2323 lines
219 KiB
Text
2323 lines
219 KiB
Text
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<noscript><meta http-equiv="Refresh" content="0; URL=/big_pipe/no-js?destination=/funding/awarded%3Fpage%3D3%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>
|
||
|
||
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|
||
<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>
|
||
|
||
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|
||
<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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|
||
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|
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|
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<button class="expand-btn" aria-label="expand-button"></button>
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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/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>
|
||
|
||
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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/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>
|
||
|
||
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|
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|
||
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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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<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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|
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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>
|
||
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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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|
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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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|
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</li>
|
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</ul>
|
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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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|
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|
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|
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</ul>
|
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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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<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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|
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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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<li class="menu-item no-bullets nav-list-item-1">
|
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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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<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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<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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|
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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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|
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|
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|
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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>
|
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|
||
|
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|
||
</li>
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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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<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>
|
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</div>
|
||
|
||
|
||
<div class="layout-content">
|
||
<div>
|
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<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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|
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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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|
||
<div class='container'>
|
||
<div class="dynamic_content">
|
||
|
||
|
||
<div class="views-element-container form-group"><div class="funding js-view-dom-id-cc9131cd3a1786996e56a84efe4be9a2b34f9ede0a5f681aa7709f050867c96d">
|
||
|
||
|
||
|
||
|
||
<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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|
||
|
||
|
||
|
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|
||
|
||
<div class="container">
|
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<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">
|
||
<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">
|
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<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">
|
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</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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Reset
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<tr class="odd">
|
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|
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
|
||
<span id="project-title-33716"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9821520&amp;icde=46462934" target="_blank">3UG3DA047793-01S1</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">tDCS to decrease opioid 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">BUTLER HOSPITAL (PROVIDENCE, RI) </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Abrantes, Ana M </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Providence, RI </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </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> 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>Neurostimulation techniques, such as transcranial direct current stimulation (tDCS), have been used as interventions for substance use disorders. This is a supplement to the currently NIDA-funded UG3 DA047793, “tDCS to Decrease Opioid Relapse,” which will measure behavioral and brain responses following tDCS stimulation delivered during tasks that use a particular brain network involved in cognitive control, and utilizing FMRI to assess the effects. This supplement allows the researchers to add an EEG measurement to the study, to get a complete picture of how tDCS might affect the function of key brain networks in ways that could be helpful for SUDs.</p>
|
||
|
||
|
||
</div>
|
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</td>
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</tr> <!-- summary-->
|
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<tr class="even">
|
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
|
||
<span id="project-title-34131"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9796231&amp;icde=46453373" target="_blank">1UG3DA048338-01A1</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">A Long-Acting Bioabsorbable Naltrexone Subcutaneous Implant for Opioid Use Disorder </td>
|
||
|
||
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/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">DRUG DELIVERY COMPANY, LLC, THE </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">COHEN, STEVEN M; BENNER, JEFFREY </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Salisbury, MD </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
|
||
|
||
</tr> <!-- closing head of time -->
|
||
|
||
<tr id="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/rfa-files/RFA-DA-19-002.html" target="_blank">RFA-DA-19-002</a>
|
||
<br>
|
||
<strong>Summary:</strong>
|
||
<br>
|
||
<p>Naltrexone (NTX) has proven to be an important, safe, and effective therapy for helping patients overcome opioid use disorders (OUD) and for preventing overdose. Unfortunately, the therapeutic potential of NTX has been blunted by poor adherence. To combat this issue, a system must be developed to deliver NTX for longer durations than currently available and with a more patient-friendly format. To address this problem, we will develop a long-acting and bioabsorbable NTX subcutaneous implant for the treatment of OUD. The proposed research will (a) determine the optimal chemical preparation of NTX inside the implant, (b) optimize the composition and porosity of the drug delivery substrate, and (c) refine the surgical procedure and instrumentation to be used during implantation. Once the safety and efficacy of this novel NTX implant is established, we will conduct the necessary clinical trials. The proposed study is highly relevant to and complementary of other efforts, either in consideration or already deployed to stem the tide of the lingering opioid crisis. If successful, this solution has the potential to enhance health, lengthen life, and reduce illness and disability for those suffering from 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-34546"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9585836&amp;icde=46462245" target="_blank">1R34DA046730-01</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">Web-Based Treatment for Perinatal 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">MEDICAL UNIVERSITY OF SOUTH CAROLINA </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Guille, Constance </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Charleston, SC </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
|
||
|
||
</tr> <!-- closing head of time -->
|
||
|
||
<tr id="summary3" class="summary collapse odd fullSummary">
|
||
<td colspan="9">
|
||
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
|
||
<strong>NOFO Title:</strong> Behavioral & Integrative Treatment Development Program (R34)
|
||
<br>
|
||
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-16-073.html" target="_blank">PA-16-073</a>
|
||
<br>
|
||
<strong>Summary:</strong>
|
||
<br>
|
||
<p>The increased risk of maternal, obstetric, and newborn morbidity and mortality associated with perinatal prescription opioid (PO) misuse and opioid use disorder (OUD) is well established. Despite clear advances in maternal, fetal, and newborn health with treatment of perinatal opioid misuse and OUD, much work remains. Preliminary data has demonstrated significant reductions in opioid misuse as a result of our Cognitive Behavioral Therapy (CBT) program for pain combined with shared decision making for medication management for pregnant women misusing POs or with OUD (including heroin). However, access to the program is still limited and several obstacles to its expansion remain. This proposal will fill this critical gap by converting their CBT intervention from in-person sessions to a web-based interface. The proposed research will result in a critical advance in the management of opioid use and abuse during pregnancy and prevent both the acute and long-term risks associated with pre- and perinatal PO misuse and OUD, including overdose and death.</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-34796"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9789248&amp;icde=46463423" target="_blank">5UG3DA048385-02</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">Development of novel therapeutics for opioid dependence </td>
|
||
|
||
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/therapeutic-options" hreflang="en">Novel Therapeutic Options for Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/therapeutic-options/focusing-development" hreflang="en">Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
|
||
|
||
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Kenny, Paul J. </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="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/rfa-files/RFA-DA-19-002.html">DA19-002</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-34951"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9750304&icde=48650389&ddparam=&ddvalue=&ddsub=&cr=1&csb=default&cs=ASC&pball=" target="_blank">1UG3DA048508-01</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">Combined tDCS and Cognitive Training for the Treatment of 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">University of Minnesota </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Lim, Kelvin </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Minneapolis, MN </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
|
||
|
||
</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> Device-Based Treatments for Substance Use Disorders (UG3/UH3, Clinical Trial Optional)
|
||
<br>
|
||
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/par-18-494.html">PAR-18-494</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-35146"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9734706&amp;icde=46452832" target="_blank">1UG3DA048353-01</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">Opioid use disorders: UF Pharmacy medications discovery and development </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 FLORIDA </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">MCMAHON, LANCE R; MCCURDY, CHRISTOPHER R </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Gainesville, FL </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
|
||
|
||
</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> 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>Opioids have been significantly over-prescribed and are associated with numerous deaths, resulting in the nation’s current opioid crisis. The FDA recently approved the ?2 adrenergic agonist lofexidine as a non-addictive, non-opioid treatment for opioid use disorder (OUD), but there is a continued, urgent need to develop additional pharmacological alternatives to address both pain and OUD. The psychoactive, natural product, Mitragyna speciosa (kratom), has triggered significant interest in this space because Mitragynine, its main alkaloid, can interact with both mu opioid and ?2 receptors, offering a totally new approach for treating OUD. This project involves the synthesis and research of a series of Mitragynine analogs to better understand the pharmacological mechanisms that underlie Mitragynine’s opioid and adrenergic activities. If successful, this project will result in templates for the design of novel opioid receptor ligands. This advance would greatly improve the knowledge of interactions of these structurally novel compounds with opioid receptors and facilitate the development of these ligands as treatments 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-35431"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9902945" target="_blank">1UG3DA050303-01</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">Development of an implantable closed-loop system for delivery of naloxone for the prevention of opioid-related overdose deaths </td>
|
||
|
||
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/therapeutic-options" hreflang="en">Novel Therapeutic Options for Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/therapeutic-options/focusing-development" hreflang="en">Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
|
||
|
||
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">Washington University </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Rogers, John </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">St. Louis, MO </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
|
||
|
||
</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> Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
|
||
<br>
|
||
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-002.html" target="_blank">RFA-DA-19-002</a>
|
||
<br>
|
||
<strong>Summary:</strong>
|
||
<br>
|
||
<p>Current opioid overdose treatment requires administration of naloxone by first responders, which requires timely identification of the overdose, the need for a rescue injection, and immediate availability of the medication. The development of a fail-safe treatment that would provide a life-saving dose of naloxone without the need for intervention by another party could significantly reduce mortality. The researchers aim to develop a new medical device comprising an implantable, closed-loop system that senses the presence of an opioid overdose, automatically administers a life-saving bolus injection of naloxone, and simultaneously alerts first responders.</p>
|
||
|
||
|
||
</div>
|
||
</td>
|
||
</tr> <!-- summary-->
|
||
|
||
|
||
|
||
<tr class="even">
|
||
|
||
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
|
||
<span id="project-title-35816"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9675407&amp;icde=46450748" target="_blank">1UG3DA047699-01</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">Development of ITI-333, a ?-opioid Receptor Partial Agonist and 5HT2A and D1 Receptor Antagonist, for the Treatment of Opioid Use Disorders </td>
|
||
|
||
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/therapeutic-options" hreflang="en">Novel Therapeutic Options for Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/therapeutic-options/focusing-development" hreflang="en">Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
|
||
|
||
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">INTRA-CELLULAR THERAPIES, INC. </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">VANOVER, KIMBERLY E </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">New York, NY </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
|
||
|
||
</tr> <!-- closing head of time -->
|
||
|
||
<tr id="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/rfa-files/RFA-DA-19-002.html" target="_blank">RFA-DA-19-002</a>
|
||
<br>
|
||
<strong>Summary:</strong>
|
||
<br>
|
||
<p>Deaths from opioid overdose continue to rise; from 2015 to 2016, there was a 28 percent increase in the number of fatal overdoses. Currently available pharmacotherapies include MOR agonists (e.g., buprenorphine) and antagonists (e.g., naloxone), all of which suffer from specific and clear limitations. To address some of the key limitations, Intra-Cellular Therapies Inc (ITI) is developing ITI-333, a novel compound with high-affinity activity at mu opiate (MOP), 5-HT2A, and D1 receptors, that lacks abuse liability and thus offers great promise for the treatment of opioid use disorders. This proposal is for a 2-year UG3 program, including a first-in-human, single ascending dose (SAD) study to assess the safety, tolerability, and pharmacokinetics of ITI-333 in healthy volunteers. This study will then be repeated in a single-center in-patient study with the goal of determining a maximally- tolerated dose (MTD) and completed with human abuse liability and functional pharmacology studies. Together, the researchers believe this clinical development plan will inform further development of ITI-333 and the selection of a cogent Phase 3 clinical path toward FDA approval as a medication for the treatment of OUD.</p>
|
||
|
||
|
||
</div>
|
||
</td>
|
||
</tr> <!-- summary-->
|
||
|
||
|
||
|
||
<tr class="odd">
|
||
|
||
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
|
||
<span id="project-title-33846"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9778805&amp;icde=46451247" target="_blank">1UG3DA047709-01</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">An ultra-long-acting oral treatment for opioid use disorder </td>
|
||
|
||
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/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">LYNDRA THERAPEUTICS, INC. </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">BELLINGER, ANDREW MARTIN </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="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> 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>Buprenorphine (BUP) is an FDA-approved medication-assisted therapy (MAT) that improves outcomes and saves lives in patients with opioid use disorder (OUD). It is available in multiple dosage forms and routes of administration, including daily sublingual (SL) and buccal tablets and films, a monthly subcutaneous (SC) injectable, and a 6-month SC implant; however, these forms leave many patients untreated or undertreated. This product, in a partnership with Lyndra Therapeutics, aims to develop a once-weekly oral BUP dosage form for maintenance therapy for OUD, using a new oral dosage formulation developed by Lyndra. A long-acting oral BUP may address important limitations of current MATs by providing improved PK with less euphoria than SL, a patient- and provider-preferred route of administration, and an optimal dosing interval for improved patient adherence with the potential for cost-effective direct observed therapy.</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-34176"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9905262" target="_blank">1UG3DA050317-01</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">Targeting the Ghrelin System for Novel Opioid Use Disorder Therapeutics </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">The University of Texas Medical Branch at 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">2019 </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="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 address the need for novel therapeutics for opioid use disorder (OUD), this research group identified ghrelin as an endogenous regulator of the mesocorticostriatal circuit, which contributes to the enhanced motivational attributes of addictive drugs and drug-associated cues. Ghrelin binds to the growth hormone secretagogue receptor 1? (GHS1?R) to transduce several physiological and behavioral processes, including the reward-related effects of opioid agonists. Systemic administration of a GHS1?R antagonist/inverse agonist dose-dependently attenuated self-administration of the addictive opioid analgesic oxycodone as well as oxycodone-seeking. This project proposes to employ a suite of validated rodent OUD models to define the preclinical profile for PF5190457, a selective GHS1?R antagonist/inverse agonist. PF5190457’s abuse liability, ability to suppress withdrawal and relapse-like behaviors, drug metabolism and pharmacokinetics, and brain penetrability in rats will be assessed. Phase 1 clinical studies in non–treatment seeking OUD participants will follow to assess the safety and tolerability of PF5190457.</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-34611"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9904355" target="_blank">1UG3DA050308-01</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">Clinical Evaluation of C4X3256, a Non-Opioid, Highly-Selective Orexin-1 Receptor Antagonist for the Treatment of Opioid Use Disorder </td>
|
||
|
||
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/therapeutic-options" hreflang="en">Novel Therapeutic Options for Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/therapeutic-options/focusing-development" hreflang="en">Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
|
||
|
||
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">Indivior </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Heidbreder, Christian </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">North Chesterfield, 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="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> 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 pharmacologic treatment options for opioid use disorder (OUD) that do not pose addiction liability and do not require complete withdrawal from opioids prior to treatment. Nonclinical studies support a role for the orexin system in drug seeking; compounds that selectively block signaling at the orexin-1 receptor (OX1R) reduce drug use. C4X3256, a non-opioid, highly selective OX1R antagonist, has a long residence time at the OX1R along with reduced intravenous self-administration and cue-induced reinstatement in animal models of nicotine addiction, suggesting it could be an addiction treatment. Proposed studies will move C4X3256 from preclinical development through Phase I testing in subjects with OUD. The clinical, preclinical, and supporting pharmaceutical development studies proposed will allow C4X3256 to move to Phase II studies.</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-34846"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9900195" target="_blank">1UG3DA050271-01</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">R-methadone-TAAP/MPAR: an abuse deterrent methadone prodrug with overdose protection: Pre-Clinical Development and Phase 1 Clinical Trial </td>
|
||
|
||
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/therapeutic-options" hreflang="en">Novel Therapeutic Options for Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/therapeutic-options/focusing-development" hreflang="en">Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
|
||
|
||
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">Ensysce Biosciences, Inc. </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Kirkpatrick, Lynn </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">San Diego, CA </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
|
||
|
||
</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="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-002.html" target="_blank">RFA-DA-19-002</a>
|
||
<br>
|
||
<strong>Summary:</strong>
|
||
<br>
|
||
<p>Methadone is useful in the treatment of opioid dependence; however, methadone misuse and methadone-related fatalities have increased. Ensysce has created two complementary, novel technologies that can be applied to methadone. Their Trypsin Activated Abuse Protection (TAAP™) prodrugs are “enzyme-activated” to release clinically effective opioid drugs only when taken orally and exposed to the correct physiologic conditions, such as exposure to trypsin in the small bowel. Their multi-pill abuse resistance (MPAR™) feature involves in situ bioregulation of opioid delivery from the TAAP™ systems, enabling control over oral multi-dose pharmacokinetic profiles. It is envisaged that an R-methadone-TAAP™ prodrug would demonstrate similar reduced addiction liability as with other opioid-TAAP products. The objective of this proposal is to develop an R-methadone-TAAP™/MPAR™ drug through Phase 1 clinical studies and to translate R-methadone-TAAP™/MPAR™ results into humans, to ultimately reduce the misuse and oral overdose potential of methadone.</p>
|
||
|
||
|
||
</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-35031"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9684195&amp;icde=46454014" target="_blank">1R01DA046532-01A1</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">Evaluation of drug mixtures for treating pain: behavioral and pharmacological interactions between opioids and serotonin agonists </td>
|
||
|
||
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/therapeutic-options" hreflang="en">Novel Therapeutic Options for Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/therapeutic-options/focusing-development" hreflang="en">Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
|
||
|
||
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">UNIVERSITY OF TEXAS HLTH SCIENCE CENTER </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Maguire, David Richard </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">San Antonio, TX </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
|
||
|
||
</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> NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
|
||
<br>
|
||
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-484.html" target="_blank">PA-18-484</a>
|
||
<br>
|
||
<strong>Summary:</strong>
|
||
<br>
|
||
<p>Opioids remain the gold standard for treating moderate to severe pain, but their use is limited by numerous adverse effects, including tolerance, dependence, abuse, and overdose. Adverse effects could be avoided by combining an opioid with another drug, such that smaller doses of the opioid (in combination with another drug) produce the desired therapeutic effect. Direct-acting serotonin type 2 (5-HT2) receptor agonists interact in a synergistic manner with the opioid morphine to produce antinociceptive effects, suggesting a 5-HT2 receptor agonist could be combined with small amounts of an opioid to treat pain, thereby lowering the risk associated with larger doses. Unfortunately, very little is known about interactions between 5-HT2 receptor agonists and other opioids. The proposed studies will evaluate the therapeutic potential of mixtures of opioids and 5-HT2 receptor agonists using highly translatable and well-established procedures to characterize the antinociceptive, respiratory-depressant (overdose), positive-reinforcing (leading to misuse), and discriminative-stimulus (subjective) effects of drug mixtures as well as the impact of chronic treatment on the development of tolerance to and physical dependence on opioids. If successful, these studies will provide proof-of-concept for this innovative approach to pain treatment and evaluate the utility of targeting 5-HT receptors for analgesic drug development.</p>
|
||
|
||
|
||
</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-35281"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9796274&amp;icde=46453701" target="_blank">1UG3DA048774-01</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">Injectable naltrexone 2-month depot formulations </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">PURDUE UNIVERSITY </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">PARK, KINAM </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">West Lafayette, IN </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="summary14" class="summary collapse even fullSummary">
|
||
<td colspan="9">
|
||
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
|
||
<strong>NOFO Title:</strong> Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
|
||
<br>
|
||
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-002.html" target="_blank">RFA-DA-19-002</a>
|
||
<br>
|
||
<strong>Summary:</strong>
|
||
<br>
|
||
<p>Naltrexone (NTX) has been proven as an important, safe, and effective therapy in helping patients overcome opioid addition and in preventing overdose. Unfortunately, the therapeutic potential of NTX has been blunted by poor adherence. To combat this issue, a system must be developed to deliver NTX for longer durations than are currently available with a more patient-friendly format. The goal of this research is to optimize and scale up our laboratory PLGA-based microparticle formulations of NTX delivery (either 2 months or 7–10 days) and bridge it to a Phase 1 clinical trial. This innovation will result in a more patient-friendly format consisting of less painful injections and improved release kinetics. PLGA-based drug delivery systems have been used successfully in a number of small-molecule products and are the most widely utilized and studied biocompatible polymer systems in controlled release. Thus, the regulatory and development hurdles with the FDA will be lower than with other novel excipients or technologies. The significance of this research and product development is that the final outcome of this project will ultimately provide a new, readily viable, essential tool to help patients overcome opioid dependence.</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-35666"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9713551&amp;icde=46462567" target="_blank">1R21DA048074-01</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">Prescription Opioid Formulation to Deter Extraction, Injection, Insufflation, and Smoking </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">PURDUE UNIVERSITY </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Solorio, Luis </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">West Lafayette, IN </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="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> NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
|
||
<br>
|
||
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-489.html" target="_blank">PA-18-489</a>
|
||
<br>
|
||
<strong>Summary:</strong>
|
||
<br>
|
||
<p>This project aims to develop a novel abuse deterrent formulation (ADF) that will be uniquely designed to prevent abuse of the prescription pill. The study will focus on the development of the ADF with design aspects specifically focused on abuse through insufflation, smoking, injection, and taking multiple pills. The study will also validate the design by putting the pill through a rigorous test following the procedures outlined by the FDA Abuse-Deterrent-Opioids-Evaluation and Labeling guidelines. The study could result in the development of a novel ADF that will be resistant to a wide range of tampering, resulting in a safer formulation and pill design.</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-36101"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9736906&amp;icde=46453085" target="_blank">1UG3DA048371-01</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">Development of Next-generation Pharmacotherapy for Opioid Use Disorders </td>
|
||
|
||
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/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">ASTRAEA THERAPEUTICS, LLC </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">ZAVERI, NURULAIN T </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Mountain View, 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="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="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>Although effective, current pharmacotherapies for opioid use disorder (OUD) present serious limitations. For example, methadone, a mu opioid receptor (MOP) full agonist, has significant abuse liability and causes withdrawal after chronic use, while buprenorphine (Bup), an MOP partial agonist and kappa opioid receptor (KOP) antagonist, produces limited respiratory depression and is less effective than methadone in reducing drug use, craving, and relapse. To address the limitation of currently available MATs, this project uses a phased plan that will fast-track the IND development of a next-generation medication for OUD based on small-molecule compounds targeting the nociception opioid receptor (NOP)—with no misuse or dependence liability—that have shown promising efficacy in reducing oxycodone intake in rhesus monkeys trained to self-administer, with efficacies similar to that of buprenorphine. The project’s ultimate goal is to file an IND application for an NOP agonist as a promising new approach to treat illicit and prescription OUD that may offer an alternative to buprenorphine.</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-33891"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9778810&amp;icde=46452352" target="_blank">1UG3DA047720-01</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">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; NUNES, EDWARD V. </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">New York, NY </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
|
||
|
||
</tr> <!-- closing head of time -->
|
||
|
||
<tr id="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> 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>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="even">
|
||
|
||
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
|
||
<span id="project-title-34436"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9735591&amp;icde=46462363" target="_blank">1R01DA048417-01</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">A novel opioid receptor antagonist for treating abuse and overdose </td>
|
||
|
||
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/therapeutic-options" hreflang="en">Novel Therapeutic Options for Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/therapeutic-options/focusing-development" hreflang="en">Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
|
||
|
||
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">UNIVERSITY OF TEXAS HLTH SCIENCE CENTER </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">France, Charles P </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">San Antonio, TX </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
|
||
|
||
</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> NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
|
||
<br>
|
||
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-484.html" target="_blank">PA-18-484</a>
|
||
<br>
|
||
<strong>Summary:</strong>
|
||
<br>
|
||
<p>Deaths from opioid overdose continue to rise; from 2015 to 2016, there was a 28 percent increase in the number of fatal overdoses. Currently available pharmacotherapies include MOR agonists (e.g., buprenorphine) and antagonists (e.g., naloxone), all of which suffer from specific and clear limitations. To address the main deficits in these treatments, the researchers will develop and optimize medications with longer duration of action that prevent and reverse the effects of opioids in a manner that is not surmounted by increasing doses of agonist. Their pilot studies in monkeys show that the pseudo irreversible MOR selective antagonist methocinnamox (MCAM) decreases heroin but not cocaine self-administration, decreases choice for remifentanil in a food/drug choice procedure, and reverses—as well as protects against—respiratory depression by heroin, with a single injection being effective for a week or longer. Bringing a medication like this to marketable fruition could significantly improve the treatment of OUD and save lives by providing insurmountable extended protection after rescue from overdose, including from ultra-potent fentanyl analogs.</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-34681"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9905182&icde=48650371&ddparam=&ddvalue=&ddsub=&cr=7&csb=default&cs=ASC&pball=" target="_blank">1UG3DA050323-01</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 in the treatment of opioid use disorder </td>
|
||
|
||
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/therapeutic-options" hreflang="en">Novel Therapeutic Options for Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/therapeutic-options/focusing-development" hreflang="en">Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
|
||
|
||
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">Icahn School of Medicine Mount Sinai </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Hurd, Yasmin </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">New York, NY </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
|
||
|
||
</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>Responding to urgent calls for non-opioid treatment, this research group has been evaluating the therapeutic potential of cannabidiol (CBD), a non-intoxicating cannabinoid, for the treatment of some clinical aspects of opioid use disorder (OUD). Preclinical animal studies show that CBD decreases cue-induced heroin-seeking behavior during drug abstinence, associated with incubation of craving. Clinical work has also shown that CBD was safe in combination with a potent opioid agonist to address a potential relapse condition and decreased craving and anxiety associated with heroin cues in abstinent individuals with heroin use disorder. Building on this foundation, the researchers will investigate an oral CBD powered by a novel patented technology (leveraging the kinetics of long-chain fatty acid absorption) in a gelcap delivery system that improves bioavailability, reduces the incidence of gastrointestinal side effects, reduces first pass metabolism, and enhances onset time. This study could lead to the development of a non-opioid, non-intoxicating FDA-approved medication to reduce opioid craving and relapse and restore global functioning in individuals with OUD.</p>
|
||
|
||
|
||
</div>
|
||
</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-34891"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9778809&amp;icde=46450472" target="_blank">1UG3DA047700-01</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">Biased Mu-Opioid Receptor Analgesics to Prevent Overdose and 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">MEBIAS DISCOVERY, LLC </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">KUO, LAWRENCE C </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Philadelphia, PA </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
|
||
|
||
</tr> <!-- closing head of time -->
|
||
|
||
<tr id="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" target="_blank">RFA-DA-19-002</a>
|
||
<br>
|
||
<strong>Summary:</strong>
|
||
<br>
|
||
<p>The adverse effects of morphine and other mu-opioid receptor (MOR) agonists are linked to the ?-arrestin pathway, while analgesia is tied to the G-protein pathway. Pathway specific or “biased” drug development can target G-protein specific agonists that avoid the negative consequences of ?-arrestin signaling activation and produce analgesia. Highly “biased” MOR agonists have promise as effective analgesics but devoid of opioid-induced adverse effects. Preclinical studies compared two compounds, MEB-1166 and MEB-1170, against Oliceridine and morphine. Both compounds displayed no respiratory depression, even at high doses, while morphine and Oliceridine significantly reduced respiratory function. In contrast to morphine, neither MEB-1166 nor MEB-1170 produced conditioned place preference, suggesting an absence of abuse liability. This study will characterize the pharmaceutical and pharmacological profiles and perform liability studies for these compounds.</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-35121"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9789862&amp;icde=46452917" target="_blank">1UG3DA048351-01</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">A Phase I/IIa Clinical Trial Testing the Safety and Immunogenicity of a Heroin Vaccine and its Efficacy Against Morphine Challenge. </td>
|
||
|
||
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/therapeutic-options" hreflang="en">Novel Therapeutic Options for Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/therapeutic-options/focusing-development" hreflang="en">Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
|
||
|
||
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">HENRY M. JACKSON FDN FOR THE ADV MIL/MED </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">MATYAS, GARY R </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Bethesda, MD </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
|
||
|
||
</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> Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
|
||
<br>
|
||
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-002.html" target="_blank">RFA-DA-19-002</a>
|
||
<br>
|
||
<strong>Summary:</strong>
|
||
<br>
|
||
<p>In order to address the opioid crisis, this group has developed a candidate heroin/opioid vaccine that induces antibodies that bind heroin/opioid upon injection and subsequently prevent the drug from crossing the blood-brain barrier and interacting with the brain's µ-opioid receptor. They completed pre-clinical testing of the vaccine candidate in mice and rats and demonstrated that the animals were protected from subcutaneous and intravenous heroin challenge. Ongoing durability studies have demonstrated that antibody titer and protective efficacy were maintained 6 months after the last vaccination. This project proposes to advance the development of the vaccine candidate by conducting a Phase I/IIa human clinical trial, by performing vaccine synthesis, nonclinical studies, and then a clinical trial. The supplemental award will allow for testing the efficacy of fentanyl haptens and of the combination heroin–fentanyl vaccine.</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-35326"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9737173&amp;icde=46453085" target="_blank">1UG3DA048386-01</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">Vaccines for fentanyl and its derivatives: A strategy to reduce illicit use and overdose </td>
|
||
|
||
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/therapeutic-options" hreflang="en">Novel Therapeutic Options for Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/therapeutic-options/focusing-development" hreflang="en">Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
|
||
|
||
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">UNIVERSITY OF MINNESOTA </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">PRAVETONI, MARCO </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Minneapolis, MN </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
|
||
|
||
</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>The United States has seen dramatic increases in fatal overdoses due to heroin, counterfeit prescription drugs, and cocaine adulterated with fentanyl or fentanyl-like analogs. Current medications may not be sufficient to address the opioid overdose epidemic. As a complementary strategy, the researchers plan to develop vaccines against fentanyl and fentanyl-like compounds to reduce their abuse liability and the growing incidence of fatal overdoses. This research team has already developed vaccines against heroin and oxycodone that stimulate the production of antibodies effective in reducing opioid distribution to the brain, opioid-induced behaviors, and opioid-induced respiratory depression and have identified a promising fentanyl vaccine candidate cued up for optimization. Successful completion of an anti-fentanyl vaccine development project could offer a long-lasting, safe, and cost-effective intervention complementary to medication-assisted treatment (MAT) and may reduce overdoses in opioid users as well as protect people in professions (e.g., law enforcement, airport security, postal workers) at risk of accidental exposure to fentanyl and fentanyl analogs.</p>
|
||
|
||
|
||
</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-35801"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9730818&amp;icde=46452774" target="_blank">1UG3DA048234-01</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 a novel drug for treating 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">NIRSUM LABORATORIES, INC. </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">TUSCHE, MICHAEL; SHAH, NIKEJ </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">New York, NY </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
|
||
|
||
</tr> <!-- closing head of time -->
|
||
|
||
<tr id="summary23" class="summary collapse odd fullSummary">
|
||
<td colspan="9">
|
||
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
|
||
<strong>NOFO Title:</strong> Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
|
||
<br>
|
||
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-002.html" target="_blank">RFA-DA-19-002</a>
|
||
<br>
|
||
<strong>Summary:</strong>
|
||
<br>
|
||
<p>The ongoing epidemic of opioid use disorder (OUD), overdose, and death is unprecedented. Available pharmacologic therapies for OUD have failed to stem the tide, plagued by poor adherence and retention, the principal factors associated with relapse and treatment failure. More than 80 percent of individuals with OUD are untreated. More treatment options are needed. This proposal seeks to develop a better antagonist-based OUD pharmacotherapy for populations highly motivated to achieve abstinence, such as military personnel, criminal justice clients, and the currently employed. A series of novel and proprietary small molecules will be designed and synthesized to address the adherence problem by inducing effective opioid antagonism with a single injection lasting at least 2 months, and up to 4 months or more. The goal of this project is to advance to Phase 3 clinical trials toward FDA approval of our lead compound. If successful, this project could lead to a novel therapeutic with superior adherence and retention, resulting in a significant public health impact by reducing rates of relapse, overdose, and death.</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-33796"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9905066" target="_blank">1UG3DA048745-01A1</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">Nalmefene Long-Acting Injectable (AP007) for the Treatment of Opioid Use Disorder </td>
|
||
|
||
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/therapeutic-options" hreflang="en">Novel Therapeutic Options for Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/therapeutic-options/focusing-development" hreflang="en">Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose</a> </td>
|
||
|
||
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
|
||
|
||
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">Emergent Product Development Gaithersburg Inc. </td>
|
||
|
||
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Barry, John </td>
|
||
|
||
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Gaithersburg, MD </td>
|
||
|
||
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
|
||
|
||
</tr> <!-- closing head of time -->
|
||
|
||
<tr id="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>Although medications are available to treat opioid use disorder (OUD), adherence with treatment programs remains a problem. Nalmefene is an opioid receptor antagonist that was previously approved for treatment of opioid overdose–induced respiratory depression that has a longer duration of action than naloxone. AP007 is a unique formulation of nalmefene-loaded poly(lactic-co-glycolic acid) (PLGA) microparticles that when injected intramuscularly continually releases an effective dose of nalmefene and thus reduces opioid cravings in OUD patients. This group is developing AP007 and will have a lead formulation selected based on in vitro release kinetics data and in vivo pharmacokinetics data in rats. The objectives of the project are to determine safety and efficacy of AP007 in a swine opioid use/withdrawal model, preliminary safety in a first-in-human Phase 1 study, and preliminary efficacy in a Phase 2a multidose study. These results will be used to develop Phase 2 human and Phase 3 clinical studies.</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-34146"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9993692&amp;icde=46730459" target="_blank">3UG3DA047711-02S1</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">PHASE 1A/1B CLINICAL TRIALS OF MULTIVALENT OPIOID VACCINE COMPONENTS </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">COMER, SANDRA D; PRAVETONI, MARCO </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="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>Opioid use disorder (OUD) is a serious public health problem that is associated with high rates of morbidity and mortality. The proposed Phase 1a/1b studies are designed to evaluate a novel treatment strategy for OUD. Specifically, the safety, immunogenicity and preliminary efficacy of a vaccine (OXY-KLH) targeted against oxycodone (Study 1) and a vaccine (M-KLH) targeted against heroin/morphine (Study 2) will be evaluated in participants diagnosed with OUD.</p>
|
||
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</div>
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||
</tr> <!-- summary-->
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