长效纳曲酮预防刑事司法罪犯阿片类药物复吸。
Extended-Release Naltrexone to Prevent Opioid Relapse in Criminal Justice Offenders.
机构信息
From the Departments of Population Health (J.D.L., R.M., M.N.G.), Medicine, Division of General Internal Medicine and Clinical Innovation (J.D.L.), and Psychiatry (J.R.), New York University, and the New York State Psychiatric Institute, Columbia University College of Physicians and Surgeons (E.V.N.) - both in New York; the Division of General Internal Medicine, the Department of Medicine, Rhode Island Hospital and Alpert Medical School of Brown University, Providence (P.D.F., R.A.H., D.W.); Friends Research Institute (T.W.K., M.G., M.F.), the University of Baltimore, School of Criminal Justice (T.W.K.), and Maryland Treatment Centers (M.F.) - all in Baltimore; the University of Pennsylvania (T.Y.B., J.W.C., C.P.O.) and the Philadelphia Veterans Affairs Medical Center (J.W.C.) - both in Philadelphia; the Center for Biomedical Ethics and Humanities, School of Medicine (D.T.C.) and the School of Law (R.J.B.), University of Virginia, Charlottesville; and Washington State University, Spokane (S.M.M.).
出版信息
N Engl J Med. 2016 Mar 31;374(13):1232-42. doi: 10.1056/NEJMoa1505409.
BACKGROUND
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.
METHODS
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.
RESULTS
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).
CONCLUSIONS
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. (Funded by the National Institute on Drug Abuse; ClinicalTrials.gov number, NCT00781898.).
背景
长效纳曲酮，一种全 μ 阿片受体拮抗剂的持续释放每月注射制剂，对于预防阿片类药物依赖的复发是有效的。支持其在美国刑事司法人群中有效性的数据有限。
方法
在这项五个地点、开放标签、随机试验中，我们比较了 24 周的长效纳曲酮（Vivitrol）治疗与常规治疗，常规治疗包括简短的咨询和转介到社区治疗计划，以预防有阿片类药物依赖史且偏爱无阿片类药物而非阿片类药物维持治疗且在随机分配时已戒除阿片类药物的成年刑事司法罪犯（即参与美国刑事司法系统的人）的阿片类药物复发。主要结局是阿片类药物复发事件的时间，定义为在 28 天期间自我报告或每两周采集一次尿液样本检测到 10 天或以上的阿片类药物使用；阳性或缺失样本被计算为 5 天的阿片类药物使用。治疗后随访发生在第 27、52 和 78 周。
结果
共有 153 名参与者被分配到长效纳曲酮组，155 名参与者被分配到常规治疗组。在 24 周的治疗阶段，与常规治疗组相比，接受长效纳曲酮治疗的参与者复发的中位时间更长（10.5 周 vs. 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% vs. 64%的参与者，P<0.001；优势比，0.43；95%CI，0.28 至 0.65），阿片类药物阴性尿液样本率较高（74% vs. 56%，P<0.001；优势比，2.30；95%CI，1.48 至 3.54）。在第 78 周（治疗阶段结束后约 1 年），阿片类药物阴性尿液样本率相等（每组 46%，P=0.91）。其他预定的次要结局指标——自我报告的可卡因、酒精和静脉药物使用、不安全性行为和再监禁——的发生率在长效纳曲酮组与常规治疗组之间没有显著差异。在观察的总共 78 周中，长效纳曲酮组没有发生过药物过量事件，而常规治疗组有 7 起（P=0.02）。
结论
在这项涉及刑事司法罪犯的试验中，长效纳曲酮的阿片类药物复发率低于常规治疗。治疗停止后，阿片类药物预防效果减弱。（由国家药物滥用研究所资助；临床试验.gov 编号，NCT00781898。）
Zotero 插件