Funded Projects

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Project #	Project Title	Research Focus Area	Research Program	Administering IC	Institution(s)	Investigator(s)	Location(s)	Year Awarded
1U01DA055347-01 Show Summary	6/6 HBCD Prenatal Experiences and Longitudinal Development (PRELUDE) Consortium Vanderbilt	Enhanced Outcomes for Infants and Children Exposed to Opioids	HEALthy Brain and Child Development Study (HBCD)	NIDA	VANDERBILT UNIVERSITY	CUTTING, LAURIE E (contact); OSMUNDSON, SARAH SCHEIDERICH	Vanderbilt, TN	2021
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed) NOFO Number: RFA-DA-21-020 Summary: 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 Vanderbilt University site will enroll a diverse sample of mother-infant dyads reflective of the racial, ethnic, and economic composition of the demographics of Tennessee, including rural areas dramatically affected by the opioid crisis.
1U01DA055343-01 Show Summary	1/2 Assessing the Cumulative Impact of Early Life Substance and Environment Exposure on Child Neurodevelopment and Health	Enhanced Outcomes for Infants and Children Exposed to Opioids	HEALthy Brain and Child Development Study (HBCD)	NIDA	RHODE ISLAND HOSPITAL	DEONI, SEAN CL (contact); D'SA, VIREN ANDREW	Providence, RI	2021
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed) NOFO Number: RFA-DA-21-020 Summary: This study aims to determine how exposure to opioids and other substances affects the developing fetal brain and shapes later child cognitive outcomes. Researchers will collect neuroimaging and behavioral data, as well as measures of environmental exposures related to social equity, COVID-19, and socioeconomic factors. The project will reduce traditional barriers to participation by using innovative data collection methods and mobile labs to bring the research to underrepresented and marginalized communities. This approach aims to clarify the impact of substance exposure on child development through an equitable approach to research, with generalizable findings. The study will take place at Rhode Island Hospital, where participants will be drawn from a largely rural population.
1UG1HD107580-01 Show Summary	UAB Clinical Site HEAL Neonatal Opioid Withdrawal Pharmacological Treatments	Enhanced Outcomes for Infants and Children Exposed to Opioids	Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW)	NICHD	UNIVERSITY OF ALABAMA AT BIRMINGHAM (AL)	AMBALAVANAN, NAMASIVAYAM	Birmingham, AL	2021
NOFO Title: HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial - Clinical Sites (UG1 Clinical Trial Required) NOFO Number: RFA-HD-21-031 Summary: 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 Alabama at Birmingham routinely treats newborns with NOWS and has been part of NICHD’s Neonatal Research Network (NRN) for more than 25 years. The center has an excellent track record of enrollment in clinical studies, with successful follow-up to 2 years of age and beyond.
1R24DA055306-01 Show Summary	Wake Forest IMPOWR Dissemination Education and Coordination Center (IDEA-CC)	Clinical Research in Pain Management	Reducing Opioid-Related Harms to Treat Chronic Pain (IMPOWR and MIRHIQL)	NIDA	WAKE FOREST UNIVERSITY HEALTH SCIENCES	ADAMS, MEREDITH C B	Winston-Salem, NC	2021
NOFO Title: HEAL Initiative: Integrative Management of Chronic Pain and OUD for Whole Recovery (IMPOWR): Coordination and Dissemination Center (R24 Clinical Trial Optional) NOFO Number: RFA-DA-21-029 Summary: The IMPOWR (Integrative Management of Chronic Pain and OUD for Whole Recovery) Dissemination, Education, and Coordination Center (IDEA-CC) will develop infrastructure to amplify and create momentum for the findings of the IMPOWR initiative and other linked research networks. This center will i) rapidly deploy a communication framework to link IMPOWR clinical sites with each other and the larger HEAL research frameworks; ii) develop an educational infrastructure addressing stigma and health disparities in patients with co-morbid chronic pain and opioid misuse/disorder; iii) disseminate research findings effectively to targeted audiences; iv) develop a novel composite screening tool for chronic pain and opioid misuse/disorder; and v) harmonize processes for data collection and common data elements of chronic pain and opioid misuse/disorder measures across the IMPOWR research centers, providing a coordinated platform for gathering data from these studies. This center will rapidly disseminate key findings to stakeholders, clinicians, and patients to improve the health and wellbeing of individuals with co-occurring chronic pain and opioid misuse/disorder.
1R01MH128904-01 Show Summary	Supporting Treatment Access and Recovery for Co-Occurring Opioid Use and Mental Health Disorders (STAR-COD)	New Strategies to Prevent and Treat Opioid Addiction	Optimizing Care for People with Opioid Use Disorder and Mental Health Conditions	NIMH	University of Massachusetts Medical School	SMELSON, DAVID A (contact); GONZALEZ, GERARDO ; LI, WENJUN ; OLMSTEAD, TODD ALDEN	Worcester, MA	2021
NOFO Title: HEAL Initiative: Optimizing Multi-Component Service Delivery Interventions for People with Opioid Use Disorder, Co-Occurring Conditions, and/or Suicide Risk (R01 Clinical Trials Optional) NOFO Number: RFA-MH-21-145 Summary: Opioid use disproportionally affects people with co-occurring mental health disorders. Although medication for opioid use disorder (MOUD) is the gold standard of care, engagement rates are low. Also, it is unclear whether addition of one or more behavioral interventions improves outcomes of MOUD treatment, particularly in patients with co-occurring mental health disorders. This project evaluates the effectiveness of the “Maintaining Independence and Sobriety through Systems Integration, Outreach and Networking (MISSION)” intervention—a multi-component, cross-disciplinary, team-based treatment approach that combines three evidence-based practices with MOUD—in people with co-occurring mental health disorders. The 4-year, five-arm, randomized controlled clinical trial will determine the therapeutic benefit of adding MISSION to MOUD and identify the MISSION components that yield the largest clinical improvement and offer the greatest return on investment.