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<select aria-label="Research Focus Area" data-drupal-selector="edit-rfa" id="edit-rfa" name="rfa" class="form-select"><option value="All" selected="selected">Research Focus Area</option><option value="81">Clinical Research in Pain Management</option><option value="40331">Cross-Cutting Research</option><option value="71">Enhanced Outcomes for Infants and Children Exposed to Opioids</option><option value="66">New Strategies to Prevent and Treat Opioid Addiction</option><option value="76">Novel Therapeutic Options for Opioid Use Disorder and Overdose</option><option value="86">Preclinical and Translational Research in Pain Management</option><option value="46831">Training the Next Generation of Researchers in HEAL</option><option value="61">Translation of Research to Practice for the Treatment of Opioid Addiction</option></select>
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<span id="project-title-39441"> <a href="https://reporter.nih.gov/project-details/10379751" target="_blank">1U01DA055316-01</a>
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<td headers="view-title-table-column" class="views-field views-field-title">16/24 Healthy Brain and Child Development National Consortium </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/infants-and-children" hreflang="en">Enhanced Outcomes for Infants and Children Exposed to Opioids</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/infants-and-children/healthy-brain" hreflang="en">HEALthy Brain and Child Development (HBCD) Study</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">UNIV OF MARYLAND, COLLEGE PARK </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">FOX, NATHAN A (contact); HARDEN, BRENDA J; RIGGINS, TRACY L </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">College Park, MD </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
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<strong>NOFO Title:</strong> HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-21-020.html" target="_blank">RFA-DA-21-020</a>
<br>
<strong>Summary:</strong>
<br>
<p>The&nbsp;HEALthy&nbsp;Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life.&nbsp;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.&nbsp;The HBCD-NC will collect&nbsp;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&nbsp;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&nbsp;pairs from across the region.</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-39481"> <a href="https://reporter.nih.gov/project-details/10378974" target="_blank">1U01DA055360-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">4/24 Healthy Brain and Child Development National Consortium </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/infants-and-children" hreflang="en">Enhanced Outcomes for Infants and Children Exposed to Opioids</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/infants-and-children/healthy-brain" hreflang="en">HEALthy Brain and Child Development (HBCD) Study</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">EMORY UNIVERSITY </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">KABLE, JULIE A (contact); COLES, CLAIRE D </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Atlanta, GA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-21-020.html" target="_blank">RFA-DA-21-020</a>
<br>
<strong>Summary:</strong>
<br>
<p>The&nbsp;HEALthy&nbsp;Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life.&nbsp;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.&nbsp;The HBCD-NC will collect&nbsp;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&nbsp;followed for the first 10 years of life.&nbsp;This study will be conducted at&nbsp;Emory University School of Medicine&nbsp;in&nbsp;Atlanta, Georgia,&nbsp;allowing access to a diverse population&nbsp;with&nbsp;a high representation of&nbsp;Black/African American women.</p>
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<span id="project-title-39526"> <a href="https://reporter.nih.gov/project-details/10378922" target="_blank">1U01DA055363-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">12/24 Healthy Brain and Child Development National Consortium </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/infants-and-children" hreflang="en">Enhanced Outcomes for Infants and Children Exposed to Opioids</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/infants-and-children/healthy-brain" hreflang="en">HEALthy Brain and Child Development (HBCD) Study</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">OREGON HEALTH &amp; SCIENCE UNIVERSITY </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">SULLIVAN, ELINOR L (contact); GRAHAM, ALICE M; NAGEL, BONNIE J </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Portland, OR </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-21-020.html" target="_blank">RFA-DA-21-020</a>
<br>
<strong>Summary:</strong>
<br>
<p>The&nbsp;HEALthy&nbsp;Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life.&nbsp;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.&nbsp;The HBCD-NC will collect&nbsp;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&nbsp;followed for the first 10 years of life.&nbsp;This study will take place at Oregon Health and Science University, giving researchers access to&nbsp;people&nbsp;in a region with very high rates of opioid misuse.</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-39566"> <a href="https://reporter.nih.gov/project-details/10378942" target="_blank">1UG1HD107627-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial New Mexico Site </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/infants-and-children" hreflang="en">Enhanced Outcomes for Infants and Children Exposed to Opioids</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/infants-and-children/act-now" hreflang="en">Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW)</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NICHD </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR  (NM) </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">LEEMAN, LAWRENCE M </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Albuquerque, NM </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
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<strong>NOFO Title:</strong> HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial - Clinical Sites (UG1 Clinical Trial Required)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/rfa-hd-21-031.html" target="_blank">RFA-HD-21-031</a>
<br>
<strong>Summary:</strong>
<br>
<p>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.&nbsp;</p>
<p>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.&nbsp;</p>
<p>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.</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-39251"> <a href="https://reporter.nih.gov/search/DKEWtMnAD02-vkKfT7qn7w/project-details/10267804" target="_blank">1OT2NS122680-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">A Randomized, Double-blind, Placebo-controlled, Parallel, 20-week, Phase 2b Study of Topical Pirenzepine (WST-057) or Placebo in Type 2 Diabetes Mellitus Patients with Painful Diabetic Peripheral Neuropathy </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/clinical-research" hreflang="en">Clinical Research in Pain Management</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/clinical-research/eppic-net" hreflang="en">Early Phase Pain Investigation Clinical Network (EPPIC-Net)</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NINDS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">ROBINSON-PAPP, JESSICA </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">New York, NY </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
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<strong>NOFO Title:</strong> HEAL Initiative: EPPIC-Net Pain Research - Application for Clinical Trial and Related Activities (OT2)
<br>
<strong>NOFO Number:</strong> <a href="">OTA-20-008</a>
<br>
<strong>Summary:</strong>
<br>
<p>People with diabetes are at risk for painful diabetic peripheral neuropathy. This pain may be experienced as burning, aching, hypersensitivity to touch, or simply as pain, and there are no currently FDA-approved medications that reduce its symptoms. This phase 2 clinical trial, through the EPPIC-NET program, will test a potential new treatment for painful diabetic peripheral neuropathy. The treatment, WST-057 (topical pirenzepine 4%), is a molecule that was developed in the 1980s and marketed throughout Europe and Asia in an oral form to treat gastric ulcers. Studies show that this type of molecule can increase the density of certain nerve fibers, which has been linked with improve patient-reported outcome measures for painful diabetic peripheral neuropathy.</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-39291"> <a href="https://reporter.nih.gov/project-details/10397259" target="_blank">3-UH3-DA050173-02</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Optimized Interventions to Prevent Opioid Use Disorder among Adolescents and Young Adults in the Emergency Department </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/new-strategies" hreflang="en">New Strategies to Prevent and Treat Opioid Addiction</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/new-strategies/preventing-opioid-use-disorder" hreflang="en">Preventing Opioid Use Disorder </a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">UNIVERSITY OF MICHIGAN AT ANN ARBOR </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">WALTON, MAUREEN A </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations"> </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
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<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Number:</strong> <a href=""></a>
<br>
<strong>Summary:</strong>
<br>
<p>The emergency department (ED) is an ideal venue to reach and intervene with adolescents and young adults at risk for opioid misuse, particularly as young adults may disconnect from primary care when transitioning out of pediatric medicine. This study will evaluate the efficacy of interventions of varying type/intensity to prevent/reduce opioid misuse or opioid use disorder (OUD). The research leverages technology that is appealing to youth to facilitate intervention delivery by health coaches. In this study, adolescents and young adults in the ED screening positive for opioid use or misuse will be randomly assigned to one of four intervention conditions with outcomes measured at 4, 8, and 12 months. Technology-driven, scalable interventions delivered via health coach allow for real-time tailoring to the rapidly changing opioid epidemic, with the potential for a sustainable impact on preventing escalation of opioid misuse among adolescents and young adults.&nbsp;While we know that Black/African American youth are at increased risk for opioid and other substance use, they&nbsp;often do not participate in research studies. As a result, we do not know how well prevention interventions work with Black/African American individuals.&nbsp;This supplement will focus on increasing participant diversity and inclusion by recruiting additional Black/African American participants for this ongoing randomized controlled trial to study technology-driven prevention interventions.</p>
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<span id="project-title-39366"> <a href="https://reporter.nih.gov/project-details/10378982" target="_blank">1U01DA055359-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">18/24 Healthy Brain and Child Development National Consortium </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/infants-and-children" hreflang="en">Enhanced Outcomes for Infants and Children Exposed to Opioids</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/infants-and-children/healthy-brain" hreflang="en">HEALthy Brain and Child Development (HBCD) Study</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">BAKHIREVA, LUDMILA NICOLE (contact); LEEMAN, LAWRENCE M </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Albuquerque, NM </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
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<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-21-020.html" target="_blank">RFA-DA-21-020</a>
<br>
<strong>Summary:</strong>
<br>
<p>The&nbsp;HEALthy&nbsp;Brain and Child Development National Consortium (HBCD-NC) will establish a normative template of developmental trajectories over the first 10 years of life.&nbsp;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.&nbsp;The HBCD-NC will collect&nbsp;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&nbsp;followed for the first 10 years of life. The University of New Mexico Health Science Center study site&nbsp;is in&nbsp;a largely rural/mixed state with one of the highest rates of overdose in the nation. This site will enroll&nbsp;diverse&nbsp;mother-infant pairs and partners or caregivers, including Hispanic/Latinx and American Indian individuals.</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-39416"> <a href="https://reporter.nih.gov/project-details/10154341" target="_blank">1UG3DA050942-01A1</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">An Intranasal GDNF Gene Therapy for Opioid Relapse Reduction </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/therapeutic-options" hreflang="en">Novel Therapeutic Options for Opioid Use Disorder and Overdose</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/therapeutic-options/focusing-development" hreflang="en">Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">NORTHEASTERN UNIVERSITY </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">WASZCZAK, BARBARA LEE </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Boston, MA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
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<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PAR-20-092.html" target="_blank">PAR-20-092</a>
<br>
<strong>Summary:</strong>
<br>
<p>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&nbsp;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.</p>
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<span id="project-title-39456"> <a href="https://reporter.nih.gov/project-details/10379601" target="_blank">1U01DA055354-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">20/24 The Healthy Brain and Child Development National Consortium </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/infants-and-children" hreflang="en">Enhanced Outcomes for Infants and Children Exposed to Opioids</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/infants-and-children/healthy-brain" hreflang="en">HEALthy Brain and Child Development (HBCD) Study</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">UNIVERSITY OF VERMONT &amp; ST AGRIC COLLEGE </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">POTTER, ALEXANDRA S (contact); GARAVAN, HUGH P </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Burlington, VT </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
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<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-21-020.html" target="_blank">RFA-DA-21-020</a>
<br>
<strong>Summary:</strong>
<br>
<p>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).</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-39496"> <a href="https://reporter.nih.gov/project-details/10379745" target="_blank">1U01DA055338-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">8/24 The Healthy Brain and Child Development National Consortium </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/infants-and-children" hreflang="en">Enhanced Outcomes for Infants and Children Exposed to Opioids</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/infants-and-children/healthy-brain" hreflang="en">HEALthy Brain and Child Development (HBCD) Study</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">NEW YORK UNIVERSITY SCHOOL OF MEDICINE </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">THOMASON, MORIAH E (contact); BERRY, OBIANUJU ; SHUFFREY, LAUREN CHRISTINE </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">New York, NY </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
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<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-21-020.html" target="_blank">RFA-DA-21-020</a>
<br>
<strong>Summary:</strong>
<br>
<p>The&nbsp;HEALthy&nbsp;Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life.&nbsp;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.&nbsp;The HBCD-NC will collect&nbsp;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&nbsp;followed for the first decade of life. This study will take place at New York University School of Medicine, allowing researchers to recruit participants from two of the largest private and public health systems in the country&nbsp;and include&nbsp;racial and ethnic minorities of varying economic levels.</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-39541"> <a href="https://reporter.nih.gov/project-details/10381046" target="_blank">1U24DA055330-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Healthy Brain and Child Development National Consortium Data Coordinating Center </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/infants-and-children" hreflang="en">Enhanced Outcomes for Infants and Children Exposed to Opioids</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/infants-and-children/healthy-brain" hreflang="en">HEALthy Brain and Child Development (HBCD) Study</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">WASHINGTON UNIVERSITY </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">SMYSER, CHRISTOPHER DANIEL (contact); DALE, ANDERS M; FAIR, DAMIEN A </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">St Louis, MO </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
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<strong>NOFO Title:</strong> HEAL Initiative: HEALthy Brain and Child Development Data Coordinating Center (U24)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-21-023.html" target="_blank">RFA-DA-21-023</a>
<br>
<strong>Summary:</strong>
<br>
<p>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 consortiums 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 consortiums 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.</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-39581"> <a href="https://reporter.nih.gov/project-details/10380355" target="_blank">1UG1HD107649-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Neonatal Opioid Withdrawal Syndrome (NOWS) in Kentucky: Improving Outcomes for Infants </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/infants-and-children" hreflang="en">Enhanced Outcomes for Infants and Children Exposed to Opioids</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/infants-and-children/act-now" hreflang="en">Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW)</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NICHD </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">UNIVERSITY OF LOUISVILLE  (KY) </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">DEVLIN-PHINNEY, LORI ANN (contact); TELANG, SUCHETA </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Louisville, KY </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
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<strong>NOFO Title:</strong> HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial - Clinical Sites (UG1 Clinical Trial Required)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/rfa-hd-21-031.html" target="_blank">RFA-HD-21-031</a>
<br>
<strong>Summary:</strong>
<br>
<p>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.&nbsp;</p>
<p>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.&nbsp;</p>
<p>The University of Louisville serves a large, diverse population that is disproportionately affected by the opioid crisis. Mothers and infants treated by the universitys healthcare team live in rural<br>
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.</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-39266"> <a href="https://reporter.nih.gov/project-details/10391075" target="_blank">1RM1DA055437-01</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">Integrated Care for Chronic Pain and Opioid Use Disorder: The IMPOWR Research Center at Montefiore/Einstein (IMPOWR-ME) </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/clinical-research" hreflang="en">Clinical Research in Pain Management</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/clinical-research/integrative-management-chronic-pain" hreflang="en">Reducing Opioid-Related Harms to Treat Chronic Pain (IMPOWR and MIRHIQL)</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">ALBERT EINSTEIN COLLEGE OF MEDICINE </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">STARRELS, JOANNA L (contact); ARNSTEN, JULIA H; GABBAY, VILMA </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Bronx, NY </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
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<strong>NOFO Title:</strong> HEAL Initiative: Integrative Management of Chronic Pain and OUD for Whole Recovery (IMPOWR): Research Centers (RM1 Clinical Trial Required)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-21-030.html" target="_blank">RFA-DA-21-030</a>
<br>
<strong>Summary:</strong>
<br>
<p>Chronic pain and opioid use disorder often occur together, but there are a striking lack of integrated treatments accessible to people in need, particularly Black and Hispanic individuals living and seeking care in under resourced settings. This research will examine multi-modal, evidence-based practices in diverse health care settings and among diverse populations with both chronic pain and opioid misuse/disorder. The first project will examine the effects of yoga and physical therapy onsite at methadone opioid treatment clinics. The second project will test Acceptance and Commitment Therapy and a care-management smartphone app for individuals in&nbsp;primary-care&nbsp;based buprenorphine treatment. The third project will compare&nbsp;microdosing&nbsp;versus standard doses/timing of buprenorphine for hospitalized patients. All three projects will improve access to care for Black and Hispanic individuals in&nbsp;under resourced settings by bringing integrated treatments to them. The interventions have high potential to be used broadly.</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-39336"> <a href="https://reporter.nih.gov/project-details/10426755" target="_blank">1K24AR081143-01</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">Mentorship of Junior Investigators on HEAL-SKOAP </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/clinical-research" hreflang="en">Clinical Research in Pain Management</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIAMS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">JOHNS HOPKINS UNIVERSITY </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Campbell, Claudia Michelle </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Baltimore, MD </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
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<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> Midcareer Investigator Award in Patient-Oriented Research (Parent K24 Independent Clinical Trial Required)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-20-193.html" target="_blank">PA-20-193</a>
<br>
<strong>Summary:</strong>
<br>
<p>The HEAL-funded Sequenced-strategy for Improving Outcomes in People with Knee Osteoarthritis Pain (SKOAP) clinical trial evaluates behavioral, pharmacologic, and procedural interventions for patients with knee osteoarthritis pain. It is designed to mimic clinical care for these patients by first testing the effectiveness of conservative and nonsurgical interventions before considering surgical interventions. It is a large-scale clinical trial with a novel design that evaluates multidisciplinary treatments. Therefore, it offers a unique training opportunity for junior investigators from various disciplines who are interested in pain research and management. This mentoring award will allow a selected investigator to train junior investigators by providing protected, mentorship-focused time.</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-39386"> <a href="https://reporter.nih.gov/project-details/10379631" target="_blank">1U01DA055353-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">5/24 Healthy Brain and Child Development National Consortium </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/infants-and-children" hreflang="en">Enhanced Outcomes for Infants and Children Exposed to Opioids</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/infants-and-children/healthy-brain" hreflang="en">HEALthy Brain and Child Development (HBCD) Study</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">BOSTON CHILDREN&#039;S HOSPITAL </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">GRANT, PATRICIA ELLEN (contact); BOSQUET ENLOW, MICHELLE A </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Boston, MA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
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<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-21-020.html" target="_blank">RFA-DA-21-020</a>
<br>
<strong>Summary:</strong>
<br>
<p>The&nbsp;HEALthy&nbsp;Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life.&nbsp;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.&nbsp;The HBCD-NC will collect&nbsp;neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most&nbsp; participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and&nbsp;followed for the first 10 years of life.&nbsp;The Boston Childrens Hospital study site&nbsp;is in&nbsp;Massachusetts,&nbsp;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.</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-39431"> <a href="https://reporter.nih.gov/project-details/10378969" target="_blank">1U01DA055361-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">13/24 The Healthy Brain and Child Development National Consortium </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/infants-and-children" hreflang="en">Enhanced Outcomes for Infants and Children Exposed to Opioids</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/infants-and-children/healthy-brain" hreflang="en">HEALthy Brain and Child Development (HBCD) Study</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">PENNSYLVANIA STATE UNIVERSITY-UNIV PARK </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">PEREZ-EDGAR, KORALY E (contact); ZGIERSKA, ALEKSANDRA EWA </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">University Park, PA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-21-020.html" target="_blank">RFA-DA-21-020</a>
<br>
<strong>Summary:</strong>
<br>
<p>The&nbsp;HEALthy&nbsp;Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life.&nbsp;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.&nbsp;The HBCD-NC will collect&nbsp;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&nbsp;followed for the first 10 years of life. The Pennsylvania State University study site&nbsp;is in&nbsp;a region hard hit by opioid and methamphetamine use&nbsp;disorders and will recruit mother-infant pairs from&nbsp;largely rural communities.</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-39471"> <a href="https://reporter.nih.gov/project-details/10379506" target="_blank">1U01DA055358-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">15/24 Healthy Brain and Child Development National Consortium </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/infants-and-children" hreflang="en">Enhanced Outcomes for Infants and Children Exposed to Opioids</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/infants-and-children/healthy-brain" hreflang="en">HEALthy Brain and Child Development (HBCD) Study</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">UNIVERSITY OF FLORIDA </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">GURKA, MATTHEW JAMES (contact); GURKA, KELLY K; SCOTT, LISA S </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Gainesville, FL </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
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<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-21-020.html" target="_blank">RFA-DA-21-020</a>
<br>
<strong>Summary:</strong>
<br>
<p>The&nbsp;HEALthy&nbsp;Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life.&nbsp;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.&nbsp;The HBCD-NC will collect&nbsp;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&nbsp;followed for the first 10 years of life.&nbsp;The University of Florida study site will recruit a diverse group of mother-infant pairs from urban and rural communities in&nbsp;North Central Florida.</p>
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<span id="project-title-39516"> <a href="https://reporter.nih.gov/project-details/10378328" target="_blank">1U01DA055370-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">21/24 Healthy Brain and Child Development National Consortium </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/infants-and-children" hreflang="en">Enhanced Outcomes for Infants and Children Exposed to Opioids</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/infants-and-children/healthy-brain" hreflang="en">HEALthy Brain and Child Development (HBCD) Study</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">UNIVERSITY OF WISCONSIN-MADISON </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">DEAN III, DOUGLAS CARL (contact); POEHLMANN-TYNAN, JULIE A </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Madison, WI </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
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<tr id="summary18" class="summary collapse even fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-21-020.html" target="_blank">RFA-DA-21-020</a>
<br>
<strong>Summary:</strong>
<br>
<p>The&nbsp;HEALthy&nbsp;Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life.&nbsp;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.&nbsp;The HBCD-NC will collect&nbsp;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&nbsp;followed for the first 10 years of life.&nbsp;This study will take place at the University of Wisconsin, Madison, where researchers will have access to a diverse group of&nbsp;people, including women with criminal justice involvement.</p>
</div>
</td>
</tr> <!-- summary-->
<tr class="odd">
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-39556"> <a href="https://reporter.nih.gov/project-details/10380359" target="_blank">1UG1HD107650-01</a>
</span>
<br>
<a class="expand-link" data-toggle="collapse" href="#summary19" role="button" aria-expanded="false" aria-controls="collapseExample">
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</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial Clinical Site </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/infants-and-children" hreflang="en">Enhanced Outcomes for Infants and Children Exposed to Opioids</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/infants-and-children/act-now" hreflang="en">Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW)</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NICHD </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">UNIV OF ARKANSAS FOR MED SCIS  (AR) </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">HALL, RICHARD WHITTINGTON  </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Little Rock, AR </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
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<tr id="summary19" class="summary collapse odd fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial - Clinical Sites (UG1 Clinical Trial Required)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/rfa-hd-21-031.html" target="_blank">RFA-HD-21-031</a>
<br>
<strong>Summary:</strong>
<br>
<p>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.&nbsp;</p>
<p>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.&nbsp;</p>
<p>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.</p>
</div>
</td>
</tr> <!-- summary-->
<tr class="even">
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-39281"> <a href="https://reporter.nih.gov/project-details/10426787" target="_blank">1K24NS126570-01</a>
</span>
<br>
<a class="expand-link" data-toggle="collapse" href="#summary20" role="button" aria-expanded="false" aria-controls="collapseExample">
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</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">Mentorship in Precision Pain Medicine via the Early Phase Pain Investigation Clinical Network </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/clinical-research" hreflang="en">Clinical Research in Pain Management</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NINDS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">Brigham and Women&#039;s Hospital </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Edwards, Robert R </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Boston, MA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
</tr> <!-- closing head of time -->
<tr id="summary20" class="summary collapse even fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> Midcareer Investigator Award in Patient-Oriented Research (Parent K24 Independent Clinical Trial Required)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/pa-20-193.html" target="_blank">PA-20-193</a>
<br>
<strong>Summary:</strong>
<br>
<p>Throughout&nbsp;clinical pain research, there is a need to increase the workforce of&nbsp;researchers familiar with individualized treatment strategies known as precision pain medicine. This mentoring award will leverage EPPIC-Nets Clinical Coordinating Center resources to encourage interest in&nbsp;clinical pain management, in particular through multidisciplinary pain research projects. A selected clinician-researcher&nbsp; will mentor&nbsp;early career investigators and provide them with hands-on training activities and other skill-building&nbsp;experiences&nbsp;in&nbsp;clinical pain research, with a focus on precision pain medicine, biomarker development, and pain assessment. Mentoring activities will include formal educational coursework, inclusion in EPPIC-Net working groups, and collaborative writing experiences.</p>
</div>
</td>
</tr> <!-- summary-->
<tr class="odd">
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-39356"> <a href="https://reporter.nih.gov/project-details/10381109" target="_blank">1U01DA055342-01</a>
</span>
<br>
<a class="expand-link" data-toggle="collapse" href="#summary21" role="button" aria-expanded="false" aria-controls="collapseExample">
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</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">4/6 HBCD Prenatal Experiences and Longitudinal Development (PRELUDE) Consortium </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/infants-and-children" hreflang="en">Enhanced Outcomes for Infants and Children Exposed to Opioids</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/infants-and-children/healthy-brain" hreflang="en">HEALthy Brain and Child Development (HBCD) Study</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">CINCINNATI CHILDRENS HOSP MED CTR </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">MERHAR, STEPHANIE L (contact); VANNEST, JENNIFER J </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Cincinnati, OH </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
</tr> <!-- closing head of time -->
<tr id="summary21" class="summary collapse odd fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-21-020.html" target="_blank">RFA-DA-21-020</a>
<br>
<strong>Summary:</strong>
<br>
<p>The objective of the HEALthy Brain and Child Development (HBCD) Prenatal Experiences and Longitudinal Development (PRELUDE) multi-site consortium&nbsp;is&nbsp;to characterize typical brain development from birth through childhood.&nbsp;All sites in this&nbsp;consortium&nbsp;will measure the influence of key biological and environmental factors on child social, cognitive, and emotional development. Researchers will&nbsp;assess how prenatal exposure to opioids and other substances, as well as other adverse environmental factors, affect brain development and other child health&nbsp;outcomes.&nbsp;The&nbsp;Cincinnati Childrens Hospital study site&nbsp;is in&nbsp;a&nbsp;region hit hard by the opioid crisis&nbsp;and has a large catchment area that includes many rural counties in Ohio, Kentucky, Indiana, and West Virginia.</p>
</div>
</td>
</tr> <!-- summary-->
<tr class="even">
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-39406"> <a href="https://reporter.nih.gov/project-details/10400321" target="_blank">1UF1DA054817-01A1</a>
</span>
<br>
<a class="expand-link" data-toggle="collapse" href="#summary22" role="button" aria-expanded="false" aria-controls="collapseExample">
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</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">Preclinical Development of Novel Dual OXR/KOR Antagonists for Treatment of Substance Use Disorder </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/therapeutic-options" hreflang="en">Novel Therapeutic Options for Opioid Use Disorder and Overdose</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/therapeutic-options/focusing-development" hreflang="en">Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">HAGER BIOSCIENCES, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">BUTERA, JOHN A </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Bethlehem, PA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
</tr> <!-- closing head of time -->
<tr id="summary22" class="summary collapse even fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> Grand Opportunity in Medications Development for Substance-Use Disorders (U01 - Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PAR-19-327.html" target="_blank">PAR-19-327</a>
<br>
<strong>Summary:</strong>
<br>
<p>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.</p>
</div>
</td>
</tr> <!-- summary-->
<tr class="odd">
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-39446"> <a href="https://reporter.nih.gov/project-details/10400589" target="_blank">1UF1DA053806-01A1</a>
</span>
<br>
<a class="expand-link" data-toggle="collapse" href="#summary23" role="button" aria-expanded="false" aria-controls="collapseExample">
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</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">Development of a novel OTC naloxone product to be affordably priced and widely accessible </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/therapeutic-options" hreflang="en">Novel Therapeutic Options for Opioid Use Disorder and Overdose</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/therapeutic-options/focusing-development" hreflang="en">Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">POCKET NALOXONE CORP. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">KIM, SONNIE </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Bethesda, MD </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
</tr> <!-- closing head of time -->
<tr id="summary23" class="summary collapse odd fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> Grand Opportunity in Medications Development for Substance-Use Disorders (U01 - Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PAR-19-327.html" target="_blank">PAR-19-327</a>
<br>
<strong>Summary:</strong>
<br>
<p>Naloxone is a safe and effective opioid antagonist, but currently available products are burdened with high cost and limited accessibility due to a need for a prescription or being kept behind-the-counter. In response to the FDA putting out an unprecedented call for an&nbsp;over the counter&nbsp;naloxone product, Pocket Naloxone Corp. is developing a novel intranasal delivery method for naloxone intended to be low-priced and widely accessible. This project will culminate in a New Drug Application to the FDA for over-the-counter approval to meet the urgent need for widespread access to a reliable, easy-to-use naloxone product for use in an emergency by non-medical individuals.</p>
</div>
</td>
</tr> <!-- summary-->
<tr class="even">
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-39486"> <a href="https://reporter.nih.gov/project-details/10380210" target="_blank">1U01DA055350-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">7/24 Healthy Brain and Child Development National Consortium </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/infants-and-children" hreflang="en">Enhanced Outcomes for Infants and Children Exposed to Opioids</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/infants-and-children/healthy-brain" hreflang="en">HEALthy Brain and Child Development (HBCD) Study</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">JOHNS HOPKINS UNIVERSITY </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">VOLK, HEATHER E (contact); PEKAR, JAMES J; SATIN, ANDREW J </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Baltimore, MD </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
</tr> <!-- closing head of time -->
<tr id="summary24" class="summary collapse even fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-21-020.html" target="_blank">RFA-DA-21-020</a>
<br>
<strong>Summary:</strong>
<br>
<p>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 be conducted at Johns Hopkins University in Baltimore, Maryland, and researchers will recruit diverse participants from a range of backgrounds.</p>
</div>
</td>
</tr> <!-- summary-->
<tr class="odd">
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-39531"> <a href="https://reporter.nih.gov/project-details/10378274" target="_blank">1U01DA055371-01</a>
</span>
<br>
<a class="expand-link" data-toggle="collapse" href="#summary25" role="button" aria-expanded="false" aria-controls="collapseExample">
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">17/24 Healthy Brain and Child Development National Consortium </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/infants-and-children" hreflang="en">Enhanced Outcomes for Infants and Children Exposed to Opioids</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/infants-and-children/healthy-brain" hreflang="en">HEALthy Brain and Child Development (HBCD) Study</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">UNIVERSITY OF MINNESOTA </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">WILSON, SYLIA (contact); GEORGIEFF, MICHAEL K; ZILVERSTAND, ANNA </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Minneapolis, MN </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
</tr> <!-- closing head of time -->
<tr id="summary25" class="summary collapse odd fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-21-020.html" target="_blank">RFA-DA-21-020</a>
<br>
<strong>Summary:</strong>
<br>
<p>The&nbsp;HEALthy&nbsp;Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life.&nbsp;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.&nbsp;The HBCD-NC will collect&nbsp;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&nbsp;followed for the first 10 years of life.&nbsp;This study will take place at the University of Minnesota&nbsp;and will provide access to a&nbsp;largely&nbsp;rural population.</p>
</div>
</td>
</tr> <!-- summary-->
</tbody>
</table>
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