Opioid Relaps & HIV Risk: 48 vs. 24 Weeks of ER Injectable Naltrexone

描述（由申请人提供）：俄罗斯是世界上海洛因成瘾注射吸毒者中艾滋病毒发病率最高的国家之一。 使用激动剂进行解毒或维持是非法的，因此纳洛酮是唯一有效的药物治疗。 预防复发和相关的艾滋病毒危险行为。 在美国和俄罗斯进行的为期12周和24周的试验中，缓释（ER）纳洛酮（Vivitrol（R））大大降低了海洛因IDU和艾滋病毒的风险。我们最近的24周试验表明，ER纳洛酮植入剂（Prodetoxone（R））在预防复发方面上级安慰剂和口服纳洛酮，但大约一半仍在治疗中并且在24周治疗期结束时没有复发的患者在ER纳洛酮治疗结束后几个月内复发并增加了HIV风险行为。本研究的目的是回答关于最有效地使用ER纳洛酮预防艾滋病毒传播的两个关键问题：延长治疗时间在多大程度上减少海洛因注射吸毒者的复吸和艾滋病毒风险？宾夕法尼亚大学（UPENN）和位于莫斯科的国家成瘾研究中心（NRCA）（俄罗斯卫生部的PEPFAR站点）之间的这一合作项目是一项前瞻性、随机、安慰剂对照试验，其中130名艾滋病毒阴性、脱毒、同意海洛因注射吸毒者在过去一年内共用药物注射设备，将被随机分配至48周的注射ER纳洛酮（Vivitrol）或24周的Vivitrol，随后再接受24周的安慰剂Vivitrol。 两个队列将进行为期48周的双周咨询，并在第60周和第72周进行随访评估。 主要结果是在48至72周随访期间复发的患者比例和HIV注射风险行为的减少。次要结局是1）阿片类药物阳性尿液药物筛查~ 2）HIV性风险行为~ 3）复发时间~ 4）预约比例~ 5）精神症状~ 6）阿片类药物渴望~ 7）自我报告的药物使用~ 8）药物花费~ 9）就业~ 10）逮捕~ 11）总体调整~ 12）不良事件。 假设：1）随机分配至48周Vivitrol条件的患者在主要和次要结局方面的结局将显著优于24周Vivitrol加24周安慰剂条件的患者~ 2）五个或更多次要结局将有利于48周条件~并且没有一个将有利于24周条件。

DESCRIPTION (provided by applicant): Russia has one of the highest incidences of HIV among heroin addicted injection drug users (IDUs) in the world. Use of agonists for detoxification or maintenance is illegal, thus naltrexone is the only effective pharmacotherapy for preventing relapse and the associated HIV risk behaviors. Extended release (ER) naltrexone (Vivitrol(R)) has dramatically reduced heroin IDU and HIV risk in 12 and 24-week long trials in the U.S. and Russia. Our recent 24-week trial showed that an ER Naltrexone implant (Prodetoxone(R)) was superior to both placebo and oral naltrexone in preventing relapse, but that approximately half the patients who remained in treatment and did not relapse by the end of the 24-week treatment period, have relapsed and increased HIV risk behavior within months after ER Naltrexone treatment ended. The goal of this study is to answer the two critical questions on the most effective use of ER Naltrexone in the prevention of the spread of HIV: To what degree does extending the duration of treatment reduce relapse to drug use and HIV risk in heroin IDUs? This collaborative project between the University of Pennsylvania (UPENN) and the National Research Center on Addiction (NRCA) in Moscow, a PEPFAR site in the Russian Ministry of Health, is a prospective, randomized, placebo-controlled trial in which 130 HIV-negative, detoxified, consenting heroin IDUs who shared drug injection equipment within the last year, will be randomized to a 48-week course of injectable ER Naltrexone (Vivitrol) or 24 weeks of Vivitrol followed by additional 24 weeks of placebo Vivitrol. Both cohorts will have bi-weekly counseling for 48 weeks and follow-up assessments at weeks 60 and 72. Primary outcomes are the proportion of patients who relapsed during the week 48 to 72 follow-up period and reduction in HIV injecting risk behaviors. Secondary outcomes are 1) opioid positive urine drug screens~ 2) HIV sex risk behaviors~ 3) Time to relapse~ 4) Proportion of appointments kept~ 5) Psychiatric symptoms~ 6) Opioid craving~ 7) Self-reported drug use~ 8) Money spent for drugs~ 9) Employment~ 10) Arrests~ 11) Overall adjustment~ 12) Adverse events. Hypotheses: 1) Patients randomized to the 48-week Vivitrol condition will have significantly better outcomes on the primary and secondary outcomes than those in the 24-week Vivitrol plus 24-week placebo condition~ 2) Five or more secondary outcomes will favor the 48-week condition~ and none will favor the 24-week condition.