2290 lines
212 KiB
Text
2290 lines
212 KiB
Text
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<noscript><meta http-equiv="Refresh" content="0; URL=/big_pipe/no-js?destination=/funding/awarded%3Fpage%3D2%26research_program%3D146" />
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</noscript><meta name="description" content="View all awarded funding as part of the NIH HEAL (Helping to End Addiction Long-term) Initiative." />
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<meta property="og:title" content="Awarded Funding" />
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<meta property="og:updated_time" content="Thu, 09/21/2023 - 7:31am" />
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<title>Funded Projects | NIH HEAL Initiative</title>
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<a href="/research/clinical-research/pain-signatures" class="menu-link gtm-topnav-third" tabindex="0" data-drupal-link-system-path="node/186">Acute to Chronic Pain Signatures Program</a>
|
||
|
||
</li>
|
||
|
||
<li class="menu-item no-bullets nav-list-item-2">
|
||
<a href="/research/clinical-research/back-pain" class="menu-link gtm-topnav-third" tabindex="0" data-drupal-link-system-path="node/161">Back Pain Consortium Research Program</a>
|
||
|
||
</li>
|
||
|
||
<li class="menu-item no-bullets nav-list-item-2">
|
||
<a href="/research/clinical-research/biomarkers" class="menu-link gtm-topnav-third" tabindex="0" data-drupal-link-system-path="node/191">Discovery and Validation of Biomarkers, Endpoints and Signatures for Pain Conditions</a>
|
||
|
||
</li>
|
||
|
||
<li class="menu-item no-bullets nav-list-item-2">
|
||
<a href="/research/clinical-research/eppic-net" class="menu-link gtm-topnav-third" tabindex="0" data-drupal-link-system-path="node/176">Early Phase Pain Investigation Clinical Network (EPPIC-Net)</a>
|
||
|
||
</li>
|
||
|
||
<li class="menu-item no-bullets nav-list-item-2">
|
||
<a href="/research/clinical-research/hemodialysis" class="menu-link gtm-topnav-third" tabindex="0" data-drupal-link-system-path="node/181">Integrated Approach to Pain and Opioid Use in Hemodialysis Patients</a>
|
||
|
||
</li>
|
||
|
||
<li class="menu-item no-bullets nav-list-item-2">
|
||
<a href="/research/clinical-research/pain-management-research" class="menu-link gtm-topnav-third" tabindex="0" data-drupal-link-system-path="node/166">Pain Management Effectiveness Research Network</a>
|
||
|
||
</li>
|
||
|
||
<li class="menu-item no-bullets nav-list-item-2">
|
||
<a href="/research/clinical-research/prism" class="menu-link gtm-topnav-third" tabindex="0" data-drupal-link-system-path="node/171">Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM)</a>
|
||
|
||
</li>
|
||
|
||
<li class="menu-item no-bullets nav-list-item-2">
|
||
<a href="/research/clinical-research/chronic-pain-rural-populations" class="menu-link gtm-topnav-third" tabindex="0" data-drupal-link-system-path="node/44091">Prevention and Management of Chronic Pain in Rural Populations</a>
|
||
|
||
</li>
|
||
|
||
<li class="menu-item no-bullets nav-list-item-2">
|
||
<a href="/research/clinical-research/integrative-management-chronic-pain" class="menu-link gtm-topnav-third" tabindex="0" data-drupal-link-system-path="node/39621">Reducing Opioid-Related Harms to Treat Chronic Pain (IMPOWR and MIRHIQL)</a>
|
||
|
||
</li>
|
||
</ul>
|
||
|
||
|
||
|
||
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|
||
|
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|
||
<a href="/research/preclinical-translational" class="menu-link gtm-topnav-drop" tabindex="0" data-drupal-link-system-path="node/86">Preclinical and Translational Research in Pain Management</a>
|
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|
||
<button class="expand-btn" aria-label="expand-button"></button>
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|
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|
||
|
||
</li>
|
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|
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|
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<a href="/research/preclinical-translational/novel-targets" class="menu-link gtm-topnav-third" tabindex="0" data-drupal-link-system-path="node/216">Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain</a>
|
||
|
||
</li>
|
||
|
||
<li class="menu-item no-bullets nav-list-item-2">
|
||
<a href="/research/preclinical-translational/integrated-research" class="menu-link gtm-topnav-third" tabindex="0" data-drupal-link-system-path="node/44116">Integrated Basic and Clinical Team-Based Research in Pain</a>
|
||
|
||
</li>
|
||
|
||
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|
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<a href="/research/preclinical-translational/screening-platform" class="menu-link gtm-topnav-third" tabindex="0" data-drupal-link-system-path="node/211">Preclinical Screening Platform for Pain</a>
|
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|
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|
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|
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|
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|
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|
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<a href="/research/preclinical-translational/discoveries-into-devices" class="menu-link gtm-topnav-third" tabindex="0" data-drupal-link-system-path="node/201">Translating Discoveries into Effective Devices to Treat Pain</a>
|
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||
</li>
|
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|
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|
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<a href="/research/preclinical-translational/novel-drugs-screening-platforms" class="menu-link gtm-topnav-third" tabindex="0" data-drupal-link-system-path="node/196">Translational Research to Advance Testing of Novel Drugs and Human Cell-Based Screening Platforms to Treat Pain and Opioid Use Disorder</a>
|
||
|
||
</li>
|
||
</ul>
|
||
|
||
|
||
|
||
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|
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|
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|
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|
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<a href="/research/cross-cutting-research/small-business-programs" class="menu-link gtm-topnav-third" tabindex="0" data-drupal-link-system-path="node/42111">Small Business Programs </a>
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<a href="/research/cross-cutting-research/stigma-pain-management-opioid-disorder" class="menu-link gtm-topnav-third" tabindex="0" data-drupal-link-system-path="node/40256">Stigma in Pain Management and Opioid Use Disorder</a>
|
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|
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|
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<li class="menu-item no-bullets nav-list-item-2">
|
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<a href="/research/cross-cutting-research/translating-data-action-prevent-overdose" class="menu-link gtm-topnav-third" tabindex="0" data-drupal-link-system-path="node/42121">HEAL Data2Action (HD2A)</a>
|
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|
||
</li>
|
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</ul>
|
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|
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|
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</li>
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<li class="menu-item no-bullets nav-list-item-1">
|
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<a href="/research/training-next-generation-researchers" class="menu-link gtm-topnav-drop" tabindex="0" data-drupal-link-system-path="node/46831">Training the Next Generation of Researchers in HEAL</a>
|
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|
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</li>
|
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</ul>
|
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|
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|
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</li>
|
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<a href="/data/heal-data-ecosystem" class="menu-link gtm-topnav-drop" tabindex="0" data-drupal-link-system-path="node/38836">About the HEAL Data Ecosystem</a>
|
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|
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|
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<a href="/data/complying-heal-data-sharing-policy" class="menu-link gtm-topnav-drop" tabindex="0" data-drupal-link-system-path="node/39216">Complying With the HEAL Data Sharing Policy</a>
|
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|
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<a href="/data/common-data-elements" class="menu-link gtm-topnav-drop" tabindex="0" data-drupal-link-system-path="node/39116">Common Data Elements (CDEs) Program</a>
|
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|
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<a href="/data/common-data-elements-repository" class="menu-link gtm-topnav-drop" tabindex="0" data-drupal-link-system-path="node/42871">Common Data Elements (CDEs) Repository</a>
|
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</li>
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<li class="menu-item no-bullets nav-list-item-1">
|
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<a href="/data/ecosystem-events-outreach" class="menu-link gtm-topnav-drop" tabindex="0" data-drupal-link-system-path="node/40321">HEAL Data Ecosystem Events and Outreach</a>
|
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|
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<a href="/data/public-access-data" class="menu-link gtm-topnav-drop" tabindex="0" data-drupal-link-system-path="node/51">HEAL Public Access and Data Sharing</a>
|
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|
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<a href="/data/data-ecosystem-collective-board" class="menu-link gtm-topnav-drop" tabindex="0" data-drupal-link-system-path="node/40951">HEAL Data Ecosystem Collective Board</a>
|
||
|
||
</li>
|
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</ul>
|
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|
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|
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|
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</li>
|
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<li class="menu-item menu-item--expanded menu-item--active-trail no-bullets nav-list-item-0">
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<a href="/funding" class="menu-link gtm-topnav-link" tabindex="0" data-drupal-link-system-path="node/221">Funding</a>
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<a href="/funding/awarded" class="menu-link gtm-topnav-drop" tabindex="0" data-drupal-link-system-path="node/881">Funded Projects</a>
|
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|
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<a href="/funding/open" class="menu-link gtm-topnav-drop" tabindex="0" data-drupal-link-system-path="node/871">Open Funding Opportunities</a>
|
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<a href="/funding/closed" class="menu-link gtm-topnav-drop" tabindex="0" data-drupal-link-system-path="node/876">Closed Funding Opportunities</a>
|
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|
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<a href="/funding/research-concepts" class="menu-link gtm-topnav-drop" tabindex="0" data-drupal-link-system-path="node/40206">Research Concepts</a>
|
||
|
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<a href="/news" class="menu-link gtm-topnav-link" tabindex="0" data-drupal-link-system-path="node/226">News & Events</a>
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|
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<a href="/news/events/headliners" class="menu-link gtm-topnav-drop" tabindex="0" data-drupal-link-system-path="node/42551">Headliners Webinar Series</a>
|
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<li class="menu-item no-bullets nav-list-item-1">
|
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<a href="/news/stories" class="menu-link gtm-topnav-drop" tabindex="0" data-drupal-link-system-path="node/33676">Research Spotlights</a>
|
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</li>
|
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|
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<li class="menu-item no-bullets nav-list-item-1">
|
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<a href="/videos" class="menu-link gtm-topnav-drop" tabindex="0" data-drupal-link-system-path="node/36351">Videos</a>
|
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<a href="/resources/engagement" class="menu-link gtm-topnav-drop" tabindex="0" data-drupal-link-system-path="node/43166">Patient and Community Engagement</a>
|
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|
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</li>
|
||
</ul>
|
||
|
||
|
||
|
||
</li>
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|
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|
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</nav>
|
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|
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</header>
|
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|
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<div data-drupal-messages-fallback class="hidden"></div><span data-big-pipe-placeholder-id="callback=Drupal%5CCore%5CRender%5CElement%5CStatusMessages%3A%3ArenderMessages&args%5B0%5D&token=_HAdUpwWmet0TOTe2PSiJuMntExoshbm1kh2wQzzzAA">
|
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</span>
|
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|
||
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<div class="color-gradient"></div>
|
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|
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<main role="main">
|
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<div class="container">
|
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<a id="main-content" tabindex="-1"></a>
|
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<div class="row">
|
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<div class="col-sm-12 breadcrumb-col col-md-7">
|
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<div id="block-particle-breadcrumbs">
|
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|
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|
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|
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|
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<nav aria-label="breadcrumb" role="navigation">
|
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<ol class="breadcrumb">
|
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<li class="breadcrumb-item gtm-breadcrumb"><a href="/" class="gtm-breadcrumb">Home</a></li>
|
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<li class="breadcrumb-item gtm-breadcrumb"><a href="/funding" class="gtm-breadcrumb">Funding</a></li>
|
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<li class="breadcrumb-item active is-active gtm-breadcrumb" aria-current="page">Funded Projects</li>
|
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</ol>
|
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</nav>
|
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|
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|
||
</div>
|
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|
||
|
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</div>
|
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<div class="col-sm-12 col-md-5">
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
|
||
<div class="layout-content">
|
||
<div>
|
||
<div id="block-particle-content">
|
||
|
||
|
||
|
||
|
||
<h1> Funded Projects </h1>
|
||
|
||
|
||
<div>
|
||
|
||
<div class="paragraph paragraph--type--basic-content paragraph--view-mode--default">
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
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|
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|
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|
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|
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|
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<div class="container">
|
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<div class='basic-content content-align-left padding-bottom--1'>
|
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<div class='basic-content-grid-container ' style=''>
|
||
<div class="basic-content-grid-no-media">
|
||
<div>
|
||
|
||
<p>Explore our currently funded projects. You may search with all three fields, then focus your results by applying any of the dropdown filters. After customizing your search, you may download results and even save your specific search for later.</p>
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
</div>
|
||
|
||
|
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<div class="paragraph paragraph--type--dynamic-content paragraph--view-mode--default">
|
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||
|
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|
||
<div class='container'>
|
||
<div class="dynamic_content">
|
||
|
||
|
||
<div class="views-element-container form-group"><div class="funding js-view-dom-id-e00dd9413b3942829d9213015554d6dd49beb0046219cc5962c35ceaa165873f">
|
||
|
||
|
||
|
||
|
||
<div class="container">
|
||
<form class="views-exposed-form" data-drupal-selector="views-exposed-form-database-block-6" action="/database/export" method="get" id="views-exposed-form-database-block-6" accept-charset="UTF-8">
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
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|
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|
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|
||
|
||
|
||
|
||
|
||
<div class="container">
|
||
<div id="filters" class="filters">
|
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<div class='filter-row'>
|
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<div class="form-item-input">
|
||
|
||
<div class="form-group js-form-item form-item js-form-type-textfield form-item-institutions js-form-item-institutions form-no-label">
|
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<input placeholder="PI or Grantee Institution" aria-label="PI or Grantee Institution" class="gtm-database-category form-text" data-drupal-selector="edit-institutions" type="text" id="edit-institutions" name="institutions" value="" size="30" maxlength="128" />
|
||
|
||
</div>
|
||
|
||
</div>
|
||
<div class="form-item-input">
|
||
|
||
<div class="form-group js-form-item form-item js-form-type-textfield form-item-locations js-form-item-locations form-no-label">
|
||
<input placeholder="Grantee Location" aria-label="Grantee Location" class="gtm-database-category form-text" data-drupal-selector="edit-locations" type="text" id="edit-locations" name="locations" value="" size="30" maxlength="128" />
|
||
|
||
</div>
|
||
|
||
</div>
|
||
<div class="form-item-input">
|
||
|
||
<div class="form-group js-form-item form-item js-form-type-textfield form-item-combine js-form-item-combine form-no-label">
|
||
<input placeholder="Enter Keywords" aria-label="Enter Keywords" class="combine-field form-text" data-drupal-selector="edit-combine" type="text" id="edit-combine" name="combine" value="" size="30" maxlength="128" />
|
||
|
||
</div>
|
||
|
||
</div>
|
||
<div class="form-item-submit keywords">
|
||
<input class="btn btn-alto gtm-database-search button js-form-submit form-submit" data-drupal-selector="edit-submit-database" type="submit" id="edit-submit-database" value="Search">
|
||
</div>
|
||
</div>
|
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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">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" selected="selected">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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<select data-drupal-selector="edit-year" id="edit-year" name="year" class="form-select"><option value="" selected="selected">Year Awarded</option><option value="2024">2024</option><option value="2023">2023</option><option value="2022">2022</option><option value="2021">2021</option><option value="2020">2020</option><option value="2019">2019</option><option value="2018">2018</option></select>
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Reset
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<a href="#" class="gtm-copy-query copybutton" aria-label="Copy the URL for your results" data-copy="https://heal.nih.gov/funding/awarded?research_program=146">Save this Search</a>
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<th id="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number" scope="col"><a href="?page=2&research_program=146&rfa=All&institutions1=&locations1=&goal=All&combine=&grant=All&locations=&institutions=&select_location=All&year=&items_per_page=25&order=field_reporter_number&sort=asc" title="sort by Project #">Project #</a></th>
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<th id="view-field-investigators-table-column" class="views-field views-field-field-investigators" scope="col"><a href="?page=2&research_program=146&rfa=All&institutions1=&locations1=&goal=All&combine=&grant=All&locations=&institutions=&select_location=All&year=&items_per_page=25&order=field_investigators&sort=asc" title="sort by Investigator(s)">Investigator(s)</a></th>
|
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<th id="view-field-locations-table-column" class="views-field views-field-field-locations" scope="col"><a href="?page=2&research_program=146&rfa=All&institutions1=&locations1=&goal=All&combine=&grant=All&locations=&institutions=&select_location=All&year=&items_per_page=25&order=field_locations&sort=asc" title="sort by Location(s)">Location(s)</a></th>
|
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<th id="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded" scope="col"><a href="?page=2&research_program=146&rfa=All&institutions1=&locations1=&goal=All&combine=&grant=All&locations=&institutions=&select_location=All&year=&items_per_page=25&order=field_year_awarded&sort=asc" title="sort by Year Awarded">Year Awarded</a></th>
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<tr class="odd">
|
||
|
||
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
|
||
<span id="project-title-39451"> <a href="https://reporter.nih.gov/project-details/10322644" target="_blank">1UG3DA054825-01</a>
|
||
</span>
|
||
<br>
|
||
<a class="expand-link" data-toggle="collapse" href="#summary1" role="button" aria-expanded="false" aria-controls="collapseExample">
|
||
Show Summary
|
||
</a>
|
||
</td>
|
||
|
||
<td headers="view-title-table-column" class="views-field views-field-title">A novel and highly selective orexin 1 receptor antagonist for the treatment of 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/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">ASTRAZENECA PHARMACEUTICALS </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">INAMDAR, AMIR </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Wilmington, DE </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
|
||
|
||
</tr> <!-- closing head of time -->
|
||
|
||
<tr id="summary1" class="summary collapse odd fullSummary">
|
||
<td colspan="9">
|
||
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
|
||
<strong>NOFO Title:</strong> Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
|
||
<br>
|
||
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PAR-20-092.html" target="_blank">PAR-20-092</a>
|
||
<br>
|
||
<strong>Summary:</strong>
|
||
<br>
|
||
<p>In collaboration with Eolas Therapeutics and the NIH Blueprint Neurotherapeutics Network, AstraZeneca has developed a novel compound for treatment of opioid use disorder, AZD4041, which targets orexin 1 (OX1) receptors in the brain. In animal studies, AZD4041 reduced the motivation to consume opioids or nicotine, reduced relapse-like drug-seeking behaviors, and showed a favorable safety profile. The compound also has proven to be safe in an initial Phase 1 clinical trial in healthy human volunteers. This project will further evaluate the safety (e.g., respiratory depression profile) of AZD4041 in human volunteers, using multiple and increasing doses. Upon successful completion of these studies, the compound will be tested in a proof-of-concept efficacy study in patients with opioid use disorder. If this is successful, the compound will advance to larger Phase 2 and Phase 3 pivotal clinical trial to tests its effectiveness in the treatment of opioid use disorder.</p>
|
||
|
||
</div>
|
||
</td>
|
||
</tr> <!-- summary-->
|
||
|
||
|
||
|
||
<tr class="even">
|
||
|
||
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
|
||
<span id="project-title-39411"> <a href="https://reporter.nih.gov/project-details/10157937" target="_blank">1UG3DA053123-01</a>
|
||
</span>
|
||
<br>
|
||
<a class="expand-link" data-toggle="collapse" href="#summary2" role="button" aria-expanded="false" aria-controls="collapseExample">
|
||
Show Summary
|
||
</a>
|
||
</td>
|
||
|
||
<td headers="view-title-table-column" class="views-field views-field-title">Bacteriophage virus-like particle vaccines for fentanyl and heroin 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 NEW MEXICO HEALTH SCIS CTR </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">CHACKERIAN, BRYCE C </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Albuquerque, NM </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
|
||
|
||
</tr> <!-- closing head of time -->
|
||
|
||
<tr id="summary2" class="summary collapse even fullSummary">
|
||
<td colspan="9">
|
||
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
|
||
<strong>NOFO Title:</strong> Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
|
||
<br>
|
||
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PAR-20-092.html" target="_blank">PAR-20-092</a>
|
||
<br>
|
||
<strong>Summary:</strong>
|
||
<br>
|
||
<p>Opioids account for nearly 70 percent of overdose deaths in the United States, with fentanyl and heroin use the most common causes. The goal of this project is to create a vaccine to elicit serum antibodies that bind and sequester the drug in the blood, preventing it from crossing the blood-brain barrier where it acts on the central nervous system. Current opioid vaccine strategies require multiple boosts and months to reach peak titers, the level of antibodies in a blood sample, and have yet to show protection against lethal overdose. In this project, researchers will use a bacteriophage virus-like particle vaccine platform to engineer and test the effectiveness of a combined vaccine to elicit high titer antibodies quickly to protect against lethal overdose from fentanyl or heroin.</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-39436"> <a href="https://reporter.nih.gov/project-details/10320676" target="_blank">1UG3DA054799-01</a>
|
||
</span>
|
||
<br>
|
||
<a class="expand-link" data-toggle="collapse" href="#summary3" role="button" aria-expanded="false" aria-controls="collapseExample">
|
||
Show Summary
|
||
</a>
|
||
</td>
|
||
|
||
<td headers="view-title-table-column" class="views-field views-field-title">Development of Lofexidine as a First-line Non-Opioid Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome </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">USWM, LLC </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">GULLO, KRISTEN LEANN </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Louisville, KY </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
|
||
|
||
</tr> <!-- closing head of time -->
|
||
|
||
<tr id="summary3" class="summary collapse odd fullSummary">
|
||
<td colspan="9">
|
||
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
|
||
<strong>NOFO Title:</strong> Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
|
||
<br>
|
||
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PAR-20-092.html" target="_blank">PAR-20-092</a>
|
||
<br>
|
||
<strong>Summary:</strong>
|
||
<br>
|
||
<p>The nation’s opioid epidemic remains a public health emergency, marked by high rates of opioid use and misuse among adults and a correlated rising incidence of neonatal opioid withdrawal syndrome (NOWS) in infants exposed to opioids before they are born. There are currently no pharmacotherapies approved by the Food and Drug Administration (FDA) for the treatment of NOWS. This research will complete manufacturing and clinical trial activities to evaluate and support FDA approval of a pediatric-appropriate formulation of lofexidine, a non-opioid medication approved for mitigation of opioid withdrawal symptoms in adults, as a first line-therapy in NOWS patients through two clinical trials to (1) identify an optimal dosing regimen of lofexidine for treatment of NOWS, and (2) evaluate the risks and benefits of its use in improving withdrawal symptoms, limiting infant exposure to other off-label narcotic medications and shortening the infant’s overall stay in the hospital.</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-39461"> <a href="https://reporter.nih.gov/project-details/10250727" target="_blank">1UG3DA052173-01A1</a>
|
||
</span>
|
||
<br>
|
||
<a class="expand-link" data-toggle="collapse" href="#summary4" role="button" aria-expanded="false" aria-controls="collapseExample">
|
||
Show Summary
|
||
</a>
|
||
</td>
|
||
|
||
<td headers="view-title-table-column" class="views-field views-field-title">Combating opioid addiction using CVL-936, a novel D3/D2 receptor antagonist </td>
|
||
|
||
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/therapeutic-options" hreflang="en">Novel Therapeutic Options for Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/therapeutic-options/focusing-development" hreflang="en">Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
|
||
|
||
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">CEREVEL THERAPEUTICS, LLC </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">CHAKILAM, ANANTHSRINIVAS RAO </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Cambridge, MA </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
|
||
|
||
</tr> <!-- closing head of time -->
|
||
|
||
<tr id="summary4" class="summary collapse even fullSummary">
|
||
<td colspan="9">
|
||
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
|
||
<strong>NOFO Title:</strong> Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
|
||
<br>
|
||
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PAR-20-092.html" target="_blank">PAR-20-092</a>
|
||
<br>
|
||
<strong>Summary:</strong>
|
||
<br>
|
||
<p>Opioid use and addiction affects more than 2 million Americans and contribute to a large proportion of all drug overdose deaths. Current treatments for opioid use disorder (e.g., methadone and buprenorphine) are not always effective, may be misused, and can have side effects that discourage treatment continuation. Therefore, Cerevel Therapeutics is evaluating a novel compound, CVL-936, which targets brain molecules called dopamine D3 receptors. These receptors are involved in the brain’s reward and relapse pathways and are present in higher levels in people with addictions. In animal studies, the molecule reduced self-administration of nicotine and fentanyl, including in relapse situations. The project will test the safety and tolerability of CVL-936 in animals and healthy humans and will examine its effectiveness in reducing craving in people with opioid use disorder.</p>
|
||
|
||
</div>
|
||
</td>
|
||
</tr> <!-- summary-->
|
||
|
||
|
||
|
||
<tr class="odd">
|
||
|
||
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
|
||
<span id="project-title-39416"> <a href="https://reporter.nih.gov/project-details/10154341" target="_blank">1UG3DA050942-01A1</a>
|
||
</span>
|
||
<br>
|
||
<a class="expand-link" data-toggle="collapse" href="#summary5" role="button" aria-expanded="false" aria-controls="collapseExample">
|
||
Show Summary
|
||
</a>
|
||
</td>
|
||
|
||
<td headers="view-title-table-column" class="views-field views-field-title">An Intranasal GDNF Gene Therapy for Opioid Relapse Reduction </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">NORTHEASTERN UNIVERSITY </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">WASZCZAK, BARBARA LEE </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Boston, MA </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
|
||
|
||
</tr> <!-- closing head of time -->
|
||
|
||
<tr id="summary5" class="summary collapse odd fullSummary">
|
||
<td colspan="9">
|
||
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
|
||
<strong>NOFO Title:</strong> Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
|
||
<br>
|
||
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PAR-20-092.html" target="_blank">PAR-20-092</a>
|
||
<br>
|
||
<strong>Summary:</strong>
|
||
<br>
|
||
<p>There are currently no effective non-opioid-based pharmacotherapies for treatment of opioid use disorder (OUD). Glial cell line-derived neurotrophic factor (GDNF) is a beneficial protein normally present in low levels in the adult brain, and there is strong evidence that it has clinical potential as a therapy for OUD and relapse reduction. Researchers have developed a non-invasive approach that bypasses the blood-brain barrier to increase levels of GDNF using intranasal administration of gene nanoparticles that make GDNF protein within the brain. This project will test whether this intranasal GDNF gene therapy can suppress drug craving and reduce the tendency to start using a drug again after a period of abstinence in experimental models, thus providing a long-term therapeutic strategy for reducing opioid craving and preventing relapse.</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-39446"> <a href="https://reporter.nih.gov/project-details/10400589" target="_blank">1UF1DA053806-01A1</a>
|
||
</span>
|
||
<br>
|
||
<a class="expand-link" data-toggle="collapse" href="#summary6" role="button" aria-expanded="false" aria-controls="collapseExample">
|
||
Show Summary
|
||
</a>
|
||
</td>
|
||
|
||
<td headers="view-title-table-column" class="views-field views-field-title">Development of a novel OTC naloxone product to be affordably priced and widely accessible </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">POCKET NALOXONE CORP. </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">KIM, SONNIE </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">2021 </td>
|
||
|
||
</tr> <!-- closing head of time -->
|
||
|
||
<tr id="summary6" 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> Grand Opportunity in Medications Development for Substance-Use Disorders (U01 - Clinical Trial Optional)
|
||
<br>
|
||
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PAR-19-327.html" target="_blank">PAR-19-327</a>
|
||
<br>
|
||
<strong>Summary:</strong>
|
||
<br>
|
||
<p>Naloxone is a safe and effective opioid antagonist, but currently available products are burdened with high cost and limited accessibility due to a need for a prescription or being kept behind-the-counter. In response to the FDA putting out an unprecedented call for an over the counter naloxone product, Pocket Naloxone Corp. is developing a novel intranasal delivery method for naloxone intended to be low-priced and widely accessible. This project will culminate in a New Drug Application to the FDA for over-the-counter approval to meet the urgent need for widespread access to a reliable, easy-to-use naloxone product for use in an emergency by non-medical individuals.</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-39406"> <a href="https://reporter.nih.gov/project-details/10400321" target="_blank">1UF1DA054817-01A1</a>
|
||
</span>
|
||
<br>
|
||
<a class="expand-link" data-toggle="collapse" href="#summary7" role="button" aria-expanded="false" aria-controls="collapseExample">
|
||
Show Summary
|
||
</a>
|
||
</td>
|
||
|
||
<td headers="view-title-table-column" class="views-field views-field-title">Preclinical Development of Novel Dual OXR/KOR Antagonists for Treatment of Substance Use Disorder </td>
|
||
|
||
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/therapeutic-options" hreflang="en">Novel Therapeutic Options for Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/therapeutic-options/focusing-development" hreflang="en">Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
|
||
|
||
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">HAGER BIOSCIENCES, INC. </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">BUTERA, JOHN A </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Bethlehem, PA </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
|
||
|
||
</tr> <!-- closing head of time -->
|
||
|
||
<tr id="summary7" 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> Grand Opportunity in Medications Development for Substance-Use Disorders (U01 - Clinical Trial Optional)
|
||
<br>
|
||
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PAR-19-327.html" target="_blank">PAR-19-327</a>
|
||
<br>
|
||
<strong>Summary:</strong>
|
||
<br>
|
||
<p>Substance use disorder (SUD) is a serious public health and socioeconomic burden. In this project, researchers will develop novel drug compounds that dually target orexin receptors and kappa opioid receptors, which have both been implicated in SUD. The compounds will then be tested for effectiveness in preclinical models of SUD, including models of cocaine, methamphetamine, and fentanyl use. This research has the potential to provide highly impactful and innovative treatment options for SUD via simultaneous modulation of multiple signaling pathways.</p>
|
||
|
||
</div>
|
||
</td>
|
||
</tr> <!-- summary-->
|
||
|
||
|
||
|
||
<tr class="even">
|
||
|
||
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
|
||
<span id="project-title-39421"> <a href="https://reporter.nih.gov/project-details/10321502" target="_blank">1UG3DA052166-01A1</a>
|
||
</span>
|
||
<br>
|
||
<a class="expand-link" data-toggle="collapse" href="#summary8" role="button" aria-expanded="false" aria-controls="collapseExample">
|
||
Show Summary
|
||
</a>
|
||
</td>
|
||
|
||
<td headers="view-title-table-column" class="views-field views-field-title">CVL-354, a kappa opioid receptor antagonist for treatment of opioid use disorder, withdrawal and relapse </td>
|
||
|
||
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/therapeutic-options" hreflang="en">Novel Therapeutic Options for Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/therapeutic-options/focusing-development" hreflang="en">Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
|
||
|
||
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">CEREVEL THERAPEUTICS, LLC </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">IREDALE, PHILIP </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Cambridge, MA </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2021 </td>
|
||
|
||
</tr> <!-- closing head of time -->
|
||
|
||
<tr id="summary8" class="summary collapse even fullSummary">
|
||
<td colspan="9">
|
||
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
|
||
<strong>NOFO Title:</strong> Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
|
||
<br>
|
||
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PAR-20-092.html" target="_blank">PAR-20-092</a>
|
||
<br>
|
||
<strong>Summary:</strong>
|
||
<br>
|
||
<p>Kappa opioid receptors (KOR) are expressed in brain areas that control reward, motivation, and anxiety. Upon opioid drug withdrawal and abstinence, dysregulated KOR signaling can result in aversive physical and affective states that are a major driver of relapse. Preclinical data have demonstrated that antagonism of KOR can reduce the physical symptoms of opioid withdrawal. Currently, the alpha 2-adrenergic agonist lofexidine is the only approved therapy for the mitigation of the physical symptoms of opioid withdrawal but it is only modestly effective and can have significant unwanted side effects. Cerevel Therapeutics has identified a novel selective KOR antagonist, CVL-354, with unique properties and good preclinical safety margins. This project will assess this drug in early human safety/pharmacokinetics and occupancy studies. Future studies will then be able to assess efficacy of this drug in acute opioid withdrawal.</p>
|
||
|
||
</div>
|
||
</td>
|
||
</tr> <!-- summary-->
|
||
|
||
|
||
|
||
<tr class="odd">
|
||
|
||
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
|
||
<span id="project-title-38601"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9738472&icde=51907504&ddparam=&ddvalue=&ddsub=&cr=1&csb=default&cs=ASC&pball=" target="_blank">1U01DA046430-01A1</a>
|
||
</span>
|
||
<br>
|
||
<a class="expand-link" data-toggle="collapse" href="#summary9" role="button" aria-expanded="false" aria-controls="collapseExample">
|
||
Show Summary
|
||
</a>
|
||
</td>
|
||
|
||
<td headers="view-title-table-column" class="views-field views-field-title">Efficacy of buprenorphine and XR-naltrexone combination for relapse prevention in opioid use disorder </td>
|
||
|
||
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/therapeutic-options" hreflang="en">Novel Therapeutic Options for Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/therapeutic-options/focusing-development" hreflang="en">Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
|
||
|
||
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">NEW YORK STATE PSYCHIATRIC INSTITUTE </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Bisaga, Adam </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">2020 </td>
|
||
|
||
</tr> <!-- closing head of time -->
|
||
|
||
<tr id="summary9" 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>
|
||
<br>
|
||
<strong>NOFO Number:</strong> <a href="">PA18-345</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-38316"> <a href="https://reporter.nih.gov/project-details/10130067" target="_blank">1UG3DA051383-01A1</a>
|
||
</span>
|
||
<br>
|
||
<a class="expand-link" data-toggle="collapse" href="#summary10" role="button" aria-expanded="false" aria-controls="collapseExample">
|
||
Show Summary
|
||
</a>
|
||
</td>
|
||
|
||
<td headers="view-title-table-column" class="views-field views-field-title">Brexpiprazole as an Adjunctive Treatment to Buprenorhpine to Treat Opioid Use Disorder </td>
|
||
|
||
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/therapeutic-options" hreflang="en">Novel Therapeutic Options for Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/therapeutic-options/focusing-development" hreflang="en">Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
|
||
|
||
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION, INC. </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Forbes, Andy </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Princeton, NJ </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2020 </td>
|
||
|
||
</tr> <!-- closing head of time -->
|
||
|
||
<tr id="summary10" 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="">RFA-DA-19-002</a>
|
||
<br>
|
||
<strong>Summary:</strong>
|
||
<br>
|
||
<p>Over 2 million Americans have an Opioid Use Disorder (OUD) and the risks associated with misuse of opioids have prompted a public health crisis. There are three effective FDA-approved drugs for medication assisted treatment (MAT) of OUD. However, while MAT can reduce overall OUD related mortality by as much as fifty percent, relapse and treatment discontinuation are common within the first 5 to 12 weeks of MAT. As longer treatment retention is correlated with better long-term outcomes, the development of an adjunctive medication to alleviate key psychiatric symptoms associated with treatment failure would address an important unmet need. This study seeks to evaluate the safety and efficacy of brexpiprazole as adjunctive treatment to buprenorphine/naloxone in OUD. If successful, this study could enhance the effectiveness of OUD treatments by extending the duration of treatment, thereby reducing the likelihood for relapse and overdose.</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-38341"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=10132101&icde=51902548&ddparam=&ddvalue=&ddsub=&cr=1&csb=default&cs=ASC&pball=" target="_blank">1R61HL156240-01 </a>
|
||
</span>
|
||
<br>
|
||
<a class="expand-link" data-toggle="collapse" href="#summary11" role="button" aria-expanded="false" aria-controls="collapseExample">
|
||
Show Summary
|
||
</a>
|
||
</td>
|
||
|
||
<td headers="view-title-table-column" class="views-field views-field-title">Treatment of Fentanyl Overdose-Induced Respiratory Failure by Low-Dose Dexmedetomidine </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">NHLBI </td>
|
||
|
||
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">PENNSYLVANIA STATE UNIV HERSHEY MED CTR </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">HAOUZI, PHILIPPE A </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Hershey, PA </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2020 </td>
|
||
|
||
</tr> <!-- closing head of time -->
|
||
|
||
<tr id="summary11" 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: Pharmacotherapies to Reverse Opioid Overdose Induced Respiratory Depression without Central Opioid Withdrawal (Target Validation and Candidate Therapeutic Development (R61/R33 - Clinical Trial Not Allowed)
|
||
<br>
|
||
<strong>NOFO Number:</strong> <a href="">RFA-HL-20-031</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-38301"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9968676&icde=51813385" target="_blank">1UG3DA050923-01</a>
|
||
</span>
|
||
<br>
|
||
<a class="expand-link" data-toggle="collapse" href="#summary12" role="button" aria-expanded="false" aria-controls="collapseExample">
|
||
Show Summary
|
||
</a>
|
||
</td>
|
||
|
||
<td headers="view-title-table-column" class="views-field views-field-title">AMPA Antagonism: A Novel Pharmacology for Launching Recovery from Opioid Addiction </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">INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Chambers, Robert </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Indianapolis, IN </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2020 </td>
|
||
|
||
</tr> <!-- closing head of time -->
|
||
|
||
<tr id="summary12" 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="">RFA-DA-19-002</a>
|
||
<br>
|
||
<strong>Summary:</strong>
|
||
<br>
|
||
<p>The excruciating multiday experience of opioid withdrawal syndrome (OWS), is exacerbated by the opioid antagonist drugs naloxone and naltrexone. This industry-academia collaboration will explore the potential of the glutamate AMPA receptor antagonist Tezampanel (TZP). Animal studies have shown reduced hyperactivity in brain circuits involved in OWS, without relying on direct stimulation or antagonism of the opioid system ,and has already been delivered to over 500 human subjects and found to be safe for a potential migraine indication. This proposal will build up the evidence needed to apply for and conduct open label and blinded placebo-controlled human trials of TZP safety and efficacy for OWS. If successful, this project will allow planning for a pivotal registration trial for TZP for OWS, and as a transitional treatment to long-term recovery on naltrexone and help us stem the tide of the opioid crisis.</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-38606"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9983431&icde=51907525&ddparam=&ddvalue=&ddsub=&cr=1&csb=default&cs=ASC&pball=" target="_blank">1UG3DA048502-01A1</a>
|
||
</span>
|
||
<br>
|
||
<a class="expand-link" data-toggle="collapse" href="#summary13" role="button" aria-expanded="false" aria-controls="collapseExample">
|
||
Show Summary
|
||
</a>
|
||
</td>
|
||
|
||
<td headers="view-title-table-column" class="views-field views-field-title">Non-Invasive Vagal Nerve Stimulation in Patients with Opioid Use Disorders </td>
|
||
|
||
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/therapeutic-options" hreflang="en">Novel Therapeutic Options for Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/therapeutic-options/focusing-development" hreflang="en">Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
|
||
|
||
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">EMORY UNIVERSITY </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Bremner, James Douglas </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Atlanta, Georgia </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2020 </td>
|
||
|
||
</tr> <!-- closing head of time -->
|
||
|
||
<tr id="summary13" 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>
|
||
<br>
|
||
<strong>NOFO Number:</strong> <a href="">PAR18-494</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-38321"> <a href="https://reporter.nih.gov/search/QdVTb6CJSkqm3HHKLmyJOQ/project-details/10155301" target="_blank">1U01DA051071-01A1</a>
|
||
</span>
|
||
<br>
|
||
<a class="expand-link" data-toggle="collapse" href="#summary14" role="button" aria-expanded="false" aria-controls="collapseExample">
|
||
Show Summary
|
||
</a>
|
||
</td>
|
||
|
||
<td headers="view-title-table-column" class="views-field views-field-title">Process Development, Manufacturing, and Preclinical Evaluation of a Monoclonal Antibody for Fentanyl 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">CESSATION THERAPEUTICS, LLC </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Bremer, Paul T. </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">San Jose, CA </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2020 </td>
|
||
|
||
</tr> <!-- closing head of time -->
|
||
|
||
<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> Grand Opportunity in Medications Development for Substance-Use Disorders (U01 - Clinical Trial Optional)
|
||
<br>
|
||
<strong>NOFO Number:</strong> <a href="">PAR-19-327</a>
|
||
<br>
|
||
<strong>Summary:</strong>
|
||
<br>
|
||
<p>Opioid use disorder (OUD) is a significant public health problem in the United States. Particularly troubling is the rapid evolution of an opioid epidemic within the past decade, characterized by a surge in unintentional overdose deaths involving synthetic opioids, such as fentanyl. The current standard of care for opioid overdose is reversal with opioid antagonist naloxone. Naloxone is effective at reversing overdose from prescription opioids and heroin, but less effective when combating fentanyl, due to fentanyl?s high potency. Therapeutic monoclonal antibodies (mAbs) against fentanyl could overcome this problem by specifically preventing the drug from entering the central nervous system, averting overdose and attenuating opioid-induced respiratory depression. This study will develop and design of laboratory protocols needed to establish a Good Manufacturing Practice (GMP) process, quality assurance protocol, and stability profile for a new human mAb against fentanyl. Subsequent production of current GMP material will enable Good Laboratory Practice (GLP) toxicology studies in rats and dogs and eventually a Phase I/IIa clinical trial. This material will also be used in final opioid-induced respiratory depression studies in mice and non-human primates to confirm therapeutic efficacy of final drug product. If successful, these activities will enable filing for an investigational new drug application for this mAb candidate with the FDA.</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-38596"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=10026953&icde=51907489&ddparam=&ddvalue=&ddsub=&cr=1&csb=default&cs=ASC&pball=" target="_blank">1UG3DA051392-01 </a>
|
||
</span>
|
||
<br>
|
||
<a class="expand-link" data-toggle="collapse" href="#summary15" role="button" aria-expanded="false" aria-controls="collapseExample">
|
||
Show Summary
|
||
</a>
|
||
</td>
|
||
|
||
<td headers="view-title-table-column" class="views-field views-field-title">Evaluation of the Safety and Efficacy of a New Oral Small Molecule GABA-B Receptor Positive Allosteric Modulator (PAM) as an Add-on Maintenance Therapy for Opioid Use Disorder (OUD) </td>
|
||
|
||
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/therapeutic-options" hreflang="en">Novel Therapeutic Options for Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/therapeutic-options/focusing-development" hreflang="en">Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
|
||
|
||
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">ASTELLAS PHARMA GLOBAL DEVELOPMENT, INC. </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Blahunka, Paul </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">NORTHBROOK, IL </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2020 </td>
|
||
|
||
</tr> <!-- closing head of time -->
|
||
|
||
<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>
|
||
<br>
|
||
<strong>NOFO Number:</strong> <a href="">DA19-002</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-38311"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=10085851&icde=51813408" target="_blank">1UG3DA052282-01</a>
|
||
</span>
|
||
<br>
|
||
<a class="expand-link" data-toggle="collapse" href="#summary16" role="button" aria-expanded="false" aria-controls="collapseExample">
|
||
Show Summary
|
||
</a>
|
||
</td>
|
||
|
||
<td headers="view-title-table-column" class="views-field views-field-title">NOP Receptor Antagonist for OUD Pharmacotherapy </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 MED BR GALVESTON </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Cunningham, Kathryn </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Galveston, TX </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2020 </td>
|
||
|
||
</tr> <!-- closing head of time -->
|
||
|
||
<tr id="summary16" 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="">RFA-DA-19-002</a>
|
||
<br>
|
||
<strong>Summary:</strong>
|
||
<br>
|
||
<p>Medication-based treatment for opioid use disorder OUD aids in reducing mortality, opioid withdrawal, intake and opioid-seeking behaviors, however there is a clear need to increase the armamentarium of therapeutics for OUD. The ?non-classical? NOcicePtin receptor (NOPr) binds the endogenous neuropeptide nociceptin/orphanin FQ (N/OFQ) and is a promising target based on the evidence for its function in the regulation of the rewarding and motivational effects of opioids and alcohol. This study plans to assess the ability of the novel and selective NOPr antagonist BTRX-246040 to block oxycodone intake without abuse liability, and to suppress oxycodone withdrawal and relapse-like behaviors in rats. The study will also determine Drug Metabolism and Pharmacokinetics interactions (DMPK) between oxycodone and BTRX-246040 and brain penetrability in male and female rats. If successful, these preclinical studies will be followed by a Phase 1 clinical trial in non-treatment seeking OUD participants. These investigations will advance the prospects of validating a novel medication for OUD.</p>
|
||
|
||
|
||
</div>
|
||
</td>
|
||
</tr> <!-- summary-->
|
||
|
||
|
||
|
||
<tr class="odd">
|
||
|
||
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
|
||
<span id="project-title-38336"> <a href="https://reporter.nih.gov/project-details/10132101" target="_blank">1R61HL156248-01 </a>
|
||
</span>
|
||
<br>
|
||
<a class="expand-link" data-toggle="collapse" href="#summary17" role="button" aria-expanded="false" aria-controls="collapseExample">
|
||
Show Summary
|
||
</a>
|
||
</td>
|
||
|
||
<td headers="view-title-table-column" class="views-field views-field-title">Intranasal Leptin as A Novel Treatment of Opioid-Induced Respiratory Depression </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">NHLBI </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">POLOTSKY, VSEVOLOD Y </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">2020 </td>
|
||
|
||
</tr> <!-- closing head of time -->
|
||
|
||
<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> HEAL Initiative: Pharmacotherapies to Reverse Opioid Overdose Induced Respiratory Depression without Central Opioid Withdrawal (Target Validation and Candidate Therapeutic Development (R61/R33 - Clinical Trial Not Allowed)
|
||
<br>
|
||
<strong>NOFO Number:</strong> <a href="">RFA-HL-20-031</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-33886"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9917086&amp;icde=46463053" target="_blank">3UG3DA047720-01S1</a>
|
||
</span>
|
||
<br>
|
||
<a class="expand-link" data-toggle="collapse" href="#summary18" role="button" aria-expanded="false" aria-controls="collapseExample">
|
||
Show Summary
|
||
</a>
|
||
</td>
|
||
|
||
<td headers="view-title-table-column" class="views-field views-field-title">Evaluation of safety and pharmacokinetics of naltrexone implant </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">NEW YORK STATE PSYCHIATRIC INSTITUTE </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Bisaga, Adam </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="summary18" 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>New medication treatment approaches are needed to help address the severe epidemic of opioid use disorder (OUD) and opioid overdose deaths in the U.S. Currently available medications, such as methadone, buprenorphine, and extended release injection naltrexone (XR-NTX; trade name: Vivitrol), are highly efficacious, but their effectiveness in practice is limited by poor adherence, with many patients stopping treatment prematurely and relapsing. The goal of this proposal is to develop an innovative long-acting subcutaneous implanted formulation of naltrexone, the O’Neil Long-Acting Naltrexone Implant (OLANI), toward FDA approval. Expected to produce naltrexone blood levels sufficient to block the effects of opioids for 6 months after implant, OLANI circumvents the need for adherence to monthly injections with XR-NTX and could represent an important new addition to the medical armamentarium for treatment of OUD.</p>
|
||
|
||
|
||
</div>
|
||
</td>
|
||
</tr> <!-- summary-->
|
||
|
||
|
||
|
||
<tr class="odd">
|
||
|
||
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
|
||
<span id="project-title-34346"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9736906&amp;icde=46453085" target="_blank">1UG3DA048388-01</a>
|
||
</span>
|
||
<br>
|
||
<a class="expand-link" data-toggle="collapse" href="#summary19" role="button" aria-expanded="false" aria-controls="collapseExample">
|
||
Show Summary
|
||
</a>
|
||
</td>
|
||
|
||
<td headers="view-title-table-column" class="views-field views-field-title">Cannabidiol Effects on Craving and Relapse Prevention in Opioid Use Disorder </td>
|
||
|
||
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/therapeutic-options" hreflang="en">Novel Therapeutic Options for Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/therapeutic-options/focusing-development" hreflang="en">Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
|
||
|
||
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">INSYS DEVELOPMENT COMPANY </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">ELKASHEF, AHMED </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Chandler, AZ </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="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>To tackle the national public health emergency posed by opioid misuse, addiction, and overdose deaths, the development of effective new medications and the FDA drug approval process must be accelerated. In response to this call, INSYS Development Company, Inc. (INSYS) has developed a cannabidiol (CBD) oral solution that shows promise as a novel medication for prevention of relapse that addresses one of the five opportunities specified in the HEAL Initiative to improve treatment options. The first phase of this project involves clinical trials of CBD on cue-induced cravings, modulation of withdrawal, alterations of negative affect states, relapse to opioid use, and treatment retention in patients with OUD receiving buprenorphine treatment in a residential drug treatment facility. The findings from this phase will inform further studies in an outpatient setting. If successful, this project could advance to the development of a new monotherapy for the treatment of OUD.</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-34676"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9843839" target="_blank">1UG3DA049599-01</a>
|
||
</span>
|
||
<br>
|
||
<a class="expand-link" data-toggle="collapse" href="#summary20" role="button" aria-expanded="false" aria-controls="collapseExample">
|
||
Show Summary
|
||
</a>
|
||
</td>
|
||
|
||
<td headers="view-title-table-column" class="views-field views-field-title">Development of a Potent and Highly Selective NaV1.7 Inhibitor for the Treatment of Acute Pain with the Goal of Reducing Opioid Use and Preventing Opioid Use Disorders </td>
|
||
|
||
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/therapeutic-options" hreflang="en">Novel Therapeutic Options for Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/therapeutic-options/focusing-development" hreflang="en">Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
|
||
|
||
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">University of British Columbia </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Hunter, John; Phillips, Anthony </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Vancouver, BC, Canada </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
|
||
|
||
</tr> <!-- closing head of time -->
|
||
|
||
<tr id="summary20" class="summary collapse even fullSummary">
|
||
<td colspan="9">
|
||
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
|
||
<strong>NOFO Title:</strong> 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-34876"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9745990&amp;icde=46462827" target="_blank">1R34DA046635-01A1</a>
|
||
</span>
|
||
<br>
|
||
<a class="expand-link" data-toggle="collapse" href="#summary21" role="button" aria-expanded="false" aria-controls="collapseExample">
|
||
Show Summary
|
||
</a>
|
||
</td>
|
||
|
||
<td headers="view-title-table-column" class="views-field views-field-title">Treatment of chronic low back pain with transcutaneous auricular vagus nerve stimulation </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">MASSACHUSETTS GENERAL HOSPITAL </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Kong, Jian </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>
|
||
|
||
</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> Behavioral & Integrative Treatment Development Program (R34 Clinical Trial Optional)
|
||
<br>
|
||
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-073.html" target="_blank">PA-18-073</a>
|
||
<br>
|
||
<strong>Summary:</strong>
|
||
<br>
|
||
<p>Low back pain (LBP) is one of the most common reasons for all physician visits in the U.S. The financial costs associated with the care of LBP are staggering. The treatments for chronic low back pain (cLBP) are far from satisfactory, and opioids are often prescribed with varying degrees of success. This study builds on prior work suggesting that auricular transcutaneous vagus nerve stimulation (tVNS), a non-invasive therapeutic, can significantly reduce symptoms of chronic pain and common comorbidities of chronic pain, such as depression and anxiety. This proposal aims to investigate the treatment effect and underlying mechanism of tVNS on chronic low back pain. Patients with chronic low back pain will be randomized to either real or sham tVNS treatment for 1 month, with a 3-month follow-up. This study, if successful, could provide new treatment options for chronic low back pain and reduce the use of opioid analgesics in chronic pain management.</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-35111"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9904461" target="_blank">1UG3DA050306-01</a>
|
||
</span>
|
||
<br>
|
||
<a class="expand-link" data-toggle="collapse" href="#summary22" role="button" aria-expanded="false" aria-controls="collapseExample">
|
||
Show Summary
|
||
</a>
|
||
</td>
|
||
|
||
<td headers="view-title-table-column" class="views-field views-field-title">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="summary22" class="summary collapse even fullSummary">
|
||
<td colspan="9">
|
||
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
|
||
<strong>NOFO Title:</strong> Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
|
||
<br>
|
||
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/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>
|
||
|
||
|
||
</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-35311"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9905430" target="_blank">1UG3DA050316-01</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">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>
|
||
|
||
</tr> <!-- closing head of time -->
|
||
|
||
<tr id="summary23" class="summary collapse odd fullSummary">
|
||
<td colspan="9">
|
||
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
|
||
<strong>NOFO Title:</strong> Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
|
||
<br>
|
||
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/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 brain’s 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>
|
||
|
||
|
||
</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-35746"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9667901&amp;icde=46449716" target="_blank">1UG3DA047680-01</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">A novel therapeutic to ameliorate chronic pain and reduce opiate use </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">LOHOCLA RESEARCH CORPORATION </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">TABAKOFF, BORIS </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Aurora, CO </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
|
||
|
||
</tr> <!-- closing head of time -->
|
||
|
||
<tr id="summary24" class="summary collapse even fullSummary">
|
||
<td colspan="9">
|
||
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
|
||
<strong>NOFO Title:</strong> Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
|
||
<br>
|
||
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-002.html" target="_blank">RFA-DA-19-002</a>
|
||
<br>
|
||
<strong>Summary:</strong>
|
||
<br>
|
||
<p>More than 100 million adults in the U.S. suffer from intermittent or constant chronic pain, and chronic pain affects at least 10 percent of the world’s population. The primary pharmaceuticals for treatment of chronic pain have been natural or synthetic opioids, and the use of opioids for pain treatment has resulted in what has been called an “epidemic” of opioid abuse, addiction, and lethal overdoses. Through a process of rational drug design, the research team has generated a new chemical entity (NCE) and have given it the name Kindolor, a non-opiate, non-addicting molecule that was shown to reduce or eliminate chronic pain in five animal models at doses compatible with use of Kindolor in humans. This project intends to complete the pre-clinical studies required for an IND application, which, if approved, would allow for proceeding onto the Phase 1 and 2 studies to assess safety and efficacy of the compound against osteoarthritic 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-36116"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9904032" target="_blank">1UG3DA050311-01</a>
|
||
</span>
|
||
<br>
|
||
<a class="expand-link" data-toggle="collapse" href="#summary25" role="button" aria-expanded="false" aria-controls="collapseExample">
|
||
Show Summary
|
||
</a>
|
||
</td>
|
||
|
||
<td headers="view-title-table-column" class="views-field views-field-title">Mu Opioid Receptor Modulator Development to Treat Opioid Use Disorder </td>
|
||
|
||
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/therapeutic-options" hreflang="en">Novel Therapeutic Options for Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/therapeutic-options/focusing-development" hreflang="en">Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
|
||
|
||
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">Virginia Commonwealth University </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Zhang, Yan </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Richmond, VA </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
|
||
|
||
</tr> <!-- closing head of time -->
|
||
|
||
<tr id="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> 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 to develop a mu-opioid receptor (MOR) treatment with enhanced therapeutic effects and reduced undesirable effects. Recently, several highly selective and potent MOR modulators have been identified as novel leads for opioid use disorder treatment. They all showed more promising pharmacological profiles compared to other known drugs in this category. The current proposal will focus on further development of these leads for preclinical IND-enabling studies and dynamic drug discovery and development pipeline construction. This project plans to further validate therapeutic profiles of the current leads with self-administration and pharmacokinetic studies and expand the small-molecule library to build a dynamic drug discovery and development pipeline. Preclinical IND-enabling studies on the identified lead(s) will be conducted, and in vivo pharmacokinetics and pharmacodynamics profiles of the new hits will be compared with current leads to define the next generation of lead compound(s).</p>
|
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