A clinical protocol of a comparative effectiveness trial of extended-release naltrexone versus extended-release buprenorphine with individuals leaving jail.
A clinical protocol of a comparative effectiveness trial of extended-release naltrexone versus extended-release buprenorphine with individuals leaving jail.
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DOI：
10.1016/j.jsat.2020.108241
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发表时间：
2021-09
影响因子：
3.9
通讯作者：
Jarvis DK
中科院分区：
文献类型：
--
作者：
Gordon MS;Mitchell SG;Blue TR;Vocci FJ;Fishman MJ;Murphy SM;Couvillion K;Maher K;Ryan D;Wenzel K;Danner ML;Jarvis DK
本研究是一项在马里兰州监狱中比较缓释丁丙诺啡（XR-B; BRIXADI™制剂）与缓释纳曲酮（XR-NTX）的随机、开放标签、对照试验。一项7个研究中心的开放标签等效设计将随机分配240名有阿片类药物使用障碍（OUD）史的成年人，按性别和监狱分层，他们即将被释放到两个治疗组之一：1）监狱中的XR-B或2）监狱中的XR-NTX，随后在社区治疗计划中每月注射6次。主要目的是确定与XR-NTX相比，XR-B的药物治疗依从性（每月接受注射的次数）。这项拟议的研究是创新的，因为它将是美国第一个评估在县监狱接受XR-B与XR-NTX的有效性的随机临床试验。这项研究的公共卫生影响将是非常重要和深远的，因为大多数OUD患者在监禁期间不接受治疗，从而大大提高了他们复发吸毒、过量死亡和再次监禁的可能性。了解如何在监狱中扩大对OUD药物的接受，特别是缓释药物，并支持向社区过渡的治疗参与和药物依从性，对改善这一人群的治疗获得和成功具有深远的影响。
This study is a randomized, open label, controlled trial of extended-release buprenorphine (XR-B; BRIXADI™ formulation) versus extended-release naltrexone (XR-NTX) in Maryland jails. A 7-site, open-label, equivalence design will randomly assign 240 adults with a history of opioid use disorder (OUD), stratified by gender and jail, who are nearing release to one of two treatment arms: 1) XR-B in jail or 2) XR-NTX in jail, both followed by 6 monthly injections postrelease at a community treatment program. The primary aim is to determine the rate of pharmacotherapy adherence (number of monthly injections received) of XR-B compared to XR-NTX. The proposed study is innovative because it will be the first randomized clinical trial in the U.S. assessing the effectiveness of receiving XR-B vs. XR-NTX in county jails. The public health impact of the study will be highly significant and far-reaching because most individuals with OUD do not receive treatment while incarcerated, thereby substantially raising their likelihood of relapse to drug use, overdose death, and re-incarceration. Understanding how to expand acceptance of medications for OUD in jails, particularly extended-release medications, and supporting treatment engagement and medication adherence in transition to the community, has far-reaching implications for improving treatment access and success in this population.
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影响因子：
3.5
作者：
Friedmann PD;Hoskinson R;Gordon M;Schwartz R;Kinlock T;Knight K;Flynn PM;Welsh WN;Stein LA;Sacks S;O'Connell DJ;Knudsen HK;Shafer MS;Hall E;Frisman LK;Mat Working Group Of CJ-Dats
通讯作者：
Mat Working Group Of CJ-Dats
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通讯作者：
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作者：
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通讯作者：
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4.2
作者：
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通讯作者：
Rosenblum, Andrew
影响因子：
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作者：
Krawczyk, Noa;Picher, Caroline E.;Saloner, Brendan
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