A multi-center randomized trial of buprenorphine-naloxone versus clonidine for opioid, detoxification: findings from the National Institute on Drug Abuse Clinical Trials Network
A multi-center randomized trial of buprenorphine-naloxone versus clonidine for opioid, detoxification: findings from the National Institute on Drug Abuse Clinical Trials Network
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DOI：
10.1111/j.1360-0443.2005.01154.x
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发表时间：
2005-08-01
期刊：
影响因子：
6
通讯作者：
Ziedonis, D
中科院分区：
文献类型：
--
作者：
Ling, W;Amass, L;Ziedonis, D
目的 在国家药物滥用研究所临床试验网络的首批研究中，调查了丁丙诺啡纳洛酮 (bup-nx) 和可乐定在住院和门诊社区治疗项目中用于阿片类药物解毒的临床有效性。设计诊断和统计手册第四版 (DSM IV) 诊断的寻求短期治疗的阿片类药物依赖个体被随机分配，比例为 2:1 bup-nx，使用 bup-nx 或可乐定进行为期 13 天的戒毒。方法 共有 113 名住院患者（77 名 bup-nx，36 名可乐定）和 231 名门诊患者（157 名 bup-nx，74 名可乐定）参与。支持性干预措施包括适当的辅助药物和自助手册指导的标准咨询程序。治疗成功的标准定义为在整个研究期间保留在研究中并在就诊最后一天提供不含阿片类药物的尿液样本的每种情况的参与者的比例。次要结局指标包括辅助药物的使用、报告的副作用数量以及戒断和渴望评级。 结果 分配到 bup-nx 病症的 77 名住院患者中，共有 59 名 (77%) 达到了治疗成功标准，而分配到可乐定的 36 名住院患者中有 8 名 (22%) 达到了治疗成功标准，而分配到 bup-nx 病症的 157 名门诊患者中有 46 名 (29%) 达到了治疗成功标准。 74 名中的 4 名 (5%) 分配给可乐定。结论 bup-nx 对阿片类药物解毒的益处得到了支持，并说明了在社区治疗计划中进行临床研究的重要方法。
Aims The clinical effectiveness of buprenorphine-naloxone (bup-nx) and clonidine for opioid detoxification in in-patient and out-patient community treatment programs was investigated in the first studies of the National Institute of Drug Abuse Clinical Trials Network.Design Diagnostic and Statistical Manual version IV (DSM IV)-diagnosed opioid-dependent individuals seeking short-term treatment were randomly assigned, in a 2 : 1 ratio favoring bup-nx, to a 13-day detoxification using bup-nx or clonidine.Methods A total of 113 in-patients (77 bup-nx, 36 clonidine) and 231 out-patients (157 bup-nx, 74 clonidine) participated. Supportive interventions included appropriate ancillary medications and standard counseling procedures guided by a self-help handbook. The criterion for treatment success was defined as the proportion of participants in each condition who were both retained in the study for the entire duration and provided an opioid-free urine sample on the last day of clinic attendance. Secondary outcome measures included use of ancillary medications, number of side effects reported and withdrawal and craving ratings.Findings A total of 59 of the 77 (77%) in-patients assigned to the bup-nx condition achieved the treatment success criterion compared to eight of the 36 (22%) assigned to clonidine, whereas 46 of the 157 (29%) out-patients assigned to the bup-nx condition achieved the treatment success criterion, compared to four of the 74 (5%) assigned to clonidine.Conclusions The benefits of bup-nx for opioid detoxification are supported and illustrate important ways in which clinical research can be conducted in community treatment programs.