A comparative effectiveness trial of extended release naltrexone versus extended-release buprenorphine with individuals leaving jail

缓释纳曲酮与缓释丁丙诺啡对出狱人员的效果比较试验

• 批准号: 10388285
• 负责人: Michael Scott Gordon
• 金额: $ 216.94万
• 依托单位: FRIENDS RESEARCH INSTITUTE, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-15 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10388285
• 关键词: AIDS/HIV problem; Adherence; Administrator; Adverse event; Agonist; Area; Award; Buprenorphine; Clinical Trials; Communities; Continuity of Patient Care; County; Crime; Criminal Justice; Death Rate; Drug usage; Effectiveness; Ensure; Epidemic; Event; FDA approved; Formulation; Funding; Gender; HIV risk; Health Personnel; Health system; Imprisonment; Individual; Infection; Injectable; Injections; Intervention; Intramuscular; Jail; Learning; Letters; Literature; Maryland; Mental Health; Methadone; Naltrexone; Needles; Opiate Addiction; Opioid; Opioid agonist; Overdose; Patient Self-Report; Pharmaceutical Preparations; Pharmacotherapy; Phase; Population; Prevention; Prisoner; Prisons; Public Health; Quality of life; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Regulation; Relapse; Research Design; Risk Behaviors; Safety; Sex Behavior; Site; Subcutaneous Injections; Supervision; Test Result; Urine; Woman; acceptability and feasibility; antagonist; arm; comparative effectiveness trial; cost; disorder later incidence prevention; economic value; effectiveness evaluation; effectiveness implementation study; effectiveness implementation trial; heroin use; illicit opioid; implementation facilitation; innovation; medication compliance; men; opioid use; opioid use disorder; opioid withdrawal; overdose death; physical conditioning; preference; prescription opioid; prescription opioid misuse; primary outcome; programs; randomized trial; reduced substance use; risk minimization; scale up; secondary outcome; treatment program

Abstract The proposed study is a Type 1 hybrid effectiveness-implementation trial. Early adopters from the Maryland extended-release naltrexone (XR-NTX) initiative and additional counties who are willing to provide CAM2038, a new extended-release-buprenorphine (XR-B) formulation will participate in a randomized controlled trial conducted in 7 counties (10 jails) throughout the state of Maryland, in which 240 incarcerated men and women will be randomly assigned within gender within jail to one of two groups: Arm 1. XR-B (n=120). XR-B in jail followed by 6 monthly injections post-release at a community treatment program. Arm 2. XR-NTX (n=120). One injection of XR-NTX in jail, followed by 6 monthly injections post-release at a community treatment program. Aim 1. To determine the effectiveness of XR-B compared to XR-NTX in terms of: Primary. (a) pharmacotherapy adherence (number of monthly injections received). Secondary. (b) illicit opioid urine test results; (c) self-reported illicit opioid use; (d) overdose events (non-fatal and fatal); (e) quality of life (i. physical health; ii. mental health); (f) HIV risk behaviors (i. sexual behavior; ii. needle use or sharing); and (g) criminal activity (i. crime days; ii. re-arrest; iii. re-incarceration). Aim 2. To use a learning collaborative involving all 7 RCT county jurisdictions as well as 3 additional counties that selected not to participate in the randomized trial to understand factors related to: (a) acceptability of providing long-acting agonists and antagonists in jail settings; and (b) feasibility of providing medication continuity of care from jail to community treatment providers. Aim 3. Calculate the cost to the correctional health system of implementing an XR-B or XR-NTX program, and determine the relative value of each strategy, including the costs associated with the subsequent interventions in the community, from a state- policymaker and societal perspective. The proposed study is innovative because it would be the first randomized clinical trial in the US assessing effectiveness of receiving XR-B vs. XR-NTX in county jails. The public health impact of the study will be highly significant and far-reaching because most individuals with OUD do not receive treatment while incarcerated, thereby substantially raising their likelihood of relapse to drug use, overdose death, HIV/AIDS infection, and re-incarceration. Finally, understanding how to expand acceptance of medications for opioid use disorder in jails, particularly long-acting medications, has far-reaching implications for treatment expansion in this population.

抽象的 拟议的研究是一项1型混合有效性实施试验。早期采用者 马里兰州扩展释放纳曲酮（XR-NTX）倡议和其他县 愿意提供CAM2038，一种新的扩展释放 - 加压肾上球（XR-B）配方将 参加在全州7个县（10个监狱）进行的随机对照试验 马里兰州，其中有240名被监禁的男人和女人被随机分配 监狱内的性别对两组之一：臂1。xr-b（n = 120）。 XR-B监狱，随后每月6个 在社区治疗计划中发射后的注射。臂2。XR-NTX（n = 120）。一 在监狱注射XR-NTX，然后在社区每月进行6次注射。 治疗计划。目的1。确定与XR-NTX相比的XR-B的有效性 条款：主要。 （a）药物疗法依从性（收到的每月注射次数）。 次要。 （b）非法阿片类药物尿液测试结果； （c）自我报告的非法阿片类药物使用； （d）过量 事件（非致命和致命）； （e）生活质量（i。身体健康；ii。心理健康）； （f）艾滋病毒风险 行为（i。性行为；ii。针头使用或共享）； （g）犯罪活动（i。犯罪日； ii。 重新犯下； iii。重新监禁）。目标2。使用涉及所有7 RCT县的学习协作 司法管辖区以及其他选择不参加随机的县 了解与以下因素有关的试验：（a）提供长效激动剂和 监狱设置中的对手； （b）从监狱提供药物连续性的可行性 到社区治疗提供者。目标3。计算惩教卫生系统的成本 实施XR-B或XR-NTX程序，并确定每个策略的相对值， 包括与社区随后的干预措施相关的费用，来自国家 决策者和社会观点。 拟议的研究具有创新性，因为它将是美国首次随机临床试验 评估在县监狱接受XR-B与XR-NTX的有效性。公共卫生影响 这项研究将具有很大的意义和深远的角度，因为大多数拥有Oud的人都不会 被监禁时接受治疗，从而大大增加了他们复发的可能性 药物使用，过量死亡，艾滋病毒/艾滋病感染和重新监禁。最后，了解如何 扩大监狱中阿片类药物使用障碍药物的接受，尤其是长效 药物对该人群的治疗扩张具有深远的影响。