nih-gov/heal.nih.gov/funding/awarded?page=31
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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-34121"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9898106" target="_blank">1U19AR076734-01</a>
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<br>
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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 (contact); HASSETT, AFTON L </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">2019 </td>
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<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 Michigan (UM) will lead a Mechanistic Research Center (MRC) as part of the broader BACPAC initiative that will take patients with chronic low back pain (cLBP) and use a patient-centric, SMART design study to follow these individuals longitudinally as they try several different evidence-based therapies while mechanistic studies are overlaid to draw crucial inferences about what treatments will work in what patient endotypes. Interventional Response Phenotyping describes the need in any precision medicine initiative to phenotype participants based on what therapies they do and do not respond to so that one can later link mechanistically distinct disease endophenotypes with those who preferentially respond to therapies targeting those mechanisms.</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-34161"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9626713&amp;amp;icde=41340823" target="_blank">1R21AT010109-01</a>
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<td headers="view-title-table-column" class="views-field views-field-title">MINDFULNESS ORIENTED RECOVERY ENHANCEMENT AS AN ADJUNCT TO METHADONE TREATMENT FOR OPIOID USE AND CHRONIC PAIN MANAGEMENT </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">Robert Wood Johnson Medical School </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">COOPERMAN, NINA; KLINE, ANNA </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">PISCATAWAY, NJ </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2018 </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> Clinical Trials or Observational Studies of 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-18-002.html" target="_blank">RFA-AT-18-002</a>
<br>
<strong>Summary:</strong>
<br>
<p>MAT is the most effective intervention for opioid use disorder (OUD), and methadone maintenance treatment (MMT) is the most commonly prescribed MAT; however, approximately half of people who begin MMT discontinue within a year, and half of people retained in MMT have an opioid relapse within six months. Chronic pain, affecting most people on MMT, could be contributing to relapse in this group. Novel behavioral interventions that address both chronic pain and opioid relapse among people on MAT are needed. Mindfulness Oriented Recovery Enhancement (MORE) was recently developed to treat both pain and opioid misuse. MORE is a group intervention that combines training in mindfulness, cognitive reappraisal, and positive emotion regulation skills to target the dysfunctional cognitive, affective, and behavioral pathways that lead to opioid use relapse. The objective of this proposal is to examine the impact of MORE on opioid relapse and chronic pain among individuals receiving MMT.</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-34201"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9892437" target="_blank">1UG3DA050235-01</a>
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<td headers="view-title-table-column" class="views-field views-field-title">Development and Implementation of a Culturally Centered Opioid Prevention Intervention for American Indian/Alaska Native Young Adults in California </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/new-strategies" hreflang="en">New Strategies to Prevent and Treat Opioid Addiction</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/new-strategies/preventing-opioid-use-disorder" hreflang="en">Preventing Opioid Use Disorder </a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">RAND CORPORATION </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">D&#039;AMICO, ELIZABETH J (contact); DICKERSON, DANIEL LEE </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Santa Monica, CA </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="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: Preventing Opioid Use Disorder in Older Adolescents and Young Adults (ages 1630) (UG3/UH3 Clinical Trial Required
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-035.html" target="_blank">RFA-DA-19-035</a>
<br>
<strong>Summary:</strong>
<br>
<p>Data from 2015 show that American Indians/Alaska Natives (AI/AN) have the highest rates of diagnosis for opioid use disorder (OUD) and death from drug overdose. Of particular concern is the prevalence in emerging adults (ages 18-25), as this is a developmental period of heightened vulnerability and critical social, neurological, and psychological development. This study will develop and implement a culturally centered intervention to address opioid misuse among urban AI/AN emerging adults in California: POMANAYA (Preventing Opioid Misuse Among Native American Young Adults). POMANAYA will developed by adapting and enhancing our existing culturally sensitive prevention intervention program that uses motivational interviewing in AI/AN youth to address social network factors in emerging adults that amplify (or reduce) opioid and other drug use risk. Results from this study could significantly advance scientific knowledge and clinical practice for AI/AN emerging adults.</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-34241"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9901764" target="_blank">1U01DK123813-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">UPENN Scientific and Data Research Center for the HOPE Consortium to Reduce Pain and Opioid Use in Hemodialysis </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/hemodialysis" hreflang="en">Integrated Approach to Pain and Opioid Use in Hemodialysis Patients</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDDK </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">DEMBER, LAURA M (contact); FARRAR, JOHN T; KAMPMAN, KYLE MATTHEW; LANDIS, J RICHARD </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>
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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: Integrated Approach to Pain and Opioid Use in Hemodialysis Patients: The Hemodialysis Opioid Prescription Effort (HOPE) Consortium - Scientific and Data Research Center (U01 Clinical Trial Required)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DK-18-031.html" target="_blank">RFA-DK-18-031</a>
<br>
<strong>Summary:</strong>
<br>
<p>The University of Pennsylvania Perelman School of Medicine serves as the Scientific and Data Research Center (SDRC) for the Hemodialysis Opioid Prescription Effort (HOPE) Consortium. Specifically, the SDRC will 1) provide scientific leadership for the HOPE Consortium clinical trial; 2) provide comprehensive operational support to the Clinical Centers for implementing the collaboratively designed trial protocol; 3) develop and lead a Stakeholder Engagement Working Group; 4) integrate and analyze data from the electronic health records of the participating Clinical Centers; 5) establish, promote, and maintain consortium-wide high standards for quality assurance and practices; 6) initiate and oversee contracts with industry partners; 7) prepare reports for the Data and Safety Monitoring Board, and support the preparation of Consortium reports of scientific findings; 8) prepare, document, and transfer Consortium data and biosamples to a Central Repository; and 9) develop approaches for disseminating the trial findings to diverse stakeholders.</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-34281"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9905187" target="_blank">1UG3DA050322-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Preclinical and clinical evaluation of the NMDA modulator NYX-783 for OUD </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">Yale University </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">DiLeone, Ralph </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">New Haven, CT </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>This study will conduct preclinical and clinical assessments of the NMDA modulator NYX-783 for treatment of opioid drug-seeking and relapse to opioid use disorder (OUD). NYX-783, a novel small molecule being developed by Aptinyx, has shown evidence of safety/tolerability in Phase 1 studies and is currently in Phase 2 trials for post-traumatic stress disorder. This project will test the safety, tolerability, and pharmacokinetics (PK) of NYX-718 in morphine-maintained patients in residential settings and then conduct a combined inpatient (safety/tolerability/PK) / outpatient (preliminary efficacy) study testing NYX-783s effects on opioid use and relapse, stress/cue reactivity, craving, and quality of life in OUD subjects maintained on standard extended release naltrexone over a 10-week period. Successful completion of these studies will set the stage for larger scale Phase 2/3 studies of efficacy in OUD that will ultimately be required for FDA approval of NYX-783 for the treatment of drug-seeking and relapse in OUD.</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-34321"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9806827&amp;amp;icde=43814688" target="_blank">3UG1DA013714-17S3</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Preventing and Identifying Opioid Use Disorder (OUD) Using the Six Building Blocks (6BBs) for Improving Opioid Prescription Management </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 Washington </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">DONOVAN, DENNIS; HATCH-MAILLETTE, MARY AKIKO </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">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> 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>This project seeks to develop and test a “train-the-trainer” curriculum and training experience that will facilitate the spread and use of the 6BBs by adapting the 6BBs framework and toolkit for health systems and other organizations, training personnel to facilitate its implementation and monitoring results of this implementation.</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-34361"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9899486" target="_blank">1R34DA050288-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">2/5 The Cumulative Risk of Substance Exposure and Early Life Adversity on Child Health Development and Outcomes </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">AVERA MCKENNAN </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">ELLIOTT, AMY J </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Sioux Falls, SD </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> 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>Despite increased efforts to understand the neurodevelopmental sequelae of in utero opioid and other substance exposure on long-term behavioral, cognitive, and societal outcomes, important questions remain, specifically, 1) How is brain growth disrupted by fetal substance and related pre- and post-natal exposures? and 2) How are these disrupted growth patterns causally related to later cognitive and behavioral outcomes? This project seeks to formulate an approach to addressing these key questions and decipher the individual and cumulative effect of these intertwined pre- and post-natal exposures on child neurodevelopment. First, researchers will address the legal, ethical, and mother-child care and support concerns implicit in this study. Next, they will integrate across our areas of neuroimaging expertise to develop, implement, and harmonize a multi-modal MRI and EEG protocol to assess maturing brain structure, function, and connectivity. Finally, researchers will develop and test advanced statistical approaches to model and analyze this multidimensional and longitudinal data.</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-34401"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9890338" target="_blank">1UG3DA050251-01</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">A digital intervention to prevent the initiation of opioid misuse in adolescents in school-based health centers </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/new-strategies" hreflang="en">New Strategies to Prevent and Treat Opioid Addiction</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/new-strategies/preventing-opioid-use-disorder" hreflang="en">Preventing Opioid Use Disorder </a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">Yale University </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Fiellin, Lynn E. </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">New Haven, CT </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: Preventing Opioid Use Disorder in Older Adolescents and Young Adults (ages 1630) (UG3/UH3 Clinical Trial Required
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-035.html" target="_blank">RFA-DA-19-035</a>
<br>
<strong>Summary:</strong>
<br>
<p>Most opioid misuse begins during adolescence and young adulthood. Adolescence is the best time for prevention interventions in settings like school-based health centers (HCs), yet few programs focus on preventing initiation of opioid misuse. This study harnesses the power of video game interventions and incorporates components of effective substance use prevention programs to develop an evidence-informed intervention to prevent the initiation of opioid misuse in adolescents. In partnership with the national School-Based Health Alliance (SBHA), researchers will develop and test a new video game intervention, PlaySmart. It will build on our previous video game intervention that has demonstrated efficacy in improving attitudes and knowledge related to risk behaviors. The study will evaluate the game in a randomized controlled trial (RCT) in 10 school-based HCs and examine strategies for implementing PlaySmart in school-based HCs nationally. This research has considerable potential for wide implementation, reach, and impact on high-risk adolescents through school-based HCs.</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-34441"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?icde=0&amp;aid=9909401" target="_blank">1R43DE029379-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Therapeutic in Situ Analgesic Implant for improved Oral-Facial Post-Operative Pain Outcomes </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">NIDCR </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">EPIGEN BIOSCIENCES, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">FRIEDMAN, CRAIG; CAUDLE, ROBERT M </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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<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, 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>Analgesia for post-operative populations remains a significant health need that calls for innovative therapies which improve both safety and outcome measures. Recent FDA drug safety warnings and studies focusing on post-operative analgesia have highlighted the imperative need for new approaches that can be utilized for common clinical scenarios. Accordingly, novel treatment options that are safe and afford additional benefit in relief of pain are needed. In this proposal, the development of an innovative surgical sealant technology is proposed that functions at the level of the surgical wound bed and actively delivers local pharmacologic agents to therapeutically address post-operative pain. New formulations of several analgesic regimens will be assessed for their ability to seal wounds and provide appropriate pain management.</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-34481"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9888896" target="_blank">1UG3NS114947-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Novel HCN1-selective small molecule inhibitors for the 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"><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">WEILL MEDICAL COLL OF CORNELL UNIV </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">GOLDSTEIN, PETER A </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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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> Optimization of Non-addictive Therapies [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-19-010.html" target="_blank">RFA-NS-19-010</a>
<br>
<strong>Summary:</strong>
<br>
<p>Neuropathic pain is characterized by neuronal hyperexcitability and spontaneous activity, properties associated with activity of hyperpolarization-activated, cyclic nucleotide-regulated (HCN1-4) channels, the source of the pacemaker current, Ih. Inhibition of HCN1-mediated Ih elicits marked antihyperalgesia in multiple animal models of neuropathic pain, including models for direct nerve injury and chemotherapy-induced peripheral neuropathy, and does so with little or no disruption to either normal pain processing or baseline behaviors and activities. The overall objective is to develop a peripherally restricted HCN1 inverse-agonist as a therapeutic for neuropathic pain. Researchers have generated a novel small molecule that combines an antihyperalgesic HCN1 inhibitor with a motif that controls distribution and membrane presentation and is a potential non-opioid antihyperalgesic treatment for peripheral 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-34521"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9821308&amp;amp;icde=46430537" target="_blank">3R01DA045745-02S1</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">Intervention to Increase Naloxone Engagement and Distribution in Community Pharmacies: A Four-State Randomized Trial </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">BOSTON MEDICAL CENTER </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Green, Traci C </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">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> 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>Expanding access to naloxone in the community through the pharmacy can be a critical mechanism for extending this lifesaving medications reach. This study will partner with two large retail pharmacy chains and integrate two interventions that provide knowledge and training for pharmacists to identify and effectively engage with patients who may be at high risk for an opioid overdose. The interventions will be combined into a cohesive educational program, implemented in 160 community pharmacies and tested for effectiveness. Study findings will create a generalizable, evidence-based training and toolkit for pharmacists caring for patients who use prescribed or illicit opioids, in more than 40 states adopting or expanding pharmacy naloxone.</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-34561"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9899532" target="_blank">1R34DA050299-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Florida Development in Early Childhood: Adversity and Drug Exposure (FL-DECADE) 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">UNIVERSITY OF FLORIDA </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">GURKA, MATTHEW JAMES </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Gainesville, FL </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">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> 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>This study will determine the feasibility of a multifaceted approach to recruitment of normal and high-risk pregnant women and their children. Three inter-related tasks will support this comprehensive feasibility study. First, an interdisciplinary summit will occur early in the study focused on how best to mitigate risks and maximize benefits to children and families recruited in a future cohort. Second, the feasibility of a multi-faceted recruitment strategy will be assessed. Third, select pregnancy and birth assessments will be collected from recruited participants in this feasibility study while leveraging data across early childhood from existing resources, to inform Phase II study planning. This Phase I of the FL-DECADE study will provide valuable planning and feasibility data to be used for the national efforts to build a large, prospective cohort.</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-34601"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9932691&amp;icde=48650377&amp;ddparam=&amp;ddvalue=&amp;ddsub=&amp;cr=1&amp;csb=default&amp;cs=ASC&amp;pball=" target="_blank">1U18EB029354-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Treating pain in sickle cell disease by means of focused ultrasound neuromodulation </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">CARNEGIE-MELLON UNIVERSITY </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">HE, BIN </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>
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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: 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>Researchers will develop a novel transcranial focused ultrasound (tFUS) device for pain treatment and establish its effectiveness for treating sickle cell disease (SCD) pain in humanized mice. The tFUS will target the specific cortical regions involved in SCD pain using a novel non-invasive electrophysiological source imaging technique. The project’s goals have several aims. Aim 1: Develop tFUS devices for pain treatment. The mouse-scale system will be designed to validate the therapeutic effect of stimulating the anticipated cortical targets. This will inform development of the simpler human-scale system, which will use models of the skull to select cost-effective transducers to reach the targets. Aim 2: Evaluate tFUS effectiveness and optimize stimulation parameters in an SCD mice model. Researchers will determine effective tFUS parameters to chronically reduce SCD pain in mice and validate this using behavioral measures. Aim 3: Use electrophysiological source imaging to target and trigger closed-loop tFUS in animal models. This aim also includes performing safety studies to prepare for human trials. The project will develop a transformative, noninvasive tFUS device to effectively and safely treat pain in SCD. </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-34641"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=10004917&amp;icde=46798801" target="_blank">3P50MH113662-01A1S1</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Accelerator Strategies for States to Improve System Transformations Affecting Children Youth and Families </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/new-strategies" hreflang="en">New Strategies to Prevent and Treat Opioid Addiction</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/new-strategies/preventing-opioid-use-disorder" hreflang="en">Preventing Opioid Use Disorder </a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIMH </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">NYU School of Medicine </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Hoagwood, Kimberly; McKay, Mary </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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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> Advanced Laboratories for Accelerating the Reach and Impact of Treatments for Youth and Adults with Mental Illness (ALACRITY) Research Centers (P50 Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PAR-18-701.html">PAR-18-701</a>
</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-34681"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9905182&amp;icde=48650371&amp;ddparam=&amp;ddvalue=&amp;ddsub=&amp;cr=7&amp;csb=default&amp;cs=ASC&amp;pball=" target="_blank">1UG3DA050323-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Cannabidiol in the treatment of 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/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">Icahn School of Medicine Mount Sinai </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Hurd, Yasmin </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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<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>Responding to urgent calls for non-opioid treatment, this research group has been evaluating the therapeutic potential of cannabidiol (CBD), a non-intoxicating cannabinoid, for the treatment of some clinical aspects of opioid use disorder (OUD). Preclinical animal studies show that CBD decreases cue-induced heroin-seeking behavior during drug abstinence, associated with incubation of craving. Clinical work has also shown that CBD was safe in combination with a potent opioid agonist to address a potential relapse condition and decreased craving and anxiety associated with heroin cues in abstinent individuals with heroin use disorder. Building on this foundation, the researchers will investigate an oral CBD powered by a novel patented technology (leveraging the kinetics of long-chain fatty acid absorption) in a gelcap delivery system that improves bioavailability, reduces the incidence of gastrointestinal side effects, reduces first pass metabolism, and enhances onset time. This study could lead to the development of a non-opioid, non-intoxicating FDA-approved medication to reduce opioid craving and relapse and restore global functioning in individuals with OUD.</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-34721"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?icde=0&amp;aid=9908492" target="_blank">1R43DE029369-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">A Novel Opioid-Free Targeted Pain Control Method for Acute Post-Operative Localized Pain Related to Oral Surgical Procedures </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">NIDCR </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">LAUNCHPAD MEDICAL, LLC </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">JADIA, RAHUL; KAY, GEORGE </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">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> 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>There is a compelling need to develop a front line, non-opioid-based acute pain management strategy for outpatient oral surgical procedures. LaunchPad Medical has developed Tetranite® (TN), a novel bone regenerative mineral-organic self-setting adhesive biomaterial. TN has been extensively studied in vivo in a canine jaw model and shown to be effective and well-tolerated. In this project, researchers will demonstrate that drug-loaded TN can be a novel route to providing localized and time release pain medication following wisdom tooth extraction by determining the release profile of various pain medications from TN at different concentrations. The ability to release pain therapeutics in a controlled fashion and directly at the site of injury offers improved pain control following oral surgical procedures without exposing the patient to opioids. This novel approach to pain management can be extended to more invasive orthopedic procedures such as joint replacement, spinal fusions or reconstructive trauma surgery. In Phase II the team will conduct an in vivo study to assess efficacy of medicated TN to address post-operative pain following wisdom tooth odontectomy, optimize incorporation and release of medications in TN formulations, develop cGMP manufacturing process for the compounded product, and ultimately conduct clinical trials for bone void filler using medicated TN.</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-34761"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9852022" target="_blank">1UG3DA049694-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Combining Pregabalin with Lofexidine: Can it Increase the Success of Transition to Naltrexone? </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">University of Pennsylvania </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Kampman, Kyle </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>
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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>Extended-release naltrexone (XR-NTX) reduces overdose risk; however, transitioning to XR-NTX requires detoxification, which is a major hurdle. Non-opioid detoxification with an alpha-2 adrenergic receptor agonist, such as lofexidine, may shorten detoxification time, but it does not reduce the subjective effects of withdrawal. Pregabalin potentiates the activity of glutamic acid decarboxylase, inhibits calcium influx and release of excitatory neurotransmitters, raises GABA levels, and is approved for neuropathic pain, for fibromyalgia, and as an adjunctive therapy for adults with partial onset seizures. The study will test whether pregabalin can be combined with lofexidine to better reduce the subjective effects of opioid withdrawal than lofexidine alone and increase the proportion of patients that transition to XR-NTX. Such a dosing combination could lower the detoxification hurdle for patients who are interested in antagonist treatment or who are in settings where it is unavailable or difficult to access.</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-34801"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9737592&amp;amp;icde=46731192" target="_blank">1UG3DA048385-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Development of novel therapeutics for opioid dependence </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">ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">KENNY, PAUL J.; KAMENECKA, THEODORE M </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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<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>This project proposes to develop novel Gpr151 antagonists to facilitate long-term abstinence in opioid-dependent individuals. Gpr151 is an orphan G-protein coupled receptor that is expressed almost exclusively in the medial habenula and co-localizes with ?-opioid receptors to regulate the inhibitory effects of opioids on habenular neurons. Mice with a null mutation in Gpr151 (Gpr151-/- mice) are resistant to the stimulant and rewarding effects of opioids and self-administer lower quantities of oxycodone. Based on this preliminary work, the study will seek to identify Gpr151 antagonists through a variety of methods and optimize them for potency, selectivity, drug metabolism, pharmacokinetics, and brain penetration properties. The study will evaluate effects of those with the most favorable drug-like physiochemical properties on electrophysiological responses of medial habenula to opioid drugs and assess the in vivo efficacy of these novel antagonists in wild-type and Gpr151-/- mice.</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-34841"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9778797&amp;amp;icde=46450216&amp;amp;ddparam=&amp;amp;ddvalue=&amp;amp;ddsub=&amp;amp;cr=11&amp;amp;csb=default&amp;amp;cs=ASC&amp;amp;pball=" target="_blank">1UG3DA047682-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">PF614 MPAR Abuse Deterrent opioid prodrug with overdose protection: Pre-Clinical Development and Phase 1 Clinical Trial </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">ENSYSCE BIOSCIENCES, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">KIRKPATRICK, LYNN </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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<tr id="summary19" class="summary collapse odd fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> 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>Several abuse-deterrent opioid products (primarily formulations) are currently marketed or in clinical development, but they fall short of being resistant to abuse. Rather than abuse-deterrent formulations, this project, in partnership with Ensyce Biosciences, has created two complementary, novel technologies that control the release of known opioids. One technology delivers prodrugs — drugs that are not active until they have been exposed to the right conditions within the body, at which point they are gradually converted into active drugs, making them difficult to tamper with and reducing the potential for misuse. Another technology makes it so that taking increasing numbers of pills inhibits the process of converting prodrug into active drug, reducing the potential for overdose. This project aims to refine the development of these two technologies and work to combine them, and to translate promising animal results into human use.</p>
</div>
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<tr class="even">
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-34881"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9776979&amp;amp;icde=44817700" target="_blank">1R43DA049300-01A1</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">PRAPELA™ SVS: A COST-EFFECTIVE STOCHASTIC VIBROTACTILE STIMULATION DEVICE TO IMPROVE THE CLINICAL COURSE OF INFANTS WITH NEONATAL ABSTINENCE SYNDROME </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">PRAPELA, Inc. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">KONSIN, JOHN PHILLIP (contact); SINGH, RACHANA </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Concord, MA </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, 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>Maternal use and addiction to opioids or other drugs has resulted in an unprecedented rise in drug withdrawal complications in newborns known as neonatal abstinence syndrome (NAS). While there is no accepted standard for treating NAS, non-pharmacological bundles are recommended as an initial course of treatment. Unfortunately, non-pharmacological care (swaddling, rocking, frequent feedings, and skin contact) require significant use of human resources. This project studies the technical feasibility of a stochastic vibrotactile stimulation (SVS) technology incorporated into the hospital bassinet pad, which provides gentle vibrating sensory stimulation to soothe infants with NAS. Building on preliminary evidence that this type of stimulation calms NAS infants without altering their sleep, this study aims to develop a commercially viable bassinet pad that could be used in a hospital setting.</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-34921"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9770072&amp;amp;icde=41498044" target="_blank">3UG3TR002151-01S1</a>
</span>
<br>
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</a>
</td>
<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>
</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> 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>
</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-34961"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9900350" target="_blank">1R34DA050262-01</a>
</span>
<br>
<a class="expand-link" data-toggle="collapse" href="#summary22" role="button" aria-expanded="false" aria-controls="collapseExample">
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</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">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>
</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> 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>
</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-35001"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9899464" target="_blank">1U18EB029251-01</a>
</span>
<br>
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</a>
</td>
<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>
</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: 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>
</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-35041"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9897929" target="_blank">1UH2AR076724-01</a>
</span>
<br>
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</a>
</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>
</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: 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>
</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-35081"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9743491&amp;amp;icde=44243545" target="_blank">3UG1DA040309-04S3</a>
</span>
<br>
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</a>
</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>
</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> 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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