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: 10616501
• 负责人: Michael Scott Gordon
• 金额: $ 196.71万
• 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 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10616501
• 关键词: Accidents; 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; HIV/AIDS; Health Personnel; Health system; Imprisonment; Individual; Infection; Injectable; Injections; Intervention; Intoxication; Intramuscular; Jail; Learning; Letters; Literature; Maryland; Mental Health; Methadone; Naltrexone; Needles; Opiate Addiction; Opioid; Opioid agonist; Overdose; Patient Self-Report; Pharmaceutical Preparations; Pharmacotherapy; Phase; Policy Maker; Population; Prevention; Prisoner; Prisons; Public Health; Quality of life; Randomized; 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; economic value; effectiveness evaluation; effectiveness/implementation trial; heroin use; illicit opioid; implementation facilitation; innovation; medication compliance; medication for opioid use disorder; men; opioid use; opioid use disorder; opioid withdrawal; overdose death; physical conditioning; preference; prescription opioid; prescription opioid misuse; primary outcome; programs; randomized trial; randomized, clinical trials; rearrest; reduced substance use; reincarceration; relapse prevention; 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1型混合有效性-实施试验。早期采用者来自 马里兰州延长释放纳洛酮（XR-NTX）倡议和其他县谁是 愿意提供CAM 2038，一种新的缓释丁丙诺啡（XR-B）制剂将 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名被监禁的男性和女性将被随机分配 监狱内的性别分为两组：第一组。XR-B（n=120）。XR-B在监狱里，然后是6个月 在社区治疗项目中进行注射。2号臂XR-NTX（n=120）。一 在监狱中注射XR-NTX，然后在社区释放后每月注射6次 治疗方案目标1。确定XR-B与XR-NTX相比在以下方面的有效性： 条件：初级。(a)药物治疗依从性（每月接受的注射次数）。 中学。(b)非法类阿片尿检结果;（c）自我报告的非法类阿片使用情况;（d）过量 事件（非致命和致命）;（e）生活质量（即，身体健康; ii.（f）艾滋病毒风险 行为（i.性行为; ii.使用或共用针头）;及（g）犯罪活动（i.犯罪日; ii. 再次逮捕; iii.再次入狱）。目标二。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个选择不参加随机化的县 试验旨在了解与以下方面相关的因素：（a）提供长效激动剂的可接受性， 监狱环境中的拮抗剂;以及（B）从监狱提供药物治疗和护理的可行性 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，并确定每种策略的相对价值， 包括与社区后续干预相关的费用， 政策制定者和社会观点。 这项拟议中的研究是创新的，因为它将是美国第一个随机临床试验。 评估在县监狱中接受XR-B与XR-NTX的有效性。对公众健康影响 这项研究将是非常重要和深远的，因为大多数人与OUD不 在监禁期间接受治疗，从而大大增加他们复发的可能性， 吸毒、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度，特别是长效药物 药物，对这一人群的治疗扩展具有深远的影响。