Funded Projects

Neonatal Opioid Withdrawal Syndrome (NOWS) is a condition that occurs when newborns are exposed to opioids during pregnancy. Symptoms often include tremors, excessive crying, sleep deprivation, and swallowing difficulties. Cases are rising, with a newborn affected by NOWS approximately every 15 minutes. Currently, healthcare providers in the United States lack standard, evidence-based treatments for NOWS. 

This project is part of a multi-center, randomized controlled clinical trial that directly compares NOWS treatments—morphine, methadone, and buprenorphine—and takes into account other types of non-drug therapies, such as behavioral interventions. The goal is to generate results that can inform clinical practice guidelines and give newborns with NOWS the best start possible. 

Thomas Jefferson University has more than 40 years of experience optimizing approaches to the care of opioid use disorder in pregnancy and conducts clinical research on NOWS treatments. The hospital provides a robust continuum of care that supports women with opioid use disorders before, during, and after delivery. This supportive culture has resulted in a relatively high rate of clinical trial participation that will enable long-term follow up of mothers and infants.

The objective of the HBCD PRELUDE (Prenatal Experiences and Longitudinal Development) multi-site consortium is to characterize typical brain development from birth through childhood. All sites in this consortium will measure the influence of key biological and environmental factors on child social, cognitive, and emotional development. Researchers will assess how prenatal exposure to opioids and other substances, as well as other adverse environmental factors, affect brain development and other child health outcomes. The study site at the University of North Carolina, Chapel Hill will work with Wake Forest University to help recruit pregnant women with substance use disorders and enroll mother-infant dyads. This collaboration serves to expand participant diversity and extend recruitment to cover a larger region of North Carolina, a state hit hard by the opioid crisis.

Neonatal Opioid Withdrawal Syndrome (NOWS) is a condition that occurs when newborns are exposed to opioids during pregnancy. Symptoms often include tremors, excessive crying, sleep deprivation, and swallowing difficulties. Cases are rising, with a newborn affected by NOWS approximately every 15 minutes. Currently, healthcare providers in the United States lack standard, evidence-based treatments for NOWS. 

This project is part of a multi-center, randomized controlled clinical trial that directly compares NOWS treatments—morphine, methadone, and buprenorphine—and takes into account other types of non-drug therapies, such as behavioral interventions. The goal is to generate results that can inform clinical practice guidelines and give newborns with NOWS the best start possible. 

New Mexico is an epicenter of the opioid epidemic with high rates of maternal opioid use disorder and NOWS. This site has expertise in multi-center clinical trials for newborns, a history of high rates of study recruitment and follow-up, and a diverse population that includes Latinx and Native American women. The hospital currently cares for infants with NOWS in a variety of settings, including rooming in, a nursery, and a neonatal intensive care unit.

Substance use disorder (SUD) is a serious public health and socioeconomic burden. In this project, researchers will develop novel drug compounds that dually target orexin receptors and kappa opioid receptors, which have both been implicated in SUD. The compounds will then be tested for effectiveness in preclinical models of SUD, including models of cocaine, methamphetamine, and fentanyl use. This research has the potential to provide highly impactful and innovative treatment options for SUD via simultaneous modulation of multiple signaling pathways.

Neonatal Opioid Withdrawal Syndrome (NOWS) is a condition that occurs when newborns are exposed to opioids during pregnancy. Symptoms often include tremors, excessive crying, sleep deprivation, and swallowing difficulties. Cases are rising, with a newborn affected by NOWS approximately every 15 minutes. Currently, healthcare providers in the United States lack standard, evidence-based treatments for NOWS. 

This project is part of a multi-center, randomized controlled clinical trial that directly compares NOWS treatments—morphine, methadone, and buprenorphine—and takes into account other types of non-drug therapies, such as behavioral interventions. The goal is to generate results that can inform clinical practice guidelines and give newborns with NOWS the best start possible. 

This site includes newborn nurseries and intensive care nurseries at 4 large
maternity centers across the Children’s Hospital of Philadelphia (CHOP) Newborn Care Network, each with a dedicated follow-up clinic, ensuring access to a large and diverse patient population for long-term study. CHOP also has a long history of successfully conducting multi-center clinical studies.

There are a dearth of integrated treatments that simultaneously address the fundamental causes of chronic pain and opioid misuse/opioid use disorder and that focus on well-being among individuals with chronic pain and opioid misuse/disorder. This research will study how to improve the lives of patients with chronic pain and opioid misuse/disorder via tailored interventions that explicitly target increasing quality of life and engagement in valued activities, the cultural centering of interventions to meet the needs of diverse patient populations and reducing stigma of chronic pain and opioid misuse/disorder. Specific research projects will i) test the effectiveness, mechanisms, and implementation of an integrated psychosocial treatment for chronic pain and opioid use disorder among individuals receiving buprenorphine from outpatient treatment clinics, and ii) will use community-based participatory research methods to develop a culturally centered strategy for screening and brief intervention of chronic pain and opioid use disorder among American Indian/Alaska Native patients in primary care settings. This research will shed light on a difficult problem and improve health and wellbeing with a focus on diverse and underserved populations.

The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative model 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 research dataset to the scientific community. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first 10 years of life. This study will take place at Washington University in St. Louis, Missouri, and will recruit participants from an urban environment with a high African American population.

Effective medications for opioid use disorder (MOUD) are approved by the Food and Drug Administration for the treatment of people with opioid use disorder; however, only a small fraction of patients who would benefit from these medications actually use them. Several reasons contribute to low MOUD use, including lack of insurance; lack of knowledge about the medications, both among patients and providers; stigma associated with MOUD; and social norms. Innovative methods are needed to help increase MOUD use. One such option is peer-led interventions that might increase patients’ interest in MOUD. One existing peer-led intervention is the Harnessing Online Peer Education (HOPE) online community intervention that has been designed to reduce stigma and increase health behavior change among stigmatized populations, such as people living with HIV. This project will investigate whether and how HOPE can be adapted for people with opioid use disorder. It will assess whether HOPE can effectively increase MOUD requests, MOUD uptake, and sustained adherence to MOUD as well as reduce overdose rates.  

There are currently no effective non-opioid-based pharmacotherapies for treatment of opioid use disorder (OUD). Glial cell line-derived neurotrophic factor (GDNF) is a beneficial protein normally present in low levels in the adult brain, and there is strong evidence that it has clinical potential as a therapy for OUD and relapse reduction. Researchers have developed a non-invasive approach that bypasses the blood-brain barrier to increase levels of GDNF using intranasal administration of gene nanoparticles that make GDNF protein within the brain. This project will test whether this intranasal GDNF gene therapy can suppress drug craving and reduce the tendency to start using a drug again after a period of abstinence in experimental models, thus providing a long-term therapeutic strategy for reducing opioid craving and preventing relapse.

Neonatal Opioid Withdrawal Syndrome (NOWS) is a condition that occurs when newborns are exposed to opioids during pregnancy. Symptoms often include tremors, excessive crying, sleep deprivation, and swallowing difficulties. Cases are rising, with a newborn affected by NOWS approximately every 15 minutes. Currently, healthcare providers in the United States lack standard, evidence-based treatments for NOWS. 

This project is part of a multi-center, randomized controlled clinical trial that directly compares NOWS treatments—morphine, methadone, and buprenorphine—and takes into account other types of non-drug therapies, such as behavioral interventions. The goal is to generate results that can inform clinical practice guidelines and give newborns with NOWS the best start possible. 

The University of Louisville serves a large, diverse population that is disproportionately affected by the opioid crisis. Mothers and infants treated by the university’s healthcare team live in rural
and urban underserved regions where the frequency of opioid use during pregnancy is among the highest in the country, with a rate estimated at 3 times the national average.

Relapse is common in people with opioid use disorder, and recovery attempts often fail within 6 months. This research project will test a novel virtual reality intervention to improve recovery outcomes for people recovering from opioid use disorder. By increasing future orientation and delay-of-reward behavior with a precision medicine personalized experience, the intervention is designed to enhance advantageous decision-making and increase positive future outcomes. The results of this study will provide critical data for creating a commercially viable software product for facilitating relapse prevention and improving opioid use disorder recovery outcomes.

Overdose fatality review teams review cases of overdose deaths to identify system gaps and innovative prevention and intervention strategies. With the rise in overdose deaths, these multidisciplinary teams require more timely population-level data to inform their recommendations. This project will develop the Overdose Touchpoints Dashboard that uses real-time data and records from multiple sources to help visualize common “overdose touchpoints” for harm reduction services and treatment opportunities. This research will compare use of the dashboard to standard overdose fatality review practices. The project will assess multiple aspects related to use of the dashboard, including process, staff attitudes, implementation successes, and usability.

The primary cause of death associated with opioids is opioid-induced respiratory depression, and there is currently no way to prevent this condition. The goal of this research is to develop a therapy to prevent opioid-induced respiratory depression without disrupting opioids’ analgesic effects. Previous research has shown that the hormone leptin, which suppresses appetite and increases metabolic rate, also stimulates breathing. This research project in a mouse model will test if the novel, brain-penetrant leptin receptor-binding protein E1/Aca can prevent fentanyl-induced breathing failure without diminishing fentanyl’s analgesic effects.