nih-gov/heal.nih.gov/funding/awarded?page=38
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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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<span id="project-title-34606"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9778341&amp;amp;icde=44817683" target="_blank">2R44DA043325-02</a>
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<td headers="view-title-table-column" class="views-field views-field-title">SENSITIVE AND PORTABLE PHYSICIAN OFFICE-BASED URINE ANALYZER TO TACKLE PRESCRIPTION DRUG ABUSE </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">BreviTest Technologies, LLC </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Heffernan, Michael John </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">HOUSTON, TX </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>Current drug-screening immunoassays use benchtop analyzers that require experienced personnel, time, and a laboratory setup. Physicians without access to in-house testing have to send out patient samples for screening, resulting in unacceptable delays in the treatment of patients who are potentially suffering from chronic pain. This project, a partnership with BreviTest Technologies, LLC, aims to develop a low-cost, point-of-care (POC) urine drug testing (UDT) device to detect opioids. The goal is for a portable platform to deliver quantitative performance similar to a standard laboratory test for opioids within a 10-minute run time. If successful, this will provide a technology capable of performing rapid quantifications of urine drug levels in a physicians office, providing an invaluable tool to render more effective pain management dosing to patients, thus paving the way toward lower toxicity and a better quality of life.</p>
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<span id="project-title-34646"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9746820&amp;amp;icde=41243482" target="_blank">3U54GM104942-03S1</a>
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<td headers="view-title-table-column" class="views-field views-field-title">WEST VIRGINIA CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTE: IMPROVING HEALTH THROUGH PARTNERSHIPS AND TRANSFORMATIVE RESEARCH </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">NIGMS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">West Virginia University </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">HODDER, SALLY LYNN </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">MORGANTOWN, WV </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2018 </td>
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<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> Institutional Development Award (IDeA) Program Infrastructure for Clinical and Translational Research (IDeA-CTR)(U54)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PAR-14-303.html" target="_blank">PAR-14-303</a>
<br>
<strong>Summary:</strong>
<br>
<p>Mortality rates in Appalachia have progressively increased over recent years, in contrast to decreasing mortality rates observed in the remainder of the U.S. The West Virginia Clinical and Translational Science Institute (WVCTSI) was created in 2012 through the initial Clinical and Translational Research (CTR) award and has subsequently formed a well-connected, statewide research network, creating the infrastructure to address the substantial health disparities that exist in West Virginia. WVCTSI is now well positioned to attain the goals of this renewal application that include: 1) building sustainable research infrastructure that substantively contributes to improving West Virginia health outcomes by 2022; 2) recruiting the next generation of clinician scientists and translational researchers that excel in team science and are positioned for long-term success; and 3) actively engaging with multiple stakeholders that include communities, medical providers, and policy makers to drive research that improves the health of West Virginians.</p>
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<span id="project-title-34686"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9857109&amp;amp;icde=46466550" target="_blank">3R01DA044184-02S1</a>
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<td headers="view-title-table-column" class="views-field views-field-title">DEVELOPMENT &amp;amp; MALLEABILITY FROM CHILDHOOD TO ADULTHOOD </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">Johns Hopkins University </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">IALONGO, NICHOLAS S </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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<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> 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 Family School Partnership (FSP) and classroom-centered (CC) interventions targeted aggressive-coercive behavior and poor academic achievement as antecedents of the distal outcomes of antisocial behavior, substance abuse/dependence, psychiatric symptoms/disorders, high-risk sexual behavior and successful adaptation to the relevant developmental demands of the educational, work, romantic relationships and family (both family of procreation and origin/orientation) social fields/contexts. The participants of the FSP and CC original prevention trial were a population (n = 798) of urban, predominately African-American young adults, who began first grade in the fall of 1993 in nine elementary schools in predominantly low- to lower-middle-income Baltimore areas. The central purpose of the proposed study is to extend through ages 31-35 an examination of normal and pathogenic development and the impact of these two universal first-grade preventive interventions on the distal targets mentioned above. We will continue to study the role of phenotypic and genetic factors (and their interactions) as well as the impact of the interventions on the development and course of substance use/abuse/dependence, psychiatric symptoms/disorders, antisocial behavior/disorder and high-risk sexual behavior through young adulthood. The knowledge accrued over the course of the proposed assessments should serve to inform the nature, targets and timing of our future preventive intervention efforts.</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-34726"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9743912&amp;amp;icde=41242885" target="_blank">3R01AT008559-02S1</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">MECHANISMS OF PSYCHOSOCIAL TREATMENTS FOR CHRONIC LOW BACK PAIN </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/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">JENSEN, MARK P; DAY, MELISSA ANNE </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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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> NIH Research Project Grant (Parent R01)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-16-160.html" target="_blank">PA-16-160</a>
<br>
<strong>Summary:</strong>
<br>
<p>Chronic low back pain (CLBP) is a problem affecting millions of Americans. Psychosocial approaches are efficacious for addressing the multidimensional nature of CLBP. Three of the most widely implemented nonpharmacological techniques for CLBP management are cognitive therapy (CT), mindfulness meditation (MM), and behavioral activation (BA). However, there is a critical lack of research examining if these techniques work via the mechanisms specified by theory. Ecological momentary assessment (EMA) and ActiGraph technology embedded within a randomized controlled trial, consisting of daily measures of process and outcome, is ideal for testing mechanism models both during treatment and during the critical period following treatment. The current proposal seeks to utilize EMA and ActiGraph to examine if changes in cognitive content, cognitive process, and activity level are mechanisms specific to CT, MM, and BA, respectively, for reducing pain interference. Elucidating the mechanisms of pain coping skills will lead to streamlined CLBP interventions.</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-34766"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9932702&amp;icde=48650379&amp;ddparam=&amp;ddvalue=&amp;ddsub=&amp;cr=1&amp;csb=default&amp;cs=ASC&amp;pball=" target="_blank">1U18EB029353-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Development of a Wireless Endovascular Nerve Stimulator for Treatment of Refractory 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/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">BAYLOR COLLEGE OF MEDICINE </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">KAN, PETER TZE MAN; ROBINSON, JACOB T; SHETH, SUNIL </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Houston, TX </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: 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>For patients with neuropathic pain refractory to therapy using small molecules, modulation of specific neural structures in the central or peripheral nervous system can provide effective alternative treatments. While current Food and Drug Administration–approved devices for dorsal root ganglion (DRG) stimulation are safe and effective, there have been an unfortunate number of adverse events associated with pulse generator infections and lead migration. The research team will develop a wireless, millimeter-sized nerve stimulator that can be delivered through the vasculature and stimulate the DRG to alleviate symptoms of neuropathic pain and the associated minimally invasive delivery method. This endovascular nerve stimulation (EVNS) system depends on development and integration of key novel technologies into an endovascular stent. The magnetoelectric transducers and electronic circuits will convert wireless power and data into stimulus patterns that can trigger neural activity in the DRG via miniature electrodes. After chronic demonstration of safety and functionality in large animal models, the team will prepare for regulatory discussions with the FDA. If successful, the EVNS will provide a technology platform for treating other neuropathic pain syndromes. </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-34806"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9839289" target="_blank">1R44DA049493-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">A Prescription Digital Therapeutic to Promote Adherence to Buprenorphine Pharmacotherapy for Patients with Opioid Use Disorder </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">PEAR THERAPEUTICS, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">KERN, AUDREY; PALLONE, DAVINA </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> Loyalty and Reward-Based Technologies to Increase Adherence to Substance Use Disorder Pharmacotherapies (R43/R44 - Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-014.html" target="_blank">RFA-DA-19-014</a>
<br>
<strong>Summary:</strong>
<br>
<p>Opioid use disorder (OUD) is a key driver of the current opioid epidemic in the United States, but nearly 80% of individuals with OUD do not receive treatment. Buprenorphine medication-assisted treatment (MAT) is an effective form of care for OUD. This project will develop a state-of-the-art, digital therapeutic tool that effectively promotes buprenorphine adherence by providing contingency management rewards and educational content and enables home induction using a new self-monitoring support tool. This tool, named reSET-O+, will be integrated with Pear Therapeutics reSET-O, an FDA market-authorized mobile application delivering validated behavioral therapy and intended for use in conjunction with buprenorphine and standard outpatient treatment for 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-34846"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9900195" target="_blank">1UG3DA050271-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">R-methadone-TAAP/MPAR: an abuse deterrent methadone 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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<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>Methadone is useful in the treatment of opioid dependence; however, methadone misuse and methadone-related fatalities have increased. Ensysce has created two complementary, novel technologies that can be applied to methadone. Their Trypsin Activated Abuse Protection (TAAP™) prodrugs are “enzyme-activated” to release clinically effective opioid drugs only when taken orally and exposed to the correct physiologic conditions, such as exposure to trypsin in the small bowel. Their multi-pill abuse resistance (MPAR™) feature involves in situ bioregulation of opioid delivery from the TAAP™ systems, enabling control over oral multi-dose pharmacokinetic profiles. It is envisaged that an R-methadone-TAAP™ prodrug would demonstrate similar reduced addiction liability as with other opioid-TAAP products. The objective of this proposal is to develop an R-methadone-TAAP™/MPAR™ drug through Phase 1 clinical studies and to translate R-methadone-TAAP™/MPAR™ results into humans, to ultimately reduce the misuse and oral overdose potential of methadone.</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-34886"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9752205&amp;amp;icde=41497872" target="_blank">3U54EB020404-05S1</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">CENTER OF EXCELLENCE FOR MOBILE SENSOR DATA-TO-KNOWLEDGE (MD2K) - OVERALL </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">NIBIB </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">University of Memphis </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">KUMAR, SANTOSH </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">MEMPHIS, TN </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> 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>Rapid technological advances are leading to field-deployable mobile sensing devices that can quantify complex dynamics of key physical, biological, behavioral, social, and environmental factors, enabling us to understand causation in complex disorders. Significant new investment is needed to develop and disseminate data analytics tools. The Center of Excellence for Mobile Sensor Data-to-Knowledge (MD2K) will generate generalizable theory, methods, tools, and software to address major barriers to processing complex mobile sensor data and its use in biomedical knowledge discovery and just-in-time care delivery. We will develop and implement a standards-based, interoperable, extensible, and open-source big data software platform for efficient implementation of MD2K data analytics. MD2K will demonstrate the feasibility, utility, and generalizability of this approach by implementing the entire MD2K data analytics system in the context of two biomedical applications: reducing relapse among abstinent daily smokers and reducing readmission among congestive heart failure patients</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-34926"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9906345" target="_blank">1R43DA050338-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">A universal approach for improving the limit of detection for fentanyl and fentanyl derivatives in urine </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">CERES NANOSCIENCES, LLLP </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">LEPENE, BENJAMIN SCOTT </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">MANASSAS, VA </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">RFA-DA-19-019</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-34966"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9857901&amp;amp;icde=46466518" target="_blank">3R01DA046527-02S1</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">RESEARCHING EFFECTIVE STRATEGIES TO PREVENT OPIOID DEATH (RESPOND) </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">Boston Medical Center </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">LINAS, BENJAMIN P </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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<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">PA-18-591</a>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35006"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9660796&amp;amp;icde=46454074" target="_blank">1R21DA047662-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Human laboratory model to screen drugs with opioid analgesic-sparing effects: cannabidiol/morphine combinations </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">WAYNE STATE UNIVERSITY </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Lundahl, Leslie H </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Detroit, MI </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> NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-344.html" target="_blank">PA-18-344</a>
<br>
<strong>Summary:</strong>
<br>
<p>Chronic pain is a significant public health problem associated with tremendous personal and economic burden. First-line treatment consists of opioid medications, but despite only moderate efficacy and unpleasant side effects, rates of opioid prescriptions have quadrupled over the past 15 years, and this has contributed to high rates of misuse, overdose, and mortality. Clearly, alternative, or non-opioid strategies for treating pain are needed. In this context, “opioid-sparing” medications refer to compounds that can be combined with and enhance the analgesic effects of lower-dose opioids without increasing the rewarding properties of either drug. There is preclinical evidence suggesting that cannabidiol (CBD) may have the potential to function as “opioid-sparing” medications, but its ability to alter opioid-mediated analgesia in humans has yet to be determined. This proposal will fill this gap by conducting a double-blind, placebo-controlled, within-subject randomized crossover study of the effects of CBD and morphine co-administration on pain sensitivity and subjective reinforcement on 28 healthy males and females. This is the first known study to investigate the ability of CBD to alter morphines analgesic effects in humans. If successful, the model will have a lasting impact on our ability to develop and test medications that reduce our reliance on chronic use of opioid medications for pain relief.</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-35046"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?icde=0&amp;aid=9845965" target="_blank">1R43NS113726-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Pharmacokinetic and toxicology studies of AYX2, a transcription factor decoy, non-opioid, disease modifying drug candidate for the long-term treatment of chronic pain </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/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">ADYNXX, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">MAMET, JULIEN </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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<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>Chronic focal neuropathic pain, which includes pain etiologies such as radiculopathy and radiculitis, focal peripheral neuropathies, and low back pain, affects as many as 25 million patients annually in the United States. Chronic focal neuropathic pain is maintained by genome-wide transcription regulation in the dorsal root ganglia (DRG) / spinal cord network. The transcription factors driving this regulation constitute a promising class of targets with the potential to alter the course of pain with a single treatment. DNA decoys are oligonucleotides that specifically inhibit the activity of certain transcription factors. AYX2 binds and inhibits Krüppel-like transcription factors (KLF) in the DRG-spinal cord. The goal of this Phase 1 proposal is to advance AYX2 toward an IND submission, allowing for human clinical trials. We propose in Aim 1 to characterize AYX2 pharmacokinetics in the cerebrospinal fluid and plasma and its distribution in the DRG, spinal cord and brain following an IT injection. With this information, AYX2 will be tested in a panel of complementary toxicology studies in Aim 2 to allow for final IND-enabling studies, supported by Phase 2 of the grant. This research will accelerate development of AYX2 as a novel drug candidate for the non-opioid treatment of pain.</p>
</div>
</td>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35086"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9921776&amp;amp;icde=45321803" target="_blank">3UG1DA040309-05S3</a>
</span>
<br>
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</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">Ancillary Study of the Adoption and Sustainability of ED-Initiated Buprenorphine </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">
<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>For many reasons, the emergency department (ED) is a critical venue to initiate opioid use disorder (OUD) interventions. ED patients have a disproportionately high prevalence of substance use disorders and are at an elevated risk of overdose, and many do not access health care elsewhere. Despite this, OUD interventions are rarely initiated in EDs. The Emergency Department Connection to Care with Buprenorphine for Opioid Use Disorder study (CTN-0079) will assess the feasibility, acceptability and impact of introducing clinical protocols for screening for OUD, buprenorphine treatment initiation, and referral for ongoing treatment in ED settings with high need, limited resources and different staffing structures. This extension study will use the existing infrastructure to evaluate the adoption and sustainability of the clinical protocols introduced at each of the study sites and to identify factors influencing their diffusion and effectiveness.</p>
</div>
</td>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35126"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9829460&amp;amp;icde=46453701" target="_blank">3UG3DA048351-01S1</a>
</span>
<br>
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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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<tr id="summary14" 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">RFA-DA-19-002</a>
</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-35166"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9979208&amp;icde=46798750" target="_blank">3R01DA001411-45S2</a>
</span>
<br>
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</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">Monitoring the Future: Drug Use and Lifestyles of American Youth </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/new-strategies" hreflang="en">New Strategies to Prevent and Treat Opioid Addiction</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/new-strategies/preventing-opioid-use-disorder" hreflang="en">Preventing Opioid Use Disorder </a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">University of Michigan at Ann Arbor </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Miech, Richard A. </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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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> Research Project Grant (Parent R01)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-13-302.html">PA-13-302</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-35206"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9677597&amp;amp;icde=46452481" target="_blank">1UG3DA047717-01</a>
</span>
<br>
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</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">MOR/DOR Heterodimer Antagonists: A Novel Treatment 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">WASHINGTON STATE UNIVERSITY </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">MORGAN, MICHAEL M </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Pullman, 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> 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>Tens of thousands of people die each year from opioid overdose. Many of these people began taking opioids for pain. A critical treatment goal is to reduce the development of opioid dependence either by enhancing opioid analgesia so lower doses can be used or by blocking withdrawal symptoms. Current pharmacological treatments in these two categories, although effective, present serious limitations. The recent finding that reducing the signaling through mu-delta opioid heterodimers appears to enhance opioid antinociception and reduce dependence suggests that a blocker of mixed mu-delta receptors (MDOR antagonist) could be effective in reducing dependence by limiting opioid tolerance and preventing opioid withdrawal. This research group has developed a compound with that characteristic, called D24M, which preliminary studies have shown could reduce opioid dependence by enhancing opioid antinociception, reducing opioid tolerance, or directly inhibiting opioid withdrawal. They propose to extend this research by investigating whether it can reduce chronic pain in an animal model that mimics the clinical situation of pain patients who transition to dependence. If these studies are successful, they could lead to the development of an optimized drug ready for Investigational New Drug (IND) application and enable translational and clinical testing.</p>
</div>
</td>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35246"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9856648&amp;amp;icde=46466362" target="_blank">3R01DA044522-16S1</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">PROXIMAL AND DISTAL PATHWAYS TO YOUNG ADULT OPIOID MISUSE </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/new-strategies" hreflang="en">New Strategies to Prevent and Treat Opioid Addiction</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/new-strategies/preventing-opioid-use-disorder" hreflang="en">Preventing Opioid Use Disorder </a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">University of Washington </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">OESTERLE, SABRINA </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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<tr id="summary17" 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">PA-18-591</a>
</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-35286"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9653772&amp;amp;icde=46453835" target="_blank">1R01DA047574-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">In vivo characterization of opioid biased agonists </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">MCLEAN HOSPITAL </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Paronis, Carol A; Bergman, Jack </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Belmont, 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> Prescription Drug Abuse (R01 Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-058.html" target="_blank">PA-18-058</a>
<br>
<strong>Summary:</strong>
<br>
<p>The ongoing opioid crisis has led to renewed concerns about the clinical prescription of addictive opioid analgesics. However, there are currently no suitable alternatives for treating severe or malignant pain. Studies of opioid signaling mechanisms in mice deficient in ?-arrestin have suggested that biased agonists displaying preferential activation of G-protein signaling over ?-arrestin signaling could offer a promising avenue for the development of opioid analgesics with a reduced adverse effects profile. However, there is no concluding evidence showing that such biased signaling can indeed be associated with reduced opioid side effects and, consequently, an improved safety profile. This research will address the need for preclinical data to rigorously evaluate this hypothesis with a program of in vivo studies to compare the effects of “balanced” opioids (morphine, oxycodone, and fentanyl) with that of the “biased” agonists PZM21 and two novel ligands provided by colleagues at the NIDA IRP in nonhuman primates. The results of these studies will provide critical information regarding the dependence liability of “biased” agonists that, in clinical practice, might be given on a repeated, or chronic, basis, potentially adding a powerful new tool for the safer management of severe or malignant 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-35326"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9737173&amp;amp;icde=46453085" target="_blank">1UG3DA048386-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Vaccines for fentanyl and its derivatives: A strategy to reduce illicit use and overdose </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 MINNESOTA </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">PRAVETONI, MARCO </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Minneapolis, MN </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">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>The United States has seen dramatic increases in fatal overdoses due to heroin, counterfeit prescription drugs, and cocaine adulterated with fentanyl or fentanyl-like analogs. Current medications may not be sufficient to address the opioid overdose epidemic. As a complementary strategy, the researchers plan to develop vaccines against fentanyl and fentanyl-like compounds to reduce their abuse liability and the growing incidence of fatal overdoses. This research team has already developed vaccines against heroin and oxycodone that stimulate the production of antibodies effective in reducing opioid distribution to the brain, opioid-induced behaviors, and opioid-induced respiratory depression and have identified a promising fentanyl vaccine candidate cued up for optimization. Successful completion of an anti-fentanyl vaccine development project could offer a long-lasting, safe, and cost-effective intervention complementary to medication-assisted treatment (MAT) and may reduce overdoses in opioid users as well as protect people in professions (e.g., law enforcement, airport security, postal workers) at risk of accidental exposure to fentanyl and fentanyl analogs.</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-35366"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9856898&amp;amp;icde=46466632" target="_blank">3R21DA045092-01A1S1</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">EVALUATING COGNITIVE AND DEVELOPMENTAL RISK FACTORS FOR OPIOID MISUSE AMONG ADOLESCENT CANNABIS USERS </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/new-strategies" hreflang="en">New Strategies to Prevent and Treat Opioid Addiction</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/new-strategies/preventing-opioid-use-disorder" hreflang="en">Preventing Opioid Use Disorder </a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">University of Washington </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">RAMIREZ, JASON </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>The opioid epidemic continues unabated in the United States, and despite the rapid expansion of this crisis, the nature of the risk factors that contribute to opioid misuse remain poorly understood compared with other substances of abuse. The goal of this project is to examine cannabis use and cannabis identification measures as risk factors for opioid misuse while also developing and evaluating novel implicit measures of opioid associations as risk factors for opioid misuse among an at-risk sample of adolescents. Findings from the proposed research are intended to improve the prediction of opioid misuse among adolescents and to potentially identify novel targets for prevention and intervention strategies that aim to combat the opioid epidemic.</p>
</div>
</td>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35406"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9674683&amp;amp;icde=43814439" target="_blank">1R43DA047722-01</a>
</span>
<br>
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</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">PERIPHERALLY-RESTRICTED AND LONG-ACTING MAS1(LA-MAS1) AGONISTS FOR 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">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">Peptide Logic, LLC </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Riviere, Pierre </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>
</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> 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>This project seeks to develop a first-in-class (FIC), peripherally restricted and long-acting drug with potential to reduce or replace opioid for moderate to severe pain, and that will be non-addictive, safe, and convenient to use. The program is based on strong scientific evidence showing that activation of a receptor called MAS1 produces opioid-independent and peripheral pain relieving activity in a wide range of animal models of chronic pain, including inflammatory, neuropathic, and bone cancer pain. This project focuses on the development of potent, stable, and specific molecules that stimulate MAS1. Researchers will then attach peptides that stimulate MAS to antibody carriers that make them last longer and selectively affect only the peripheral nervous system, which could allow for once a week or twice a month dosing while maintaining the drugs efficacy and reducing potential side effects, and test the resulting molecule in animal models.</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-35446"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9879277&amp;amp;icde=46595977" target="_blank">3UG1DA013035-17S7</a>
</span>
<br>
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Show Summary
</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy </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/duration-retention-discontinuation" hreflang="en">Optimizing the Duration, Retention, and Discontinuation of Medication Treatment for 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>
</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>This study will (1) test pharmacologic and behavioral strategies to improve OUD pharmacotherapy treatment retention and to improve outcomes among patients who have been successfully stabilized on OUD medications and want to stop medication and (2) identify predictors of successful outcome and develop a stage model of relapse risk.</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-35486"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9923866&amp;map=y" target="_blank">3UG1DA013035-18S3</a>
</span>
<br>
<a class="expand-link" data-toggle="collapse" href="#summary23" role="button" aria-expanded="false" aria-controls="collapseExample">
Show Summary
</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">Emergency Department-INitiated bupreNOrphine and VAlidaTIOn Network Trial (ED-INNOVATION) </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">NEW YORK UNIVERSITY SCHOOL OF MEDICINE </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">ROTROSEN, JOHN P; NUNES, EDWARD V. </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="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> 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>Emergency department (ED)-initiated buprenorphine/naloxone (BUP) with referral for ongoing BUP is superior to referral alone in engaging patients with untreated opioid use disorder (OUD) in treatment at 30 days and is cost-effective. However, logistical barriers exist in translating research into practice. New BUP formulations such as the extended-release injectable BUP (CAM2038, XR-BUP) hold promise in addressing many of the barriers more effectively than sublingual buprenorphine (SL-BUP) by treating the patients symptoms for up to seven days. This study will recruit, train and provide resources to 30 ED sites throughout the U.S. using implementation facilitation strategies to address stigma and provide ED-initiated BUP for patients presenting with OUD who are not receiving medications for OUD. Once implementation is adequately achieved, the sites will conduct a randomized controlled trial (RCT) to compare the effectiveness of SL-BUP versus XR-BUP on ED patients engagement in formal addiction treatment seven days after their ED visit. In addition, in an ancillary component of the study, the use of XR-BUP will be assessed in ED patients with Clinical Opioid Withdrawal Scale (COWS) scores of</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-35526"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9827922&amp;amp;icde=46454420" target="_blank">1R01NS113257-01</a>
</span>
<br>
<a class="expand-link" data-toggle="collapse" href="#summary24" role="button" aria-expanded="false" aria-controls="collapseExample">
Show Summary
</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">Discovery and validation of a novel orphan GPCR as a target for therapeutic intervention in 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/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">St. Louis University </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">SALVEMINI, DANIELA </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">St. Louis, MO </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">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> Discovery and Validation of Novel Targets for Safe and Effective Pain Treatment (R01 Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-18-043.html" target="_blank">RFA-NS-18-043</a>
<br>
<strong>Summary:</strong>
<br>
<p>Neuropathic pain conditions are exceedingly difficult to treat, and novel non-opioid analgesics are desperately needed. Receptomic and unbiased transcriptomic approaches recently identified the orphan G-protein coupled receptor (oGPCR), GPR160, as a major oGPCR whose transcript is significantly increased in the dorsal horn of the spinal cord (DH-SC) ipsilateral to nerve injury, in a model of traumatic nerve-injury induced neuropathic pain caused by constriction of the sciatic nerve in rats (CCI). De-orphanization of GPR160 led to the identification of cocaine- and amphetamine-regulated transcript peptide (CARTp) as a ligand which activates pathways crucial to persistent pain sensitization. This project will test the hypothesis that CARTp/GPR160 signaling in the spinal cord is essential for the development and maintenance of neuropathic pain states. It will also validate GPR160 as a non-opioid receptor target for therapeutic intervention in neuropathic pain, and characterize GPR160 coupling and downstream molecular signaling pathways underlying chronic neuropathic pain.</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-35566"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9849933&amp;amp;icde=43391028" target="_blank">3R44DA044053-02S1</a>
</span>
<br>
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Show Summary
</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">DEVELOPMENT AND EVALUATION OF VIDEO-BASED DIRECTLY OBSERVED THERAPY FOR OFFICE-BASED TREATMENT OF OPIOID USE DISORDERS WITH BUPRENORPHINE </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">emocha Mobile Health, Inc. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Seiguer, Sebastian </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Owings Mills, 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 Title:</strong> PHS 2016-02 Omnibus Solicitation of the NIH, CDC, FDA, and ACF for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-16-302.html" target="_blank">PA-16-302</a>
<br>
<strong>Summary:</strong>
<br>
<p>Since 2002, persons with opioid use disorders who desire medication-assisted treatment can be treated with buprenorphine, which has been shown to be efficacious. Buprenorphine treatment can occur in any medical office-based setting, is prescribed by any physician who seeks to become waivered, and is taken by patients at home unsupervised. However, without visual confirmation of medication ingestion, providers remain unsure if patients divert part or all of their buprenorphine medication. This project will develop the technical and logistical workflow needed to implement a video-­based application, miDOT, for office-­based buprenorphine monitoring during the initial months of care, which will allow health care providers to monitor whether patients ingest the drug and adhere to treatment. The project will configure a video-based DOT platform, evaluate its effectiveness in securing medication ingestion and care retention for illicit opiate users, and solidify routes of sustainable commercial viability with commercial partners.</p>
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