Injectable Extended-Release Buprenorphine (XR-B) in a Correctional Setting: A Pilot Randomized Controlled Trial

项目总结 K23的应用为阿片类药物使用障碍(OUD)的矫正治疗提出了新的研究 医疗保健环境和强有力的培训计划，以支持医学博士贾斯汀·伯克的成功过渡 公共卫生硕士MBA(PI)至独立临床医生兼科学家。他在公共卫生、健康管理和 临床医学为进一步发展成为专家科学家奠定了坚实的基础。他已经集合好了 由国家认可的导师和顾问组成的高度成就和多样化的团队，具有互补性 在弱势人群中的临床试验和其他研究方面的专门知识，包括定性方法 和实施学。拟议的研究工作将为Dr。 伯克作为临床试验者的职业发展为未来多站点R01应用提供了初步数据。这个 罗德岛州惩教署(RIDOC)是这类试点研究的理想场所。 阿片类药物使用障碍(Moud)是社区和 被监禁的人。鉴于监狱和监狱中的高流行率以及阿片类药物的高风险 服药过量释放后，刑事司法(CJ)系统提供了一个有针对性的机会，让个人参与 开始治疗。尽管穆德有强大的证据基础，但很少有惩教机构提供这样的生活- 节省药物。立法和法院裁决中不断变化的政策格局将导致更多的设施 提供Moud治疗。然而，交付障碍仍然存在。一种新的注射用缓释片 丁丙诺啡(XR-B)可以帮助克服这些障碍，尽管还没有发表关于它的文献 在CJ环境中的有效性或实施。本K23提出了一项随机对照试验(RCT)，以 演示XR-B的初步有效性、可接受性和可行性，并使用伴随过程 评价，以及实施科学中经常使用的框架，以调查这一新的治疗方法 可以在CJ环境中使用该设备，以防止在再次进入CJ的高危时间阿片类药物过量 社区。 这项K23提案的具体目标包括：(目标1)比较XR-B启动和照常治疗 服刑人员舌下含丁丙诺啡治疗参与、再监禁、 服药过量、丁丙诺啡依从性和非法阿片类药物使用。(目标2)使用RE进行流程评估- AIM评价框架和IPARIHS实施科学框架，以评估#年执行情况 XR-B启动并确定CJ环境中Moud治疗的促进者和障碍。 为了实现这些目标并走向研究独立，伯克博士将接受培训 和临床试验研究经验，包括支持定性方法和实施 科学，并建立一项事业，在边缘人群中进行高影响力和伦理研究。

PROJECT SUMMARY This K23 application proposes novel research in opioid use disorder (OUD) treatment in a correctional healthcare setting and a robust training plan to support the successful transition of the Dr. Justin Berk, MD MPH MBA (PI) to independent clinician-scientist. His background in public health, health management, and clinical medicine creates a strong foundation for further development as an expert scientist. He has assembled a highly accomplished and diverse team of nationally recognized mentors and advisors with complementary expertise in clinical trials and other research among vulnerable populations including qualitative methodologies and implementation science. The proposed research work will provide hands-on experience instrumental to Dr. Berk’s career progression as a clinical trialist preliminary data for a future multi-site R01 application. The Rhode Island Department of Corrections (RIDOC) is an ideal setting for this type of pilot study. Medications for opioid use disorder (MOUD) are an effective treatment in the community and among incarcerated individuals. Given the high prevalence OUD in jails and prisons and the high risk of opioid overdose upon release, the criminal justice (CJ) system offers a targeted opportunity to engage individuals in treatment initiation. Despite the strong evidence-base for MOUD, few correctional facilities offer these life- saving medications. A shifting policy landscape in legislation and court rulings will lead to more facilities offering MOUD treatment. Delivery barriers, however, still exist. A new injectable extended-release form of buprenorphine (XR-B) can help overcome these barriers, though there is no published literature on its effectiveness or implementation in a CJ setting. This K23 proposes a randomized controlled trial (RCT) to demonstrate preliminary effectiveness, acceptability, and feasibility of XR-B and uses a concomitant process evaluation, with frameworks frequently used in implementation science, to investigate how this novel treatment modality may be used in a CJ setting to prevent opioid overdose in the high-risk time of re-entry to the community. The specific aims of this K23 proposal include: (Aim 1) Compare XR-B initiation to treatment-as-usual sublingual buprenorphine among incarcerated individuals on treatment engagement, re-incarceration, overdose, buprenorphine adherence, and illicit opioid use. (Aim 2) Conduct a process evaluation using the RE- AIM evaluative framework and iPARIHS implementation science framework to assess the implementation of XR-B initiation and identify facilitators to and barriers of MOUD treatment in a CJ setting. In order to achieve these aims and move towards research independence, Dr. Berk will receive training and experience in clinical trial research, including supporting qualitative methodologies and implementation science, and build a career to conduct high-impact and ethical research in a marginalized population.