权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

Reducing Chronic Pain and Opioid Use in Hemodialysis Patients

减少血液透析患者的慢性疼痛和阿片类药物的使用

基本信息

批准号：
9902131
负责人：
Sahir Kalim
金额：
$ 241.1万
依托单位：
MASSACHUSETTS GENERAL HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-09-24 至 2024-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9902131
关键词：
Address Adult Affective Analgesics Anxiety Behavior Behavior Therapy Behavioral Blinded Blood Vessels Brief Pain Inventory Buprenorphine Centers for Disease Control and Prevention (U.S.)Chronic Client satisfaction Clinical Clinical Trials Cognitive Cognitive Therapy Comorbidity Cues Data Dialysis procedure Dose Educational Materials Enrollment Etiology Exercise Fracture Future General Population Group Processes Group Therapy Health Hemodialysis High Prevalence Hospitalization Hour Individual International Interview Kidney Diseases Medical Research Medicine Mental Depression Metabolic Mindfulness Training Mission Mood Disorders Morbidity - disease rate Musculoskeletal Diseases National Institute of Diabetes and Digestive and Kidney Diseases Needles Nonpharmacologic Therapy Opioid Outcome Outpatients Pain Pain Research Pain management Pathway interactions Patients Population Problem Sets Procedures Psychological Factors Psychopathology Public Health Quality of life Randomized Randomized Controlled Trials Recovery Renal Osteodystrophy Research Screening procedure Severities Social Workers Stress Surveys Therapeutic Time Training Vascular Diseases addiction arm buprenorphine dependence buprenorphine treatment chronic pain chronic pain patient clinical care cognitive reappraisal common symptom coping falls hospitalization rates improved innovation mental state mindfulness mindfulness meditation misuse of prescription only drugs mortality multidisciplinary neuropsychiatry novel open label opioid use opioid use disorder pain perception prescription opioid primary endpoint programs psychoeducation psychological distress psychosocial recruit response reward processing satisfaction secondary endpoint social social health determinants targeted treatment

项目摘要

Project Summary/ Abstract Despite the high prevalence of chronic pain and opioid use in hemodialysis patients, and compelling data associating chronic pain and opioid prescriptions with poor outcomes, evidence from clinical trials to address these problems in hemodialysis patients is lacking and signifies a pressing unmet clinical need. This proposal is to participate as a Clinical Center in the Hemodialysis Opioid Prescription Effort (HOPE) Consortium. Because pain is a multidimensional phenomenon with physical and psychosocial components, a unidimensional approach to pain management relying solely on analgesics is unlikely to be efficacious. Nonpharmacologic therapies for co-occurring chronic pain and opioid use in hemodialysis patients should target and alter cognitive-affective circuits that govern responses elicited by pain, stress, mood disorders, and opioid-related cues. These domains are directly addressed through the behavioral therapy program known as MORE (Mindfulness-Oriented Recovery Enhancement)—a multi-pronged mindfulness-oriented individualized group therapy that integrates mindfulness training, cognitive reappraisal, and enhancement of natural reward processing. The central hypothesis for this proposal is that MORE therapy will alter the dysfunctional cognitive, affective, and behavioral pathways that influence chronic pain perception and opioid use, resulting in significant reductions in pain severity and opioid use among hemodialysis patients, and that for patients with opioid use disorder, engagement in the MORE program will increase the likelihood of starting buprenorphine treatment. Guided by MORE's demonstrated efficacy in the general population, the specific aims are: 1) Determine the impact of MORE on chronic pain and opioid use in hemodialysis patients; and 2) Determine predictors of chronic pain, opioid use, and response to MORE. The approach to Aim 1 is an open-label, assessor-blinded, randomized superiority trial (1:1 randomization) comparing assignments to MORE therapy versus control conditions among adult hemodialysis patients with chronic pain treated with a ≥90-day prescription of opioids (120 patients per Clinical Center). The Aim 2 approach will assess which comorbidities, psychological factors, and social determinants of health predict baseline pain and opioid dose (cross-sectional) as well as response to MORE (longitudinal) using data from patients enrolled in the clinical trial outlined in Aim 1. The proposed study will be critical to establish new avenues of research and clinical care that directly impact chronic pain management and opioid use in dialysis and general populations. The expected outcome is a comprehensive understanding of the impact of the MORE program on co-occurring chronic pain and opioid use in hemodialysis patients, and identification of future therapy targets. The proposed research is significant as it stands to improve quality of life, satisfaction, morbidity, and mortality in hemodialysis patients.

项目摘要/摘要尽管血液透析患者慢性疼痛和阿片类药物的使用率很高，但有令人信服的数据将慢性疼痛和阿片类药物处方与不良结果联系起来，来自临床试验的证据需要解决这些问题在血液透析患者中是缺乏的，意味着迫切的未得到满足的临床需求。这项建议是作为临床中心参加血液透析阿片类药物处方努力(HOPE)联盟。由于疼痛是一种多维现象，包括生理和心理社会因素，因此单纯依靠止痛药进行疼痛控制的单一方法不太可能有效。血液透析患者慢性疼痛和阿片类药物并存的非药物治疗应瞄准并改变控制疼痛、压力、情绪障碍和阿片类药物相关的线索。这些领域是通过行为治疗计划直接解决的，称为 MORE(正念导向的恢复增强)--多管齐下的正念导向的个体化结合正念训练、认知重新评估和增强自然奖赏的团体治疗正在处理。这一提议的中心假设是，更多的治疗将改变认知功能障碍，影响慢性疼痛感知和阿片类药物使用的情感和行为途径，导致显著血液透析患者和使用阿片类药物的患者疼痛严重程度和阿片类药物使用的减少障碍，参与更多的计划将增加开始丁丙诺啡治疗的可能性。以MORE在普通人群中证明的有效性为指导，具体目标是：1)确定更多对血液透析患者慢性疼痛和阿片类药物使用的影响；以及2)确定慢性疼痛，阿片类药物的使用，以及对更多的反应。实现目标1的方法是开放标签、评估人员盲目的、随机优势试验(1：1随机化)比较更多治疗与对照的分配成人血液透析患者使用≥90天阿片类药物处方治疗慢性疼痛的情况 (每个临床中心120名患者)。Aim 2方法将评估哪些并发症、心理因素、健康的社会决定因素预测基线疼痛和阿片类药物剂量(横截面)以及反应更多地(纵向)使用目标1中概述的临床试验登记患者的数据。建议的研究将是建立直接影响慢性疼痛的研究和临床护理的新途径的关键透析和普通人群中的管理和阿片类药物使用。预期结果是全面的了解MORE计划对慢性疼痛和阿片类药物使用的影响血液透析患者，以及未来治疗目标的确定。拟议的研究具有重要意义，因为它旨在提高血液透析患者的生活质量、满意度、发病率和死亡率。