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