nih-gov/heal.nih.gov/funding/awarded?page=36
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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-35031"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9684195&amp;amp;icde=46454014" target="_blank">1R01DA046532-01A1</a>
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<td headers="view-title-table-column" class="views-field views-field-title">Evaluation of drug mixtures for treating pain: behavioral and pharmacological interactions between opioids and serotonin 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">UNIVERSITY OF TEXAS HLTH SCIENCE CENTER </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Maguire, David Richard </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">San Antonio, 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> NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-484.html" target="_blank">PA-18-484</a>
<br>
<strong>Summary:</strong>
<br>
<p>Opioids remain the gold standard for treating moderate to severe pain, but their use is limited by numerous adverse effects, including tolerance, dependence, abuse, and overdose. Adverse effects could be avoided by combining an opioid with another drug, such that smaller doses of the opioid (in combination with another drug) produce the desired therapeutic effect. Direct-acting serotonin type 2 (5-HT2) receptor agonists interact in a synergistic manner with the opioid morphine to produce antinociceptive effects, suggesting a 5-HT2 receptor agonist could be combined with small amounts of an opioid to treat pain, thereby lowering the risk associated with larger doses. Unfortunately, very little is known about interactions between 5-HT2 receptor agonists and other opioids. The proposed studies will evaluate the therapeutic potential of mixtures of opioids and 5-HT2 receptor agonists using highly translatable and well-established procedures to characterize the antinociceptive, respiratory-depressant (overdose), positive-reinforcing (leading to misuse), and discriminative-stimulus (subjective) effects of drug mixtures as well as the impact of chronic treatment on the development of tolerance to and physical dependence on opioids. If successful, these studies will provide proof-of-concept for this innovative approach to pain treatment and evaluate the utility of targeting 5-HT receptors for analgesic drug development.</p>
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<span id="project-title-35071"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9860426" target="_blank">1U24NS113784-01</a>
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<td headers="view-title-table-column" class="views-field views-field-title">University of Rochester Hub and Spokes for the EPPIC Network - Specialized Clinical Center </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/clinical-research" hreflang="en">Clinical Research in Pain Management</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/clinical-research/eppic-net" hreflang="en">Early Phase Pain Investigation Clinical Network (EPPIC-Net)</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NINDS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">UNIVERSITY OF ROCHESTER </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">MARKMAN, JOHN DOUGLAS (contact); GEWANDTER, JENNIFER </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Rochester, NY </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">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: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trials Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-19-025.html" target="_blank">RFA-NS-19-025</a>
<br>
<strong>Summary:</strong>
<br>
<p>The NIHs HEAL Initiative aims to support collaboration between clinical research experts in academia and industry to accelerate the development of highly efficacious, nonaddictive analgesics for well-defined chronic pain syndromes. The University of Rochester (UR), and its leadership for the UR Hub and Spokes within Early Phase Pain Investigation Clinical Network (EPPIC-Net), will recruit subjects with a broad range of pain conditions, with a focus on leveraging clinical trial infrastructure to support patient recruitment and retention, timely and accurate data entry, and regulatory documentation, as well as recruit additional Spoke sites through a national network of analgesic researchers.</p>
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<span id="project-title-35111"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9904461" target="_blank">1UG3DA050306-01</a>
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<td headers="view-title-table-column" class="views-field views-field-title">1-Year Sustained Release Naltrexone Implant for the prevention of relapse to 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">Delpor, Inc. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Martin, Francis </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">South 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="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> 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>There is a need for longer-acting prophylactic pharmacologic options for opioid use disorder (OUD) patients during maintenance therapy. This study tests a titanium implant loaded with a formulation of naltrexone and a naturally occurring carboxylic acid. The device is implanted subcutaneously with local anesthetic during an in-office procedure. The technology is based on a unique formulation that keeps the pH within the reservoir low and promotes passive diffusion of naltrexone. The benefits of the product include complete medication adherence for one year after administration, fewer relapses, smooth profile ensuring complete prophylaxis without sub-therapeutic plasma troughs, full reversibility, and similar efficacy with less drug exposure. This technology has been validated clinically with another drug and tested preclinically with naltrexone. This project will finalize the chemistry manufacturing and controls, produce IND supplies, conduct an IND-enabling safety study, and submit the IND.</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-35151"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9739061&amp;amp;icde=41243362" target="_blank">3U24DK116214-02S1</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">ILLUMINATING DRUGGABLE DARK MATTER </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">NIDDK </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">MCMANUS, MICHAEL T; JAN, LILY Y </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">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>The goal of this project is to generate data and reagents that help uncover critical functions of the poorly characterized members of ion channels. It focuses on co-perturbation of ion channel genes and their interacting genetic components as opposed to singly altering ion channel genes in mouse models. This approach will validate our proteomics approaches in the most definitive manner: in vivo. We see in vivo exploration as an essential step to evaluate ion channel function. Our major aims include mapping ion channel interactions and complexes using a high-throughput proteomics platform at UCSF. These data will be interrogated using integrative approaches established by the Monarch Initiative, where biochemical interactions will be validated and prioritized for further study. Another major aim is function-centric: We use mouse models for elucidation of human disease mechanisms, where we embrace a genetic interaction scheme to uncover ion channel redundancy and polygenic effects.</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-35191"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9912345" target="_blank">1R43DA050393-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Evaluation of the therapeutic potential of exclusive antagonists of extrasynaptic NMDA receptors for treatment of opioid use disorders </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/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">NEURANO BIOSCIENCE </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">MOLOKANOVA, ELENA </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Encinitas,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> HEAL Initiative: Americas Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-019.html" target="_blank">RFA-DA-19-019</a>
<br>
<strong>Summary:</strong>
<br>
<p>Novel therapies that could alleviate the severe symptoms of opioid withdrawal and/or reduce risk of relapse could help address the devastating opioid crisis. Memantine, an FDA-approved NMDA receptor antagonist, has shown encouraging results as an adjunct to existing opioid use therapies. Its therapeutic efficacy likely derives from its preferential binding to NMDA receptors located outside the synapse, since broad spectrum NMDA receptor antagonists are associated with multiple clinical side effects. This project will use a preclinical model to evaluate a nanostructured version of memantine (AuM) that physically prevents its binding to synaptic NMDA receptors but allows activation of extrasynaptic receptors with potency exceeding that of free memantine.</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-35231"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9898607" target="_blank">1R34DA050289-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">4/5 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">BOSTON CHILDREN&#039;S HOSPITAL </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">NELSON, CHARLES ALEXANDER </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> 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>
</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-35271"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9828185&amp;amp;icde=46454433" target="_blank">1RF1NS113256-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Dnmt3a as an epigenetic target for chronic pain treatment </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">UNIVERSITY OF TX MD ANDERSON CAN CTR </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">PAN, ZHIZHONG Z </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> 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>It is unclear what changes in the brain mediate the development of chronic pain from acute pain and how chronic pain may change responses to opioid reward for the altered liability of opioid abuse under chronic pain. Preliminary studies have found that Dnmt3a, a DNA methyltransferase that catalyzes DNA methylation for gene repression, is significantly downregulated in the brain in a time-dependent manner during the development of chronic pain and after repeated opioid treatment. This project will investigate whether Dnmt3a acts as a key protein in the brain for the development of chronic pain, and whether Dnmt3a could be a novel epigenetic target for the development of new drugs and therapeutic options for the treatment of chronic pain while decreasing abuse liability of opioids.</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-35311"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9905430" target="_blank">1UG3DA050316-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Development of SBI-553, an allosteric modulator of NTR1, for the treatment of substance use disorders </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/therapeutic-options" hreflang="en">Novel Therapeutic Options for Opioid Use Disorder and Overdose</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/therapeutic-options/focusing-development" hreflang="en">Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">Sanford Burnham Prebys Medical Discovery Institute </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Pinkerton, Anthony </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">La Jolla, 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>Addiction to opioids is related to the physiology of the brains dopamine-based reward system. As a modulator of dopaminergic systems, the neurotensin 1 receptor (NTR1) should be a molecular target for treating addictive disorders; however, few non-peptide brain penetrant neurotensin modulators have been identified, and orthosteric NTR1 ligands display side effects that have limited their clinical development. This group discovered a series of brain-penetrant NTR1 modulators, including a lead compound SBI-553, with a unique mechanism of action at NTR1. SBI-553 is an orally available, brain penetrant ?-arrestin biased allosteric modulator of NTR1, which shows efficacy in a range of addiction models and circumvents the clinically limiting side effects. While potentially high risk, the activity of SBI-553 has been validated in vitro and in vivo, and the initial safety profiling indicates no issues that would preclude further development. This study will develop SBI-553 as a treatment for opioid use disorder.</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-35351"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9864857" target="_blank">1U24NS113800-01</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">University of Florida Early Phase Pain Investigation Clinical Center </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/clinical-research" hreflang="en">Clinical Research in Pain Management</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/clinical-research/eppic-net" hreflang="en">Early Phase Pain Investigation Clinical Network (EPPIC-Net)</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NINDS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">UNIVERSITY OF FLORIDA </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">PRZKORA, RENE (contact); TIGHE, PATRICK J </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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<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trials Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-19-025.html" target="_blank">RFA-NS-19-025</a>
<br>
<strong>Summary:</strong>
<br>
<p>A major barrier to developing new pain treatments has been the absence of infrastructure to facilitate well-designed and carefully conducted clinical trials to test the efficacy of promising treatments. The UF Health Specialized Clinical Center Network will include UF Health as “hub” and statewide partners serving as spokes as part of the EPPIC Network. The University of Florida (UF) has the capability to reach more than 50% of the population of Florida, the third most populous state of the United States, and the capacity to successfully enroll patients with varying pain conditions into clinical trial protocols through its hub and spoke infrastructure as part of EPPIC-Net.</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-35391"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9751502&amp;amp;icde=41242360" target="_blank">3R21DA044443-02S1</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">DAT-OPTIMIZING THE IMPACT OF MEDICATION ASSISTED TREATMENT INTERVENTIONS IN PRISON AND JAIL SETTINGS </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"> </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">MIRIAM HOSPITAL </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">RICH, JOSIAH D </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Providence, RI </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>We propose to estimate the impact of expanded access to medication-assisted treatment (MAT) in prisons and jails on post-release rates of overdose. Our approach will use agent-based modeling, data collected through the parent study, existing surveillance data, and recently published data from similar settings to understand how different MAT interventions in the prison and jail setting impact overdose death post-release. We will examine the impact of standard of care/no intervention, providing access to depot-naltrexone alone, providing access to all three MATs to only those who were prescribed it prior to incarceration, and comprehensive provision of all three MATs on post-release rates of overdose. These models will incorporate advanced methodological techniques that will allow for the investigation of engaged treatment, program attrition, and other complex events on a population level. This studys findings may be used by health agencies, policymakers, and correctional systems to inform their efforts to expand MAT access.</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-35431"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9902945" target="_blank">1UG3DA050303-01</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">Development of an implantable closed-loop system for delivery of naloxone for the prevention of opioid-related overdose deaths </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 University </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Rogers, John </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>
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<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-002.html" target="_blank">RFA-DA-19-002</a>
<br>
<strong>Summary:</strong>
<br>
<p>Current opioid overdose treatment requires administration of naloxone by first responders, which requires timely identification of the overdose, the need for a rescue injection, and immediate availability of the medication. The development of a fail-safe treatment that would provide a life-saving dose of naloxone without the need for intervention by another party could significantly reduce mortality. The researchers aim to develop a new medical device comprising an implantable, closed-loop system that senses the presence of an opioid overdose, automatically administers a life-saving bolus injection of naloxone, and simultaneously alerts first responders.</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-35471"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9923412&amp;map=y" target="_blank">3UG1DA013035-18S4</a>
</span>
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</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">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>
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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-35511"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9940967" target="_blank">1U44NS115692-01</a>
</span>
<br>
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</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">Development and Optimization of MNK 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">4E THERAPEUTICS INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">SAHN, JAMES JEFFREY </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Austin, 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> HEAL Initiative: Optimization of Non-addictive Therapies [Small Molecules and Biologics] to Treat Pain - (U44 Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-19-020.html" target="_blank">RFA-NS-19-020</a>
<br>
<strong>Summary:</strong>
<br>
<p>MNK-eIF4E signaling is activated in nociceptors upon exposure to pain or peripheral nerve injury, promoting cytokines and growth factors and increasing nociceptor excitability, which leads to neuropathic pain. Genetic or pharmacological inhibition of MNK signaling blocks and reverses nociceptor hyperexcitability as well as behavioral signs of neuropathic pain. A clinical phase drug for cancer shows strong specificity as an MNK inhibitor but requires optimization because MNK inhibition in the central nervous system (CNS) may lead to depression, an unacceptable side effect for a neuropathic pain drug. The research team plans a targeted medicinal chemistry and screening campaign directed at generating a MNK-inhibitor-based neuropathic pain treatment with the goal of restricting its CNS penetration while retaining potency, specificity, and in vivo bioavailability and efficacy.</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-35551"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9982464" target="_blank">4R33AT010125-02</a>
</span>
<br>
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</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">Effect of Mindfulness Training on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/research-to-practice" hreflang="en">Translation of Research to Practice for the Treatment of Opioid Addiction</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/research-to-practice/brim" hreflang="en">Behavioral Research to Improve Medication-Based Treatment</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NCCIH </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">CAMBRIDGE HEALTH ALLIANCE </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">SCHUMAN OLIVIER, Z </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Cambridge, MA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">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> 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">RFA-AT-18-002</a>
</div>
</td>
</tr> <!-- summary-->
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35591"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9860960&amp;amp;icde=46466619" target="_blank">3R01DA041434-03S1</a>
</span>
<br>
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</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">IMPROVING ACCESS TO SUBSTANCE ABUSE EVIDENCE-BASED PRACTICES FOR YOUTH IN THE JUSTICE SYSTEM: STRATEGIES USED BY JPOS </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">Oregon Social Learning Center, Inc. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">SHEIDOW, ASHLI J </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Eugene, OR </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="summary15" 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>Justice-involved young adults are one of the highest-risk populations for the development of opioid use disorder (OUD) and other significant public health problems, but they usually lack access to evidence-based practices that could potentially prevent this trajectory. The risk of unintentional death and other deleterious outcomes and long-term costs for opioid misuse for young adults, their communities and society (costs estimated at more than $115 billion annually) make this a priority, with rural areas in need of the most attention and assistance. The overriding purpose of the proposed pilot study is to prevent the onset of OUD by improving young adult offenders access to evidence-based risk reduction interventions, like contingency management (CM), by testing whether officers in the adult probation and parole setting can deliver such an intervention to their young adult substance using probationers who have not yet developed OUD. The primary motivation for this pilot is the clear public health need for improving and expanding delivery of substance use risk reduction interventions for young adults in the justice system. The ultimate outcome would be prevention of OUD in this high-risk population.</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-35631"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9739674&amp;amp;icde=46462638" target="_blank">1R01DA047094-01A1</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Guanfacine Target Engagement and Validation to Improve Substance Use Outcomes in Women </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">Sinha, Rajita </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> NIH Research Project Grant (Parent R01 Clinical Trial Required)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-345.html" target="_blank">PA-18-345</a>
<br>
<strong>Summary:</strong>
<br>
<p>There are currently no FDA-approved treatments for cocaine use disorder (CUD) or co-occurring substance use disorder. High relapse rates pose a major obstacle to treatment, and this is due in part to the way that high drug cravings reduce individuals cognitive flexibility in situations where they are stressed or exposed to drug-related cues. These effects appear to be stronger in women with CUD than in men. Building on preliminary data that a drug called Guanfacine reverses these effects in women, but not in men, this 3-year pilot clinical study will test whether Guanfacine will reduce cocaine use and increase abstinence and will use laboratory challenges to determine whether it reduces cravings and enhances cognitive flexibility in stressful or drug-cue-related situations.</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-35671"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9951612&amp;amp;icde=46527679" target="_blank">3UG1DA015815-17S7</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Subthreshold Opioid Use Disorder Prevention (STOP) Trial </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/new-strategies" hreflang="en">New Strategies to Prevent and Treat Opioid Addiction</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/new-strategies/prevent-progression" hreflang="en">Prevention of Progression to Moderate or Severe Opioid Use Disorder</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">University of California, San Francisco </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">SORENSEN, JAMES L </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> The National Drug Abuse Treatment Clinical Trials Network (UG1)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-15-008.html" target="_blank">RFA-DA-15-008</a>
<br>
<strong>Summary:</strong>
<br>
<p>According to SAMHSAs 2017 National Survey on Drug Use and Health (NSDUH), 11.4 million persons in the U.S. report past-year opioid misuse; out of them, only 2.1 million individuals met criteria for an OUD. Very little is known about efficacious interventions for those who do not meet criteria for moderate/severe OUD (i.e., subthreshold OUD). The prevalence of subthreshold OUD in primary care settings is 5 percent to 10 percent, with higher rates (21 percent to 29 percent) among those receiving prescribed opioids. Although they are at high risk of developing moderate/severe OUD and/or dying from an overdose, little or no empirical evidence exists for pragmatic prevention interventions that can be adopted at integrated general medical settings. To study the efficacy of prevention interventions to arrest the progression from risky opioid use, researchers will test the efficacy of a STOP intervention in primary care settings. STOP adopts an early intervention approach, based on a collaborative care model to prevent progression to moderate/severe OUD, and consists of a practice-embedded nurse care manager who provides patient education and supports the primary care provider (PCP) in engaging, monitoring and guiding patients who have risky opioid use; brief advice delivered to patients by their PCP; and phone counseling of patients by behavioral health providers to motivate and support behavior change. Researchers will determine whether STOP reduces risky opioid use and examine the impact of STOP on progression to moderate/severe OUD, overdose risk behavior and overdose events in adults with risky use of illicit or prescription opioids.</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35711"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9882789" target="_blank">1UG1DA050069-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Kentucky Womens Justice Community Opioid Innovation Network (WJCOIN) </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">UNIVERSITY OF KENTUCKY </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">STATON, MICHELE STATON </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Lexington, KY </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: Justice Community Opioid Innovation Network (JCOIN) Clinical Research Centers (UG1 Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/rfa-da-19-025.html" target="_blank">RFA-DA-19-025</a>
<br>
<strong>Summary:</strong>
<br>
<p>Women are disproportionately affected by the opioid crisis due to increased pain sensitivity, physician prescribing practices, and self-medication, as well as a faster trajectory from opioid exposure to the development of opioid use disorder (OUD). The University of Kentucky proposes to establish the Womens Clinical Research Center as part of the NIDA Justice Community Opioid Innovation Network (W-JCOIN), with the overall goal of increasing initiation and maintenance of medications for OUD among high-risk justice-involved women in the transition from jail to the community to reduce opioid relapse and overdose. The KY W-JCOIN has the potential for significant impact on the OUD treatment field by contributing empirical evidence on the effectiveness and implementation of innovative technologies to increase initiation and maintenance of life-saving medications during a critical, high-risk time of community re-entry among vulnerable, justice-involved women in both urban and rural communities.</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35751"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9869481&amp;icde=48649972&amp;ddparam=&amp;ddvalue=&amp;ddsub=&amp;cr=1&amp;csb=default&amp;cs=ASC&amp;pball=" target="_blank">1RF1NS113881-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Discovery and validation of a new long noncoding RNA as a novel target for neuropathic pain </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/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">RBHS-NEW JERSEY MEDICAL SCHOOL </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">TAO, YUAN-XIANG </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Newark, NJ </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> 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>Identification of new targets and mechanisms underlying chronic neuropathic pain is essential for the discovery of novel treatments and preventative tactics for better neuropathic pain management. A recent exploration of next-generation RNA sequencing identified a large, native, full-length long noncoding RNA (lncRNA) in mouse and human dorsal root ganglion (DRG). It was named as nerve injury-specific lncRNA (NIS-lncRNA), since its expression was found increased in injured DRGs, in response to peripheral nerve injury, but not in response to inflammation. Preliminary findings revealed that blocking the nerve injury-induced increases in DRG NIS-lncRNA levels ameliorated neuropathic pain. This project will validate NIS-lncRNA as a therapeutic target in animal models of neuropathic pain and in cell-based functional assays utilizing human DRG neurons. Completion of this proposal will advance neuropathic pain management and might provide a novel, non-opioid pain therapeutic target.</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-35791"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9719019&amp;amp;icde=40885811" target="_blank">3R01DA044015-02S1</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">SUPPLEMENTAL APPLICATION FOR CLINICAL AND GENETIC RISK PROFILE 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/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">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">Geisinger Clinic </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">TROIANI, VANESSA; BERRETTINI, WADE H; ROBISHAW, JANET D </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">DANVILLE, PA </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>This project is focused on identifying the clinical, genetic, and neural characteristics that convey risk for prescription opioid addiction. We will leverage the central biorepository and electronic health record (EHR) database of the Geisinger Health System to conduct large-scale genomics research and phenotype development. Through a collaboration with Regeneron Pharmaceuticals, the Geisinger biobank currently contains DNA samples on about 110,000 participants and includes both Illumina OmniExpressExome genotyping and whole exome sequence data, including common and rare variants, from over 60,000 of these subjects. This discovery cohort contains thousands of chronic musculoskeletal pain patients who have been taking greater than 120 mg equivalents of morphine for more than three months. Using EHR and self-report tools to develop a case definition and quantitative scoring, we will derive a clinical/genetic profile of prescription opioid addiction. This profile will be enhanced via integration of neuroimaging data.</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-35831"> <a href="https://reporter.nih.gov/project-details/10044314" target="_blank">75N95019D00013-0-759501900091-1 </a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Clinic-Randomized Trial of Clinical Decision Support for Opioid Use Disorders in Medical Settings </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/research-to-practice" hreflang="en">Translation of Research to Practice for the Treatment of Opioid Addiction</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/research-to-practice/enhancing-clinical-trials-network" hreflang="en">Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">Emmes Corporation </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">VanVeldhuisen, Paul </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Rockville, MD </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
</tr> <!-- closing head of time -->
<tr id="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 Number:</strong> <a href=""></a>
<br>
<strong>Summary:</strong>
<br>
<p>There is a significant treatment gap between patients diagnosed with OUD and those who seek treatment, and only a small proportion of those seeking treatment receive MOUD. Primary care is the most common point of health care contact in the U.S. and is an important venue to address stigma, improve access to treatment and improve quality of care. Over the past decade, electronic health record (EHR)-linked Web-based point-of-care clinical decision support (CDS) systems designed to improve quality of chronic disease care have become increasingly sophisticated and successful. A Web-based and EHR-integrated OUD CDS system to offer expert guidance to primary care providers (PCPs) on the diagnosis and management of OUD was developed and piloted. This project will implement the OUD clinical decision support system in three large diverse health care systems and randomize a minimum of 30 clinics to receive the OUD-CDS intervention or usual care (UC). The project will evaluate the impact of OUD CDS on practice process measures and patient outcomes. The study will also prepare for scalability and dissemination by evaluating facilitators and barriers to implementation, determining the costs of implementation and maintenance and assessing the short-term cost impacts of the OUD-CDS.</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-35871"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9680193&amp;amp;icde=43814379" target="_blank">1R43DA047781-01</a>
</span>
<br>
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</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">A NOVEL FAST ACTING NALMEFENE FORMULATION FOR THE PREVENTION AND TREATMENT OF OPIOID OVERDOSE </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">AVIOR, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Vasisht, Niraj </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Cary, 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> 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>Rescue of victims of opioid overdose is accomplished by treatment with antagonist drugs, such as naloxone, that can reverse the respiratory depression. However, naloxone has serious liver toxicity and a short half-life, and its complete antagonism results in a withdrawal effect. Nalmefene is an FDA-approved opioid derivative that is an antagonist of the MOR and a weak agonist of the k-opioid receptors (KOR). An immediate release intravenous injectable formulation was approved by the FDA in 1995 for opioid overdose; however, the requirement for intravenous administration has limited its clinical use. This project, in partnership with Avior, aims to develop a fast-onset, rapidly-dissolving, mucoadhesive thin film formulation that carries uniformly distributed nalmefene nanoparticles on the surface of the film. This film, produced using Aviors proprietary Speedit™ transmucosal drug delivery technology, rapidly delivers nalmefene when the film is placed in contact with the lower lining of the inner lip. This project will generate non-clinical data to support critical human clinical trials to determine if a transmucosal film can be developed with a rapid onset of action that is required for rescue of opioid overdose patients or taken prophylactically to prevent respiratory depression, to assess whether the effective speed of delivery is sufficient to conduct a human clinical trial.</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-35911"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9942319" target="_blank">1U24NS115714-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">California Clinical and Translational Pain Research Consortium </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/clinical-research" hreflang="en">Clinical Research in Pain Management</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/clinical-research/eppic-net" hreflang="en">Early Phase Pain Investigation Clinical Network (EPPIC-Net)</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NINDS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">UNIVERSITY OF CALIFORNIA, SAN DIEGO </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">WALLACE, MARK S </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="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: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-19-036.html" target="_blank">RFA-NS-19-036</a>
<br>
<strong>Summary:</strong>
<br>
<p>The California Clinical and Translational Pain Research Consortium (CCTPRC) consists of four University of California academic medical centers with considerable experience in pain management clinical trials, phenotyping, and biomarker validation. The network will leverage solid existing Clinical and Translational Science Award (CTSA) resources to make clinical trial execution efficient and rapid. The hub will be located at the University of California, San Diego, with spokes located on the other three campuses to provide maximum flexibility, ready to accommodate studies in a variety of pain conditions and provide successful recruitment and high-quality data collection.</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-35951"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9905069&amp;icde=48650303&amp;ddparam=&amp;ddvalue=&amp;ddsub=&amp;cr=1&amp;csb=default&amp;cs=ASC&amp;pball=" target="_blank">1UF1MH121954-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Improving Access and Treatment for Co-occurring Opioid Use Disorders and Mental Illness </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/optimizing-care" hreflang="en">Optimizing Care for People with Opioid Use Disorder and Mental Health Conditions</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">RAND CORPORATION </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">WATKINS, KATHERINE E (contact); KOMAROMY, MIRIAM </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="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: Effectiveness Trials to Optimize, Implement, Scale, and Sustain the Collaborative Care Model for Individuals with Opioid Use Disorders and Mental Health Conditions (U01 Clinical Trial Required)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-MH-19-525.html" target="_blank">RFA-MH-19-525</a>
<br>
<strong>Summary:</strong>
<br>
<p>In 20152016, there were over 2 million adults with an opioid use disorder (OUD); 62% had a co-occurring mental illness and 24% had a co-occurring serious mental illness. Despite the effectiveness of treatment, many individuals never receive it, and when treatment is provided, quality is low. This is a critical treatment gap in a vulnerable and stigmatized population. Collaborative care (CC) aims to address these gaps by improving access, quality, and outcomes in primary care patients with common mental health conditions. However, CC has never been tested with co-occurring disorders (COD). In the teams CC model for COD (CC-COD), the CC team includes a behavioral health psychotherapist, medications for OUD, pharmacotherapy for depression and post-traumatic stress disorder (PTSD), motivational interviewing (MI), problem-solving therapy, and Seeking Safety. A multisite, randomized pragmatic trial will be conducted to adapt, harmonize, and then test whether CC-COD improves access, quality, and outcomes for patients with comorbid OUD and depression and/or PTSD.</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-35991"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9916202&amp;amp;icde=46527714" target="_blank">3UG1DA015831-17S6</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Subthreshold Opioid Use Disorder Prevention (STOP); which will test the efficacy of a primary care Subthreshold Opioid Use Disorder Prevention (STOP) </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/new-strategies" hreflang="en">New Strategies to Prevent and Treat Opioid Addiction</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/new-strategies/prevent-progression" hreflang="en">Prevention of Progression to Moderate or Severe Opioid Use Disorder</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">McLean Hospital </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">WEISS, ROGER D </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>
</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> The National Drug Abuse Treatment Clinical Trials Network (UG1)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-15-008.html" target="_blank">RFA-DA-15-008</a>
<br>
<strong>Summary:</strong>
<br>
<p>According to SAMHSAs 2017 National Survey on Drug Use and Health (NSDUH), 11.4 million persons in the U.S. report past-year opioid misuse; out of them, only 2.1 million individuals met criteria for an OUD. Very little is known about efficacious interventions for those who do not meet criteria for moderate/severe OUD (i.e., subthreshold OUD). The prevalence of subthreshold OUD in primary care settings is 5 percent to 10 percent, with higher rates (21 percent to 29 percent) among those receiving prescribed opioids. Although they are at high risk of developing moderate/severe OUD and/or dying from an overdose, little or no empirical evidence exists for pragmatic prevention interventions that can be adopted at integrated general medical settings. To study the efficacy of prevention interventions to arrest the progression from risky opioid use, researchers will test the efficacy of a STOP intervention in primary care settings. STOP adopts an early intervention approach, based on a collaborative care model to prevent progression to moderate/severe OUD, and consists of a practice-embedded nurse care manager who provides patient education and supports the primary care provider (PCP) in engaging, monitoring and guiding patients who have risky opioid use; brief advice delivered to patients by their PCP; and phone counseling of patients by behavioral health providers to motivate and support behavior change. Researchers will determine whether STOP reduces risky opioid use and examine the impact of STOP on progression to moderate/severe OUD, overdose risk behavior and overdose events in adults with risky use of illicit or prescription opioids.</p>
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