Randomized Clinical Trial Intervention to Treat Chronic Pain Among Persons Maintained on Methadone for Opioid Use Disorder

随机临床试验干预治疗因阿片类药物使用障碍而维持美沙酮治疗的慢性疼痛

• 批准号: 10458799
• 负责人: Kelly E Dunn
• 金额: $ 74.32万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-01 至 2027-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10458799
• 关键词: Absence of pain sensation; Address; Adopted; Age; Analgesics; Bolus Infusion; Buprenorphine; Caring; Clinic; Counseling; Data; Distress; Dose; Double-Blind Method; Drug Kinetics; Ecological momentary assessment; Enrollment; General Population; Goals; Grant; Home; Hour; Individual; Infrastructure; Intervention; Intervention Trial; Laboratories; Logistics; Maryland; Measures; Mental Depression; Methadone; Methods; Moods; Outcome; Pain; Pain Measurement; Pain interference; Pain management; Participant; Patients; Persons; Pharmaceutical Preparations; Phase; Placebo Control; Population; Prevalence; Professional counselor; Provider; Public Health; Randomized; Randomized Clinical Trials; Schedule; Secure; Sensory; Severities; Sleep disturbances; Structure; Testing; Training and Infrastructure; Treatment outcome; Visit; acceptability and feasibility; base; chronic pain; chronic pain management; clinically significant; comorbidity; daily pain; disability; effective therapy; experience; human data; improved; insight; methadone clinic/center; methadone treatment; operation; opioid treatment program; opioid use disorder; opioid withdrawal; pain reduction; patient subsets; pre-clinical; primary outcome; response; satisfaction; standard of care; substance use

ABSTRACT This R01 application follows a successfully completed R34 project and addresses our overarching goal of optimizing methadone dosing as a method for managing comorbid chronic pain and opioid use disorder (OUD) among persons receiving methadone for the treatment of OUD. Up to 62% of persons maintained on methadone for OUD experience clinically significant pain, versus 31% in the general population. Pain in MMP is associated with poor OUD treatment outcomes and severe distress. No effective treatment for comorbid pain and OUD currently exists; though preclinical and human data suggest divided methadone dosing may be a more optimal strategy for managing pain than once daily dosing, this has never been empirically examined. This study will evaluate an intervention for comorbid chronic pain among MMP using a double-blind, randomized, placebo-controlled comparison of ONCE versus TWICE daily methadone dosing. This project is strongly supported by our recent successful completion of an R34, which demonstrated strong feasibility and acceptability of an electronic, autonomous, cellular-enabled commercially available pillbox (MedMinder) to manage methadone take-home dosing. Participants in that study indicated they would use the pillbox again (86%) and recommend it to others (95%), local clinics adopted the MedMinder box into their routine take-home management operations, and preliminary within-person data showed clear and orderly pain reductions during the TWICE vs. ONCE dosing periods. Patients from two methadone clinics will be enrolled into a Phase II between-group study and randomized to ONCE versus TWICE-daily methadone dosing for 12-weeks. Methadone will be dispensed via the same electronic pillbox used in the R34. Primary outcomes are weekly assessments of pain and OUD outcomes, ecological momentary assessment of pain before and after dosing, and point-prevalence measures of laboratory-induced pain to explore mechanism of effects. We will assess the following aims: (Primary 1) Determine impact of methadone dose interval (ONCE vs. TWICE) on pain severity, (Primary 2) Determine impact of methadone dose interval (ONCE vs. TWICE) on pain-related function, (Primary 3) Determine impact of methadone dose interval (ONCE vs. TWICE) on OUD-related metrics, and (Secondary 1) Determine impact of methadone dosing interval on response to laboratory-induced pain using quantitative sensory testing. We expect participants assigned to TWICE daily dosing will show decreases in pain severity, improved pain-related function, and no change or improvements in OUD-related outcomes relative to persons receiving standard-of-care ONCE daily dosing. If effective, this approach could transform the care of MMP with pain because it would be feasible to implement within the operational structure of a methadone clinic and would impose low provider burden. Results could provide a high magnitude treatment for the substantial number of MMP who experience daily pain with no reliable form of treatment.

抽象的 该R01应用程序遵循成功完成的R34项目，并解决了我们的总体目标 优化美沙酮剂量作为管理合并症慢性疼痛和阿片类药物使用障碍（OUD）的方法 在接受美沙酮治疗Oud的人中。多达62％的人保持 美沙酮的OUD经历临床上的疼痛，而普通人群为31％。 MMP疼痛 与不良治疗结果和严重困扰有关。没有合并疼痛的有效治疗 目前存在Oud；尽管临床前和人类的数据表明，划分美沙酮给药可能是 与每天给药相比，治疗疼痛的最佳策略比从未经过经验检查。 这项研究将使用双盲， 每天与美沙酮剂量的随机，安慰剂对照的比较。这个项目是 通过我们最近成功完成R34的强烈支持，这表明了强大的可行性和 电子，自主，支持细胞的市售药盒（MedMinder）的可接受性 管理美沙酮带回家的剂量。该研究的参与者表明他们将再次使用药盒 （86％），并将其推荐给其他人（95％），当地诊所将Medminder盒子采用到常规的带入室内 管理操作以及初步的人内数据显示出明显而有序的疼痛减轻 两次与曾经给药期。来自两个美沙酮诊所的患者将纳入II期 组间研究和每天两次的美沙酮剂量为12周。 美沙酮将通过R34中使用的相同电子药盒分配。主要结果是每周 评估疼痛和结局，给药前后对疼痛的生态瞬时评估， 以及实验室引起的疼痛的点态度量，以探索效应机制。我们将评估 以下目的：（初级1）确定美沙酮剂量间隔（一次与两次）对疼痛严重程度的影响， （初级2）确定美沙酮剂量间隔（一次与两次）对疼痛相关功能的影响， （主要3）确定美沙酮剂量间隔（一度与两次）对与Oud相关指标的影响，并且 （次要1）确定美沙酮给药间隔对实验室引起的疼痛的反应的影响 定量感觉测试。我们希望分配给参与者每天两次给药将显示下降 疼痛严重程度，改善与疼痛相关的功能以及与OUD相关结果的变化或改善 相对于每天获得护理标准的人，每天给予护理标准。如果有效，这种方法可能会改变 痛苦的MMP护理，因为在某人的操作结构中实施是可行的 美沙酮诊所，会施加较低的提供商负担。结果可以为 每天疼痛的大量MMP，没有可靠的治疗形式。