nih-gov/heal.nih.gov/funding/awarded?page=21
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<title>Funded Projects | NIH HEAL Initiative</title>
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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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<select aria-label="Research Program" data-drupal-selector="edit-research-program" id="edit-research-program" name="research_program" class="form-select"><option value="All" selected="selected">Research Program</option><option value="186">Acute to Chronic Pain Signatures Program</option><option value="136">Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW)</option><option value="42106">Advancing Health Equity in Pain Management </option><option value="161">Back Pain Consortium Research Program</option><option value="106">Behavioral Research to Improve Medication-Based Treatment</option><option value="42126">Collaborative Care for Polysubstance Use in Primary Care Settings (Co-Care)</option><option value="206">Development and Optimization of Non-Addictive Therapies to Treat Pain</option><option value="151">Development of Novel Immunotherapeutics for Opioid Addiction</option><option value="191">Discovery and Validation of Biomarkers, Endpoints, and Signatures for Pain Conditions</option><option value="216">Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain</option><option value="176">Early Phase Pain Investigation Clinical Network (EPPIC-Net)</option><option value="96">Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids</option><option value="146">Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose</option><option value="41416">Harm Reduction Research Network</option><option value="42121">HEAL Data2Action (HD2A)</option><option value="91">HEALing Communities Study</option><option value="141">HEALthy Brain and Child Development (HBCD) Study</option><option value="42146">Improving Delivery of Healthcare Services for Polysubstance Use</option><option value="181">Integrated Approach to Pain and Opioid Use in Hemodialysis Patients</option><option value="44116">Integrated Basic and Clinical Team-Based Research in Pain</option><option value="101">Justice Community Overdose Innovation Network (JCOIN)</option><option value="42116">Leveraging Existing and Real-Time Opioid and Pain Management Data</option><option value="42586">Native Collective Research Effort to Enhance Wellness (N CREW) Program: Addressing Overdose, Substance Use, Mental Health, and Pain </option><option value="111">Optimizing Care for People with Opioid Use Disorder and Mental Health Conditions</option><option value="126">Optimizing the Duration, Retention, and Discontinuation of Medication Treatment for Opioid Use Disorder</option><option value="44086">Optimizing the Quality, Reach, and Impact of Addiction Services</option><option value="44106">Oral Complications Arising From Pharmacotherapies to Treat Opioid Use Disorders</option><option value="166">Pain Management Effectiveness Research Network (ERN)</option><option value="171">Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM)</option><option value="211">Preclinical Screening Platform for Pain</option><option value="116">Preventing Opioid Use Disorder </option><option value="44091">Prevention and Management of Chronic Pain in Rural Populations</option><option value="131">Prevention of Progression to Moderate or Severe Opioid Use Disorder</option><option value="44111">Rapidly Assessing the Public Health Impact of Emerging Opioid Threats</option><option value="39646">Recovery Research Networks</option><option value="39621">Reducing Opioid-Related Harms to Treat Chronic Pain (IMPOWR and MIRHIQL)</option><option value="42136">Restoring Joint Health and Function to Reduce Pain (RE-JOIN)</option><option value="121">Sleep Dysfunction as a Core Feature of Opioid Use Disorder and Recovery</option><option value="42111">Small Business Programs</option><option value="40256">Stigma in Pain Management and Opioid Use Disorder</option><option value="44096">The Biology of Opioid Exposure During Pregnancy and Effects on Early Neuro-Behavioral Development</option><option value="42151">The Continuum of Care in Hospitalized Patients with Opioid Use Disorder and Infectious Complications of Drug Use (CHOICE)</option><option value="201">Translating Discoveries into Effective Devices to Treat Pain</option><option value="196">Translational Research to Advance Testing of Novel Drugs and Human Cell-Based Screening Platforms to Treat Pain and Opioid Use Disorder</option><option value="44101">Virtual Assessments to Understand Developmental Trajectories of Substance Use Exposure</option></select>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-39731"> <a href="https://reporter.nih.gov/project-details/10400379" target="_blank">3PL1HD101059-01S2</a>
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<td headers="view-title-table-column" class="views-field views-field-title">Administrative Supplement to Increase Participant Diversity, Inclusion and Engagement in the ACT NOW OBOE Study </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">RESEARCH TRIANGLE INSTITUTE </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">BANN, CARLA M </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Research Triangle Park, NC </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="summary1" 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: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
<br>
<strong>NOFO Number:</strong> <a href="">NOT-NS-21-025</a>
<br>
<strong>Summary:</strong>
<br>
<p>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 <em>in utero </em>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.</p>
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<span id="project-title-39776"> <a href="https://reporter.nih.gov/project-details/10415416" target="_blank">3U19AR076734-01S3</a>
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<td headers="view-title-table-column" class="views-field views-field-title">University of Michigan BACPAC Mechanistic Research Center </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/back-pain" hreflang="en">Back Pain Consortium Research Program</a> </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">UNIVERSITY OF MICHIGAN AT ANN ARBOR </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">CLAUW, DANIEL J </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Ann Arbor, MI </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="summary2" 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> Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for Administrative Supplements to Support Career Enhancement Related to Clinical Research on Pain (Admin Supp Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="">NOT-NS-21-048</a>
<br>
<strong>Summary:</strong>
<br>
<p>There are numerous pharmacological and non-pharmacological interventions for chronic low back pain, yet no treatment is universally effective. This award supports an early career physician to develop skills to prepare for a career in clinical pain research in an environment aiming to understand patient characteristics that predict differential responses to pain interventions and thus allow for tailored treatments. This research assesses the impact of mindfulness-based stress reduction on pain interference reported by people with chronic low back pain and explores neurobiological effects of mindfulness-based stress reduction through advanced imaging and clinical assessments.</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-39821"> <a href="https://reporter.nih.gov/project-details/10398444" target="_blank">3U19AR076734-01S4</a>
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<td headers="view-title-table-column" class="views-field views-field-title">University of Michigan BACPAC Mechanistic Research Center </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/back-pain" hreflang="en">Back Pain Consortium Research Program</a> </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">UNIVERSITY OF MICHIGAN AT ANN ARBOR </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">CLAUW, DANIEL J </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Ann Arbor, MI </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="summary3" 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: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
<br>
<strong>NOFO Number:</strong> <a href="">NOT-NS-21-025</a>
<br>
<strong>Summary:</strong>
<br>
<p>Chronic overlapping pain conditions represent up to half of all chronic pain cases and can be more debilitating than other forms of chronic pain. These conditions include but are not limited to the following: temporomandibular disorders, fibromyalgia, irritable bowel syndrome, vulvodynia, interstitial cystitis/painful bladder syndrome, painful endometriosis, chronic tension type headache, migraine headache, chronic low back pain, and chronic fatigue syndrome. Common neurobiological mechanisms have been suspected to account for the overlap between these conditions, but until recently it has been difficult to efficiently classify each condition within individual patients. A digital classification tool for clinicians has been developed for this purpose, but access to the tool remains limited. Here we propose converting this chronic overlapping pain conditions classification tool into a common web-based application format.</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-39891"> <a href="https://reporter.nih.gov/project-details/10386456" target="_blank">2R44NS115460-02</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Drug Free Nerve Block Device for the Relief of Pain and Symptoms in Migraines and other Headaches </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</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">THERMAQUIL, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">POPIELARSKI, STEPHEN (contact); YUAN, HSIANGKUO </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Philadelphia, 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: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Required)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-20-010.html" target="_blank">RFA-NS-20-010</a>
<br>
<strong>Summary:</strong>
<br>
<p>Migraines and other headaches are often debilitating for patients, yet few treatment options providing sustained relief exist. All available therapies, including frequently prescribed opioids, have considerable side effects or limitations. Therefore, novel treatment approaches are needed to reduce or eliminate the need to use opiates and other systemic pharmaceuticals. Thermaquil Inc. has developed a new way of stopping migraine and other headache pain by noninvasively blocking pain signal transmission in the head, which in initial studies allowed patients to discontinue use of opioids and other addictive pain medications. Thermaquil will now be conducting a larger randomized controlled trial to demonstrate the safety and effectiveness of this novel approach. After a baseline period, patients will be randomly assigned to the active or control condition and receive a single treatment. The study will continue for 12 weeks with the active versus control arms, before all patients will be given active therapy for an additional 12 weeks.</p>
</div>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-39931"> <a href="https://reporter.nih.gov/project-details/10400459" target="_blank">3U24AR076730-01S1</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Back Pain Consortium (BACPAC) Research Program Data Integration, Algorithm Development and Operations Management Center </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/back-pain" hreflang="en">Back Pain Consortium Research Program</a> </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">UNIV OF NORTH CAROLINA CHAPEL HILL </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">LAVANGE, LISA </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Chapel Hill, NC </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: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
<br>
<strong>NOFO Number:</strong> <a href="">NOT-NS-21-025</a>
<br>
<strong>Summary:</strong>
<br>
<p>The NIH Back Pain Consortium (BACPAC) Research Program brings together leading centers with expertise in studying and treating chronic low back pain to advance understanding of the mechanisms that underlie the condition and to identify novel treatment strategies. BACPAC is undertaking a multisite precision medicine clinical trial taking into account patient-specific information to understand which patients with chronic low back pain respond best to various nonopioid, evidence-based treatments. The trial seeks to enroll a racially, ethnically, and socioeconomically diverse patient population to ensure that the results are applicable to all Americans with chronic low back pain. This project aims to develop comprehensive recruitment and retention plans for study sites that can recruit from historically underrepresented populations in clinical research (e.g., Black and Hispanic populations) and to provide dedicated financial resources to engage patients from these populations using tailored, culturally appropriate strategies.</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-39656"> <a href="https://reporter.nih.gov/project-details/10405235" target="_blank">3U2CDA050097-03S1</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">JCOIN Coordination and Translation Center </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/research-to-practice" hreflang="en">Translation of Research to Practice for the Treatment of Opioid Addiction</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/research-to-practice/jcoin" hreflang="en">Justice Community Overdose Innovation Network (JCOIN)</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">GEORGE MASON UNIVERSITY </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">TAXMAN, FAYE S (contact); FERGUSON, WARREN J; MOLFENTER, TODD DAVID; RUDES, DANIELLE </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Fairfax, VA </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> Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for PA-20-222: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-NS-20-107.html" target="_blank">NOT-NS-20-107</a>
<br>
<strong>Summary:</strong>
<br>
<p>This research is designed to further understand implementation of medication-delivery programs in jail and/or community treatment programs based on perceptions of staff delivering medications for opioid use disorder and related services. The primary study uses a mainly quantitative approach to examine medication-delivery program implementation in jail and/or treatment settings. The study compliments ongoing research by incorporating a qualitative approach to assess perceptions of diverse staff through two interviews each with 80 individuals working in jail and/or treatment facilities involved in an ongoing study. Qualitative methods will add depth and nuance to our understanding of how medication-delivery programmatic outcomes relate to correctional staff perceptions.</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-39701"> <a href="https://reporter.nih.gov/project-details/10351640" target="_blank">3UM1DA049412-03S2</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Research Supplement to Promote Diversity in Health-Related Research under MassHEAL - Reducing overdose deaths by 40% (2019-2023) </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/research-to-practice" hreflang="en">Translation of Research to Practice for the Treatment of Opioid Addiction</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/research-to-practice/healing-communities" hreflang="en">HEALing Communities 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 MEDICAL CENTER </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">SAMET, JEFFREY H </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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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for PA-20-222: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-NS-20-107.html" target="_blank">NOT-NS-20-107</a>
<br>
<strong>Summary:</strong>
<br>
<p>Understanding municipal policies that influence implementation of effective evidence-based practices (EBPs) as well as effective strategies for working with municipal groups may inform local efforts to translate EBPs. Just as important, engaging with local stakeholders may help to facilitate the long-term sustainability of EBPs. This can only occur if diverse local actors in municipal governance are thinking about health and behavioral health in the context of municipal planning and policy. Building from research related opioid use disorder and the risk environment, built environment, and zoning, this research will work to support coalition-based approach currently implemented by the HEALing Communities Study. The research aims to develop an understanding of local policies that may affect implementation of community action plans in the HEALing Communities Study Massachusetts communities.</p>
</div>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-39751"> <a href="https://reporter.nih.gov/project-details/10400476" target="_blank">3U24NS114416-01S1</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Administrative Supplement to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in EPPIC NET </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">DUKE UNIVERSITY </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">LIMKAKENG, ALEXANDER TAN </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Durham, NC </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: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
<br>
<strong>NOFO Number:</strong> <a href="">NOT-NS-21-025</a>
<br>
<strong>Summary:</strong>
<br>
<p>A main goal of the NIH HEAL Initiative and the Early Phase Pain Intervention Clinical Network (EPPIC-Net) is to improve non-opioid pain management. This award will leverage the resources at one of EPPIC-Nets Specialized Clinical Centers by implementing and evaluating strategies to improve the engagement, recruitment, and retention of individuals from underserved racial/ethnic minority populations to participate in EPPIC-Net clinical trials. Since environmental, cultural, and genetic factors may account for observed differences in pain responses between racial and ethnic groups, enrollment of a diverse sample in pain research is crucial to obtain a complete understanding of the effectiveness of any proposed pain therapeutic intervention. The success of these activities will be evaluated, and a toolkit will be created to define best practices that can be by other EPPIC-Net sites and additional trials.</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-39796"> <a href="https://reporter.nih.gov/project-details/10398627" target="_blank">1R34NS126032-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Stem cell-loaded microgels to treat discogenic low back pain </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/preclinical-translational" hreflang="en">Preclinical and Translational 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/preclinical-translational/optimization-non-addictive-therapies" hreflang="en">Development and Optimization of Non-Addictive Therapies to Treat Pain</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">CEDARS-SINAI MEDICAL CENTER </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">SHEYN, DMITRIY </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Los Angeles, CA </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: Planning Studies for Initial Analgesic Development Initial Translational Efforts [Small Molecules and Biologics] (R34 Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-21-016.html" target="_blank">RFA-NS-21-016</a>
<br>
<strong>Summary:</strong>
<br>
<p>Pain caused by the degeneration of discs between vertebrae in the spine makes up a significant proportion of all chronic low back pain conditions. Although opioids are prescribed as treatments for this chronic condition, they often do not provide effective pain management, and currently there are no treatments that target the underlying disc disease. Notochordal cells mature into the cells that make up discs between vertebrae. Preliminary studies have shown that notochordal cells can be made from induced pluripotent stem cells, offering a potential replacement for diseased cells between discs. This study aims to develop a novel treatment for painful disc degeneration using a microgel/microtissue embedded with human notochordal cells made in the lab from induced pluripotent stem cells.</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-39856"> <a href="https://reporter.nih.gov/project-details/10326595" target="_blank">9R42NS120548-02A1</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Development of KLS-13019 for Neuropathic Pain </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</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">KANNALIFE SCIENCES, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">BRENNEMAN, DOUGLAS ERIC (contact); WARD, SARA J </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Lloyd Harbor, NY </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: Development of Therapies and Technologies Directed at Enhanced Pain Management (R41/R42 Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-20-009.html" target="_blank">RFA-NS-20-009</a>
<br>
<strong>Summary:</strong>
<br>
<p>Neuropathic pain adversely affects quality of life and remains challenging to treat, presenting high unmet medical need. One example of this type of pain, chemotherapy-induced peripheral neuropathy, is a chronic, severely debilitating consequence of cancer therapy for which there are no effective treatment strategies. This research is testing a new cannabidiol (CBD) analogue (KLS-13019) with neuroprotective properties and which has improved drug-like properties compared to CBD. This project will optimize the process to manufacture KLS-13019, develop analytical methods, optimize its formulation, evaluate its safety and toxicity, and test KLS-13019s efficacy of in a rat model of chemotherapy-induced peripheral neuropathy.</p>
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</td>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-39906"> <a href="https://reporter.nih.gov/project-details/10139200" target="_blank">1R43NS120335-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Closed-Loop Micromagnetic Neuromodulation as a Non-Opioid Treatment for Neuropathic Pain </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</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">QUANTUM NANOSTIM </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">REILLY, THOMAS </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Treasure Island, FL </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: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-20-011.html" target="_blank">RFA-NS-20-011</a>
<br>
<strong>Summary:</strong>
<br>
<p>Spinal cord stimulation (SCS) has been shown to provide effective relief for most people with chronic pain and eliminated the need for opioid therapy in more than half of those treated. However, traditional SCS approaches have encountered problems when glial cells coat the stimulation electrodes that distance the device from targeted neurons. This project will develop a novel hybrid Closed Loop Omnidirectional Neuromodulation with Electromagnetic fields (CLONE) system that is combined with magnetic-based stimulation to overcome glial coating of SCS electrodes, better target neurons in dorsal spine tissue, which may lead to better treatment of chronic neuropathic neck and low back pain.</p>
</div>
</td>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-39671"> <a href="https://reporter.nih.gov/project-details/10406102" target="_blank">3U44NS115111-03S1</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">High-Resolution, Spinal Cord Stimulation for Non-Opioid Treatment of Neuropathic Pain </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/preclinical-translational" hreflang="en">Preclinical and Translational 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">MICRO-LEADS, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">MCLAUGHLIN, BRYAN L </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Somerville, MA </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> Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for PA-20-222: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="">NOT-NS-20-107</a>
<br>
<strong>Summary:</strong>
<br>
<p>This research seeks to develop a high-resolution spinal cord stimulation therapy for treating chronic neuropathic pain of the lower extremities, groin, and lower back. Systems that use wireless communication methods require robust strategies to prevent various forms of cyberattacks on implantable devices. The focus of this project's research will be to develop a new cybersecurity risk-reduced architecture for Bluetooth low-energy implant communication.</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-39721"> <a href="https://reporter.nih.gov/project-details/10458307" target="_blank">3R01DE029951-01S1</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Targeting Endosomal Receptors for Treatment of Chronic Pain </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/preclinical-translational" hreflang="en">Preclinical and Translational 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/preclinical-translational/novel-targets" hreflang="en">Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDCR </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">NEW YORK UNIVERSITY </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">BUNNETT, NIGEL W </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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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for PA-20-222: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-NS-20-107.html" target="_blank">NOT-NS-20-107</a>
<br>
<strong>Summary:</strong>
<br>
<p>G protein-coupled receptors (GPCRs) are the largest family of transmembrane signaling proteins and play important roles in inflammation and pain. GPCR signaling is fast and temporary, making it hard to measure in clinical studies of potential drugs to interfere with the signaling. This research is using selectively designed nanoparticles to stimulate or block GPCRs toward identifying new treatments for oral cancer pain. This award will use a new nanoformulation approach to understand how nanoparticles affect nerve function by i) testing the effects of continuous release of a GPCR inhibitor in an oral cancer microenvironment and ii) investigating the influence of various physicochemical characteristics of nanoparticles on nerve function in an oral cancer microenvironment.</p>
</div>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-39766"> <a href="https://reporter.nih.gov/project-details/10413418" target="_blank">3U24NS113784-01S1</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">University of Rochester Hub and Spokes for the EPPIC Network - Specialized Clinical Center </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">UNIVERSITY OF ROCHESTER </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">MARKMAN, JOHN DOUGLAS </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Rochester, NY </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> Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for Administrative Supplements to Support Career Enhancement Related to Clinical Research on Pain (Admin Supp Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="">NOT-NS-21-048</a>
<br>
<strong>Summary:</strong>
<br>
<p>Improving pain treatment for is a major goal of the NIH HEAL Initiative. This award supports an early career physician toward achieving a future in clinical pain research and in conducting phase II clinical trials focused on pain. Research activities will provide this individual with the skills needed to serve as a primary investigator for future clinical trials in chronic pain and will help to answer a key question that could improve the design of analgesic clinical trials for neurogenic intermittent claudication, a distinct form of chronic low back pain for which no available treatment exists.</p>
</div>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-39811"> <a href="https://reporter.nih.gov/project-details/10304570" target="_blank">1UG3NS123964-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Disease Modifying Analgesia with CA8 Gene Therapy </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/preclinical-translational" hreflang="en">Preclinical and Translational 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/preclinical-translational/optimization-non-addictive-therapies" hreflang="en">Development and Optimization of Non-Addictive Therapies to Treat Pain</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">UNIVERSITY OF MIAMI SCHOOL OF MEDICINE </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">LEVITT, ROY C </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Coral Gables, FL </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: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-21-010.html" target="_blank">RFA-NS-21-010</a>
<br>
<strong>Summary:</strong>
<br>
<p>Efforts to identify non-opioid analgesics for treatment of chronic pain have identified a protein, carbonic anhydrase-8 (CA8), in pain-sensing nerve cells in the spinal cord (dorsal root ganglion cells) whose expression regulates analgesic responses. Gene therapy delivering CA8 to dorsal root ganglion cells through clinically relevant routes of administration functions as a “local anesthetic” that induces long-lasting pain relief in animal models of chronic pain. This project will further develop CA8 gene therapy with the goal of treating chronic knee osteoarthritis pain. It will assess several gene therapy constructs to determine the doses needed, safety, efficacy, and specificity to nerve cells for each construct. It will then select the safest and most effective construct that can be administered via the least invasive route for further development. The project will include all steps necessary to identify one candidate gene therapy construct that will be suitable to begin clinical trials in patients with chronic knee osteoarthritis pain.</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-39871"> <a href="https://reporter.nih.gov/project-details/10326651" target="_blank">1R43NS120617-01A1</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">Chemokine-receptor profiling for painful diabetic neuropathy in biological samples from human clinical trials </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</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">PLUMERIA THERAPEUTICS, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">RICHARDSON, THOMAS P (contact); WANG, YIPING </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Plainsboro, NJ </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: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-20-011.html" target="_blank">RFA-NS-20-011</a>
<br>
<strong>Summary:</strong>
<br>
<p>Chronic pain is a major healthcare burden. However, the types and underlying mechanisms of pain vary greatly, as do patient responses to currently available pain medications. Inflammation in the nervous system (neuroinflammation) is involved in several types of pain, and targeting key molecules involved in neuroinflammation is therefore a promising treatment approach. The chemokine receptor system, a complex network of more than 20 different receptors and more than 80 molecules that bind to these receptors, has a central role in neuroinflammation. Researchers do not yet fully understand the functioning of this network and how specific receptors vary in different chronic pain conditions. Therefore, this project aims to further characterize the expression of one specific receptor, using samples collected from participants in clinical trials evaluating a compound that interferes with the receptors function. This information should allow researchers to classify pain patients and identify those most likely to benefit from a treatment with compounds targeting the receptor.</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-39921"> <a href="https://reporter.nih.gov/project-details/10385311" target="_blank">2R44DA050349-02</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">Development of a Novel Chemokine Receptor Antagonist as a Treatment for Opioid Use Disorder </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</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">CREATIVE BIO-PEPTIDES, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">RUFF, MICHAEL R </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Potomac, MD </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: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-20-011.html" target="_blank">RFA-NS-20-011</a>
<br>
<strong>Summary:</strong>
<br>
<p>Chemokines (hormones of the immune system that mediate innate immune inflammation) enhance pain, reduce opioid analgesia, and promote drug-seeking behavior and addiction, giving them a central role at the crossroads of chronic pain and the opioid crisis. Blocking chemokines (rather than opioid receptors) provides an exciting treatment opportunity for both pain and opioid use disorder. This research continues previous work studying the efficacy of RAP-103, a small, orally stable chemokine receptor blocker. The previous research has shown that RAP-103 is safety and effective in preclinical models that mimic human drug-taking. This research will now optimize the dose required to achieve decreased motivation to maintain opioid use, establish manufacturing scale-up feasibility, provide RAP-103 for safety testing in animals, and conduct stability testing of RAP-103 toward the goal of submitting an Investigational New Drug application to the FDA.</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-39586"> <a href="https://reporter.nih.gov/project-details/10380398" target="_blank">1UG1HD107653-01</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">Incorporating nonpharmacologic approaches into a comparative effectiveness pharmacologic trial for neonates with neonatal opioid withdrawal syndrome (NOWS) </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">INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS (IN) </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">SOKOL, GREGORY M </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Indianapolis, IN </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: 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.</p>
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<span id="project-title-39256"> <a href="https://reporter.nih.gov/project-details/10378422" target="_blank">1RM1DA055301-01</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">Integrative Treatment for Achieving Holistic Recovery from Comorbid Chronic Pain and Opioid Use Disorder </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">UNIVERSITY OF NEW MEXICO </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">WITKIEWITZ, KATIE A (contact); PEARSON, MATTHEW RYAN </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: 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>There are a dearth of integrated treatments that simultaneously address the fundamental causes of chronic pain and opioid misuse/opioid use disorder and that focus on well-being among individuals with chronic pain and opioid misuse/disorder. This research will study how to improve the lives of patients with chronic pain and opioid misuse/disorder via tailored interventions that explicitly target increasing quality of life and engagement in valued activities, the cultural centering of interventions to meet the needs of diverse patient populations and reducing stigma of chronic pain and opioid misuse/disorder. Specific research projects will i)&nbsp;test the effectiveness, mechanisms, and implementation of an integrated psychosocial treatment for chronic pain and opioid use disorder among individuals receiving buprenorphine from outpatient treatment clinics,&nbsp;and&nbsp;ii)&nbsp;will use community-based participatory research methods to develop a&nbsp;culturally centered&nbsp;strategy for screening and brief intervention of chronic pain and opioid use disorder among American Indian/Alaska Native patients in primary care settings. This research will shed light on a difficult problem and improve health and wellbeing with a focus on diverse and underserved populations.</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-39316"> <a href="https://reporter.nih.gov/project-details/10429456" target="_blank">1K24NS126781-01</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">Mentoring in discovery and validation of clinical chronic pain biomarkers </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">STANFORD UNIVERSITY </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Mackey, Sean C </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Stanford, CA </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>Enhancing the workforce of pain investigators and practitioners is a key goal of the NIH HEAL Initiative. This mentoring award will allow a selected investigator to train early career investigators in patient-oriented research focusing on the development of diagnostic and prognostic biomarkers for high-impact chronic pain. Mentoring activities will include training in designing and implementing pain research studies, preparing scientific papers and presentations, writing successful grant applications, the responsible conduct of research, and successful navigation of the academic process to achieve scientific independence. This training will allow mentees to advance their independent careers as pain researchers.</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-39371"> <a href="https://reporter.nih.gov/project-details/10378875" target="_blank">1U01DA055366-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">1/24 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">CEDARS-SINAI MEDICAL CENTER </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">GAO, WEI (contact); GREGORY, KIMBERLY D; JOHNSON, SCOTT P; SMITH, LYNNE M </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Los Angeles, CA </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&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 Cedars-Sinai Medical Center study site&nbsp;is in&nbsp;Los Angeles where marijuana is legal and methamphetamine use is prevalent, enabling&nbsp;researchers&nbsp;to recruit participants from&nbsp;high-risk&nbsp;populations.</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-39421"> <a href="https://reporter.nih.gov/project-details/10321502" target="_blank">1UG3DA052166-01A1</a>
</span>
<br>
<a class="expand-link" data-toggle="collapse" href="#summary22" role="button" aria-expanded="false" aria-controls="collapseExample">
Show Summary
</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">CVL-354, a kappa opioid receptor antagonist for treatment of opioid use disorder, withdrawal and relapse </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">CEREVEL THERAPEUTICS, LLC </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">IREDALE, PHILIP </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Cambridge, 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="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> 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>Kappa opioid receptors (KOR) are expressed in brain areas that control reward, motivation, and anxiety. Upon opioid drug withdrawal and abstinence, dysregulated KOR signaling can result in aversive physical and affective states that are a major driver of relapse. Preclinical data have demonstrated that antagonism of KOR can reduce the physical symptoms of opioid withdrawal. Currently, the alpha 2-adrenergic agonist&nbsp;lofexidine&nbsp;is the only approved therapy for the mitigation of the physical symptoms of opioid withdrawal but it is only modestly effective and can have significant unwanted side effects.&nbsp;Cerevel&nbsp;Therapeutics has identified a novel selective KOR antagonist, CVL-354, with unique properties and good preclinical safety margins. This project will assess this drug in early human safety/pharmacokinetics and occupancy studies. Future studies will then be able to assess efficacy of this drug in acute opioid withdrawal.</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-39461"> <a href="https://reporter.nih.gov/project-details/10250727" target="_blank">1UG3DA052173-01A1</a>
</span>
<br>
<a class="expand-link" data-toggle="collapse" href="#summary23" role="button" aria-expanded="false" aria-controls="collapseExample">
Show Summary
</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">Combating opioid addiction using CVL-936, a novel D3/D2 receptor antagonist </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">CEREVEL THERAPEUTICS, LLC </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">CHAKILAM, ANANTHSRINIVAS RAO </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Cambridge, 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="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> 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>Opioid use and addiction affects more than 2 million Americans and contribute to a large proportion of all drug overdose deaths. Current treatments for opioid use disorder (e.g., methadone and buprenorphine) are not always effective, may be misused, and can have side effects that discourage treatment continuation. Therefore, Cerevel Therapeutics is evaluating a novel compound, CVL-936, which targets brain molecules called dopamine D3 receptors. These receptors are involved in the brains reward and relapse pathways and are present in higher levels in people with addictions. In animal studies, the molecule reduced self-administration of nicotine and fentanyl, including in relapse situations. The project will test the safety and tolerability of CVL-936 in animals and healthy humans and will examine its effectiveness in reducing craving in people with opioid use disorder.</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-39506"> <a href="https://reporter.nih.gov/project-details/10380426" target="_blank">1U01DA055322-01</a>
</span>
<br>
<a class="expand-link" data-toggle="collapse" href="#summary24" role="button" aria-expanded="false" aria-controls="collapseExample">
Show Summary
</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">HEALthy Brain and Child Development Study at UAB and UA </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 ALABAMA AT BIRMINGHAM </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">PERALTA-CARCELEN, ADA MYRIAM (contact); NEWMAN, SHARLENE D; NEWSOM, CASSANDRA R; YERBY, LEA GEORGETTE </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Birmingham, AL </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 (U01- Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-21-021.html" target="_blank">RFA-DA-21-021</a>
<br>
<strong>Summary:</strong>
<br>
<p>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.&nbsp;This study will take place at the University of Alabama at Birmingham, recruiting participants from mainly rural populations with low access to&nbsp;obstetric/gynecological (OB/GYN) care and high rates of substance use.</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-39546"> <a href="https://reporter.nih.gov/project-details/10378283" target="_blank">1U24HD107621-01</a>
</span>
<br>
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Show Summary
</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">Data Coordinating Center (DCC) for the Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial (NOWS PhaCET) </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">RESEARCH TRIANGLE INSTITUTE (NC) </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">DAS, ABHIK </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Research Triangle Park, NC </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: Data Coordinating Center for the Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial (U24 Clinical Trial Required)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/rfa-hd-21-032.html" target="_blank">RFA-HD-21-032</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>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.</p>
</div>
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