nih-gov/heal.nih.gov/funding/awarded?page=32
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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-34921"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9770072&amp;amp;icde=41498044" target="_blank">3UG3TR002151-01S1</a>
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<td headers="view-title-table-column" class="views-field views-field-title">INTEGRATED MICROPHYSIOLOGICAL SYSTEM OF CEREBRAL ORGANOID AND BLOOD VESSEL FOR DISEASE MODELING AND NEUROPSYCHIATRIC DRUG SCREENING </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">NCATS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">COLUMBIA UNIVERSITY HEALTH SCIENCES </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">LEONG, KAM 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">2018 </td>
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<strong>NOFO Title:</strong> Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-591.html" target="_blank">PA-18-591</a>
<br>
<strong>Summary:</strong>
<br>
<p>The clinical utility of opioids for pain treatment is limited by its risk for developing opioid usage disorders (OUD). These untoward effects impose a severe burden on society and present difficult therapeutic challenges for clinicians. We propose to extend our cerebral organoid MPS to facilitate the investigation of neuronal response to opioids and identify cellular and molecular signatures in patients vulnerable to OUD. We have assembled a team with complementary expertise in clinical characterization of OUD, cerebral organoid MPS modeling, single cell RNA-seq technology, and functional characterization of neurons in a mesolimbic reward system to test the hypothesis that midbrain MPS is a clinically relevant pre-clinical model for study of opioid usage disorder.</p>
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<span id="project-title-34961"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9900350" target="_blank">1R34DA050262-01</a>
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<td headers="view-title-table-column" class="views-field views-field-title">1/5 Establishing Innovative Approaches for the HEALthy Brain and Child Development 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/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 NORTH CAROLINA CHAPEL HILL </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">LIN, WEILI (contact); GILMORE, JOHN HORACE; GREWEN, KAREN M; JONES, HENDREE E </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">2019 </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 (HEALthy BCD) (Collaborative R34 Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-029.html" target="_blank">RFA-DA-19-029</a>
<br>
<strong>Summary:</strong>
<br>
<p>A more than 5-fold increase in the incidence of neonatal abstinence syndrome has been reported since 2000. Preliminary studies show that prenatal opioid exposure is associated with increased risk of impaired neurodevelopment. Five institutions (Duke University, Arkansas Childrens Research Institute, Cincinnati Childrens Hospital, University of Illinois at UrbanaChampaign, and University of North Carolina at Chapel Hill) have formed a consortium to develop strategies for the Phase II HEALthy Brain and Child Development Study. Research teams will develop instruments and strategies (recruitment/retention protocols, assessment batteries, and novel tools); conduct pilot studies (fetal and postnatal imaging, advanced imaging harmonization and quality control, assessment administration, biosampling) to evaluate instruments; and analyze available data, including imaging, behavioral, cognitive, and maternal data from studies on early brain development, to guide the Phase II study design. Upon completion, the consortium aims to conduct the Phase II study.</p>
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<span id="project-title-35001"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9899464" target="_blank">1U18EB029251-01</a>
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<td headers="view-title-table-column" class="views-field views-field-title">The Injectrode - A Truly Injectable Electrode for Dorsal Root Ganglion Stimulation to Treat 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/discoveries-into-devices" hreflang="en">Translating Discoveries into Effective Devices to Treat Pain</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIBIB </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">LUDWIG, KIP A (contact); WEBER, DOUGLAS J </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">2019 </td>
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<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: Translational Development of Devices to Treat Pain (U18 Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-EB-18-003.html" target="_blank">RFA-EB-18-003</a>
<br>
<strong>Summary:</strong>
<br>
<p>While traditional epidural spinal cord stimulation (SCS) for intractable pain has been very efficacious for the patients responsive to it, the success rate has held at approximately 55%. Dorsal root ganglion (DRG) stimulation has shown promise in early trials to provide greater pain relief. Although the decrease in back pain at 3 months was significantly greater in the DRG arm vs. SCS, the adverse event rate related to the device or implant procedure was significantly higher in the DRG arm. Researchers will develop the “Injectrode” system to make the procedure simpler and safer by using an alternative to implantation: using an injectable pre-polymer liquid composite that cures quickly after injection adjacent to the DRG. They will compare an Injectrode-based system with traditional electrode stimulation at the DRG as an alternative to opioid administration. Researchers will perform benchtop characterization and refinement as a precursor to a clinical study, use modeling and animal testing to refine the efficiency of energy transfer from a transcutaneous electrical nerve stimulation unit to an Injectrode/Injectrode collector concept, and optimize the procedure for the complex anatomy of the human DRG.</p>
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<span id="project-title-35041"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9897929" target="_blank">1UH2AR076724-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Technology Research Site for Advanced, Faster Quantitative Imaging for BACPAC </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 CALIFORNIA, SAN FRANCISCO </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">MAJUMDAR, SHARMILA </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">San Francisco, CA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<strong>NOFO Title:</strong> HEAL Initiative: Back Pain Consortium (BACPAC) Research Program Technology Research Sites (UH2/UH3 Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-AR-19-028.html" target="_blank">RFA-AR-19-028</a>
<br>
<strong>Summary:</strong>
<br>
<p>Despite the significance of spine disorders, there are few reliable methods to determine appropriate patient care and evaluate intervention effectiveness. The research and tool development take the critical next step in the clinical translation of faster, quantitative magnetic resonance imaging (MR) of patients with lower back pain. The multidisciplinary Technology Research Site (Tech Site) of BACPAC will develop Phase IV (i.e., technology optimization) technologies and/or methods (TTMs) to leverage two key technical advancements: development of machine learning-based, faster MR acquisition methods and machine learning for image segmentation and extraction of objective disease related features from images. The team will develop, validate, and deploy end-to-end deep learning-based technologies (TTMs) for accelerated image reconstruction, tissue segmentation, and detection of spinal degeneration to facilitate automated, robust assessment of structure-function relationships between spine characteristics, neurocognitive pain response, and patient-reported outcomes.</p>
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<span id="project-title-35081"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9743491&amp;amp;icde=44243545" target="_blank">3UG1DA040309-04S3</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Expanding Clinical Research Training on Implementing the Evidence-based Hub and Spoke Model of Medication for Opioid Use Disorder (MOUD) </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/enhancing-clinical-trials-network" hreflang="en">Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids</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">DARTMOUTH COLLEGE </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">MARSCH, LISA A. </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Hanover, NH </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
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<strong>NOFO Title:</strong> Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-591.html" target="_blank">PA-18-591</a>
<br>
<strong>Summary:</strong>
<br>
<p>As part of an ongoing teleECHO learning collaborative (LC),this study will expand clinical research training in evidence-based quality improvementmethods that were central to delivering and sustaining science-based medication-assisted treatment for opioid use disorder (MOUD) within the Vermont Hub-and-Spoke Model (HSM) with fidelity. Participating primary care practices will be trained in the (1) use of astudy-developedtoolkit of research and evaluationquality improvementmethodsintended to expand provider knowledge and performance in the delivery of evidence-based MOUD, (2) systematic tracking of standardized outcome metrics, and (3) sharing of these standardized data with other LC membersso that practices can use this empirical information to refine their care model over time. The study will measure changes in providers knowledge about best practices for MOUD, their comfort in caring for OUD patients with MOUD and their performance on all the standardized outcome metrics.</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-35121"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9789862&amp;amp;icde=46452917" target="_blank">1UG3DA048351-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">A Phase I/IIa Clinical Trial Testing the Safety and Immunogenicity of a Heroin Vaccine and its Efficacy Against Morphine Challenge. </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">HENRY M. JACKSON FDN FOR THE ADV MIL/MED </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">MATYAS, GARY R </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">2019 </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> 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/rfa-files/RFA-DA-19-002.html" target="_blank">RFA-DA-19-002</a>
<br>
<strong>Summary:</strong>
<br>
<p>In order to address the opioid crisis, this group has developed a candidate heroin/opioid vaccine that induces antibodies that bind heroin/opioid upon injection and subsequently prevent the drug from crossing the blood-brain barrier and interacting with the brain&#039;s µ-opioid receptor. They completed pre-clinical testing of the vaccine candidate in mice and rats and demonstrated that the animals were protected from subcutaneous and intravenous heroin challenge. Ongoing durability studies have demonstrated that antibody titer and protective efficacy were maintained 6 months after the last vaccination. This project proposes to advance the development of the vaccine candidate by conducting a Phase I/IIa human clinical trial, by performing vaccine synthesis, nonclinical studies, and then a clinical trial. The supplemental award will allow for testing the efficacy of fentanyl haptens and of the combination heroinfentanyl vaccine.</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-35161"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9823898&amp;icde=48650031&amp;ddparam=&amp;ddvalue=&amp;ddsub=&amp;cr=1&amp;csb=default&amp;cs=ASC&amp;pball=" target="_blank">5R01NS104295-03</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Cellular and Molecular Role of CXCR4 signaling in Painful Diabetic Neuropathy </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">NINDS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">Northwestern University </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">MENICHELLA, DANIELA M </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Evanston, IL </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<strong>NOFO Title:</strong> Administrative Supplements for Validation of Novel Non-Addictive Pain Targets (Clinical Trials Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-NS-18-073.html" target="_blank">NOT-NS-18-073</a>
<br>
<strong>Summary:</strong>
<br>
<p>Neuropathic pain is a debilitating affliction present in 26% of diabetic patients, with substantial impact on the quality of life. Despite this significant impact and prevalence, current therapies for painful diabetic neuropathy (PDN) are only partially effective, and the molecular mechanisms underlying neuropathic pain in diabetes are not well understood. Our long-term goal is to elucidate the molecular mechanisms responsible for PDN in order to provide targets for the development of therapeutic agents. Our objective is to identify the molecular cascade linking CXCR4/SDF-1 chemokine signaling to DRG nociceptor hyper-excitability, neuropathic pain, and small fiber degeneration. Our aims will determine: 1) the ion-channel current profile of the nociceptor hyper-excitable state produced by CXCR4/SDF-1 signaling in PDN; 2) the gene expression profile of the nociceptor hyper-excitable state produced by CXCR4/SDF-1 signaling in PDN; and 3) the specific features of nociceptor mitochondrial dysfunction produced by CXCR4/SDF-1 signaling in PDN.</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-35201"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?icde=0&amp;aid=9845353" target="_blank">1R43NS112088-01A1</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">Repression of Sodium Channels via a Gene Therapy for Treatment of Chronic 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">NAVEGA THERAPEUTICS, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">MORENO, ANA MARIA; ALEMAN GUILLEN, FERNANDO </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">San Diego, CA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<strong>NOFO Title:</strong> PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-574.html" target="_blank">PA-18-574</a>
<br>
<strong>Summary:</strong>
<br>
<p>Voltage-gated sodium channels are responsible for the transmission of pain signals. Nine genes have been identified, each having unique properties and tissue distribution patterns. Genetic studies have correlated a hereditary loss-of-function mutation in one human Na+ channel isoform ?Na?V?1.7 with a rare genetic disorder known as Congenital Insensitivity to Pain (CIP). Individuals with CIP are not able to feel pain without any significant secondary alteration. Thus, selective inhibition of ?Na?V?1.7 in normal humans could recapitulate the phenotype of CIP. This research team developed a non-permanent gene therapy to target pain that is non-addictive (because it targets a non-opioid pathway), highly specific (only targeting the gene of interest), and long-term lasting (around 3 weeks in preliminary assays in mice). During this Phase I , the team will 1) test additional pain targets ?in vitro?, and 2) evaluate the new targets ?in vivo ?in mice models of inflammatory and neuropathic pain.&nbsp;</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-35216"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9761823&amp;amp;icde=45214299" target="_blank">1U44NS111779-01</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">DISCOVERY OF NAV1.7 INHIBITORS FOR THE TREATMENT OF 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">SITEONE THERAPEUTICS, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">MULCAHY, JOHN VINCENT; ODINK, DEBRA </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">BOZEMAN, MT </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<strong>NOFO Title:</strong> Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PAR-18-541.html" target="_blank">PAR-18-541</a>
<br>
<strong>Summary:</strong>
<br>
<p>We propose to develop a safe and effective nonopioid analgesic to treat neuropathic pain that targets an isoform of the voltage-gated sodium ion channel, NaV1.7. Voltage-gated sodium channels are involved in the transmission of nociceptive signals from their site of origin in the peripheral terminals of DRG neurons to the synaptic terminals in the dorsal horn. NaV1.7 is the most abundant tetrodotoxin-sensitive sodium channel in small diameter myelinated and unmyelinated afferents, where it has been shown to modulate excitability and set the threshold for action potentials. Development of systemic NaV1.7 inhibitors has been complicated by the challenge of achieving selectivity over other NaV isoforms expressed throughout the body. We have discovered a series of potent, state-independent NaV1.7 inhibitors that exhibit &gt;1000-fold selectivity over other human isoforms. Work conducted under this program will support advancement of a lead candidate into clinical development as a therapeutic for neuropathic 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-35256"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9900353" target="_blank">1R34DA050261-01</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">3/5 Establishing Innovative Approaches for the HEALthy Brain and Child Development 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/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">ARKANSAS CHILDREN&#039;S HOSPITAL RES INST </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">OU, XIAWEI (contact); ACHESON, ASHLEY </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">2019 </td>
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<strong>NOFO Title:</strong> HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (Collaborative R34 Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-029.html" target="_blank">RFA-DA-19-029</a>
<br>
<strong>Summary:</strong>
<br>
<p>A more than 5-fold increase in the incidence of neonatal abstinence syndrome has been reported since 2000. Preliminary studies show that prenatal opioid exposure is associated with increased risk of impaired neurodevelopment. Five institutions (Duke University, Arkansas Childrens Research Institute, Cincinnati Childrens Hospital, University of Illinois at UrbanaChampaign, and University of North Carolina at Chapel Hill) have formed a consortium to develop strategies for the Phase II HEALthy Brain and Child Development Study. Research teams will develop instruments and strategies (recruitment/retention protocols, assessment batteries, and novel tools); conduct pilot studies (fetal and postnatal imaging, advanced imaging harmonization and quality control, assessment administration, biosampling) to evaluate instruments; and analyze available data, including imaging, behavioral, cognitive, and maternal data from studies on early brain development, to guide the Phase II study design. Upon completion, the consortium aims to conduct the Phase II study.</p>
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<span id="project-title-35296"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9713716&amp;amp;icde=41243747" target="_blank">3R01MH107540-04S1</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">FROM IRRITABILITY TO IMPAIRMENT: HOW NEURODEVELOPMENT OF EXECUTIVE FUNCTION AND PARENT-CHILD NEURAL SYNCHRONY INFLUENCE THE TRANSITION FROM NORMAL TO ABNORMAL FUNCTIONING </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"> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIMH </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">University of Pittsburgh at Pittsburgh </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">PERLMAN, SUSAN B </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Pittsburgh, PA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2018 </td>
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<strong>NOFO Title:</strong> Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-591.html" target="_blank">PA-18-591</a>
<br>
<strong>Summary:</strong>
<br>
<p>The goal of this proposal is to launch an innovative, multi-modal neuroimaging program that will investigate the longitudinal trajectory of the neurodevelopment of irritability across the preschool period. Differentiating clinically salient irritability from developmentally normative temperamental variation has proven to be a difficult task. This is made even more challenging during the preschool period, when irritability has hit its normative peak and measuring neurodevelopment is impeded by methodological constraints. This research will (1) identify specific biomarkers underlying preschool vulnerability for psychopathology by examining neural maturation in executive function as a predictor for clinical outcome; and (2) examine how the parenting environment moderates this vulnerability, with the overarching objective of identifying aberrant irritable trajectories as the foundation for future brain-based behavioral intervention. Primary analyses will (1) probe underlying executive function as a predictor of clinical outcome; and (2) examine parent-child neural synchrony as a predictor of executive function maturation.</p>
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<span id="project-title-35336"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9537037&amp;amp;icde=41267890" target="_blank">1R21AT009932-01</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">MINDFUL BODY AWARENESS TRAINING AS AN ADJUNCT TO MEDICATION ASSISTED 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/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"> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NCCIH </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">University of Washington </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">PRICE, CYNTHIA J; MERRILL, JOSEPH O </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">SEATTLE, WA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2018 </td>
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<strong>NOFO Title:</strong> Behavioral Interventions for Prevention of Opioid Use Disorder or Adjunct to Medication Assisted Treatment-SAMHSA Opioid STR Grants (R21/R33)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-AT-18-001.html" target="_blank">RFA-AT-18-001</a>
<br>
<strong>Summary:</strong>
<br>
<p>This study leverages recent federal and state opioid use disorder treatment initiatives as a platform for testing a promising mind-body intervention, Mindful Awareness in Body-oriented Therapy (MABT) as an adjunct to MAT in two clinical settings funded through the Washington Opioid State Targeted Response (STR) program. MABT, a novel mindfulness-based intervention, uniquely addresses aspects of awareness, interoception, and regulation that may be associated with pain, mental health distress, and behavioral control that increase risk of relapse and poor treatment outcomes. Each setting employs a variation of the nationally recognized Massachusetts Nurse Care Manager model. Using a randomized, two-group, repeated measures design, we will compare those who receive MABT+MAT to MAT only. The overarching goal of this application is to test MABT to improve MAT health outcomes among patients receiving buprenorphine to treat OUD.</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-35376"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9894581&amp;icde=48650112&amp;ddparam=&amp;ddvalue=&amp;ddsub=&amp;cr=1&amp;csb=default&amp;cs=ASC&amp;pball=" target="_blank">1R01DA051067-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Hub and Spoke Opioid Treatment Networks: 2nd Generation Approaches to Improve Medication Treatment for Opioid Use Disorders </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/brim" hreflang="en">Behavioral Research to Improve Medication-Based Treatment</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">Brandeis University </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">REIF, SHARON </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Waltham, MA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<strong>NOFO Title:</strong> HEAL Initiative Limited Competition: Behavioral Research to Improve MAT: Ancillary Studies to Enhance Behavioral or Social Interventions to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders (R01 Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/rfa-at-19-007.html" target="_blank">RFA-AT-19-007</a>
<br>
<strong>Summary:</strong>
<br>
<p>Washington state used federal Opioid-STR funding to develop the Washington State Hub and Spoke Model (H&amp;S), an integrated care model to expand access to OUD medications by incorporating primary care and substance use treatment programs, referral organizations, nurse care managers, and care navigators. Based on the initial success, Washington provided more funding and developed a second-generation, low-barrier H&amp;S model, to place medication initiation sites in nontraditional settings, such as emergency departments, syringe exchanges, jails, and homeless shelters, and to have community partners offer OUD medication maintenance. The study will determine the implementation and effectiveness of the new H&amp;S model, maintaining a hybrid effectiveness-implementation approach, and utilizing social network analysis to understand how H&amp;S networks develop to serve the OUD population. The findings will demonstrate what makes the H&amp;S model effective for increasing OUD medication treatment, improving outcomes for people with OUD, and reaching individuals who may not seek treatment.</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-35416"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9912651" target="_blank">1R43DA050380-01</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">Neurofeedback-EEG-VR (NEVR) System for Non-opioid Pain Therapy </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">QUASAR, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">ROBERTS, BROOKE </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">San Diego, CA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </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: Americas Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-019.html" target="_blank">RFA-DA-19-019</a>
<br>
<strong>Summary:</strong>
<br>
<p>Pain is one of the most common and debilitating symptoms of a wide range of injuries and diseases. Safe and effective alternatives for treating pain that reduce dependence on opioids are, therefore, a primary goal of the NIH. This project proposes a non-invasive, non-pharmacological alternative to treat pain by combining an innovative electroencephalography (EEG)-based Neurofeedback (NF) solution in an immersive virtual reality (VR) environment. NF and VR have been shown to independently produce ameliorative effects on pain, and it is hypothesized that an NF training in VR would have synergistic effects, as VR would distract from pain perception to improve patient compliance in more engaging NF protocols that improve their ability to control pain perception. In the scope of this project, we will initially focus our work on chronic low back pain (cLBP), as this is a growing segment of chronic pain sufferers with a 39 percent worldwide lifetime prevalence, and whose sufferers have historically been heavy users of opiates; later stages of this project will expand this application to address other forms of 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-35456"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9914612&amp;amp;icde=46527775" target="_blank">3UG1DA013035-17S9</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">Subthreshold Opioid Use Disorder Prevention (STOP); which will test the efficacy of a primary care Subthreshold Opioid Use Disorder Prevention (STOP) </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/prevent-progression" hreflang="en">Prevention of Progression to Moderate or Severe 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">New York University School of Medicine </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">ROTROSEN, JOHN P </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">2019 </td>
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<strong>NOFO Title:</strong> The National Drug Abuse Treatment Clinical Trials Network (UG1)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-15-008.html" target="_blank">RFA-DA-15-008</a>
<br>
<strong>Summary:</strong>
<br>
<p>According to SAMHSAs 2017 National Survey on Drug Use and Health (NSDUH), 11.4 million persons in the U.S. report past-year opioid misuse; out of them, only 2.1 million individuals met criteria for an OUD. Very little is known about efficacious interventions for those who do not meet criteria for moderate/severe OUD (i.e., subthreshold OUD). The prevalence of subthreshold OUD in primary care settings is 5 percent to 10 percent, with higher rates (21 percent to 29 percent) among those receiving prescribed opioids. Although they are at high risk of developing moderate/severe OUD and/or dying from an overdose, little or no empirical evidence exists for pragmatic prevention interventions that can be adopted at integrated general medical settings. To study the efficacy of prevention interventions to arrest the progression from risky opioid use, researchers will test the efficacy of a STOP intervention in primary care settings. STOP adopts an early intervention approach, based on a collaborative care model to prevent progression to moderate/severe OUD, and consists of a practice-embedded nurse care manager who provides patient education and supports the primary care provider (PCP) in engaging, monitoring and guiding patients who have risky opioid use; brief advice delivered to patients by their PCP; and phone counseling of patients by behavioral health providers to motivate and support behavior change. Researchers will determine whether STOP reduces risky opioid use and examine the impact of STOP on progression to moderate/severe OUD, overdose risk behavior and overdose events in adults with risky use of illicit or prescription opioids.</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-35496"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9908597" target="_blank">1R43DA050349-01</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">A Novel Chemokine Receptor Antagonist to Block Opioid Reinforcement, Relapse and Physical Dependence </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 </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">2019 </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: Americas Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-019.html" target="_blank">RFA-DA-19-019</a>
<br>
<strong>Summary:</strong>
<br>
<p>Current agonist treatments for opioid use disorder (OUD) are not adequate to address the opioid crisis and have abuse liability concerns. 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. So blocking chemokines (rather than opioid receptors) provides an exciting and untested treatment opportunity for pain and OUD. This proposal will assess, in animal self-administration models that mimic human drug-taking, whether a chemokine antagonist peptide R103 reduces morphine intake, as well as if R103 will prevent or blunt naloxone-precipitated withdrawal signs in morphine-dependent rats and stop relapse.</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-35536"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9910942" target="_blank">1R43DA050358-01</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">A Project to Test The Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders </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">MINDLIGHT, LLC </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">SCHIFFER, FREDRIC (contact); TEICHER, MARTIN H </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Newton, MA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </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: Americas Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-019.html" target="_blank">RFA-DA-19-019</a>
<br>
<strong>Summary:</strong>
<br>
<p>This project aims to demonstrate the safety and effectiveness of a novel treatment for opiate addiction using a technique called photobiomodulation, application of light to the forehead. The treatment consists of using a 4-minute application of transcranial photobiomodulation, near-infrared mode, through a supra-luminous LED, to one side of the forehead over the brain hemisphere that has been determined to have a more positive emotional valence. The study will examine differences in opioid cravings, anxiety, depression, and opioid use between participants receiving the treatment and those receiving a sham treatment. We will evaluate patients weekly for safety and efficacy for 3 weeks post-treatment. In Aim II, a highly-regarded product engineer will work with the company to design a marketable product that may have patentable elements.</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-35576"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9828948&amp;amp;icde=46542978" target="_blank">1R61NS113269-01</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">Validation of a novel cortical biomarker signature for 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/clinical-research/biomarkers" hreflang="en">Discovery and Validation of Biomarkers, Endpoints, and Signatures for Pain Conditions</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 Maryland, Baltimore </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">SEMINOWICZ, DAVID </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">2019 </td>
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<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> Discovery of Biomarkers, Biomarker Signatures, and Endpoints for Pain (R61/R33 Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-18-041.html" target="_blank">RFA-NS-18-041</a>
<br>
<strong>Summary:</strong>
<br>
<p>Chronic pain is a major health burden associated with immense economic and social costs. Predictive biomarkers that can identify individuals at risk of developing severe and persistent pain, which is associated with worse disability and greater reliance on opioids, would promote aggressive, early intervention that could halt the transition to chronic pain. The applicants team uncovered evidence of a unique cortical biomarker signature that predicts pain susceptibility (severity and duration). This biomarker signature could be capable of predicting the severity of pain experienced by an individual minutes to months in the future, as well as the duration of pain (time to recovery). Analytical validation of this biomarker will be conducted in healthy participants using a standardized model of the transition to sustained myofascial temporomandibular pain. Specifically the biomarker signature will be tested for its ability to predict an individuals pain sensitivity, pain severity, and pain duration and will perform initial clinical validation.</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-35616"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9889726" target="_blank">1R61NS114926-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">SPRINT: Signature for Pain Recovery IN Teens </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/clinical-research/biomarkers" hreflang="en">Discovery and Validation of Biomarkers, Endpoints, and Signatures for Pain Conditions</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">STANFORD UNIVERSITY </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">SIMONS, LAURA E </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">2019 </td>
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<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> Discovery of Biomarkers, Biomarker Signatures, and Endpoints for Pain (R61/R33 Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-18-041.html" target="_blank">RFA-NS-18-041</a>
<br>
<strong>Summary:</strong>
<br>
<p>Up to 5 percent of adolescents suffer from high-impact chronic musculoskeletal (MSK) pain, and only about 50 percent with chronic MSK pain who present for treatment recover. Current treatments for chronic MSK pain are suboptimal and have been tied to the opioid crisis. Discovery of robust markers of the recovery versus persistence of pain and disability is essential to develop more resourceful and patient-specific treatment strategies, requiring measurements across multiple dimensions in the same patient cohort in combination with a suitable computational analysis pipeline. Preliminary data has implicated novel candidates for neuroimaging, immune, quantitative sensory, and psychological markers for discovery. In addition, a standardized specimen collection, processing, storage, and distribution system is in place, along with expertise in machine learning approaches to extract reliable and prognostic bio-signatures from a large and complex data set. This project will facilitate risk stratification and a resourceful selection of patients who are likely to respond to current multidisciplinary pain treatment approaches.</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-35656"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9777758" target="_blank">1R41DA048689-01</a>
</span>
<br>
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</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">BEST-OUD: Behavioral Economic Screening Tool of Opioid Use Disorder for use in clinical practice </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">BEAM DIAGNOSTICS, INC </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">SNIDER, SARAH EMILY </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Roanoke, VA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </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> PHS 2018-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-575.html" target="_blank">PA-18-575</a>
<br>
<strong>Summary:</strong>
<br>
<p>A critical line of defense against opioid use disorder (OUD), one of the nations leading preventable causes of death, must be standardized screening provided by the patients primary care physician, psychiatrist, and/or counselor. Standardized screening methods for opioids, however, are simply inferior and no gold standards exist. This project aims to develop a validated, theoretically guided tool that provides clinicians with information beyond OUD symptoms using reinforcer pathology, a measure of severity derived from the synergy between excessive delay discounting and high behavioral economic demand. The Behavioral Economic Screening Tool (BEST-OUD) will use these combined measures in a mobile tablet application to enable clinicians to screen for OUD.</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-35696"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9897966" target="_blank">1U19AR076725-01</a>
</span>
<br>
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</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">HEALing LB3P: Profiling Biomechanical, Biological and Behavioral phenotypes </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 PITTSBURGH AT PITTSBURGH </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">SOWA, GWENDOLYN A (contact); VO, NAM V </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Pittsburgh, PA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </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: Back Pain Consortium (BACPAC) Research Program: Mechanistic Research Centers (U19 Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-AR-19-026.html" target="_blank">RFA-AR-19-026</a>
<br>
<strong>Summary:</strong>
<br>
<p>The University of Pittsburgh Low Back Pain: Biological, Biomechanical, and Behavioral Phenotypes (LB3P) Mechanistic Research Center (MRC) will to perform in-depth phenotyping of patients with chronic low back pain (cLBP), using a multimodal approach to characterize patients and provide insight into the phenotypes associated with experience of cLBP to direct targeted and improved treatments. The LB3P MRC will be formed of three Research Cores, three support cores, and one research project. This approach will leverage and integrate distinctive resources at the University of Pittsburgh laboratories to deliver quantified biomechanical, biological, and behavioral characteristics; functional assessments; and patient-reported outcomes, coupled with advanced data analytics using a novel Network Phenotyping Strategy (NPS). By eliminating isolated and disconnected approaches to treatment and focusing on personalized patient-centric approaches, this approach will yield improved outcomes and patient satisfaction.</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-35736"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9897014&amp;amp;icde=45321272" target="_blank">3UG1DA013720-20S2</a>
</span>
<br>
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</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">Medication treatment for Opioid-dependent expecting Mothers (MOMs): A Pragmatic Randomized Trial Comparing Extended-Release and Daily Buprenorphine Formulations (CTN-0080) </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/enhancing-clinical-trials-network" hreflang="en">Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids</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 MIAMI SCHOOL OF MEDICINE </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">SZAPOCZNIK, JOSE; FEASTER, DANIEL J </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">2019 </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> Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-591.html" target="_blank">PA-18-591</a>
<br>
<strong>Summary:</strong>
<br>
<p>The growing opioid use epidemic in the U.S. has been associated with a significant increase in the prevalence of pregnant opioid-dependent women and neonatal abstinence syndrome, which is associated with adverse health effects for the infant and with costly hospitalizations. Maintenance with sublingual (SL) buprenorphine (BUP) is efficacious for opioid use disorder but has disadvantages that may be heightened in pregnant women, including the potential for poor adherence, treatment dropout, and negative maternal/fetal effects associated with daily BUP peak-trough cycles. Extended release (XR) formulations may address some of these disadvantages. The primary objective of CTN-0080 is to evaluate the impact of treating opioid use disorder in pregnant women (n = 300) with BUP-XR, compared to BUP-SL, on maternal-infant outcomes. Other objectives include testing a conceptual model of the mechanisms by which BUP-XR may improve maternal-infant outcomes, relative to BUP-SL; determining the economic value of BUP-XR, compared with BUP-SL, to treat OUD in pregnant women; and evaluating the impact of BUP-XR, relative to BUP-SL, on neurodevelopment when the infant/child is approximately 12 and 24 months of age. Ultimately, this study will help in increasing access to treatment as well as provide quality care for pregnant/postpartum women.</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-35776"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9900231" target="_blank">1R34DA050297-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">A feasibility study of novel technologies to minimize motion-induced biases in functional and structural MRI of young, opioid-affected cohorts </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 PENNSYLVANIA </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">TISDALL, MATTHEW DYLAN (contact); MACKEY, ALLYSON PATRICIA </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">2019 </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> HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (R34 Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-036.html" target="_blank">RFA-DA-19-036</a>
<br>
<strong>Summary:</strong>
<br>
<p>Structural and functional neuroimaging measures are prone to errors induced by subject motion. Many comorbid features of opioid exposure are likely to increase childrens in-scanner motion. In total, this raises substantial concern that existing neuroimaging methods are not sufficiently motion-robust to be used in studies of children ages 35. Researchers will address these concerns with a feasibility study, comparing the existing methods developed for the Adolescent Brain Cognitive Development (ABCD) study with novel methods we will develop and optimize for young children. They will evaluate research methods in a sample of 100 children and test whether novel technologies improve the quality of the raw imaging data and reduce motion biases in the derived measures. Researchers will determine predictors of successful imaging to inform sampling strategies in future studies. The primary outcomes will be novel, validated structural and functional neuroimaging imaging methods for young children and feasibility data to inform the design of future studies addressing developmental questions, particularly those related to opioid exposure.</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-35816"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9675407&amp;amp;icde=46450748" target="_blank">1UG3DA047699-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Development of ITI-333, a ?-opioid Receptor Partial Agonist and 5HT2A and D1 Receptor Antagonist, for the Treatment of Opioid Use Disorders </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">INTRA-CELLULAR THERAPIES, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">VANOVER, KIMBERLY E </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">2019 </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> 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/rfa-files/RFA-DA-19-002.html" target="_blank">RFA-DA-19-002</a>
<br>
<strong>Summary:</strong>
<br>
<p>Deaths from opioid overdose continue to rise; from 2015 to 2016, there was a 28 percent increase in the number of fatal overdoses. Currently available pharmacotherapies include MOR agonists (e.g., buprenorphine) and antagonists (e.g., naloxone), all of which suffer from specific and clear limitations. To address some of the key limitations, Intra-Cellular Therapies Inc (ITI) is developing ITI-333, a novel compound with high-affinity activity at mu opiate (MOP), 5-HT2A, and D1 receptors, that lacks abuse liability and thus offers great promise for the treatment of opioid use disorders. This proposal is for a 2-year UG3 program, including a first-in-human, single ascending dose (SAD) study to assess the safety, tolerability, and pharmacokinetics of ITI-333 in healthy volunteers. This study will then be repeated in a single-center in-patient study with the goal of determining a maximally- tolerated dose (MTD) and completed with human abuse liability and functional pharmacology studies. Together, the researchers believe this clinical development plan will inform further development of ITI-333 and the selection of a cogent Phase 3 clinical path toward FDA approval as a medication for the treatment of OUD.</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-35856"> <a href="https://reporter.nih.gov/project-details/10044330" target="_blank">75N95019D00013-0-759501900098-1</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Rural Expansion of Medication 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/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/enhancing-clinical-trials-network" hreflang="en">Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids</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">Emmes Corporation </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">VanVeldhuisen, Paul </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Rockville, MD </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </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 Number:</strong> <a href=""></a>
<br>
<strong>Summary:</strong>
<br>
<p>People who use opioids in rural areas suffer worse health and less insurance coverage. The opioid problem in rural areas is of particular concern, as rural areas have higher overdose rates despite equivalent rates of OUD. This is because rural areas have a scant number of clinics and clinicians who provide medication treatment for OUD. Thus, people living in rural areas must travel long distances to access clinics that may or may not have expertise in providing treatment to patients with OUD. Telemedicine (TM) could efficiently increase capacity for delivery of buprenorphine in rural areas and may increase the number of patients receiving medication treatment and improve treatment retention and outcomes. While the development of medication treatments for opioid use disorder (MOUD) capacity in primary care settings with optimal/comprehensive services is desirable, the current opioid crisis with escalating overdose death rates in rural areas suggests a need to implement an efficient, cost-effective system of MOUD services that can be scaled up quickly. The use of a centralized and Medicare-covered TM vendor utilizing a developed methodology and established organizational infrastructure offers the great potential for a rapid rollout to increase access to MOUD and improve treatment retention in rural areas. This cluster randomized clinical trial with two phases will test expanded treatment access to improve retention on MOUD in highly affected rural areas. Phase I will include implementing telemedicine in a limited number of rural sites with varying levels of office-based opioid treatment (OBOT) to inform implementation strategies for the main trial, and Phase II will include evaluate comparative effectiveness between OBOT alone and OBOT + TM at 30 sites.</p>
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<li><a class="gtm-footer-link" href="/research/research-to-practice">Translation of Research to Practice for the Treatment of Opioid Addiction</a></li>
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<li><a class="gtm-footer-link" href="/research/infants-and-children">Enhanced Outcomes for Infants and Children Exposed to Opioids</a></li>
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