Extended-Release Naltrexone to Prevent Opioid Relapse in Criminal Justice Offenders.
Extended-Release Naltrexone to Prevent Opioid Relapse in Criminal Justice Offenders.
复制标题
DOI：
10.1056/nejmoa1505409
复制
发表时间：
2016-03-31
期刊：
影响因子：
--
通讯作者：
O'Brien CP
中科院分区：
文献类型：
--
作者：
Lee JD;Friedmann PD;Kinlock TW;Nunes EV;Boney TY;Hoskinson RA Jr;Wilson D;McDonald R;Rotrosen J;Gourevitch MN;Gordon M;Fishman M;Chen DT;Bonnie RJ;Cornish JW;Murphy SM;O'Brien CP
缓释纳曲酮是一种完全 mu-阿片受体拮抗剂的缓释每月注射制剂，可有效预防阿片类药物依赖复发。支持其在美国刑事司法人群中有效性的数据有限。在这项五中心、开放标签、随机试验中，我们将缓释纳曲酮 (Vivitrol) 的 24 周疗程与常规治疗（包括简短咨询和转介社区治疗计划）进行了比较，以预防有阿片类药物依赖史且偏好无阿片类药物而不是阿片类药物维持治疗以及正在接受阿片类药物维持治疗的成年刑事司法罪犯（即参与美国刑事司法系统的人员）的阿片类药物复发。在随机分组时戒除阿片类药物。主要结局是阿片类药物复发事件的时间，其定义为通过自我报告或每两周获取的尿液样本检测来评估，在 28 天内使用阿片类药物 10 天或以上；阳性或缺失样本按阿片类药物使用 5 天计算。治疗后随访发生在第 27、52 和 78 周。共有 153 名参与者被分配到缓释纳曲酮治疗组，155 名参与者被分配到常规治疗组。在 24 周治疗阶段，分配至缓释纳曲酮的参与者比分配至常规治疗的参与者有更长的中位复发时间（10.5 周与 5.0 周，P<0.001；风险比，0.49；95% 置信区间 [CI]，0.36 至 0.68），复发率较低（43% 与 64% 的参与者，P<0.001；比值比，0.43；95% CI，0.28 至 0.65），并且阿片类药物阴性尿液样本的比例较高（74% vs. 56%，P<0.001；比值比，2.30；95% CI，1.48 至 3.54）。在第 78 周（治疗阶段结束后大约 1 年），阿片类药物阴性尿液样本的比率相等（每组均为 46%，P = 0.91）。其他预先设定的次要结局指标——自我报告的可卡因、酒精和静脉吸毒、不安全性行为和再监禁——的发生率在缓释纳曲酮治疗中并不显着低于常规治疗。在观察的总共 78 周中，缓释纳曲酮组没有发生用药过量事件，常规治疗组有 7 例发生用药过量事件（P = 0.02）。在这项涉及刑事司法罪犯的试验中，缓释纳曲酮与阿片类药物复发率相关，该复发率低于常规治疗的复发率。停止治疗后，阿片类药物使用的预防效果减弱。
Extended-release naltrexone, a sustained-release monthly injectable formulation of the full mu-opioid receptor antagonist, is effective for the prevention of relapse to opioid dependence. Data supporting its effectiveness in U.S. criminal justice populations are limited. In this five-site, open-label, randomized trial, we compared a 24-week course of extended-release naltrexone (Vivitrol) with usual treatment, consisting of brief counseling and referrals for community treatment programs, for the prevention of opioid relapse among adult criminal justice offenders (i.e., persons involved in the U.S. criminal justice system) who had a history of opioid dependence and a preference for opioid-free rather than opioid maintenance treatments and who were abstinent from opioids at the time of randomization. The primary outcome was the time to an opioid-relapse event, which was defined as 10 or more days of opioid use in a 28-day period as assessed by self-report or by testing of urine samples obtained every 2 weeks; a positive or missing sample was computed as 5 days of opioid use. Post-treatment follow-up occurred at weeks 27, 52, and 78. A total of 153 participants were assigned to extended-release naltrexone and 155 to usual treatment. During the 24-week treatment phase, participants assigned to extended-release naltrexone had a longer median time to relapse than did those assigned to usual treatment (10.5 vs. 5.0 weeks, P<0.001; hazard ratio, 0.49; 95% confidence interval [CI], 0.36 to 0.68), a lower rate of relapse (43% vs. 64% of participants, P<0.001; odds ratio, 0.43; 95% CI, 0.28 to 0.65), and a higher rate of opioid-negative urine samples (74% vs. 56%, P<0.001; odds ratio, 2.30; 95% CI, 1.48 to 3.54). At week 78 (approximately 1 year after the end of the treatment phase), rates of opioid-negative urine samples were equal (46% in each group, P = 0.91). The rates of other prespecified secondary outcome measures — self-reported cocaine, alcohol, and intravenous drug use, unsafe sex, and reincarceration — were not significantly lower with extended-release naltrexone than with usual treatment. Over the total 78 weeks observed, there were no overdose events in the extended-release naltrexone group and seven in the usual-treatment group (P = 0.02). In this trial involving criminal justice offenders, extended-release naltrexone was associated with a rate of opioid relapse that was lower than that with usual treatment. Opioid-use prevention effects waned after treatment discontinuation.