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: 9905501
• 负责人: Sean M. Murphy
• 金额: $ 38.46万
• 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 2023-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9905501
• 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; arm; cost; court; effective therapy; 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150万的州和联邦囚犯，和吸毒障碍的比例， 囚犯人数远远超过一般人口（50%对2%）。阿片类药物复发率很高， 从监禁中释放，阿片类药物过量是前囚犯死亡的主要原因， 在释放后的第一周内特别高。此外，复发与 暴力行为和犯罪活动的风险增加，从而累犯，以及许多其他不利的 个人和社会后果，每年总共花费美国超过930亿美元。值得关注的是， 患有阿片类药物使用障碍（OUD）的释放前囚犯的高风险人群有限，或者经常， 无法获得循证OUD治疗。缓释纳洛酮（XR-NTX; Vivitrol®）是唯一 对这一人群和公众健康产生重大影响。在FDA批准的3种 药物治疗选择OUD，纳洛酮似乎面临最少的潜在优惠和立法 在监狱系统中使用的障碍。此外，延长释放制剂阻断阿片样物质30天，从而 释放时给予刑满释放人员“保护期”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和预算有限的监狱可能不愿意 在没有改善健康结果和下游成本抵消的证据的情况下为XR-NTX提供资金（例如，从 减少犯罪活动和使用高成本，公共资助，医疗保健服务），我们的审查 文献表明有效的治疗方法能够产生。我们之前的工作是在一个社区居住的 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，以及健康相关生活质量（HRQoL）的提高。我们没有发现 在非研究医疗保健服务的利用方面存在显著差异;但是，研究不太可能 这一群体代表了释放前囚犯的高风险群体。该试验包括社区- 居住的个人谁是阿片类药物免费在登记，并纳入标准不需要监禁。 这个项目提供了一个独特的机会，大大扩大了我们对XR-NTX在这方面的影响的理解。 上下文我们将使用来自2项公共资助的随机对照有效性试验的数据，其中XR-NTX是 在OUD释放前囚犯中进行评估，以评估XR-NTX是否与 医疗保健服务利用率的变化、患者健康状况的改善以及政策带来的经济可行性- 制造商和社会的观点。我们不仅能够评估这些次要结果的差异， 每项试验的研究组之间（[XR-NTX vs.常规治疗]和[使用移动的增强XR-NTX]） 医用XR-NTX治疗后释放vs. XR-NTX]），但也要合并数据集并检验差异 跨试验。最后，我们将有前所未有的机会来测量OUD囚犯的HRQoL 在他们释放之前，并跟踪他们释放和治疗参与后的HRQoL变化。