A double-blind, placebo-controlled study of oral nalmefene for alcohol dependence
A double-blind, placebo-controlled study of oral nalmefene for alcohol dependence
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DOI：
10.1001/archpsyc.56.8.719
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发表时间：
1999-08-01
影响因子：
--
通讯作者：
Cutler, RB
中科院分区：
文献类型：
--
作者：
Mason, BJ;Salvato, FR;Cutler, RB
背景资料：纳美芬是一种较新的阿片类拮抗剂，其结构与纳洛酮相似，但在治疗酒精依赖方面具有许多潜在的药理学优势，包括对肝脏的毒性作用无剂量依赖性，口服生物利用度更高，拮抗剂作用持续时间更长，与阿片受体亚型的结合更具竞争性，这些受体亚型被认为会加强饮酒。进行了一项双盲、安慰剂对照试验，以评估2种剂量的口服纳美芬治疗酒精依赖的安全性和有效性。105名门诊志愿者在随机分配到安慰剂组或20或80 mg/d剂量的纳美芬组12周之前平均禁欲2周。治疗期间每周提供认知行为治疗。自我报告的饮酒或禁欲证实呼吸酒精浓度的测定和间接线人reports.Results：结果没有20和80毫克剂量的纳美芬组之间的差异。治疗12周后，纳美芬组复发重度饮酒的患者明显少于安慰剂组（P
Background: Nalmefene is a newer opioid antagonist that is structurally similar to naltrexone but with a number of potential pharmacological advantages for the treatment of alcohol dependence, including no dose-dependent association with toxic effects to the liver, greater oral bioavailability, longer duration of antagonist action, and more competitive binding with opioid receptor subtypes that are thought to reinforce drinking.Methods: A double-blind, placebo-controlled trial was conducted to evaluate the safety and efficacy of 2 doses of oral nalmefene for alcohol dependence. The 105 outpatient volunteers were abstinent for a mean of 2 weeks prior to random assignment to the placebo or 20- or 80-mg/d dose nalmefene groups for 12 weeks. Cognitive behavioral therapy was provided weekly during treatment. Self-reported drinking or abstinence was confirmed by determinations of breath alcohol concentration and by collateral informant reports.Results: Outcomes did not differ between the 20- and 80-mg dose nalmefene groups. Significantly fewer patients treated with nalmefene than patients given placebo relapsed to heavy drinking through 12 weeks of treatment (P