Assessing Optimal XR-Buprenorphine Initiation Points in Jail

评估监狱中 XR-丁丙诺啡的最佳起始点

• 批准号: 10673906
• 负责人: DAVID J FARABEE
• 金额: $ 60.61万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10673906
• 关键词: Address; Admission activity; Adult; Agreement; Behavioral; Birds; Buprenorphine; Caring; Collaborations; Communities; Consent; County; Criminal Justice; Data; Dose; Drug Metabolic Detoxication; Eligibility Determination; Enrollment; Evaluation; FDA approved; Formularies; Formulation; Goals; Health; Health Personnel; Health Services; High Prevalence; Imprisonment; Individual; Injections; Jail; Justice; Lead; Letters; Maintenance; Massachusetts; Measures; Medicaid; Medical; New York; Opioid; Oral Administration; Outcome; Overdose; Participant; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Pharmacotherapy; Phase; Pilot Projects; Population; Prevalence; Prisons; Problem behavior; Protocols documentation; Public Health; Randomized; Randomized, Controlled Trials; Recording of previous events; Records; Recovery; Relapse; Research; Research Infrastructure; Research Personnel; Risk Reduction; Sampling; Site; Subcutaneous Injections; Suboxone; System; Testing; Time; Toxicology; Universities; Urine; Withdrawal; Work; behavioral outcome; community reentry; community setting; craving; experience; experimental group; follow-up; illicit opioid; interest; medication for opioid use disorder; opiate tolerance; opioid mortality; opioid use; opioid use disorder; patient oriented; psychologic; psychological distress; psychological outcomes; recidivism; relapse risk; text searching; trafficking; treatment as usual; virtual; willingness

The prevalence of opioid use disorder (OUD) is especially high among individuals supervised by the criminal justice system (CJS), and a preponderance of opioid overdose deaths occur among individuals who have a history of CJS involvement (Binswanger et al., 2007; Bird et al., 2016). Because of the high prevalence of opioid use among CJS populations, jails offer a unique opportunity to identify and treat persons with OUD. In 2017, the FDA approved an extended-release formulation of buprenorphine (XR-B, Sublocade®; Indivior, Inc.) with subcutaneous injections of 100mg or 300mg buprenorphine delivered every four weeks. Early evaluations of XR-B in community setting show relatively high retention and positive opioid-use outcomes (Andorn et al., 2020; Ling et al., 2020). Current practice for delivering extended-release medication for opioid use disorder (MOUD) in jail settings is to detoxify the patient at admission, then provide an injection shortly before release (Vestal, 2018) with the targeted goal of reducing risk of relapse, overdose, and associated problems in the community. This focus on the post-release phase is widespread. In fact, all of the jail-based MOUD studies we located in literature searches for this proposal focused on initiating MOUD treatment shortly before jail/prison discharge and tracking community-based outcomes following release (e.g., continued care, relapse, and recidivism; see Moore et al., 2019). The ubiquitous focus on post-incarceration raises an important health-services question: Could there be benefits of initiating XR-B treatment at the time of jail admission, relative to the standard approach of detoxifying at admission, re-establishing opioid tolerance (with a week or more of administering oral buprenorphine), and initiating XR-B shortly before discharge? To test this, we propose a 3-year, two-site, randomized controlled trial in which new jail admissions (N=160) with OUD and sentences of < 6 months are assigned to either begin XR-B treatment immediately (experimental group) or 3-4 weeks prior to discharge (treatment as usual; TAU), including a lead-in sublingual Suboxone phase of 1-2 weeks. To assess the potential effects of in-jail XR-B maintenance, all study participants will be enrolled at jail admission and assessed monthly over their incarceration term. In-jail assessments include psychological distress (Kessler 6), opioid craving (VAS), and administrative records of in-jail behavioral infractions (administrative, serious, and related to diversion). Our inclusion of in-jail outcomes will allow us to have monthly (pre-release) follow-up data for nearly 100% of the sample, overcoming the common problem of missing data in CJS studies of MOUD. Post-release outcomes will be assessed 1 & 3 months following release from jail, and include XR-B continuation in the community (Sublocade is on the Medicaid formulary in Massachusetts), patient-centered perceived progress in recovery (TEA), opioid use (ASI, urine toxicology), and psychological distress (K-6). Six-month recidivism will be assessed through county records, though recidivism is not a focus of this project. Indivior has agreed to provide Sublocade for the study participants in both study conditions.

阿片类药物使用障碍（OUD）的患病率在受罪犯监督的个人中尤其高。 司法系统（CJS），阿片类药物过量死亡的绝大多数发生在患有 CJS参与史（Binswanger等，2007; Bird等人，2016年）。由于阿片类药物的高流行率 在CJS人群中使用，监狱为识别和治疗OUD患者提供了独特的机会。2017年 FDA批准了丁丙诺啡的缓释制剂（XR-B，Sublocade®; Indivior，Inc.）与 皮下注射100 mg或300 mg丁丙诺啡，每四周递送一次。早期评估 社区环境中的XR-B显示相对高的保留和积极的阿片类药物使用结果（Wavelyn等人，二○二○年; Ling等人，2020年）。阿片类药物使用障碍（MOUD）缓释药物的当前实践 在监狱环境中，是在入院时给病人解毒，然后在释放前不久提供注射（维斯塔尔， 2018年）的目标是减少复发，过量的风险，以及社区中的相关问题。 这种对发布后阶段的关注非常普遍。事实上，所有基于监狱的MOUD研究， 对该建议的文献检索集中在监狱/监狱释放前不久开始MOUD治疗 以及在发布之后跟踪基于社区的结果（例如，持续护理、复发和累犯;见 摩尔等人，2019年）。对监禁后的普遍关注提出了一个重要的卫生服务问题： 相对于标准方法，在入狱时开始XR-B治疗是否有好处 在入院时解毒，重新建立阿片类药物耐受性（口服给药一周或更长时间） 丁丙诺啡），并在出院前不久启动XR-B？为了验证这一点，我们提出了一个为期3年，两个地点， 随机对照试验中，新入狱的OUD患者（N=160），刑期< 6个月， 分配到立即（实验组）或出院前3-4周开始XR-B治疗 （常规治疗; TAU），包括1-2周的舌下Suboxone导入期。评估潜在 监狱中XR-B维护的影响，所有研究参与者将在监狱入院时登记，并每月进行评估 在他们的监禁期间。狱中评估包括心理困扰（Kessler 6），阿片类药物渴望 (VAS)，以及监狱内行为违规的行政记录（行政，严重， 分流）。我们将监狱中的结果包括在内，这将使我们能够获得近20年的每月（预发布）随访数据。 100%的样本，克服了MOUD CJS研究中常见的数据缺失问题。释放后 结果将在从监狱释放后的1和3个月进行评估，并包括XR-B的延续， 社区（Sublocade在马萨诸塞州的Medicaid处方集上），以患者为中心的 恢复（TEA），阿片类药物使用（ASI，尿液毒理学）和心理困扰（K-6）。六个月的累犯 通过县记录进行评估，尽管累犯不是该项目的重点。个人同意提供 两种研究条件下的研究受试者均接受Sublocade。