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: 9978020
• 负责人: Michael Scott Gordon
• 金额: $ 223.15万
• 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/9978020
• 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; arm; comparative effectiveness trial; cost; disorder later incidence prevention; economic value; effectiveness implementation study; effectiveness implementation trial; heroin use; illicit opioid; 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 1 类混合有效性实施试验。早期采用者来自 马里兰州缓释纳曲酮 (XR-NTX) 计划和其他县 愿意提供 CAM2038，一种新的缓释丁丙诺啡 (XR-B) 制剂将 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 240 名被监禁的男女将在 监狱内性别分为两组：第 1 组 XR-B (n=120)。 XR-B 入狱，随后入狱 6 个月 释放后在社区治疗计划中进行注射。第 2 臂。XR-NTX (n=120)。一 在监狱中注射 XR-NTX，释放后每月在社区注射 6 次 治疗方案。目标 1. 确定 XR-B 与 XR-NTX 相比的有效性 条款：主要。 (a) 药物治疗依从性（每月接受注射的次数）。 次要的。 (b) 非法阿片类药物尿液检测结果； (c) 自我报告非法使用阿片类药物； (d) 服药过量 事件（非致命和致命）； (e) 生活质量（一、身体健康；二、心理健康）； (f) 艾滋病毒风险 行为（i. 性行为；ii. 使用或共用针头）； (g) 犯罪活动（i. 犯罪日；ii. 再次逮捕；三.重新监禁）。目标 2. 使用涉及所有 7 个 RCT 县的学习协作 司法管辖区以及另外 3 个选择不参加随机抽样的县 尝试了解与以下相关的因素：(a) 提供长效激动剂的可接受性和 监狱里的对手； (b) 在监狱中提供药物连续性护理的可行性 给社区治疗提供者。目标 3. 计算惩教卫生系统的成本 实施 XR-B 或 XR-NTX 计划，并确定每个策略的相对价值， 包括与随后的社区干预相关的成本，来自国家- 政策制定者和社会观点。 拟议的研究具有创新性，因为这将是美国第一个随机临床试验 评估县监狱中接收 XR-B 与 XR-NTX 的有效性。公共卫生影响 这项研究的意义重大且影响深远，因为大多数患有 OUD 的人并没有 在监禁期间接受治疗，从而大大增加了他们旧病复发的可能性 吸毒、吸毒过量死亡、艾滋病毒/艾滋病感染和再次监禁。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度，特别是长效药物 药物治疗，对于扩大该人群的治疗范围具有深远的影响。