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

阿片类药物复发

• 批准号: 8310620
• 负责人: GEORGE Edward WOODY
• 金额: $ 49.07万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-01 至 2017-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8310620
• 关键词: AIDS prevention; Address; Adoption; Adverse event; Aftercare; Agonist; Appointment; Beds; Buprenorphine; Collaborations; Consent; Counseling; Country; Data; Disease remission; Double-Blind Method; Drug Formulations; Drug Metabolic Detoxication; Drug usage; Employment; Epidemic; Equipment; Goals; HIV; Health; Heroin; Implant; Incidence; Injectable; Injecting drug user; Injection of therapeutic agent; Inpatients; Laws; Length; Letters; Maintenance; Methadone; Moscow; Naltrexone; Operative Surgical Procedures; Opiate Addiction; Opiates; Opioid; Oral; Outcome; Outpatients; Participant; Patient Self-Report; Patients; Pennsylvania; Pharmaceutical Preparations; Pharmacotherapy; Placebo Control; Placebos; Policies; Preclinical Drug Evaluation; Prevention; Randomized; Relapse; Research; Risk; Risk Behaviors; Russia; Site; Symptoms; Testing; Time; USAID; United States; Universities; Urine; addiction; cohort; control trial; craving; follow-up; improved; prevent; primary outcome; programs; prospective; randomized placebo controlled trial; secondary outcome; sex risk; treatment duration; week trial

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. PUBLIC HEALTH RELEVANCE: This prospective, placebo-controlled, randomized trial is collaboration between the University of Pennsylvania and the National Center for Addictions Research (NRCA) in Moscow, Russia. It will compare a 24-week course of injectable extended release (ER) naltrexone (Vivitrol) plus a 24-week course of Vivitrol placebo, with a 48-week course of Vivitrol, in opioid dependent patients seeking treatment at the NRCA, who have shared drug injection equipment in the past year. The project aims to determine whether a longer course of Vivitrol results in less relapse to drug use and HIV drug risk behaviors that the shorter course.

描述(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。使用激动剂戒毒或维持是非法的，因此纳曲酮是唯一有效的药物疗法。 预防复发和相关的艾滋病毒危险行为。在美国和俄罗斯为期12周和24周的试验中，缓释(ER)纳曲酮(Vivitrol(R))大大降低了海洛因注射吸毒者和艾滋病毒的风险。我们最近进行的为期24周的试验表明，ER纳曲酮植入剂(Prodetoxone(R))在预防复发方面优于安慰剂和口服纳曲酮，但在24周治疗结束时仍在接受治疗且没有复发的患者中，约有一半在ER纳曲酮治疗结束后的几个月内复发并增加了艾滋病毒风险行为。这项研究的目的是回答关于在预防艾滋病毒传播中最有效地使用ER纳曲酮的两个关键问题：延长治疗时间在多大程度上减少海洛因吸毒者的复吸率和艾滋病毒风险？这项由宾夕法尼亚大学(UPenn)和莫斯科国家成瘾研究中心(NRCA)合作的项目是一项前瞻性、随机、安慰剂对照试验，由宾夕法尼亚大学(UPenn)和莫斯科的国家成瘾研究中心(NRCA)共同开展，该项目是一项前瞻性、随机、安慰剂对照试验。在该试验中，130名HIV阴性、戒毒、同意的海洛因吸毒者将被随机分成两组，分别接受48周的可注射ER Naltrexone(Vivitrol)或24周的Vivitrol治疗，然后再接受24周的安慰剂Vivitrol治疗。两组患者都将接受为期48周的每两周一次的咨询，并在第60周和72周进行后续评估。主要结果是在48至72周的随访期内复发的患者比例以及注射艾滋病毒危险行为的减少。次要结果是1)阿片类药物阳性尿液筛查~2)HIV性行为危险行为~3)复发时间~4)保留预约比例~5)精神症状~6)阿片类药物渴求~7)自我报告药物使用~8)用药金额~9)就业~10)逮捕~11)总体调整~12)不良事件。假设：1)随机接受48周Vivitrol治疗的患者在初次和次要结果上将明显好于24周Vivitrol加24周安慰剂的患者。2)5个或更多的次要结果将有利于48周条件~，没有人支持24周条件。 公共卫生相关性：这项前瞻性、安慰剂对照、随机试验是宾夕法尼亚大学和位于俄罗斯莫斯科的国家成瘾研究中心(NRCA)合作进行的。它将比较24周的可注射缓释(ER)纳曲酮(Vivitrol)加24周的Vivitrol安慰剂疗程与48周的Vivitrol疗程，这些患者在过去一年中共用药物注射设备在NRCA寻求治疗。该项目旨在确定较长疗程的Vivitrol是否会导致较少的吸毒复发和艾滋病毒药物危险行为 更短的疗程。