Combined pharmacotherapies and behavioral interventions for alcohol dependence - The COMBINE study: A randomized controlled trial
Combined pharmacotherapies and behavioral interventions for alcohol dependence - The COMBINE study: A randomized controlled trial
复制标题
DOI：
10.1001/jama.295.17.2003
复制
发表时间：
2006-05-03
影响因子：
120.7
通讯作者：
Zweben, A
中科院分区：
文献类型：
--
作者：
Anton, RF;O'Malley, SS;Zweben, A
背景
酒精依赖治疗可能包括药物治疗、行为疗法，或两者兼用。尚不清楚联合这些治疗方法会如何影响其疗效，尤其是在初级医疗和其他非专科环境中。
目的
评估药物、行为疗法及其组合治疗酒精依赖的疗效，并评估安慰剂对总体结果的影响。
设计、环境和参与者
2001年1月至2004年1月在来自美国11个学术站点的1383名近期戒酒的志愿者（中位年龄44岁）中进行随机对照试验，这些志愿者符合《精神障碍诊断与统计手册》第四版原发性酒精依赖的诊断标准。
干预措施
八组患者接受医疗管理，同时服用16周的纳曲酮（100毫克/天）或阿坎酸（3克/天），或两者都用，和/或两种安慰剂，同时接受或不接受联合行为干预（CBI）。第九组仅接受CBI（不服药）。患者在治疗后还接受了长达1年的评估。
主要结局指标
戒酒天数百分比和首次重度饮酒日的时间。
结果
所有组的饮酒量都大幅减少。在治疗期间，接受纳曲酮加医疗管理的患者（n = 302）、接受CBI加医疗管理和安慰剂的患者（n = 305），或同时接受纳曲酮和CBI加医疗管理的患者（n = 309），其戒酒天数百分比（分别为80.6、79.2和77.1）高于仅接受安慰剂和医疗管理的患者（n = 305）的75.1，纳曲酮与行为干预存在显著的交互作用（P = 0.009）。随着时间推移，纳曲酮还降低了重度饮酒日的风险（风险比，0.72；97.5%置信区间，0.53 - 0.98；P = 0.02），在接受医疗管理但未接受CBI的患者中最为明显。阿坎酸与安慰剂相比，无论是单独使用还是与纳曲酮、CBI或两者的任何组合使用，对饮酒都没有显著影响。在治疗期间，那些未服药或未接受医疗管理而仅接受CBI的患者（n = 157），其戒酒天数百分比（66.6）低于仅接受安慰剂加医疗管理的患者（n = 153）或接受安慰剂加医疗管理和CBI的患者（n = 156）（分别为73.8和79.8；P <...（此处原文似乎不完整）
Context Alcohol dependence treatment may include medications, behavioral therapies, or both. It is unknown how combining these treatments may impact their effectiveness, especially in the context of primary care and other nonspecialty settings.Objectives To evaluate the efficacy of medication, behavioral therapies, and their combinations for treatment of alcohol dependence and to evaluate placebo effect on overall outcome.Design, Setting, and Participants Randomized controlled trial conducted January 2001-January 2004 among 1383 recently alcohol-abstinent volunteers ( median age, 44 years) from 11 US academic sites with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnoses of primary alcohol dependence.Interventions Eight groups of patients received medical management with 16 weeks of naltrexone ( 100 mg/d) or acamprosate ( 3 g/d), both, and/or both placebos, with or without a combined behavioral intervention ( CBI). A ninth group received CBI only ( no pills). Patients were also evaluated for up to 1 year after treatment.Main Outcome Measures Percent days abstinent from alcohol and time to first heavy drinking day.Results All groups showed substantial reduction in drinking. During treatment, patients receiving naltrexone plus medical management (n= 302), CBI plus medical management and placebos ( n= 305), or both naltrexone and CBI plus medical management ( n= 309) had higher percent days abstinent (80.6, 79.2, and 77.1, respectively) than the 75.1 in those receiving placebos and medical management only ( n= 305), a significant naltrexone x behavioral intervention interaction ( P=. 009). Naltrexone also reduced risk of a heavy drinking day ( hazard ratio, 0.72; 97.5% CI, 0.53-0.98; P=. 02) over time, most evident in those receiving medical management but not CBI. Acamprosate showed no significant effect on drinking vs placebo, either by itself or with any combination of naltrexone, CBI, or both. During treatment, those receiving CBI without pills or medical management ( n= 157) had lower percent days abstinent (66.6) than those receiving placebo plus medical management alone ( n= 153) or placebo plus medical management and CBI ( n= 156) (73.8 and 79.8, respectively; P