Bart Gavin, Barth Kelly S, Baukol Paulette, Enns Eva, Ghitza Udi E, Harris Jacklyn, Jelstrom Eve, Liebschutz Jane M, Magane Kara M, Voronca Delia, Weinstein Zoe M, Korthuis P Todd
Department of Medicine G-5, Hennepin Healthcare and University of Minnesota, 701 Park Avenue, Minneapolis, MN, 55415, USA.
Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, 67 President Street, Charleston, SC, 29425, USA.
Addict Sci Clin Pract. 2024 Dec 2;19(1):91. doi: 10.1186/s13722-024-00510-5.
Hospitalizations involving opioid use disorder (OUD) are increasing. Addiction consultation services (ACS) initiate medications for opioid use disorder (MOUD) in hospital settings and arrange post-hospital follow-up for ongoing MOUD care. Engagement in MOUD following hospital discharge is hampered by challenges in timely access to MOUD. This protocol describes an open-label randomized comparative effectiveness trial comparing ACS treatment as usual (TAU) to a single injection of a 28-day formulation extended-release buprenorphine (XR-BUP) on MOUD engagement 34-days following hospital discharge.
Six U.S. hospitals with ACS capable of prescribing all MOUD (i.e., methadone, buprenorphine, and extended-release naltrexone) recruit and randomize hospitalized patients with OUD who have not been on MOUD in the fourteen days prior to hospitalization. TAU may consist of any MOUD other than XR-BUP. Participants randomized to XR-BUP may receive any MOUD throughout their hospital stay and receive a 28-day XR-BUP injection within 72-hours of anticipated hospital discharge. There is no intervention beyond hospital stay. Participants are followed 34-, 90-, and 180-days following hospital discharge. The primary outcome is engagement in any MOUD 34-days following hospital discharge, which we hypothesize will be greater in the XR-BUP group. Randomizing 342 participants (171 per arm) provides 90% power to detect difference in the primary outcome between groups with an odds ratio of 2.1. Safety, secondary, and exploratory outcomes include: adverse events, MOUD engagement on days 90 and 180, opioid positive urine drug tests, self-reported drug use, hospital readmissions and emergency department visits, use of non-opioid drugs, fatal and non-fatal opioid overdose, all-cause mortality, quality of life, and cost-effectiveness. Data are analyzed by intention-to-treat, with pre-planned per-protocol and other secondary analyses that examine gender as an effect modifier, differences between groups, and impact of missingness.
Engagement in MOUD care following hospitalization in individuals with OUD is low. This randomized comparative effectiveness trial can inform hospital ACS in medication selection to improve MOUD engagement 34-days following hospital discharge.
NCT04345718.
涉及阿片类药物使用障碍（OUD）的住院人数正在增加。成瘾咨询服务（ACS）在医院环境中启动阿片类药物使用障碍药物治疗（MOUD），并安排出院后持续的MOUD护理随访。出院后及时获得MOUD面临的挑战阻碍了MOUD治疗的参与。本方案描述了一项开放标签随机对照有效性试验，比较ACS常规治疗（TAU）与单次注射28天剂型的缓释丁丙诺啡（XR-BUP）对出院34天后MOUD治疗参与度的影响。
六家美国医院的ACS能够开具所有MOUD药物（即美沙酮、丁丙诺啡和缓释纳曲酮），招募住院前14天内未接受过MOUD治疗的OUD住院患者并进行随机分组。TAU可以包括除XR-BUP之外的任何MOUD药物。随机分配到XR-BUP组的参与者在整个住院期间可接受任何MOUD药物治疗，并在预计出院的72小时内接受一次28天的XR-BUP注射。出院后不再进行其他干预。在出院后34天、90天和180天对参与者进行随访。主要结局是出院34天后参与任何MOUD治疗，我们假设XR-BUP组的参与度会更高。随机分配342名参与者（每组171名）可提供90%的检验效能，以检测两组主要结局的差异，比值比为2.1。安全性、次要和探索性结局包括：不良事件、第90天和第180天的MOUD治疗参与度、阿片类药物尿液药物检测呈阳性、自我报告的药物使用情况、再次住院和急诊就诊情况、非阿片类药物的使用、致命和非致命阿片类药物过量、全因死亡率、生活质量和成本效益。数据采用意向性分析，同时进行预先计划的符合方案分析和其他次要分析，以性别作为效应修饰因素、组间差异以及缺失值的影响进行检验。
OUD患者出院后参与MOUD治疗的比例较低。这项随机对照有效性试验可以为医院的ACS在药物选择方面提供参考，以提高出院34天后的MOUD治疗参与度。
NCT04345718。
