Pain, Opioids, and ESRD risk reduction with Mindfulness and Buprenorphine (POEM-B): A 3-arm multi-site randomized trial in hemodialysis patients

摘要 尽管近6%的医疗保险基金用于治疗终末期肾病患者， 生活质量差，511，000名维持性透析患者中的大多数存在慢性疼痛， 美国的在这一人群中指导疼痛控制和阿片类麻醉剂安全使用的证据很少， 阿片类药物仍然被大多数维持性透析患者使用 死亡、住院、骨折和精神状态变化的风险增加。关于NIDDK HEAL 倡议：血液透析患者疼痛和阿片类药物使用的综合方法：血液透析阿片类药物 处方努力（HOPE）联盟（RFA-DK-18-030）以及明确需要数据来更好地指导阿片类药物的使用 在血液透析患者中，我们建议增加纽约大学医学院（NYU）作为希望 联合临床中心和疼痛和阿片类药物在终末期肾病风险降低与正念 和丁丙诺啡（POEM-B）试验：一项3组多中心随机试验。约600例血液透析 接受慢性阿片类药物治疗的患者将在HOPE联盟中随机接受强化治疗， 常规、丁丙诺啡治疗或丁丙诺啡加正念认知治疗干预 通过电话和适应疼痛（MCBT-TP）。纽约大学的主要调查员和合作调查员 临床中心在与阿片类药物患者人群合作方面经验丰富， 在血液透析人群、正念疗法和阿片类药物中进行的合作NIH临床试验 药物治疗。此外，还建立了一个包括20个独立的透析单位和20多个 2900名透析患者将允许纽约大学临床中心从独特的大量来源人群中招募 代表了美国种族、民族、性别和透析实践模式的多样性。 这些调查人员和资源将用于评估以下具体目标： 丁丙诺啡减少血液透析患者慢性阿片类药物使用和处方的有效性 基线时的阿片类药物，与常规干预的强化治疗相比，并评估有效性 丁丙诺啡改善疼痛强度、其他生活质量指标和住院治疗;目的2-评估 通过电话提供的基于正念的认知治疗干预的增量有效性， 与单独使用丁丙诺啡相比，在丁丙诺啡基础上添加适应疼痛（MBCT-TP）对疼痛的干扰作用 身体、社会和精神功能，阿片类药物使用，疼痛强度，其他生活质量指标， 住院和死亡率。POEM-B研究解决了一个关键的知识差距， 这可以很容易地实施到临床护理中，并直接提高生活质量， 不断增长的高风险人群的结果。

Abstract Despite the expenditure of nearly 6% of Medicare funds on the care of patients with end stage renal disease, quality of life is poor and chronic pain present in the majority of the 511,000 maintenance dialysis patients in the United States. Evidence to guide pain control and the safe use of opioid narcotics in this population is scant, but opioids are nevertheless utilized by the majority of maintenance dialysis patients and are associated with greatly elevated risks of death, hospitalizations, fractures, and mental status changes. In response to the NIDDK HEAL Initiative: Integrated Approach to Pain and Opioid Use in Hemodialysis Patients: The Hemodialysis Opioid Prescription Effort (HOPE) Consortium (RFA-DK-18-030) and the clear need for data to better guide opioid use in hemodialysis patients, we propose the addition of New York University School (NYU) of Medicine as a HOPE consortium clinical center and the Pain and Opioids in End Stage Renal Disease risk reduction with Mindfulness and Buprenorphine (POEM-B) Trial: a 3-arm multi-site randomized trial. Approximately 600 hemodialysis patients receiving chronic opioids will be randomized across the HOPE consortium to enhanced treatment as usual, buprenorphine therapy, or buprenorphine plus mindfulness-based cognitive therapy intervention delivered by telephone and adapted for pain (MCBT-TP). The principal investigators and the co-Investigators at the NYU clinical center are deeply experienced in working with opioid patient populations and leading high-quality and collaborative NIH clinical trials in the hemodialysis population, mindfulness-based therapies, and opioid medication treatments. Furthermore, a local network including 20 free-standing dialysis units and more than 2900 dialysis patients will allow the NYU clinical center to recruit from a uniquely large source population representative of the diversity of race, ethnicity, gender and dialysis practice patterns across the United States. These investigators and resources will be leveraged to assess the following specific aims: Aim 1—To assess the effectiveness of buprenorphine in reducing chronic opioid use and prescriptions in hemodialysis patients on opioids at baseline, compared with an enhanced treatment as usual intervention and to assess the effectiveness buprenorphine in improving pain intensity, other quality of life measures, and hospitalizations; Aim 2—To assess the incremental effectiveness of a mindfulness-based cognitive therapy intervention delivered by telephone and adapted for pain (MBCT-TP) added to buprenorphine compared to buprenorphine alone on pain-interference with physical, social, and mental functioning, opioid use, pain intensity, other quality of life measures, hospitalizations, and mortality. The POEM-B study addresses a critical knowledge gap and will provide evidence that can be readily implemented into clinical care and that directly improves quality of life and patient-centered outcomes in a growing and high-risk population.