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: 7047898
• 负责人: James C. Garbutt
• 金额: $ 17.35万
• 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 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7047898
• 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）：超过100美元的Billon年度酒精依赖成本在生产力失去的生产力和与酒精有关的犯罪活动，伤害，事故和疾病中强调了为酒精疾病提供有效治疗的必要性。鉴于现有药物的有效性少，测试新型药理剂代表了酒精治疗的特别重要策略。最近，GABAB受体激动剂巴氯芬引起了人们的注意，因为临床前药理和行为数据表明它修饰了有助于饮酒的神经生物学因素。此外，试验临床试验是积极的。为了确定Baclofen是否确实是一种有希望的酒精依赖药物治疗剂，使用随机的，双盲的，安慰剂控制的方法扩展临床试验数据库很重要。评估巴氯芬在酒精依赖性个体中的耐受性也很重要。拟议的研究将收集到这两个目标的数据，并代表美国巴氯芬对酒精依赖性的第一个安慰剂对照试验。该研究将探讨30 mg/d baclofen的12周疗法与行为疗法的疗效和耐受性，以减少酒精依赖人的大量饮酒。几项研究还发现，巴氯芬可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还减轻这些症状的能力。