A randomized placebo-controlled trial of gabapentin for cocaine dependence
A randomized placebo-controlled trial of gabapentin for cocaine dependence
复制标题
DOI：
10.1016/j.drugalcdep.2005.07.009
复制
发表时间：
2006-02-28
影响因子：
4.2
通讯作者：
Nunes, EV
中科院分区：
文献类型：
--
作者：
Bisaga, A;Aharonovich, E;Nunes, EV
背景资料：在实验动物中，GABA神经传递的增强导致可卡因自我给药的抑制和可卡因寻求行为的恢复抑制。如果在人类中观察到平行效应，GABA能药物在可卡因依赖治疗的戒断诱导和复发预防阶段都应该有效。加巴喷丁是一种抗惊厥药物，可增加人脑GABA水平。我们评估的安全性和有效性加巴喷丁结合复发预防治疗可卡因依赖individual.Design：这项研究涉及129个人与可卡因依赖。在99名参与者中，88%为男性，66%为少数民族，平均年龄为39岁（范围22-58岁）。安慰剂导入2周后，参与者随机接受加巴喷丁3200 mg（1600 in，bid）或安慰剂治疗12周，随后进行2周的安慰剂导入。在随机化之前，根据可卡因使用的主要途径（吸烟者与鼻内使用者）和导入期2周内可卡因使用的水平（高水平与低水平），将参与者分为4组。在整个16周的研究中，参与者每周接受一次个人复发预防治疗。结果指标包括：天的可卡因使用和基于尿液毒理学测试，自我报告的可卡因渴望和保留在treatment.Results：49%的随机患者完成了12周的试验的基础上禁欲的二元指标。治疗组之间的保留没有差异，但可卡因吸烟者退出治疗的速度明显快于鼻内使用者。对于整个样本，在研究过程中，加巴喷丁和安慰剂治疗的个体之间可卡因使用的几率没有差异。高使用组和低使用组之间可卡因使用的几率存在显著差异，高使用组的几率随着时间的推移而下降，低使用组的几率在研究过程中逐渐增加，因此到研究结束时，低和高使用者使用可卡因的可能性相似。在低使用组中，有一个非显著的趋势表明，加巴喷丁治疗的受试者有更有利的结果相比，安慰剂治疗的个人。对戒断率、渴望或其他物质使用没有治疗作用。加巴喷丁在3200 ingday是非常好的耐受性，在这组可卡因依赖的participators.Conclusions：当结合每周单独复发预防治疗-阿巴喷丁1600毫克bid是没有更有效的比安慰剂在治疗可卡因依赖。当与其他已发表的研究一起审查时，加巴喷丁和其他GABA增强抗惊厥药物可能值得进一步研究，作为可卡因依赖者在治疗早期实现禁欲的复发预防药物。(c)2005爱思唯尔爱尔兰有限公司保留所有权利。
Background: In laboratory animals, augmentation of GABA neurotransinission results in inhibition of cocaine self-administration and inhibition of reinstatement to cocaine-seeking behaviors. If parallel effects were observed in humans, GABA-ergic medication should be effective both in the abstinence-induction as well as in the relapse-prevent ion phase of cocaine dependence treatment. Gabapentin is an anticonvulsant medication that increases human brain GABA levels. We evaluated the safety and efficacy of gabapentin combined with relapse-prevention therapy in the treatment of cocaine-dependent individuals.Design: The study involved 129 individuals with cocaine dependence. Of the 99 participants, who were randomized into a double-blind trial 88% were males, 66% were minorities and with an average age of 39 years (range 22-58 years). After 2 weeks of placebo lead-in, participants were randomized to receive either gabapentin 3200 mg (1600 in,, bid) or placebo for 12 weeks, followed by 2 weeks of placebo lead-out. Prior to randomization, participants were stratified into four groups based on the principal route of cocaine use (smokers versus intranasal users) and the level of cocaine use during the 2 weeks of lead-in (high level versus low level). Throughout the 16 weeks study, participants received weekly individual relapse-prevention therapy. The outcome measures included: days of cocaine use and a binary indicator of abstinence based on urine toxicology test, self-reported cocaine craving and retention in treatment.Results: Forty-nine percent of randomized patients completed 12 weeks of the trial. Retention did not differ by treatment group but cocaine-smokers dropped out of treatment at a significantly faster rate than intranasal users. For the entire sample, odds of cocaine use over the course of the study did not differ between gabapentin- and placebo-treated individuals. There was a significant difference in the odds of cocaine use between high and low-use groups, with the odds in high-use groups decreasing over time and odds in the low-use groups gradually increasing over the course of the study, such that by the end of the study low and high users were similarly likely to use cocaine. In the low-use group, there was a non-significant trend suggesting that gabapentin-treated subjects had more favorable outcome compared to placebo-treated individuals. There was no treatment effect on abstinence rates, craving or other substance use. Gabapentin at 3200 ingday was very well tolerated in this group of cocaine-dependent participants.Conclusions: When combined with weekly individual relapse-prevention therapy-abapentin 1600 mg bid was no more effective than placebo in the treatment of cocaine dependence. When reviewed in conjunction with other published studies, gabapentin and other GABA enhancing anticonvulsant medications may deserve further study as relapse-preventive agents in cocaine-dependent individuals who achieve abstinence early in treatment. (c) 2005 Elsevier Ireland Ltd. All rights reserved.