Funded Projects

Explore our currently funded projects. You may search with all three fields, then focus your results by applying any of the dropdown filters. After customizing your search, you may download results and even save your specific search for later.

Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded Sort descending
1U01DA055366-01
1/24 Healthy Brain and Child Development National Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA CEDARS-SINAI MEDICAL CENTER GAO, WEI (contact); GREGORY, KIMBERLY D; JOHNSON, SCOTT P; SMITH, LYNNE M Los Angeles, CA 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 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. The Cedars-Sinai Medical Center study site is in Los Angeles where marijuana is legal and methamphetamine use is prevalent, enabling researchers to recruit participants from high-risk populations.

1U01DA055322-01
HEALthy Brain and Child Development Study at UAB and UA Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA UNIVERSITY OF ALABAMA AT BIRMINGHAM PERALTA-CARCELEN, ADA MYRIAM (contact); NEWMAN, SHARLENE D; NEWSOM, CASSANDRA R; YERBY, LEA GEORGETTE Birmingham, AL 2021
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-021
Summary:

Researchers at the University of Alabama at Birmingham and the University of Alabama will enroll pregnant women during their second trimester and follow their infants through a comprehensive longitudinal study. This program will follow 300 mother-infant pairs to understand how early life exposure to drugs and other environmental factors affects developmental trajectories. In addition, this program will determine how genetic and biological factors interact with environmental factors to influence neurodevelopment. This study will take place at the University of Alabama at Birmingham, recruiting participants from mainly rural populations with low access to obstetric/gynecological (OB/GYN) care and high rates of substance use.

1UG1HD107653-01
Incorporating nonpharmacologic approaches into a comparative effectiveness pharmacologic trial for neonates with neonatal opioid withdrawal syndrome (NOWS) Enhanced Outcomes for Infants and Children Exposed to Opioids Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) NICHD INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS (IN) SOKOL, GREGORY M Indianapolis, IN 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.

1U01DA055352-01
1/6 HBCD Prenatal Experiences and Longitudinal Development (PRELUDE) Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA ARKANSAS CHILDREN'S HOSPITAL RES INST OU, XIAWEI (contact); ACHESON, ASHLEY ; MCKELVEY, LORRAINE M Little Rock, AR 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 HEALthy Brain and Child Development (HBCD) Prenatal Experiences and Longitudinal Development (PRELUDE) 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 Arkansas Children’s Research Institute site is in a predominantly rural state with the second highest rate of opioid prescriptions in the U.S.

1U01DA055343-01
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.

3PL1HD101059-01S2
Administrative Supplement to Increase Participant Diversity, Inclusion and Engagement in the ACT NOW OBOE Study Enhanced Outcomes for Infants and Children Exposed to Opioids Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) NICHD RESEARCH TRIANGLE INSTITUTE BANN, CARLA M Research Triangle Park, NC 2021
NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
NOFO Number: NOT-NS-21-025
Summary:

The ACT NOW Outcomes of Babies with Opioid Exposure (OBOE) Study – also called the ACT NOW Longitudinal Study – is a longitudinal cohort study to prospectively examine longitudinal outcomes from birth to 2 years of age among infants who were exposed to opioids in utero as compared to matched controls. The objectives of this study are to i) determine the impact of pre-birth opioid exposure on brain structure and connectivity over the first 2 years of life, ii) define medical, developmental, and behavioral outcomes over the first 2 years of life in infants exposed to opioids, and iii) Explore whether and how the home environment, maternal mental health, and parenting affect brain connectivity and neurodevelopment trajectories over the first 2 years of life. This research will use an innovative approach to engage a more diverse study population and thereby improve the generalizability of the research findings.

1U01DA055353-01
5/24 Healthy Brain and Child Development National Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA BOSTON CHILDREN'S HOSPITAL GRANT, PATRICIA ELLEN (contact); BOSQUET ENLOW, MICHELLE A Boston, MA 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 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. The Boston Children’s Hospital study site is in Massachusetts, which has the fifth highest rate of opioid use in the U.S., and twice the U.S. average incidence of opioid use disorder in delivering mothers.

1U01DA055370-01
21/24 Healthy Brain and Child Development National Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA UNIVERSITY OF WISCONSIN-MADISON DEAN III, DOUGLAS CARL (contact); POEHLMANN-TYNAN, JULIE A Madison, WI 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 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 the University of Wisconsin, Madison, where researchers will have access to a diverse group of people, including women with criminal justice involvement.

3PL1HD101059-01S3
Administrative Supplement for ACT NOW OBOE Longitudinal Study Enhanced Outcomes for Infants and Children Exposed to Opioids Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) NICHD RESEARCH TRIANGLE INSTITUTE (NC) BANN, CARLA M Research Triangle Park, NC 2021
NOFO Title:
NOFO Number: PA-20-272
1U01DA055355-01
9/24 Healthy Brain and Child Development National Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA NORTHWESTERN UNIVERSITY AT CHICAGO WAKSCHLAG, LAUREN S (contact); NORTON, ELIZABETH SPENCER Chicago, IL 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 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 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. The Northwestern University study site is in Chicago where rates of prenatal substance use are rising and consistent with the national trend. This site will recruit a diverse urban sample of mother-infant pairs reflecting the population of Chicago.

1U01DA055349-01
10/24 Healthy Brain and Child Development National Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA OSU CENTER FOR HEALTH SCIENCES CROFF, JULIE MAY (contact); HAYS-GRUDO, JENNIFER ; MORRIS, AMANDA S Tulsa, OK 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 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 Oklahoma State University Center for Health Sciences and recruit diverse people from an urban area, including American Indian populations.

1U01DA055344-01
5/6 HBCD Prenatal Experiences and Longitudinal Development (PRELUDE) Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA UNIV OF NORTH CAROLINA CHAPEL HILL LIN, WEILI (contact); GREWEN, KAREN M Chapel Hill, NC 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 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.

1U01DA055363-01
12/24 Healthy Brain and Child Development National Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA OREGON HEALTH & SCIENCE UNIVERSITY SULLIVAN, ELINOR L (contact); GRAHAM, ALICE M; NAGEL, BONNIE J Portland, OR 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 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 Oregon Health and Science University, giving researchers access to people in a region with very high rates of opioid misuse.

1U01DA055369-01
14/24 The Healthy Brain & Child Development National Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA UNIVERSITY OF CALIFORNIA, SAN DIEGO BANDOLI, GRETCHEN E (contact); GAHAGAN, SHEILA San Diego, CA 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 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. The University of San Diego study site will recruit a diverse cohort of mother-infant pairs, including Hispanic and American Indian individuals.

1U01DA055371-01
17/24 Healthy Brain and Child Development National Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA UNIVERSITY OF MINNESOTA WILSON, SYLIA (contact); GEORGIEFF, MICHAEL K; ZILVERSTAND, ANNA Minneapolis, MN 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 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 the University of Minnesota and will provide access to a largely rural population.

1U01DA055361-01
13/24 The Healthy Brain and Child Development National Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA PENNSYLVANIA STATE UNIVERSITY-UNIV PARK PEREZ-EDGAR, KORALY E (contact); ZGIERSKA, ALEKSANDRA EWA University Park, PA 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 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. The Pennsylvania State University study site is in a region hard hit by opioid and methamphetamine use disorders and will recruit mother-infant pairs from largely rural communities.

1U24DA055325-01
The Healthy Brain and Child Development National Consortium Administrative Core Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA UNIVERSITY OF CALIFORNIA, SAN DIEGO CHAMBERS, CHRISTINA (contact); NELSON, CHARLES ALEXANDER La Jolla, CA 2021
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Consortium Administrative Core (U24 - Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-022
Summary:

The HEALthy Brain and Child Development National Consortium (HBCD-NC) Administrative Core (HCAC) will coordinate efforts across all sites in the HBCD-NC consortium to ensure that the consortium meets its primary objective to establish a normative model of developmental trajectories over the first 10 years of life. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. The HCAC will oversee study design and monitor the progress of each site’s ability to carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. This administrative core is located at the University of California, San Diego.

1U01DA055316-01
16/24 Healthy Brain and Child Development National Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA UNIV OF MARYLAND, COLLEGE PARK FOX, NATHAN A (contact); HARDEN, BRENDA J; RIGGINS, TRACY L College Park, MD 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 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. The University of Maryland College Park study site is midway between Washington, DC, and Baltimore, Maryland, and will recruit a diverse sample of mother-infant pairs from across the region.

1U24DA055330-01
Healthy Brain and Child Development National Consortium Data Coordinating Center Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA WASHINGTON UNIVERSITY SMYSER, CHRISTOPHER DANIEL (contact); DALE, ANDERS M; FAIR, DAMIEN A St Louis, MO 2021
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Data Coordinating Center (U24)
NOFO Number: RFA-DA-21-023
Summary:

The HEALthy Brain and Child Development National Consortium (HBCD-NC) Data Coordinating Center (HDCC) will provide data management and oversight to all HBCD-NC sites to ensure the consortium’s primary objective of establishing a normative template of developmental trajectories over the first 10 years of life is met. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. The HDCC will coordinate data collection, data quality, data harmonization, data sharing, and data analysis efforts that are central to the consortium’s ability to implement a common research protocol. The HDCC will assemble all data across the consortium sites and distribute a comprehensive and well curated research dataset to the scientific community at large. The HDCC is tightly integrated with the HEALthy Brain and Child Development Administrative Core (HCAC) and includes a multi-institution investigative team at the University of Minnesota, University of California, San Diego, and Washington University at St Louis.

1U01DA055354-01
20/24 The Healthy Brain and Child Development National Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA UNIVERSITY OF VERMONT & ST AGRIC COLLEGE POTTER, ALEXANDRA S (contact); GARAVAN, HUGH P Burlington, VT 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 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).

1U24HD107621-01
Data Coordinating Center (DCC) for the Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial (NOWS PhaCET) Enhanced Outcomes for Infants and Children Exposed to Opioids Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) NICHD RESEARCH TRIANGLE INSTITUTE (NC) DAS, ABHIK Research Triangle Park, NC 2021
NOFO Title: HEAL Initiative: Data Coordinating Center for the Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial (U24 Clinical Trial Required)
NOFO Number: RFA-HD-21-032
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. 

This site will serve as the Data Coordinating Center for the clinical trial to provide high-quality and impartial biostatistical expertise for all the study sites.

1U01DA055347-01
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.

1UG1HD107580-01
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.

1U01DA055358-01
15/24 Healthy Brain and Child Development National Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA UNIVERSITY OF FLORIDA GURKA, MATTHEW JAMES (contact); GURKA, KELLY K; SCOTT, LISA S Gainesville, FL 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 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. The University of Florida study site will recruit a diverse group of mother-infant pairs from urban and rural communities in North Central Florida.

1UG1HD107650-01
HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial Clinical Site Enhanced Outcomes for Infants and Children Exposed to Opioids Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) NICHD UNIV OF ARKANSAS FOR MED SCIS  (AR) HALL, RICHARD WHITTINGTON  Little Rock, AR 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. 

Arkansas is a rural state with the second highest opioid prescription rate in the nation and is in the top 3 states nationwide for opioid prescriptions to pregnant mothers. This site has extensive experience in opioid research and conducting multi-center clinical trials. It also provides care to a diverse population.