Extended-release naltrexone to prevent relapse among opioid dependent, criminal justice system involved adults: Rationale and design of a randomized controlled effectiveness trial
Extended-release naltrexone to prevent relapse among opioid dependent, criminal justice system involved adults: Rationale and design of a randomized controlled effectiveness trial
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DOI：
10.1016/j.cct.2015.01.005
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发表时间：
2015-03-01
影响因子：
2.2
通讯作者：
O'Brien, Charles P.
中科院分区：
文献类型：
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作者：
Lee, Joshua D.;Friedmann, Peter D.;O'Brien, Charles P.
背景：缓释纳洛酮（XR-NTX，Vivitrole（R）; Alkermes Inc.）是一种可注射的每月缓释μ阿片受体拮抗剂。XR-NTX是一种潜在的有效干预阿片类药物使用障碍和复发预防之间的刑事司法系统（CJS）population.Methods：这5个网站的开放标签随机对照有效性试验检查是否XR-NTX减少阿片类药物复发相比，治疗照常（TAU）在社区居住，非监禁志愿者与当前或最近的CJS参与。XR-NTX组在医疗管理访视时接受6次每月一次的XR-NTX注射; TAU组接受转介到可用的社区治疗方案。在24周治疗期内每2周进行一次评估，并在12个月和18个月随访时进行评估。主要结果是复发事件，定义为自我报告或尿毒理学证据>= 10天的阿片类药物使用在28天（4周）的时间内，与阳性或缺失的尿液检测计为5天的阿片类药物use.Results：我们描述的理由，具体目标和设计的研究。替代设计的考虑因素和广泛的次要目标和outcomes进行了讨论。结论：XR-NTX是一个潜在的重要的治疗和复发预防的选择阿片类药物依赖和CJS参与的人。(C)2015爱思唯尔公司All rights reserved.
Background: Extended-release naltrexone (XR-NTX, Vivitrole (R); Alkermes Inc.) is an injectable monthly sustained-release mu opioid receptor antagonist. XR-NTX is a potentially effective intervention for opioid use disorders and as relapse prevention among criminal justice system (CJS) populations.Methods: This 5-site open-label randomized controlled effectiveness trial examines whether XR-NTX reduces opioid relapse compared with treatment as usual (TAU) among community dwelling, non-incarcerated volunteers with current or recent CJS involvement. The XR-NTX arm receives 6 monthly XR-NTX injections at Medical Management visits; the TAU group receives referrals to available community treatment options. Assessments occur every 2 weeks during a 24-week treatment phase and at 12- and 18-month follow-ups. The primary outcome is a relapse event, defined as either self-report or urine toxicology evidence of >= 10 days of opioid use in a 28-day (4 week) period, with a positive or missing urine test counted as 5 days of opioid use.Results: We describe the rationale, specific aims, and design of the study. Alternative design considerations and extensive secondary aims and outcomes are discussed.Conclusions: XR-NTX is a potentially important treatment and relapse prevention option among persons with opioid dependence and CJS involvement. (C) 2015 Elsevier Inc. All rights reserved.