Health and Economic Outcomes of Treatment with Extended-Release Naltrexone Among Pre-Release Prisoners with Opioid Use Disorder

患有阿片类药物使用障碍的释放前囚犯接受缓释纳曲酮治疗的健康和经济结果

• 批准号: 10343700
• 负责人: Sean M. Murphy
• 金额: $ 38.38万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-15 至 2025-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10343700
• 关键词: Abstinence; Accident and Emergency department; Admission activity; Adoption; Adult; Behavioral; Budgets; Buprenorphine; Cause of Death; Clinical Trials; Communities; Counseling; Criminal Justice; Data; Data Collection; Data Set; Drug Metabolic Detoxication; Drug Use Disorder; Economics; Effectiveness; Emergency department visit; Enrollment; Ensure; Event; FDA approved; Face; Formulation; Funding; General Population; Health; Health Care Costs; Health Care Visit; Health system; Healthcare; Imprisonment; Individual; Injections; Inpatients; Intervention; Investments; Knowledge; Literature; Measures; Medical; Methadone; Naltrexone; Opioid; Opioid Antagonist; Outcome; Overdose; Participant; Patient Self-Report; Patients; Personal Satisfaction; Pharmaceutical Preparations; Pharmacotherapy; Physician Executives; Policy Maker; Population; Positioning Attribute; Primary Health Care; Prisoner; Prisons; Productivity; Public Health; Quality-Adjusted Life Years; Randomized; Relapse; Reporting; Resources; Review Literature; Risk; Running; Sampling; Security; Services; Substance Use Disorder; Surveys; System; Testing; Time; Treatment outcome; Urine; Violence; Visit; Work; Workplace; abuse liability; arm; cost; court; effective therapy; effectiveness evaluation; effectiveness testing; effectiveness trial; evidence base; experience; follow-up; health care service; health care service utilization; health economics; health related quality of life; high risk population; improved; inclusion criteria; instrument; interest; male; opioid overdose; opioid therapy; opioid use; opioid use disorder; overdose death; overdose risk; preference; prevent; primary outcome; programs; recidivism; secondary outcome; social; study population; treatment as usual

PROJECT SUMMARY There are over 1.5 million state and federal prisoners in the U.S., and the rate of drug use disorders among inmates far exceeds that of the general population (50% versus 2%). Opioid relapse occurs at high rates following release from incarceration, and opioid overdose is the leading cause of death among former prisoners, the risk for which is especially high within the first week following release. Additionally, relapse is associated with increased risk of violent behavior and criminal activity, and thereby recidivism, as well as many other adverse personal and social consequences that, in total, cost the U.S. over $93 billion each year. Of notable concern is that the high-risk population of pre-release prisoners with an opioid use disorder (OUD) has limited or, frequently, no access to evidence-based OUD therapy. Extended-release naltrexone (XR-NTX; Vivitrol®) is uniquely positioned to have a high impact on this population, and on public health. Of the 3 FDA-approved pharmacotherapy options for OUD, naltrexone appears to face the fewest potential preferential and legislative barriers to use in prison systems. Moreover, the extended-release formulation blocks opioids for 30 days, thereby giving the ex-inmate “protected time” upon release. However, at a cost of up to $1,309 per injection, the legislators who set prison healthcare budgets, and the prisons who operate on limited budgets, may be reluctant to fund XR-NTX without evidence of both improved health outcomes and downstream cost-offsets (e.g., from reduced criminal activities and use of high-cost, publicly-funded, healthcare services), which our review of the literature indicates effective therapy is capable of producing. Our previous work among a community-dwelling criminal-justice population showed XR-NTX to be effective at increasing time abstinent from opioids, reducing opioid relapse and overdose deaths, and increasing health-related quality-of-life (HRQoL). We did not find significant differences in the utilization of non-study healthcare services; however, it is unlikely that the study population was representative of the high-risk population of pre-release prisoners. The trial included community- dwelling individuals who were opioid-free at enrollment, and the inclusion criteria did not require incarceration. This project offers a unique opportunity to greatly expand our understanding of the impact of XR-NTX in this context. We will use data from 2 publicly-funded randomized controlled effectiveness trials in which XR-NTX is being evaluated among pre-release prisoners with OUD, to evaluate whether XR-NTX is associated with changes in the healthcare service utilization, enhanced patient wellbeing, and economic viability from policy- maker and societal perspectives. We will not only be able to assess differences in these secondary outcomes between study arms within each trial ([XR-NTX vs. treatment as usual] and [enhanced XR-NTX with mobile medical XR-NTX treatment post-release vs. XR-NTX]), but also to merge the data sets and test for differences across trials. Finally, we will have the unprecedented opportunity to measure HRQoL among prisoners with OUD prior to their release, and track changes in their HRQoL following their release and treatment engagement.

项目摘要 美国有超过150万州和联邦囚犯。 囚犯远远超过了普通人群（50％对2％）。阿片类中继以高率发生 从监禁中释放，阿片类药物过量是前囚犯死亡的主要原因，风险 在发行后的第一周，它尤其高。此外，继电器与 增加暴力行为和犯罪活动的风险，从而增加累犯，以及许多其他逆境 个人和社会后果总共损失了美国每年超过930亿美元的损失。值得注意的是 患有阿片类药物使用障碍（OUD）的预发行前囚犯的高风险人口有限或经常 无法获得基于证据的OUD疗法。扩展释放的纳曲酮（XR-NTX;Vivitrol®）是独特的 对该人群和公共卫生有很大影响。 3 FDA批准 OUD的药物治疗选择，Naltrexone似乎面临着最少的潜在优惠和立法 在监狱系统中使用的障碍。此外，延长释放公式将OioId挡住了30天 在释放时给予前入侵的“受保护时间”。但是，每次注射的费用高达$ 1,309， 制定监狱医疗预算的立法者以及以有限预算运营的监狱可能不愿意 为XR-NTX提供资金，而没有改善健康成果和下游成本率的证据（例如 减少了犯罪活动并使用高成本，公共资助的医疗服务），我们对 文献表明有效的治疗能够产生。我们以前在社区居住中的工作 犯罪司法人群表明XR-NTX在增加阿片类药物的时间增加时有效 Oopioid接力和过量死亡，并增加与健康相关的生活质量（HRQOL）。我们找不到 非研究医疗保健服务的利用有显着差异；但是，研究不太可能 人口代表了释放前囚犯的高风险人口。审判包括社区 - 居住在入学时无阿片类药物的人，纳入标准不需要监禁。 该项目提供了一个独特的机会，可以极大地扩展我们对XR-NTX影响的理解 语境。我们将使用来自2个由公共资助的随机控制有效性试验的数据，其中XR-NTX为 在使用OUD的预发行囚犯中评估，以评估XR-NTX是否与 医疗服务利用的变化，增强的患者福祉以及政策的经济可行性 - 制造商和社会观点。我们不仅能够评估这些次要结果的差异 每个试验中的研究臂之间（[XR-NTX与往常的治疗]和[移动增强的XR-NTX 释放后与XR-NTX的医学XR-NTX治疗]），但也合并数据集并测试差异 跨试验。最后，我们将有前所未有的机会来测量与Oud的囚犯中的HRQOL 在发布之前，并在发布和治疗参与后跟踪HRQOL的变化。