Funded Projects

Many opioid harm reduction services are designed and implemented to serve urban populations in traditional centers of opioid use and leave rural patients underserved. The proposed project seeks to demonstrate improved MAT participation, naloxone distribution, and syringe support services (SSPs) among justice-involved persons with opioid use disorders, and thus improve health and criminal justice outcomes across diverse urban and rural settings in Illinois. Reducing Opioid Mortality in Illinois (ROMI) is a multi-site trial that will be carried out using a hub-and-spoke model, with centralized long-standing social services infrastructure at the Community Outreach Intervention Projects (COIP) hosted at the University of Illinois at Chicago. COIP provides case management/transition of care services to justice-involved opioid users, extending resources and technical assistance to less-populated rural areas hardest hit by the opioid epidemic.

Migraines and other headaches are often debilitating for patients, yet few treatment options providing sustained relief exist. All available therapies, including frequently prescribed opioids, have considerable side effects or limitations. Therefore, novel treatment approaches are needed to reduce or eliminate the need to use opiates and other systemic pharmaceuticals. Thermaquil Inc. has developed a new way of stopping migraine and other headache pain by noninvasively blocking pain signal transmission in the head, which in initial studies allowed patients to discontinue use of opioids and other addictive pain medications. Thermaquil will now be conducting a larger randomized controlled trial to demonstrate the safety and effectiveness of this novel approach. After a baseline period, patients will be randomly assigned to the active or control condition and receive a single treatment. The study will continue for 12 weeks with the active versus control arms, before all patients will be given active therapy for an additional 12 weeks.

The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative template of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive and well curated research dataset to the scientific community at large. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. The majority of participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first decade of life. The University of Vermont study site will recruit mother-infant dyads from a rural area in Vermont, a state in which nearly one-third of neonatal hospitalizations are for neonatal abstinence syndrome (NAS).

About 23 million Americans identify as being in recovery from opioid and other substance use disorders. While recovery support services are an established best practice to support people in recovery, there is little scientific evidence to support the efficacy and implementation of peer recovery support services, training approaches, and delivery models. Recovery support services are particularly lacking in the U.S. Southwest and for individuals who choose to take medications for opioid use disorder as part of their recovery pathway. This project will establish the Peer Recovery Innovation Network to address research gaps. This research will incorporate input from people with lived experience in all stages of the recovery process – toward helping to set the research agenda and conducting the research, as well as enhancing infrastructure for peer recovery support services research.

This project aims to develop a new way to stimulate the delta opioid receptor to treat withdrawal and abstinence from chronic opioid use. Withdrawal can cause pain, depression, and anxiety, which contribute to relapse. The research will test promising drug candidates in animal models with the intention of bringing at least one effective and safe compound to the final stage of drug development before human clinical trials can begin.

The widespread availability of fentanyl and other potent synthetic opioids has dramatically increased opioid-related fatal overdoses. This project will develop and manufacture immune molecules (monoclonal antibodies) to reverse and treat overdose from fentanyl by keeping it out of the brain. This research will advance promising results in animal studies (preventing and reversing fentanyl- and carfentanil-induced breathing problems and irregular heartbeat) to clinical testing in people with opioid use disorder and others at high risk of opioid overdose from accidental or deliberate exposure to fentanyl and fentanyl-like drugs.

This study leverages recent federal and state opioid use disorder treatment initiatives as a platform for testing a promising mind-body intervention, Mindful Awareness in Body-oriented Therapy (MABT) as an adjunct to MAT in two clinical settings funded through the Washington Opioid State Targeted Response (STR) program. MABT, a novel mindfulness-based intervention, uniquely addresses aspects of awareness, interoception, and regulation that may be associated with pain, mental health distress, and behavioral control that increase risk of relapse and poor treatment outcomes. Each setting employs a variation of the nationally recognized Massachusetts Nurse Care Manager model. Using a randomized, two-group, repeated measures design, we will compare those who receive MABT+MAT to MAT only. The overarching goal of this application is to test MABT to improve MAT health outcomes among patients receiving buprenorphine to treat OUD.

This project will identify molecular characteristics of human sensory neurons and non-neuronal cells from the human dorsal root ganglia. This structure located outside the spinal cord is integrally involved in communicating pain signals to and from the brain. The research will use molecular approaches to characterize tissues obtained from organ donors and in patients who experience chronic pain. The findings will also help generate a connectivity map, or “connectome,” of nerve cell connections between the dorsal root ganglia of the spinal cord and the brain.

Migraine is the most common neurological disorder. Currently available treatments fail to effectively manage migraine in most patients. Development of new therapeutics has been slow due in large part to a poor understanding of the underlying pathology of migraine. Endogenous proteases, released in the meninges by resident mast cells, have been proposed as a potential driver of migraine pain via an action on protease activated receptor type 2 (PAR2). The central hypothesis is that PAR2 expression in nociceptors that project to the meninges plays a key role in the pathogenesis of migraine pain. The aims are to: 1) use the established PAR2 development pipeline to design new PAR2 antagonists with improved drug-like properties; 2) use pharmacological tools in a novel mouse migraine model to further understand the potential role of PAR2 in migraine; and 3) use mouse genetics to study the cell type–specific role of PAR2 in migraine pain.

A major barrier to developing new pain treatments has been the absence of infrastructure to facilitate well-designed and carefully conducted clinical trials to test the efficacy of promising treatments. The UF Health Specialized Clinical Center Network will include UF Health as “hub” and statewide partners serving as spokes as part of the EPPIC Network. The University of Florida (UF) has the capability to reach more than 50% of the population of Florida, the third most populous state of the United States, and the capacity to successfully enroll patients with varying pain conditions into clinical trial protocols through its hub and spoke infrastructure as part of EPPIC-Net.

Guidelines published by the Centers for Disease Control and Prevention in 2016 recommended gradual reductions in opioid medication doses (opioid tapering) for people with chronic pain and substance use disorder and recommended that those patients with pain and opioid use disorder should be switched to opioid use disorder medications. Despite wide implementation, little is known about the consequences of opioid tapering among patients with co-occurring chronic pain and substance use disorder. This project will use various databases (Cerner Real-World DataTM, American Hospital Association data, and U.S. Census data) to create a representative electronic health records database. This database will be used to determine the relationship between opioid tapering, multidisciplinary pain treatment, and medications for opioid use disorder – as well as monitor outcomes for patients with chronic pain and co-occurring substance use disorder.

Cerebral palsy (CP), the leading cause of childhood disabilities in the United States, refers to a group of neurological disorders that appear in infancy or early childhood and permanently affect body movement and muscle coordination. The experience of pain is one of the most common, poorly understood, and inadequately treated conditions in CP, impairing health and quality of life for both patients and caregivers. To understand why pain and motor dysfunction occur together, a model that accurately replicates both is needed. This project will validate an established, rabbit model of CP motor dysfunction for use in studying and developing effective treatments for CP-associated pain.

The study team developed an mHealth pain self-management intervention for the perioperative period (SurgeryPal) to target psychosocial risk factors and teach pain self-management skills. The goal of this proposal is to establish the effectiveness of the SurgeryPal psychosocial intervention to improve clinically meaningful outcomes in adolescents undergoing major musculoskeletal surgery, and to identify the optimal timing of intervention delivery. The study team will plan for the efficient implementation of a multisite randomized clinical trial at 25 centers in 500 youth ages 12–18 years undergoing spinal fusion surgery and their parents. Participants will be randomized to receive SurgeryPal or attention control condition during the preoperative and postoperative phases. Self-reported pain severity and interference and secondary outcomes will be assessed at baseline, 3-, and 6-months. If effective, this scalable, low cost intervention will allow broad implementation to prevent chronic postsurgical pain in youth.