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.

在罪犯监管的个人中，阿片类药物使用障碍(OUD)的流行率尤其高 司法系统(CJS)，阿片类药物过量死亡主要发生在有 CJS参与的历史(Binswanger等人，2007年；Bird等人，2016)。因为阿片类药物的高流行率 在CJS人群中使用，监狱提供了一个独特的机会来识别和治疗OUD患者。2017年， FDA批准了丁丙诺啡的缓释制剂(XR-B，子区带；InDior，Indior Inc.)使用 每4周皮下注射丁丙诺啡100 mg或300 mg。早期评估 XR-B在社区环境中表现出相对较高的滞留率和积极的阿片类药物使用结果(Andorn等人，2020年； Ling等人，2020)。治疗阿片类药物使用障碍的缓释药物的现行做法(穆德) 在监狱环境中，是在入院时为患者排毒，然后在出院前不久注射(维斯塔尔， 2018)，目标是减少社区中复发、过量服药和相关问题的风险。 这种对发布后阶段的关注非常普遍。事实上，我们在监狱里找到的所有穆德研究 对这一提议的文献搜索主要集中在监狱/出狱前不久启动Moud治疗 以及跟踪释放后基于社区的结果(例如，持续护理、复发和再次犯罪；见 Moore等人，2019年)。对监狱后监禁的普遍关注引发了一个重要的医疗服务问题： 与标准方法相比，在入狱时开始XR-B治疗是否有好处 入院时戒毒，重新建立阿片类药物耐受性(口服一周或更长时间 丁丙诺啡)，并在出院前不久启动XR-B？为了测试这一点，我们提议一个为期3年、两个地点、 随机对照试验，新入狱人数(N=160)和刑期为&lt；6个月 被分配立即开始XR-B治疗(实验组)或在出院前3-4周开始治疗 (照常治疗；TAU)，包括为期1-2周的舌下亚声导入期。来评估潜在的 监狱内XR-B维护的影响，所有研究参与者将在入狱时登记并每月进行评估 在他们的监禁期间。监狱中的评估包括心理困扰(凯斯勒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、严重和与 改道)。我们将狱中结果包括在内，将使我们能够获得每月(释放前)的跟踪数据， 100%的样本，克服了CJS对Moud研究中常见的数据缺失问题。发布后 结果将在出狱后1-3个月进行评估，包括XR-B继续在 社区(子区块在马萨诸塞州的医疗补助处方中)，以患者为中心 康复(茶叶)、阿片类药物使用(ASI、尿毒学)和心理痛苦(K-6)。六个月的累犯率将是 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 在两种研究条件下，为研究参与者提供亚受体阻滞剂。