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: 10624868
• 负责人: Kelly E Dunn
• 金额: $ 69.22万
• 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/10624868
• 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; Electronics; Enrollment; General Population; Goals; Grant; Home; Hour; Individual; Infrastructure; Intervention; Intervention Trial; Laboratories; 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; Recommendation; Schedule; Secure; Sensory; Severities; Sleep disturbances; Structure; Testing; Training and Infrastructure; Treatment outcome; Visit; acceptability and feasibility; 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; randomized, clinical trials; 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 此 R01 应用程序遵循成功完成的 R34 项目，并实现了我们的总体目标： 优化美沙酮剂量作为治疗慢性疼痛和阿片类药物使用障碍 (OUD) 共病的方法 接受美沙酮治疗 OUD 的人。高达 62% 的人维持在 美沙酮治疗 OUD 时会出现临床上明显的疼痛，而普通人群中的 31% 会出现这种情况。 MMP 中的疼痛 与不良的 OUD 治疗结果和严重的痛苦有关。对于合并疼痛没有有效的治疗方法 并且 OUD 目前已存在；尽管临床前和人体数据表明美沙酮分次给药可能是一种 这是比每日一次给药更优化的疼痛控制策略，但从未经过实证检验。 本研究将采用双盲、 每日一次与两次美沙酮剂量的随机、安慰剂对照比较。这个项目是 我们最近成功完成了 R34 的大力支持，该项目展示了强大的可行性和 电子、自主、支持蜂窝的商用药盒 (MedMinder) 的可接受性 管理美沙酮带回家的剂量。该研究的参与者表示他们会再次使用药盒 (86%) 并向其他人推荐 (95%)，当地诊所将 MedMinder 盒子带回家 管理操作和初步内部数据显示，在治疗期间疼痛明显有序地减轻了。 两次与一次给药周期。来自两个美沙酮诊所的患者将被纳入第二阶段 组间研究并随机分为每日一次和两次美沙酮剂量，为期 12 周。 美沙酮将通过 R34 中使用的相同电子药盒进行分配。主要结果是每周一次 疼痛和 OUD 结果的评估，给药前后疼痛的生态瞬时评估， 以及实验室引起的疼痛的点患病率测量，以探索影响机制。我们将评估 以下目标：（主要 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， （小学 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， （小学 3）确定美沙酮剂量间隔（一次与两次）对 OUD 相关指标的影响，以及 （第二部分 1）使用以下方法确定美沙酮给药间隔对实验室引起的疼痛反应的影响 定量感官测试。我们预计分配每日两次给药的参与者将显示出 疼痛严重程度、疼痛相关功能改善以及 OUD 相关结果没有变化或改善 相对于每天接受一次标准护理剂量的人。如果有效的话，这种方法可能会改变 MMP 的护理是痛苦的，因为在一个运营结构内实施是可行的 美沙酮诊所，并且会给提供者带来较低的负担。结果可以为以下疾病提供高强度的治疗： 大量 MMP 每天都会经历疼痛，但没有可靠的治疗方式。