Opioid Dose Reduction in Comprehensive Inpatient Rehabilitation: A pharmaco-behavioral approach

综合住院康复中阿片类药物剂量的减少：药物行为方法

基本信息

批准号：
10654725
负责人：
Jorge Leon Morales-Quezada
金额：
$ 15.74万
依托单位：
SPAULDING REHABILITATION HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-08-15 至 2026-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10654725
关键词：
Absence of pain sensation Adverse effects Analgesics Association Learning Attitude Behavior Therapy Behavioral Behavioral Paradigm Belief Biological Markers Burn injury Clinical Clinical Trials Clinical Trials Design Conditioned Stimulus Coupled Data Data Analyses Data Collection Development Distress Dose Electroencephalography Enrollment Environment Ethics Evaluation Funding Goals Healthcare Hospitalization Injury Inpatients Institution Intervention Interview Investigation Irritable Bowel Syndrome Journals K-Series Research Career Programs Learning Link Low Back Pain Measurement Medical Mentored Patient-Oriented Research Career Development Award Mentors Mentorship Metabolic Activation Methods Multiple Trauma Narcotics Opioid Outcome Pain Pain management Patients Pattern Peer Review Pharmaceutical Preparations Pharmacology Phase Physical Medicine Physical therapy Pilot Projects Placebo Effect Placebos Population Positioning Attribute Prevalence Procedures Publishing Qualitative Methods Randomized Randomized, Controlled Trials Recovery Rehabilitation therapy Research Research Methodology Research Personnel Research Training Resources Risk Science Signal Transduction Spinal cord injury Stimulus Symptoms Techniques Testing Training acceptability and feasibility addiction behavioral pharmacology career career development clinical effect clinical pain clinical training conditioning debilitating pain design dosage evidence base expectation functional near infrared spectroscopy health care service utilization innovation longitudinal analysis meetings multimodality neurophysiology novel open label opioid use pain behavior pain outcome pain relief pharmacologic pill prevent randomized, clinical trials response side effect standard care symposium symptom management

项目摘要

PROJECT SUMMARY This K23 career development award will position the candidate to become an independent clinical researcher with expertise in refining and testing pharmaco-behavioral interventions for pain management in patients under intensive rehabilitation. BACKGROUND. Pain is a significant problem for inpatients, and opioids are often used as a part of their analgesic treatment approach. Unfortunately, adequate pain relief by narcotic comes with adverse effects and risk of addiction. Overall, opioid usage for those in Comprehensive Inpatient Rehabilitation (CIR) is high due to the complexity of their injuries. Notably, pain in rehabilitation leads to worsened clinical outcomes, due to maladaptive healthcare engagement (e.g., avoidance or overuse of physical therapy). It is critical to developing evidence-based pharmaco-behavioral interventions, and Conditioning Open-Label Placebo (COLP) is a promising technique for reducing opioid use in CIR. Based on principles of classical conditioning, COLP takes advantage of opioids pharmacology to promote learned responses for evoked placebo-driven analgesia. SPECIFIC AIMS. The proposed studies employ mixed methods designs to: (1) evaluate, in a pilot randomized clinical trial (RCT), the feasibility and acceptability of COLP for patients with pain in CIR, (2) explore neurophysiological mechanisms and markers associated with COLP, and (3) explore within-group longitudinal patterns of pain management and their covariance across multiple timepoints. TRAINING. The candidate will achieve short-term goals through a resource-rich institutional environment and a cohesive training plan in (1) clinical trial design in CIR, (2) neurophysiology and signal analysis and longitudinal data collection, and (3) evaluation of pain management, including; beliefs, expectations, and attitudes toward the treatment. In addition to ongoing mentorship meetings and experiential training through the research plan, the candidate will complete targeted coursework, didactic training, and clinical shadowing. Presentations at local/national conferences, and publish in peer-reviewed journals, are activities also included in candidate’s training. MENTORSHIP. The candidate will be supported by a stellar mentoring team: Ross Zafonte, DO (primary mentor), Ted Kaptchuk (primary mentor) Gloria Y. Yeh, MD, MPH (co-mentor), Christine Sang, MD, MPH (co-mentor), Kevin O’Connor, MD (consultant), and Jeffrey Schneider (consultant). IMPACT. In line with NCMRR funding priorities, the proposed research will answer critical questions about (1) the feasibility and acceptability of a multimodal approach involving pharmaco-behavioral interventions for hard-to-manage symptoms and (2) develop objective biomarkers associated with the experimental intervention. While the initial clinical trial will focus on pain in CIR, it is anticipated that the candidate’s training and research will have broad applications to a variety of medical populations struggling with pain and narcotic treatment management. Through this K23 award, the candidate will gain the training and preliminary data needed to apply for a larger NCMRR clinical trial (e.g., R01 or U01) to determine the optimal integration of COLP for managing pain in patients undergoing intensive rehabilitation.

项目概要该 K23 职业发展奖将使候选人成为一名独立的临床研究员拥有完善和测试药物行为干预措施的专业知识，用于治疗以下患者的疼痛背景：疼痛是住院患者的一个重要问题，经常使用阿片类药物。不幸的是，作为镇痛治疗方法的一部分，麻醉剂可以充分缓解疼痛。总体而言，综合住院康复患者使用阿片类药物的不良反应和成瘾风险。由于其损伤的复杂性，（CIR）很高，值得注意的是，康复过程中的疼痛会导致临床恶化。由于适应不良的医疗保健参与（例如避免或过度使用物理治疗）而导致的结果。对于开发基于证据的药物行为干预措施和调理开放标签安慰剂至关重要 (COLP) 是一种基于经典调节原理的减少 CIR 中阿片类药物使用的有前景的技术。 COLP 利用阿片类药物药理学来促进安慰剂驱动的学习反应具体目标拟议的研究采用混合方法设计来：（1）在试点中进行评估。随机临床试验（RCT），COLP对于CIR疼痛患者的可行性和可接受性，（2）探讨与 COLP 相关的神经生理机制和标志物，以及（3）探索组内纵向考生将了解多个时间点的疼痛管理模式及其协方差。通过资源丰富的制度环境和有凝聚力的培训计划实现短期目标 (1) CIR 中的临床试验设计，(2) 神经生理学和信号分析以及纵向数据收集，以及 (3) 疼痛管理的评估，包括；信念、期望和对治疗的态度。通过研究计划进行持续的指导会议和体验式培训，候选人将完成有针对性的课程、教学培训和在地方/国家会议上的临床演示。在同行评审的期刊上发表，这些活动也包含在候选人的培训中。候选人将得到一流指导团队的支持：Ross Zafonte, DO（主要导师）、Ted Kaptchuk (主要导师) Gloria Y. Yeh, MD, MPH (共同导师), Christine Sang, MD, MPH (共同导师), Kevin O’Connor, MD（顾问）和 Jeffrey Schneider（顾问）根据 NCMRR 的资助优先事项，拟议的研究将回答以下关键问题：(1) 多式联运的可行性和可接受性涉及针对难以管理的症状的药物行为干预的方法，以及（2）制定目标与实验干预相关的生物标志物虽然最初的临床试验将重点关注 CIR 中的疼痛，预计候选人的培训和研究将广泛应用于各种医学领域通过这个 K23 奖项，候选人获得了与疼痛和麻醉治疗管理作斗争的人群。将获得申请更大的 NCMRR 临床试验（例如 R01 或 U01）所需的培训和初步数据确定 COLP 的最佳整合，以管理接受强化康复的患者的疼痛。