Efficacy and Safety of Baclofen for Alcohol Dependence

巴氯芬治疗酒精依赖的功效和安全性

• 批准号: 6859000
• 负责人: James C. Garbutt
• 金额: $ 17.77万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6859000
• 关键词: GABA receptor; alcoholic beverage consumption; alcoholism /alcohol abuse; alcoholism /alcohol abuse chemotherapy; anxiety; behavioral /social science research tag; clinical research; clinical trials; combination therapy; craving; drug /alcohol abstinence; drug adverse effect; drug detection; drug screening /evaluation; drug tolerance; human subject; human therapy evaluation; muscle relaxants; neurotransmitter agonist; patient oriented research; psychosocial rehabilitation; relapse /recurrence; therapy compliance; urinalysis

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.

描述（由申请人提供）：由于酒精依赖导致生产力损失以及与酒精相关的犯罪活动、伤害、事故和疾病，每年造成的损失超过 1000 亿美元，这凸显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效果有限，测试新药物代表了酒精治疗的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的结果。为了确定巴氯芬是否确实是一种有前途的酒精依赖药物治疗剂，重要的是使用随机、双盲、安慰剂对照方法扩大临床试验数据库。评估酒精依赖者对巴氯芬的耐受性也很重要。拟议的研究将为这两个目标收集数据，并将代表美国第一个针对巴氯芬治疗酒精依赖的安慰剂对照试验。该研究将探讨为期 12 周的 30 毫克/天巴氯芬治疗方案与行为疗法相结合，以减少酒精依赖者的大量饮酒的疗效和耐受性。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，拟议的研究还将评估巴氯芬减轻这些症状的能力。