Ethical and clinical safety considerations in the design of an effectiveness trial: A comparison of buprenorphine versus naltrexone treatment for opioid dependence
Ethical and clinical safety considerations in the design of an effectiveness trial: A comparison of buprenorphine versus naltrexone treatment for opioid dependence
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DOI：
10.1016/j.cct.2016.09.006
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发表时间：
2016-11-01
影响因子：
2.2
通讯作者：
Rotrosen, John
中科院分区：
文献类型：
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作者：
Nunes, Edward V.;Lee, Joshua D.;Rotrosen, John
我们研究了有效性试验（CTN-0051；X：BOT）设计中遇到的伦理挑战，将舌下含服丁丙诺啡纳洛酮（BUP-NX）（一种针对阿片类药物依赖的既定治疗方法）与较新的缓释注射纳曲酮（XR-NTX）进行比较。围绕的道德问题：1）已知一种可能的常用治疗方法如常控制病情排毒，然后进行不药物咨询的效果不佳； 2) 鉴于治疗已获得临床批准并且可供大众使用，患者对治疗的偏好的作用； 3) 不同治疗的最佳“常规治疗”临床设置之间存在差异，因此设计公平比较具有挑战性； 4）偏爱不同处理方式的既得利益集团对设计过程产生潜在影响； 5) 药物使用者和囚犯等潜在弱势群体； 6) 实施安全程序时可能存在的治疗误解； 7) 大型试验的高成本限制了可以解决的问题。我们研究了这些伦理问题背后的设计特征如何成为有效性试验的特征，这些试验通常是大型试验，在基于社区的治疗环境中，将治疗与不同程度的现有有效性数据以及患者和临床医生的熟悉程度进行比较，并采用可能涉及弱势群体的最低排除标准。因此，设计有效性试验的研究人员可能希望对类似伦理问题的可能性保持警惕。 (C) 2016 年，爱思唯尔公司出版
We examine ethical challenges encountered in the design of an effectiveness trial (CTN-0051; X:BOT), comparing sublingual buprenorphine-naloxone (BUP-NX), an established treatment for opioid dependence, to the newer extended-release injectable naltrexone (XR-NTX). Ethical issues surrounded: 1) known poor effectiveness of one possible, commonly used treatment as usual control condition detoxification followed by counseling without medication; 2) the role of patients' preferences for treatments, given that treatments were clinically approved and available to the population; 3) differences between the optimal "usual treatment" clinical settings for different treatments making it challenging to design a fair comparison; 4) vested interest groups favoring different treatments exerting potential influence on the design process; 5) potentially vulnerable populations of substance users and prisoners; 6) potential therapeutic misconception in the implementation of safety procedures; and 7) high cost of a large trial limiting questions that could be addressed. We examine how the design features underlying these ethical issues are characteristic of effectiveness trials, which are often large trials that compare treatments with varying degrees of existing effectiveness data and familiarity to patients and clinicians, in community-based treatment settings, with minimal exclusion criteria that could involve vulnerable poptilations. Hence, investigators designing effectiveness trials may wish to remain alert to the possibility of similar ethical issues. (C) 2016 Published by Elsevier Inc.