Baclofen efficacy in reducing alcohol craving and intake: A preliminary double-blind randomized controlled study

Baclofen efficacy in reducing alcohol craving and intake: A preliminary double-blind randomized controlled study
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DOI:
10.1093/alcalc/37.5.504
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发表时间:
2002-09-01
影响因子:
2.8
通讯作者:
Gasbarrini, G
Gasbarrini, G
中科院分区:
医学3区
文献类型:
--
作者:
Addolorato, G;Caputo, F;Gasbarrini, G

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目的:伽马氨基丁酸(GABA(B))受体激动剂巴氯芬最近被证明可以减少偏爱酒精的大鼠的酒精摄入量,并在一项开放的研究中减少人类的酒精消费和对酒精的渴望。本研究旨在通过双盲安慰剂对照设计首次评估巴氯芬在诱导和维持戒酒以及减少酒精依赖患者对酒精的渴求方面的疗效。方法:39例酒依赖患者连续入选研究。戒酒12~24小时后,患者随机分为两组。20名患者接受了巴氯芬治疗,19名患者接受了安慰剂治疗。口服药物和安慰剂,连续30天。前3天给予巴氯芬15 mg/d,随后27天给予30 mg/d,分3次每日给药。每周将患者作为门诊患者进行监测。在每次就诊时,评估酒精摄入量、戒酒情况、酒精渴望和情感障碍的变化。结果:与安慰剂组相比,巴氯芬组受试者在整个研究期间完全戒酒的比例和累计戒酒天数都更高。与安慰剂组相比,巴氯芬组的强迫性和强迫性渴望成分减少;同样,巴氯芬组的酒精摄入量也减少了。与安慰剂组相比,巴氯芬组的状态焦虑有所降低。在目前的抑郁症状方面,两组之间没有发现显著差异。事实证明,巴氯芬很容易控制,没有患者因副作用的存在而停止治疗。没有患者因对药物的渴望和/或药物滥用而受到影响。结论:巴氯芬能有效地诱导酒精者戒酒,减少酒精渴求和饮酒。由于涉及的受试者数量有限,这项初步的双盲研究结果表明,巴氯芬可能是一种潜在的有用药物,用于治疗酒精依赖患者,因此值得进一步研究。
Aims: The gamma-aminobutyric acid (GABA(B)) receptor agonist, baclofen, has recently been shown to reduce alcohol intake in alcohol-preferring rats and alcohol consumption and craving for alcohol in an open study in humans. The present study was aimed at providing a first evaluation of the efficacy of baclofen in inducing and maintaining abstinence and reducing craving for alcohol in alcohol-dependent patients in a double-blind placebo-controlled design. Methods: A total of 39 alcohol-dependent patients were consecutively enrolled in the study. After 12-24 h of abstinence from alcohol, patients were randomly divided into two groups. Twenty patients were treated with baclofen and 19 with placebo. Drug and placebo were orally administered for 30 consecutive days. Baclofen was administered at the dose of 15 mg/day for the first 3 days and 30 mg/day for the subsequent 27 days, divided into three daily doses. Patients were monitored as out-patients on a weekly basis. At each visit alcohol intake, abstinence from alcohol, alcohol craving and changes in affective disorders were evaluated. Results: A higher percentage of subjects totally abstinent from alcohol and a higher number of cumulative abstinence days throughout the study period were found in the baclofen, compared to the placebo, group. A decrease in the obsessive and compulsive components of craving was found in the baclofen compared to the placebo group; likewise, alcohol intake was reduced in the baclofen group. A decrease in state anxiety was found in the baclofen compared to the placebo group. No significant difference was found between the two groups in terms of current depressive symptoms. Baclofen proved to be easily manageable and no patient discontinued treatment due to the presence of side-effects. No patient was affected by craving for the drug and/or drug abuse. Conclusions: Baclofen proved to be effective in inducing abstinence from alcohol and reducing alcohol craving and consumption in alcoholics. With the limits posed by the small number of subjects involved, the results of this preliminary double-blind study suggest that baclofen may represent a potentially useful drug in the treatment of alcohol-dependent patients and thus merits further investigations.