Extended-Release Naltrexone Opioid Treatment at Jail-to-Community Re-entry

监狱重返社区时的缓释纳曲酮阿片类药物治疗

• 批准号: 8664355
• 负责人: JOSHUA D LEE
• 金额: $ 67.86万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-06-01 至 2018-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8664355
• 关键词: Abstinence; Address; Adult; Affect; African American; Agonist; Alcohol consumption; Alcohols; Behavior Therapy; Caring; Communities; Cost Effectiveness Analysis; Counseling; Disease; Dose; Drug usage; Effectiveness; Enrollment; Euphoria; Experimental Designs; FDA approved; Family; HIV; Health; Hepatitis C; Hepatitis C virus; Heroin; Hispanics; Home environment; Illicit Drugs; Imprisonment; Individual; Injectable; Injection of therapeutic agent; Intervention; Jail; Left; Medical; Mental Health; Methadone; Modality; Naltrexone; Narcotic Antagonists; Neighborhoods; New York City; Opiate Addiction; Opioid; Outcome; Overdose; Participant; Patients; Pattern; Persons; Pharmaceutical Preparations; Pharmacotherapy; Physiological; Policy Maker; Population; Poverty; Prevention; Prisoner; Provider; Public Health; Randomized; Randomized Controlled Trials; Recruitment Activity; Relapse; Risk; Risk Behaviors; Risk Reduction; Safety; Time; Tobacco use; Toxicology; Treatment Effectiveness; Unemployment; Unsafe Sex; Urine; Ventilatory Depression; addiction; adverse outcome; arm; authority; base; cohort; community reentry; comparative effectiveness; cost; disorder later incidence prevention; effectiveness trial; evidence base; experience; high risk; injection drug use; interest; methadone maintenance; mortality; mu opioid receptors; prescription opioid; programs; randomized trial; treatment as usual; treatment program; treatment strategy

This study seeks to estimate the effectiveness of newly FDA-approved extended-release naltrexone (XR-NTX) for opioid relapse prevention among opioid dependent participants leaving a large urban jail. While methadone treatment is available in NYC jails, many heroin and other opioid users, including HIV and Hepatitis C (HCV) infected individuals, decline this treatment at arrest, and instead leave jail out-of-treatment and at extraordinarily high risk for immediate opioid relapse, fatal overdose, and HIV/HCV-related adverse outcomes, including resuming patterns of injection drug use and unsafe sex. XR-NTX, an injectable non-narcotic opioid antagonist with no abuse potential, which blocks the usual physiologic effects of heroin and other opioids for up to 4 weeks, constitutes a new pharmacotherapy option for individuals not opting for agonist medications. We propose a randomized trial of XR-NTX versus enhanced treatment-as-usual to establish XR-NTX¿s effectiveness as re-entry opioid relapse and HIV/HCV risk prevention. Further, an important question is how XR-NTX compares to methadone maintenance standard-of-care, and this study will recruit an additional, non-randomized, quasi-experimental methadone cohort for comparative effectiveness purposes.

这项研究试图评估FDA新批准的缓释纳曲酮(XR-NTX)在离开城市大型监狱的阿片依赖参与者中预防阿片类药物复发的有效性。虽然纽约市监狱提供美沙酮治疗，但许多海洛因和其他阿片类药物使用者，包括艾滋病毒和丙型肝炎(丙型肝炎)感染者，在被捕时拒绝接受这种治疗，而是不接受治疗，并面临立即阿片类药物复发、致命过量和艾滋病毒/丙型肝炎相关不良后果的极高风险，包括恢复注射药物使用模式和不安全的性行为。XR-NTX是一种可注射的非麻醉性阿片类药物拮抗剂，没有滥用潜力，可在长达4周的时间内阻断海洛因和其他阿片类药物的常见生理效应，为不选择激动剂药物的个人构成了一种新的药物治疗选择。我们提出了一项XR-NTX与常规强化治疗的随机试验，以确定XR-NTX？S作为再入阿片类药物复发和艾滋病毒/丙型肝炎风险预防的有效性。此外，一个重要的问题是，XR-NTX与美沙酮维持标准护理相比如何，这项研究将招募额外的非随机、准实验美沙酮队列，用于比较有效性目的。