Naltrexone for alcohol dependence: a randomized controlled trial
Naltrexone for alcohol dependence: a randomized controlled trial
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DOI：
10.1046/j.1360-0443.2001.961115654.x
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发表时间：
2001-11-01
期刊：
影响因子：
6
通讯作者：
Drummond, E
中科院分区：
文献类型：
--
作者：
Morris, PLP;Hopwood, M;Drummond, E
瞄准我们研究了纳洛酮（阿片类拮抗剂）对酒精依赖男性样本中酒精依赖的疗效。设计为期12周的随机安慰剂对照临床试验。设置.澳大利亚墨尔本的一家退伍军人和综合教学医院的门诊部。男性酒精依赖受试者从社区和退伍军人组招募。酒精依赖受试者每天接受50 mg纳洛酮或安慰剂治疗12周。两个治疗组都参加了每周一次的教育支持小组。每周对受试者进行评估。主要研究结果是维持戒酒和复发饮酒。55名受试者被随机分配到纳洛酮组，56名被随机分配到安慰剂组。40例受试者未完成12周的治疗（17例纳洛酮，23例安慰剂）。在意向治疗样本（N=111）中，较少的纳洛酮治疗受试者复发（p = 0.001）。在完成12周试验的患者中，纳洛酮减少了酒精的消耗。纳洛酮耐受性良好，不良反应少。这些研究结果表明，纳洛酮是有效的，在有限的心理社会治疗的设置，以防止复发饮酒。进一步的研究应该检查长期维持效果所需的治疗持续时间。
Aim. We examined the efficacy of naltrexone (an opioid antagonist) for alcohol dependence in a sample of alcohol-dependent men. Design. A 12-week randomized placebo-controlled clinical trial. Setting. The outpatient clinic of a combined war veteran and general teaching hospital in Melbourne, Australia.Participants. Male alcohol-dependent subjects recruited from the community and from veteran groups.Intervention. Alcohol-dependent subjects were treated with 50 mg of naltrexone or placebo daily for 12 weeks. Both treatment groups attended a weekly education support group. Subjects were assessed weekly.Measurements. Primary study outcomes were the maintenance of abstinence and relapse to drinking.Findings. Fifty-five subjects were randomized to naltrexone and 56 to placebo. Forty subjects did not complete 12 weeks of therapy (17 naltrexone, 23 placebo). In the intention-to-treat sample (N=111) fewer naltrexone treated subjects relapsed (p = 0.001). Among patients who completed the 12-week trial, naltrexone reduced the consumption of alcohol. Naltrexone was well tolerated and there were few adverse experiences.Conclusions. These findings demonstrate that naltrexone is effective in preventing relapse to drinking in the setting of limited psychosocial treatment. Further studies should examine the duration of treatment needed to maintain the effect long term.