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.

项目总结 美国有超过150万的州和联邦囚犯，毒品使用障碍的比率 囚犯的比例远远高于普通人群(50%对2%)。阿片类药物的复发率很高， 获释，阿片类药物过量是前囚犯死亡的主要原因，风险 在释放后的第一周内，这一比例尤其高。此外，复发与 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有害行为的风险 个人和社会后果，每年给美国造成的损失总计超过930亿美元。值得注意的是 有阿片类药物使用障碍(OUD)的释放前囚犯的高危人群有限或经常， 无法获得以证据为基础的声音疗法。缓释纳曲酮(XR-NTX；Vivitrol®)是唯一 定位于对这一人群和公共健康产生重大影响。FDA批准的3家公司中的 OUD，纳曲酮的药物治疗选择似乎面临最少的潜在优惠和立法 监狱系统中使用的障碍。此外，缓释制剂可阻止阿片类药物30天，从而 在释放时给予前囚犯“受保护的时间”。然而，每次注射的成本高达1,309美元， 制定监狱医疗预算的立法者，以及以有限预算运作的监狱可能不情愿 为XR-NTX提供资金，而没有改善健康结果和下游成本抵消的证据(例如，从 减少犯罪活动和使用高成本、由公共资助的医疗服务)，我们对 文献表明，有效的治疗方法是有能力产生的。我们之前的工作是在一个社区中居住 刑事司法人群显示XR-NTX在增加阿片类药物戒断时间、减少 阿片类药物复发和过量死亡，以及与健康相关的生活质量(HRQOL)增加。我们没有找到 在非研究医疗服务的利用方面存在显著差异；然而，这项研究不太可能 人口是释放前囚犯的高危人群的代表。这项试验包括社区- 登记时不含阿片类药物的居住个人，纳入标准不要求监禁。 该项目提供了一个独特的机会，极大地扩展了我们对XR-NTX在 背景。我们将使用2个公共资助的随机对照有效性试验的数据，在这些试验中，XR-NTX是 在释放前囚犯中接受OUD评估，以评估XR-NTX是否与 医疗服务利用率的变化、患者福祉的提高以及政策带来的经济可行性- 制造者和社会的观点。我们不仅能够评估这些次要结果的差异 在每个试验中的研究分支之间([XR-NTX与常规治疗相比]和[使用移动设备增强的XR-NTX 发布后的医疗XR-NTX治疗与XR-NTX])，但也合并数据集并测试差异 历经各种考验。最后，我们将有一个前所未有的机会来测量患有抑郁症的囚犯的HRQOL。 在他们出院之前，并跟踪他们在出院和接受治疗后的HRQL变化。