Efficacy and tolerability of long-acting injectable for alcohol dependence - A randomized controlled trial
Efficacy and tolerability of long-acting injectable for alcohol dependence - A randomized controlled trial
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DOI：
10.1001/jama.293.13.1617
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发表时间：
2005-04-06
影响因子：
120.7
通讯作者：
Ehrich, EW
中科院分区：
文献类型：
--
作者：
Garbutt, JC;Kranzler, HR;Ehrich, EW
酒精依赖是一种常见的疾病，具有很高的发病率和死亡率。纳曲酮是一种阿片类拮抗剂，已被证明对治疗酒精依赖有效。然而，坚持每日口服药物治疗可能是有问题的，临床接受和口服纳曲酮的效用是有限的。目的观察纳曲酮肌注长效制剂治疗酒精依赖患者的疗效和耐受性。2002年2月至2003年9月在24家美国公立医院、私立和退伍军人管理局诊所以及三级保健医疗中心进行的一项为期6个月的随机、双盲、安慰剂对照试验。在899名被筛选的个体中，627名被诊断为积极饮酒的成年人被随机分配接受治疗，624人接受至少一次注射。干预措施：每月肌肉注射380毫克长效纳曲酮（n = 205）或190毫克长效纳曲酮（n = 210）或相应剂量的安慰剂（n = 209），并结合12次低强度社会心理干预。主要结局指标意向治疗人群中重度饮酒天数的发生率。结果与安慰剂相比，长效纳曲酮380 mg可使重度饮酒日事件率降低25% (P = 0.03)，长效纳曲酮190 mg可使重度饮酒日事件率降低17% （P = 0.07）。性别和预处理禁欲对治疗结果均与药物组有显著的相互作用，男性和先导禁欲组均表现出更大的治疗效果。380 mg组因不良事件停药的发生率为14.1%，190 mg组为6.7%，安慰剂组为6.7%。总体而言，治疗组间的停药率和停药时间相似。结论长效纳曲酮耐受性良好，在6个月的治疗期间，寻求治疗的酒精依赖患者的重度饮酒减少。这些数据表明，长效纳曲酮在治疗酒精依赖方面是有益的。
Context Alcohol dependence is a common disorder associated with significant morbidity and mortality. Naltrexone, an opioid antagonist, has been shown to be effective for treatment of alcohol dependence. However, adherence to daily oral pharmacotherapy can be problematic, and clinical acceptance and utility of oral naltrexone have been limited.Objective To determine efficacy and tolerability of a long-acting intramuscular formulation of naltrexone for treatment of alcohol-dependent patients.Design, Setting, and Participants A 6-month, randomized, double-blind, placebo-controlled trial conducted between February 2002 and September 2003 at 24 US public hospitals, private and Veterans Administration clinics, and tertiary care medical centers. Of the 899 individuals screened, 627 who were diagnosed as being actively drinking alcohol-dependent adults were randomized to receive treatment and 624 received at least 1 injection.Intervention An intramuscular injection of 380 mg of long-acting naltrexone (n = 205) or 190 mg of long-acting naltrexone (n = 210) or a matching volume of placebo (n = 209) each administered monthly and combined with 12 sessions of low-intensity psychosocial intervention.Main Outcome Measure The event rate of heavy drinking days in the intent-to-treat population.Results Compared with placebo, 380 mg of long-acting naltrexone resulted in a 25% decrease in the event rate of heavy drinking days (P = .03) and 190 mg of naltrexone resulted in a 17% decrease (P = .07). Sex and pretreatment abstinence each showed significant interaction with the medication group on treatment outcome, with men and those with lead-in abstinence both exhibiting greater treatment effects. Discontinuation due to adverse events occurred in 14.1% in the 380-mg and 6.7% in the 190-mg group and 6.7% in the placebo group. Overall, rate and time to treatment discontinuation were similar among treatment groups.Conclusions Long-acting naltrexone was well tolerated and resulted in reductions in heavy drinking among treatment-seeking alcohol-dependent patients during 6 months of therapy. These data indicate that long-acting naltrexone can be of benefit in the treatment of alcohol dependence.