Randomized ESRD Trial COmparing CBT alone VERsus with buprenorphine (RECOVER)

项目总结/摘要 长期血液透析（HD）治疗的肾衰竭患者的阿片类药物处方率更高， 是普通人群的两倍。即使是短期和/或低剂量的处方阿片类药物也与 对HD患者有显著的健康风险。阿片类药物使用频率高的一个关键驱动因素是 该患者人群中慢性疼痛的患病率，因此，任何减少HD中阿片类药物使用的干预措施 患者必须包括有效管理慢性疼痛的策略。行为干预，如 认知行为疗法（CBT）单独或加强更安全的药物，如透皮丁丙诺啡 可能减少阿片类药物的使用，同时管理疼痛，但这些干预措施对HD患者的安全性和有效性 仍然未经测试。我们建议用一个多中心的平行小组来填补我们知识上的空白 随机对照试验，以测试两种干预措施减少HD患者阿片类药物使用的有效性。在这 在一项试验中，720名严重和持续使用阿片类药物的HD患者将以1：1：1的比例随机分配至（1）远程医疗 单独CBT;（2）通过透皮丁丙诺啡增强的远程医疗CBT;和（3）常规护理，随访 最多一年。我们建议调整CBT疼痛，以满足这一患者群体的需求， 治疗失眠抑郁和焦虑研究参与者将通过有效的方法进行识别， 通过获取患者在过去365天内填写的所有处方的粒度数据进行预筛选 在全国75,000家药店中的任何一家主要结果将是处方吗啡毫克 等效（MME），3例患者报告了结局，疼痛干扰， 功能状态和生活质量将构成次要结局。虽然主要和次要的 将在6个月时评估结局，在12周和1年时进行额外评估。其他 结局将包括其他患者报告的结局（疼痛、抑郁、焦虑和失眠的严重程度）， 重大事件（住院、福尔斯、精神状态改变、骨折）和全因死亡率。我们也 建议前瞻性随访任何在接受药物治疗期间被确定患有阿片类药物使用障碍的HD患者 辅助治疗。临床中心将由三名共同主要研究者领导，他们与 五家非营利性透析提供商，为纽约阿尔伯克基的不同HD患者群体提供服务，以及 西雅图，在3年内对7000多名患者进行了一次流行调查。我们的团队有着 合作，在HD患者中进行临床试验的丰富经验，包括行为试验 通过远程医疗进行干预和提供CBT，在患者报告的HD结局方面积累了大量专业知识 患者和通过计算机辅助电话访谈进行的标准化盲态数据收集，疼痛 多发病患者管理、成瘾医学和生物统计学。我们令人信服的初步证据 数据、创新方法、社区支持以及与透析提供者的合作关系预示着很大的可能性 我们的临床中心将能够为HOPE联盟的成功做出贡献。

Project Summary/Abstract The rate of opioid prescribing for patients with kidney failure treated with long-term hemodialysis (HD) is more than twice that in the general population. Even short-term and/or low-dose prescription opioids are associated with significant health risk to HD patients. A key driver of the high frequency of opioid use is the high prevalence of chronic pain in this patient population and hence, any intervention to reduce opioid use in HD patients has to include strategies to effectively manage chronic pain. Behavioral interventions such as cognitive behavioral therapy (CBT) alone or augmented by safer drugs such as transdermal buprenorphine may reduce opioid use while managing pain, but the safety and efficacy of these interventions for HD patients remains untested. We propose to close the gaps in our knowledge with a multi-center parallel group randomized controlled trial to test the efficacy of two interventions to reduce opioid use in HD patients. In this trial, 720 HD patients with significant and ongoing opioid use will be randomly assigned 1:1:1 to (1) telehealth CBT alone; (2) telehealth CBT augmented by transdermal buprenorphine; and (3) usual care, with follow-up for up to one year. We propose adapting CBT for pain to the needs of this patient population by incorporating therapy for insomnia, depression, and anxiety. Study participants will be identified by an efficient approach to pre-screening by obtaining granular data on all prescriptions filled by the patient over the preceding 365 days in any of 75,000 pharmacies nationwide. The primary outcome will be prescribed morphine milligram equivalent (MME) over the preceding 4 weeks and three patient reported outcomes, interference by pain, functional status, and quality of life, will comprise the secondary outcomes. While the primary and secondary outcomes will be assessed at six months, additional assessments will be made at 12 weeks and 1 year. Other outcomes will include other patient reported outcomes (severity of pain, depression, anxiety, and insomnia), significant events (hospitalizations, falls, altered mental status, fractures), and all-cause mortality. We also propose to follow any HD patient identified to have opioid use disorder prospectively while receiving medication assisted treatment. The Clinical Center will be led by three co-Principal Investigators that have partnered with five non-profit dialysis providers for access to a diverse group of HD patients in Albuquerque, New York, and Seattle, with a period prevalent census over 3 years of over 7000 patients. Our team has a track record of collaboration, extensive experience in conducting clinical trials in HD patients including trials of behavioral interventions and delivering CBT via telehealth, large cumulative expertise in patient-reported outcomes for HD patients and standardized blinded collection of data by computer-assisted telephone interviewing, pain management in patients with multi-morbidity, addiction medicine, and biostatistics. Our compelling preliminary data, innovative approach, community support, and partnership with dialysis providers augur a high likelihood that our Clinical Center will be able to contribute to the success of the HOPE consortium.