据表明，它可以改变导致酒精消费的神经生物学因素。此外，试点临床试验一直是积极的。为了确定巴氯芬是否确实是一种有前途的酒精依赖药物治疗剂，重要的是使用随机、双盲、安慰剂对照的方法来扩大临床试验数据库。评估巴氯芬在酒精依赖者中的耐受性也很重要。这项拟议的研究将收集这两个目标的数据，并将代表着美国首个巴氯芬治疗酒精依赖的安慰剂对照试验。这项研究将探索为期12周的30 mg/d巴氯芬联合行为疗法减少酒精依赖者大量饮酒的有效性和耐受性。几项研究还发现，巴氯芬可以减少自我报告的焦虑和渴望；因此，拟议的研究也将评估巴氯芬缓解这些症状的能力。

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.