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

• 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
• 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

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 强化康复。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 作为镇痛治疗方法的一部分。不幸的是，麻醉剂可以充分缓解疼痛 不良反应和成瘾风险。总体而言，综合住院康复患者的阿片类药物使用情况 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症状恶化 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。这是 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) 是减少 CIR 中阿片类药物使用的一项有前途的技术。基于经典条件反射原理， COLP 利用阿片类药物药理学来促进安慰剂驱动的学习反应 镇痛。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 疼痛管理模式及其跨多个时间点的协方差。训练。候选人将 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；对治疗的信念、期望和态度。此外 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、教学培训和临床见习。在地方/国家会议上的演讲，以及 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。指导。这 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）。影响。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 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 与疼痛和麻醉治疗管理作斗争的人群。通过此次 K23 奖项，候选人 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。