Funded Projects

The Icahn School of Medicine at Mount Sinai (ISMMS) will support the mission of the Early Phase Pain Investigation Clinical Network (EPPIC-Net), through the ISMMS Department of Neurology as the core of a hub and spokes structure. The study contains four specific aims: (1) to streamline and optimize rapid implementation of EPPIC-Net studies, exceeding the required minimum of 100 subjects recruited per year to EPPIC-Net studies; (2) to ensure access to patient populations with a wide range of pain disorders, including CLBP, using a hub and spokes model to ensure effective recruitment; (3) to provide the highest-quality protocol implementation, deep clinical phenotyping of pain disorders, and accurate and complete data collection; and (4) to work collaboratively with the EPPIC-Net Coordinating Centers and investigators from the NIH HEAL Partnership to assist with development/design of clinical trials. The study team will also increase training opportunities through EPPIC-Net within ISMMS and the larger pain research community, training junior investigators to become future pain clinical trials leaders and increase and disseminate knowledge about pain research throughout the network.

The Greater New York Clinical Center (GNYCC) aims to engage experts in pain research and pain practice to build the infrastructure required to support the objectives of the Early Phase Pain Investigation Clinical Network (EPPIC-Net). The GNYCC will provide expertise and resources to perform phase 2 clinical trials to test the efficacy of novel pain treatments, as well as phenotyping and biomarker studies that will enable customized treatments. The consortium comprises four major academic centers in New York City, one of the most diverse cities in the United States and the nation’s largest metropolitan area. We will 1) build infrastructure to rapidly access clinical trial resources and a network of investigators and clinical leaders, 2) develop a plan for swift evaluation and launch of proposed studies, and 3) optimize patient retention and monitor sites to ensure protocol adherence, data quality, and efficiency.

Managing persistent pain has long been a difficult challenge, one that is heightened by the recent opioid crisis. Although many potential solutions may exist, demonstrating their efficacy in a multicenter trial is a considerable obstacle. There is broad consensus that a nationwide clinical research network is necessary to promote innovation. A hub-spoke complex of academic medical centers with considerable experience in pain management clinical trials and biomarker validation will leverage existing resources to make clinical trial execution efficient and rapid. Together, spokes will provide maximum flexibility, ready to accommodate studies in any well-characterized pain condition.

The objective of the Early Phase Pain Investigation Clinical Network (EPPIC-Net) and EPPIC- Net initiatives is to rapidly and efficiently translate advances in the neurobiology of pain into treatments for people with chronic and acute pain, conditions associated with a significant burden to both patients and society. The Clinical Coordinating Center (CCC) for EPPIC-Net will promote and facilitate, from initial conception through final analysis, clinical trials in adult and pediatric populations with acute or chronic pain by providing efficient methodological, organizational, and logistical support. The EPPIC-Net-CCC will adopt and establish processes aimed at dramatically increasing the efficiency of multicenter clinical trials, improving the overall quality of clinical trials, promoting patient recruitment and retention as well as increasing the number of clinical investigators and research staff well trained and passionate about leading and conducting multicenter clinical trials.

Exacerbation of health disparities has emerged during the COVID 19 pandemic and highlighted the recognition that minority underrepresentation in clinical research may contribute to racial disparities in health outcomes. In clinical trials related to pain, disparities in trial patient inclusion are documented by white patients often being overrepresented. Mitigating these disparities is an area in which an early-career pain investigator training and contributions may have lasting benefits. The pandemic also drove rapid expansion of telehealth for pain management without knowledge of how social and demographic factors affect utilization patterns of this care delivery model. This supplement supports research to examine the extent to which disparities exist in access to and outcomes of telehealth in socially marginalized pain patients. Findings will be applied to enrich the diversity in clinical trial populations for phase 2 safety trials performed in the HEAL EPPIC Network.

The MGH EPPIC-Net hub will utilize two well-established collaborative entities in both patient care and clinical research at the Massachusetts General Hospital (MGH): 1) MGH Division of Pain Medicine and 2) MGH Center for Translational Pain Research. This hub-spoke network at MGH will include four core spokes consisting of both academic centers and community health care organizations, as well as over a dozen spokes that can be recruited as needed based on special requirements of phase II trials and research studies. The responsibilities of this hub-spoke network at MGH include a) coordinating phase II trials/clinical biomarker validation studies; b) recruiting well-phenotyped subjects in a timely manner; c) collecting clinical data and targeted outcome data tailored to meet the needs of each clinical trial/study; and d) maintaining communications within and outside the hub, including the NIH EPPIC-Net.

The California Clinical and Translational Pain Research Consortium (CCTPRC) consists of four University of California academic medical centers with considerable experience in pain management clinical trials, phenotyping, and biomarker validation. The network will leverage solid existing Clinical and Translational Science Award (CTSA) resources to make clinical trial execution efficient and rapid. The hub will be located at the University of California, San Diego, with spokes located on the other three campuses to provide maximum flexibility, ready to accommodate studies in a variety of pain conditions and provide successful recruitment and high-quality data collection.

The NIH’s HEAL Initiative aims to support collaboration between clinical research experts in academia and industry to accelerate the development of highly efficacious, nonaddictive analgesics for well-defined chronic pain syndromes. The University of Rochester (UR), and its leadership for the UR Hub and Spokes within Early Phase Pain Investigation Clinical Network (EPPIC-Net), will recruit subjects with a broad range of pain conditions, with a focus on leveraging clinical trial infrastructure to support patient recruitment and retention, timely and accurate data entry, and regulatory documentation, as well as recruit additional Spoke sites through a national network of analgesic researchers.

This project addresses the significant challenge of providing evidence-based, non-pharmacologic pain management to veterans with chronic pain living in rural regions. This research will test whether an innovative, virtual complementary and integrative group-based treatment will improve rural veterans’ pain management, function, and well-being. The research will also devise, evaluate, and adapt strategies for implementing this intervention while working with the health care system, veteran patients, and communities. The scalable, 12-week intervention includes pain education, mindfulness, pain-specific exercises, and cognitive behavioral strategies.

Opioid overdose deaths disproportionately affect Black individuals in the United States. While the use of complementary and integrative pain treatments is effective and widely recommended, Black pain patients (especially those who also have depression) face barriers to the use of these approaches. This project will refine, test, and prepare to implement a novel approach to overcoming these treatment barriers. The research will partner with and empower Black patients to find safe, effective pain treatments that best match their values, preferences, and lifestyles.

Wound care procedures (WCPs), such as dressing changes, cause moderate to severe pain in 74% of patients, nearly half of whom experience severe pain. Mainstay recommendations to prevent pain during WCPs have focused on either administration of preventive and procedural analgesia or use of expensive, non-adherent dressings. However, it is unclear which patients to target for analgesia or expensive dressings, leading to their inappropriate over- or underuse. To achieve the aims of the study, a comprehensive set of wound, patient, and biological factors will be measured concurrently with pain during a dressing change among a sample of 450 inpatients with open wounds. A predictive model will be developed and biological mechanisms will be examined using logistic regression. The proposed study has the potential to make significant contributions because clinicians will be able to target those patients requiring preventive pain control, thereby eliminating the spiraling impact of painful procedures on nociceptor sensitization.