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.

摘要 拟议的研究是一项类型1的混合有效性-实施试验。早期采用者来自 马里兰州缓释纳曲酮(XR-NTX)倡议和其他县谁是 愿意提供CAM2038的新的缓释丁丙诺啡(XR-B)配方将 参加在全州7个县(10所监狱)进行的随机对照试验 在马里兰州，240名被监禁的男女将随机分配到 监狱内的性别对两组之一：第1组。XR-B(n=120)。XR-B入狱，之后每月6个月 在社区治疗项目中进行出院后注射。臂2，XR-NTX(n=120)。一 在监狱注射XR-NTX，然后在社区释放后每月注射6次 治疗方案。目的：1.比较XR-B和XR-NTX的疗效。 条款：主要。(A)药物治疗依从性(每月接受注射的次数)。 第二位。(B)非法阿片类药物尿检结果；(C)自行报告的非法使用阿片类药物；(D)过量使用 事件(非致命和致命)；(E)生活质量(一、身体健康；二.精神健康)；(F)艾滋病毒风险 行为(一.性行为；二.针头使用或共用)；和(G)犯罪活动(一.犯罪日；二. 再次逮捕；3.重新监禁)。目标2.使用一个涉及所有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 试验以了解与以下因素有关的因素：(A)提供长效激动剂和 监狱环境中的对抗者；和(B)提供持续服药的监狱护理的可行性 给社区治疗提供者。目标3.计算惩教保健系统的成本 实施XR-B或XR-NTX计划，并确定每种策略的相对价值， 包括与随后的社区干预相关的成本，来自一个州- 政策制定者和社会视角。 这项拟议的研究具有创新性，因为它将是美国第一个随机临床试验 评估县监狱接受XR-B与XR-NTX的效果。对公众健康的影响 这项研究将具有非常重要的意义和深远的影响，因为大多数OUD患者并不 在被监禁期间接受治疗，从而大大增加了他们复发的可能性 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的接受度，特别是长效药物 药物，对扩大这一人群的治疗具有深远的影响。