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（由申请人提供）：俄罗斯在世界上艾滋病毒中最高的艾滋病毒发病率之一是世界上全球的艾滋病毒。 使用激动剂进行排毒或维持是非法的，因此纳曲酮是唯一有效的药物治疗 防止复发和相关的艾滋病毒风险行为。 在美国和俄罗斯进行的12次和24周的长期试验中，扩展释放（ER）Naltrexone（Vivitrol（R））大大降低了海洛因IDU和HIV风险。我们最近的24周试验表明，ER纳曲酮植入物（Prodetoxone（R））在预防复发方面优于安慰剂和口服纳曲酮，但大约一半的患者在治疗期结束时仍未继续治疗，并且在24周结束时已经复发，并且在ER Naltrexone治疗后几个月内已经复发，并增加了HIV风险行为。这项研究的目的是回答有关在预防HIV传播中最有效使用ER Naltrexone的两个关键问题：在多大程度上延长治疗持续时间会减少海洛因IDUS中的药物使用和HIV风险的复发？宾夕法尼亚大学（UPENN）与莫斯科的国家成瘾研究中心（NRCA）之间的合作项目是俄罗斯卫生部的PEPFAR网站，是一项前瞻性，随机，安慰剂对照试验Naltrexone（byntrol）或24周的体内，然后再增加24周的安慰剂Vivitrol。 这两个队列将在每两周一次的咨询中进行48周的咨询，并在第60周和第72周进行随访评估。主要结果是在第48周至72周的随访期内复发的患者比例，并减少了HIV注射风险行为的患者。次要结果是1）阿片类尿液药物筛查〜2）HIV性别风险行为〜3）复发时间〜4）任命的比例〜5）〜5）精神病症状〜6）阿片类药物的渴望〜7）自我报告的药物使用〜8）用于药物用于药物的钱〜9） 假设：1）随机分配到48周的病毒状况的患者在初级和次要结果上的结果要比24周的24周内和24周的安慰剂病〜2）五个或更多的次要结局更高，而五个或更多的次要结局将有利于48周的病情〜，没有一个人会偏爱24周的24周状况。 公共卫生相关性：这种预期的，安慰剂控制的随机试验是宾夕法尼亚大学和俄罗斯莫斯科的国家成瘾研究中心（NRCA）之间的合作。 它将比较24周的可注射延长释放（ER）纳曲酮（Vivitrol）以及24周的体内安慰剂疗程，以及在过去一年中在NRCA寻求治疗的阿片类药物依赖患者进行的48周疗程。该项目的目的是确定较长的疗程是否导致对药物使用和艾滋病毒毒品风险行为的复发更少。 较短的课程。