美沙酮-丁丙诺啡与纳曲酮治疗司法涉案成年人（EXIT-CJS）。
Long-acting buprenorphine vs. naltrexone opioid treatments in CJS-involved adults (EXIT-CJS).
机构信息
School of Public Health and OHSU School of Medicine, Oregon Health & Science University, United States of America.
Dartmouth College, United States of America.
出版信息
J Subst Abuse Treat. 2021 Sep;128:108389. doi: 10.1016/j.jsat.2021.108389. Epub 2021 Apr 8.
Abstract
The EXIT-CJS (N = 1005) multisite open-label randomized controlled trial will compare retention and effectiveness of extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX) to treat opioid use disorder (OUD) among criminal justice system (CJS)-involved adults in six U.S. locales (New Jersey, New York City, Delaware, Oregon, Connecticut, and New Hampshire). With a pragmatic, noninferiority design, this study hypothesizes that XR-B (n = 335) will be noninferior to XR-NTX (n = 335) in retention-in-study-medication treatment (the primary outcome), self-reported opioid use, opioid-positive urine samples, opioid overdose events, and CJS recidivism. In addition, persons with OUD not eligible or interested in the RCT will be recruited into an enhanced treatment as usual arm (n = 335) to examine usual care outcomes in a quasi-experimental observational cohort.
摘要
EXIT-CJS（N=1005）多中心、开放性标签、随机对照试验将比较在六个美国地区（新泽西州、纽约市、特拉华州、俄勒冈州、康涅狄格州和新罕布什尔州），针对涉及刑事司法系统（CJS）的成年人中，使用延长释放丁丙诺啡（XR-B）与延长释放纳曲酮（XR-NTX）治疗阿片类药物使用障碍（OUD）的保留率和有效性。该研究采用实用、非劣效性设计，假设 XR-B（n=335）在研究中药物治疗的保留率（主要结局）、自我报告的阿片类药物使用、阿片类药物阳性尿液样本、阿片类药物过量事件和 CJS 累犯方面与 XR-NTX（n=335）无差异。此外，不符合或对 RCT 不感兴趣的 OUD 患者将被纳入强化常规治疗手臂（n=335），以在准实验观察队列中检查常规护理结局。
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