A comparative effectiveness trial of sublingual versus extended-release buprenorphine with individuals leaving a carceral setting

舌下含服与缓释丁丙诺啡对离开监狱环境的个体的有效性比较试验

• 批准号: 10718889
• 负责人: Thomas Blue
• 金额: $ 88.18万
• 依托单位: FRIENDS RESEARCH INSTITUTE, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-30 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10718889
• 关键词: Accidents; Administrator; Adoption; Adult; Adverse event; Award; Back; Buprenorphine; Cessation of life; Cities; Clinical Trials; Communities; Conduct Clinical Trials; Continuity of Patient Care; Cost Analysis; County; Crime; Day Care; Dose; Dropout; Drug usage; Effectiveness; Ensure; Event; Formulation; Funding; HIV risk; Health Services Accessibility; Health system; Healthcare; Imprisonment; Individual; Injectable; Injections; Intake; Intervention; Jail; Longterm Follow-up; Medical; Mental Health; Needles; Opioid; Opioid agonist; Overdose; Patient Preferences; Patient Self-Report; Pharmaceutical Preparations; Phase; Policy Maker; Population; Pregnant Women; Prisons; Procedures; Public Health; Quality of life; Randomized; Randomized, Controlled Trials; Regulation; Relapse; Research; Research Design; Research Personnel; Risk; Risk Behaviors; Safety; Site; Subcutaneous Injections; Suboxone; Surveys; System; Time; Toxicology; Urine; Visit; buprenorphine treatment; care coordination; community reentry; comparative effectiveness trial; compare effectiveness; cost; cost effectiveness; design; dosage; effectiveness evaluation; experience; illicit opioid; innovation; medication compliance; medication for opioid use disorder; metropolitan; open label; opioid use; overdose death; overdose risk; physical conditioning; preference; primary outcome; rearrest; reincarceration; risk minimization; secondary outcome; sexual risk behavior; substance use; timeline

Abstract Although previous research has demonstrated the effectiveness of initiating medications for opioid use disorder (MOUDs) during incarceration, there has been very little adoption nationwide of this practice. Extended-release buprenorphine (XR-B) is a promising intervention for the treatment of OUDs in carceral settings. Individuals with OUDs re-entering the community are at an elevated risk for overdose and death from relapse to opioid use among other opioid-related harms. This proposal builds on the current investigators experience conducting clinical trials using both XR-B and sublingual-buprenorphine-naloxone (SL-B) with individuals in jail and prison. This proposed study is a randomized controlled trial of XR-B vs. SL-B in a large metropolitan jail. An open-label design will randomly assign 240 adults with moderate-to-severe OUDs who are soon-to-be-released from jail to either XR-B (n = 120) or SL-B (n = 120) treatment in jail followed by 6-months of post-release buprenorphine treatment, a 7-month safety visit, and final long-term follow-up at 12-months. The study has three aims: Aim 1. Compare the effectiveness of XR-B vs. SL-B in terms of: Primary Outcome. (a) illicit opioid use (i. urine toxicology; ii. self-reported days of opioid use using Timeline Followback; and iii. time to opioid relapse). Secondary Outcomes. (b) retention in buprenorphine treatment (i. days receiving buprenorphine and ii. time to treatment dropout); (c) other illicit substance use (i. urine toxicology; ii. self-reported days of illicit substance use using Timeline Followback; (d) overdose events (non-fatal and fatal); (e) quality of life (i. physical health; ii. mental health); (f) HIV risk behaviors (i. sexual risk behavior; ii. needle use or sharing); and (g) criminal activity (i. crime days; ii. re-arrest; iii. technical violations; iv. re-incarceration). Aim 2. To calculate the cost to the state and/or jail/city health system of implementing XR-B and SL-B, and determine the relative value, including the costs associated with the interventions in the community, from a county and state-policymaker and societal perspective. Aim 3. Explore barriers and facilitators to XR-B/SL-B implementation in jail: (1) dose induction; (2) diversion and procedures for reducing diversion; (3) continuity of care after release or transfer to another facility; (4) staffing (both custody and medical) needs for daily versus XR-B buprenorphine dosing; and (5) patient preference for XR-B versus SL-B. The proposed study would be innovative because it would be the first large scale RCT in the US assessing effectiveness and cost effectiveness of XR-B versus SL-B with individuals in a jail who are re-entering community. Understanding how to expand acceptance of buprenorphine in jails, has far-reaching implications for expanding treatment access in jail.

抽象的 尽管以前的研究表明了为阿片类药物使用障碍发起药物的有效性 （mouds）在监禁期间，在全国范围内，这种做法几乎没有采用。扩展释放 丁丙诺啡（XR-B）是在碳环境中治疗OUD的有希望的干预措施。个人 随着Ouds的重新进入社区，从复发到阿片类药物的过量和死亡的风险较高 在其他与阿片类药物有关的危害中使用。该建议是基于当前调查人员进行的经验 同时使用XR-B和舌下 - 丁丙诺啡诺中（SL-B）的临床试验，并在监狱和监狱中。 这项拟议的研究是在大都市监狱中XR-B与SL-B的随机对照试验。开放标签 设计将随机分配240名具有中度至重度oud的成年人，他们即将从监狱发行到 XR-B（n = 120）或SL-B（n = 120）在监狱中进行治疗，然后进行6个月的释放后丁丙诺啡 治疗，7个月的安全访问以及12个月的最终长期随访。这项研究有三个目标：目标1。 根据以下方式比较XR-B与SL-B的有效性。 （a）非法阿片类药物使用（i。尿液 毒理学; ii。使用时间轴后背的自我报告的阿片类药物使用日期；和iii。是时候进行阿片类药物复发）。 次要结果。 （b）保留在丁丙诺啡治疗中（i。Days接受丁丙诺啡和II。 治疗辍学）； （c）其他非法药物使用（i。尿液毒理学； ii。非法物质的自我报告的日子 使用时间轴后背使用； （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。性风险行为； ii。使用针头或共享）； （g）犯罪活动 （i。犯罪日；ii。Rearrest; iii。技术违规；iv。重新监禁）。目标2。计算国家的成本 和/或监狱/城市卫生系统实施XR-B和SL-B，并确定相对价值，包括 与县和州 - 政治家和社会的社区干预措施相关的成本 看法。目标3。探索监狱中XR-B/SL-B实施的障碍和促进者：（1）剂量诱导； （2） 减少转移的转移和程序； （3）释放后的护理连续性或转移到另一个 设施; （4）每日人员与XR-B二马诺啡剂量的人员配备（既包括监护权和医疗）； （5） 患者偏爱XR-B与SL-B。拟议的研究将是创新的，因为这将是第一个 美国的大规模RCT评估XR-B与SL-B的有效性和成本效益 在重新进入社区的监狱中。了解如何扩大监狱中丁丙诺啡的接受， 对扩大监狱的治疗访问的影响深远。