Pettinati Helen M, Kampman Kyle M, Lynch Kevin G, Xie Hu, Dackis Charles, Rabinowitz Amanda R, O'Brien Charles P
Center for the Study of Addictions, Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, PA 19104, USA.
Addict Behav. 2008 May;33(5):651-67. doi: 10.1016/j.addbeh.2007.11.011. Epub 2007 Nov 17.
This is a double blind, placebo-controlled trial that evaluated the efficacy of disulfiram, naltrexone and their combination in patients with co-occurring cocaine and alcohol dependence.
208 patients were randomized to disulfiram (250 mg/day), naltrexone (100 mg/day), the combination, or placebo for 11 weeks. Outcomes were in-trial abstinence from cocaine and/or alcohol.
Few safety concerns were reported, although medication adherence was low in a number of patients for both medications, alone or in combination. In the primary analyses (GEE modeling), abstinence from cocaine as measured by cocaine-negative urines and days of self-reported abstinence from cocaine or alcohol did not differ between placebo and any of the medication groups. However, patients taking disulfiram (alone or in combination) were most likely to achieve combined abstinence from cocaine and alcohol. Secondary analyses revealed that patients taking the disulfiram-naltrexone combination were most likely to achieve 3 consecutive weeks of abstinence from cocaine and alcohol.
There was an association between disulfiram treatment and abstinence from cocaine and alcohol. More patients taking the disulfiram-naltrexone combination achieved 3 consecutive weeks of abstinence in treatment than placebo-treated patients.
这是一项双盲、安慰剂对照试验，评估了双硫仑、纳曲酮及其联合用药对同时患有可卡因和酒精依赖患者的疗效。
208名患者被随机分为接受双硫仑（250毫克/天）、纳曲酮（100毫克/天）、联合用药或安慰剂治疗，为期11周。观察指标为试验期间可卡因和/或酒精戒断情况。
尽管单独或联合使用这两种药物时，许多患者的药物依从性较低，但报告的安全问题较少。在主要分析（广义估计方程建模）中，安慰剂组与任何药物治疗组相比，通过可卡因阴性尿液测量的可卡因戒断情况以及自我报告的可卡因或酒精戒断天数并无差异。然而，服用双硫仑（单独或联合用药）的患者最有可能实现可卡因和酒精的联合戒断。次要分析显示，服用双硫仑 - 纳曲酮联合用药的患者最有可能实现连续3周戒除可卡因和酒精。
双硫仑治疗与可卡因和酒精戒断之间存在关联。与接受安慰剂治疗的患者相比，更多服用双硫仑 - 纳曲酮联合用药的患者在治疗中实现了连续3周的戒断。
