Prior National Drug Abuse Treatment Clinical Trials Network (CTN) opioid use disorder trials as background and rationale for NIDA CTN-0100 "optimizing retention, duration and discontinuation strategies for opioid use disorder pharmacotherapy (RDD)".
Prior National Drug Abuse Treatment Clinical Trials Network (CTN) opioid use disorder trials as background and rationale for NIDA CTN-0100 "optimizing retention, duration and discontinuation strategies for opioid use disorder pharmacotherapy (RDD)".
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DOI：
10.1186/s13722-021-00223-z
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发表时间：
2021-03-06
影响因子：
3.7
通讯作者：
Nunes EV
中科院分区：
文献类型：
--
作者：
Shulman M;Weiss R;Rotrosen J;Novo P;Costello E;Nunes EV
阿片类药物使用障碍仍然是美国和全世界的一个重大问题。三种药物-美沙酮，丁丙诺啡和缓释注射纳洛酮-对治疗阿片类药物使用障碍（OUD）有效。然而，这些药物的效用是有限的，部分原因是治疗中的保留率很低。此外，最低恢复里程碑和其他影响个人何时以及是否可以安全停药的因素尚不清楚。国家药物滥用治疗临床试验网络（CTN）研究“优化阿片类药物使用障碍药物治疗的保留，持续时间和停药策略”（RDD; CTN-0100）将是迄今为止最大的OUD治疗临床试验之一，包括两个阶段，保留阶段和持续时间-停药阶段。保留阶段，对开始治疗的患者开放，将测试不同剂量和配方的丁丙诺啡（标准剂量舌下，高剂量舌下或缓释注射），以及数字治疗应用程序，提供应急管理和认知行为咨询的主要结果保留治疗。停药期，开放给OUD稳定缓解并选择停药的患者（包括来自保留期或在临床研究中心接受治疗的患者人群、由外部处方者转诊或自我转诊的受试者）将研究丁丙诺啡的不同减量策略（舌下锥形与注射丁丙诺啡锥形），以及提供资源以促进恢复的数字治疗应用程序，关于无复发停药的主要结局。本文介绍了RDD试验是如何从CTN二十年的研究中获得的。最初的试验（CTN-0001; CTN-0002; CTN-0003）重点关注阿片类药物解毒，表明丁丙诺啡-纳洛酮可有效解毒，但急性解毒似乎并不是一种有效的治疗策略。关于阿片类药物使用障碍（MOUD）药物的比较有效性的试验（CTN-0027; CTN-0030;和CTN-0051）强调了治疗脱落的问题，很少有试验将MOUD的保留定义为主要结局。对这些患者样本的长期随访研究表明，长期持续用药对许多患者维持缓解的重要性。总的来说，这些试验突出了稳定的研究基础设施（如CTN）通过大型临床试验的程序性继承来提高治疗有效性的潜力。
Opioid use disorder continues to be a significant problem in the United States and worldwide. Three medications—methadone, buprenorphine, and extended-release injectable naltrexone,— are efficacious for treating opioid use disorder (OUD). However, the utility of these medications is limited, in part due to poor rates of retention in treatment. In addition, minimum recovery milestones and other factors that influence when and whether individuals can safely discontinue medications are unknown. The National Drug Abuse Treatment Clinical Trials Network (CTN) study “Optimizing Retention, Duration, and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy” (RDD; CTN-0100) will be among the largest clinical trials on treatment of OUD yet conducted, consisting of two phases, the Retention phase, and the Duration-Discontinuation phase. The Retention phase, open to patients initiating treatment, will test different doses and formulations of buprenorphine (standard dose sublingual, high dose sublingual, or extended-release injection), and a digital therapeutic app delivering contingency management and cognitive behavioral counseling on the primary outcome of retention in treatment. The Discontinuation phase, open to patients in stable remission from OUD and choosing to discontinue medication (including participants from the Retention phase or from the population of patients treated at the clinical site, referred by an outside prescriber or self-referred) will study different tapering strategies for buprenorphine (sublingual taper vs taper with injection buprenorphine), and a digital therapeutic app which provides resources to promote recovery, on the primary outcome of relapse-free discontinuation of medication. This paper describes how the RDD trial derives from two decades of research in the CTN. Initial trials (CTN-0001; CTN-0002; CTN-0003) focused on opioid detoxification, showing buprenorphine-naloxone was effective for detoxification, but that acute detoxification did not appear to be an effective treatment strategy. Trials on comparative effectiveness of medications for opioid use disorder (MOUD) (CTN-0027; CTN-0030; and CTN-0051) highlighted the problem of dropout from treatment and few trials defined retention on MOUD as the primary outcome. Long-term follow-up studies on those patient samples demonstrated the importance of long-term continuation of medication for many patients to sustain remission. Overall, these trials highlight the potential of a stable research infrastructure such as CTN to advance treatment effectiveness through a programmatic succession of large clinical trials.
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影响因子：
3.9
作者：
Marsch, Lisa A.;Guarino, Honoria;Edwards, Joyce
通讯作者：
Edwards, Joyce
影响因子：
6
作者：
Ling, W;Amass, L;Ziedonis, D
通讯作者：
Ziedonis, D
DOI：
10.1111/j.1749-6632.2011.06352.x
发表时间：
2012-01-01
期刊：
ADDICTION REVIEWS
影响因子：
--
作者：
Campbell, Nancy D.;Lovell, Anne M.
通讯作者：
Lovell, Anne M.
影响因子：
39
作者：
Liebschutz, Jane M.;Crooks, Denise;Stein, Michael
通讯作者：
Stein, Michael
影响因子：
--
作者：
Weiss, Roger D.;Potter, Jennifer Sharpe;Ling, Walter
通讯作者：
Ling, Walter