nih-gov/heal.nih.gov/funding/awarded?research_program=42111&page=4
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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">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" selected="selected">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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<th id="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number" scope="col"><a href="?page=4&amp;research_program=42111&amp;rfa=All&amp;institutions1=&amp;locations1=&amp;goal=All&amp;combine=&amp;grant=All&amp;locations=&amp;institutions=&amp;select_location=All&amp;year=&amp;items_per_page=25&amp;order=field_reporter_number&amp;sort=asc" title="sort by Project #">Project #</a></th>
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<span id="project-title-34086"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9608544&amp;amp;icde=46471183" target="_blank">1R43DA046973-01</a>
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<td headers="view-title-table-column" class="views-field views-field-title">Device to Measure Pain using Facial Expression Recognition with Patiene PAINReportitA Tablet </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">ENSURING, LLC </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">CHEN, ZHANLI </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Seattle, WA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<strong>NOFO Title:</strong> Development of a Device to Objectively Measure Pain (R43/R44)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-18-012.html" target="_blank">RFA-DA-18-012</a>
<br>
<strong>Summary:</strong>
<br>
<p>Even though pain is a nearly universal experience, objective measurements of pain remain difficult. Given that responding to the opioid crisis will require both better ways to manage pain and better ways to detect drug-seeking behavior, finding approaches to objectively measure pain is crucial. The goal of this project is to develop a product that will objectively measure pain using computer vision and machine learning technologies together with tablet-based self-reported pain data from patients for research or clinical purposes. The product will be low cost, involving one or two cameras to record the video and a computer to analyze the video in almost-real time, and will involve software that can be portable to ordinary personal computers and tablets. The project will capture facial expressions related to genuine pain and integrate it with patients self-reported pain data, in order to refine the product and create an objective measure of pain intensity that can be used in clinical settings and test its accuracy. This new tool has the potential to help rectify the poor pain outcomes that still plague Americans with opioid addiction, cancer, and other health conditions in many health care settings.</p>
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<span id="project-title-34486"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9912257" target="_blank">1R43DA050395-01</a>
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<td headers="view-title-table-column" class="views-field views-field-title">Fixed dose analgesic combination with non-opioid mechanism to prevent opioid misuse </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">SYNVENTA, LLC </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">GOMTSIAN, ARTOUR </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Tucson, AZ </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<strong>NOFO Title:</strong> HEAL Initiative: Americas Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-019.html" target="_blank">RFA-DA-19-019</a>
<br>
<strong>Summary:</strong>
<br>
<p>With nearly 116 million people suffering from chronic pain in the United States, there is a need for new analgesics without the risks posed by opioids. Antagonists acting at TRPV1 receptor have long been recognized as one of the most promising novel classes of non-opioid analgesics. Initial tests in humans have confirmed that this class of drugs produces analgesia and is safe and well-tolerated, but side effects include hyperthermia and partial loss of heat sensitivity, leading to most research being halted. This project will conduct a set of preclinical proof-of-concept studies in rats to support the claims that, at doses that have minimal, clinically acceptable, or negligible impact on cardiovascular function, a2 adrenoceptor agonists can diminish thermoregulatory effects of TRPV1 receptor antagonists.</p>
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<span id="project-title-34751"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9621132&amp;amp;icde=46470670" target="_blank">1R44DA046316-01A1</a>
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<td headers="view-title-table-column" class="views-field views-field-title">A Phase 1 Randomized Single Oral Dose Four Period Cross-Over Study Investigating Omnitram Dose Proportionality and Food Effect in Normal Human Subjects </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">SYNTRIX BIOSYSTEMS, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Kahn, Stuart J </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Auburn, WA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> PHS 2017-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-17-302.html" target="_blank">PA-17-302</a>
<br>
<strong>Summary:</strong>
<br>
<p>From 2009 to 2013, the utilization of the Schedule II opioids codeine, OxyContin, and fentanyl declined significantly, down about 14 percent for all three drugs. In sharp contrast, the use of tramadol, a Schedule IV controlled substance, increased by 32.5 percent. Schedule IV substances have lower potential for abuse and harm than Schedule II substances, and the fortuitous trend to tramadol has reduced the use of the relatively unsafe Schedule II opioids dramatically. However, tramadol is less effective in some individuals with a particular gene variant that makes them unable to metabolize it well. A new analgesic, omnitram, uses similar mechanisms to tramadol but is not as dependent on this gene. This SBIR Fast-Track project will conduct a Phase 1 clinical trial of Omnitram in normal human subjects. Success in this in-patient Phase 1 clinical trial will provide direct support for Omnitrams continued clinical development toward FDA approval.</p>
</div>
</td>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-34906"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9848428" target="_blank">1R43DA049616-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) for relapse preventionin patients with Opioid Use (OUD) </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">EVON MEDICS, LLC </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">SETH, SUMEET (contact); NWULIA, EVARISTUS A </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Elkridge, MD </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: Americas Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-019.html" target="_blank">RFA-DA-19-019</a>
<br>
<strong>Summary:</strong>
<br>
<p>The orbitofrontal cortex (OFC) plays an important role in regulation of addiction, and OFC impairment from cocaine and opioids use leads to repetitive drug use. Brief optogenetic activation of the OFC reduces self-administration of drugs in neurobiology studies. However, the OFC is less accessible for noninvasive stimulation using direct transcutaneous current stimulation or transcranial magnetic stimulation. The small business EvON Medics LLC and Howard University have created a home-based olfactory pulsing prototype, called computerized chemosensory-based orbitofrontal cortex training (CBOT), using a high-fidelity chemosensory and computerized olfactory training approach to enable home-based neuromodulation of the OFC for treatment of opioid use disorder (OUD). A pilot feasibility study in OUD samples suggests that CBOT can minimize withdrawal symptoms, reduce drug cravings, enhance positive affect, and reduce rate of positive urine drug tests. The project seeks to establish CBOT stimulation parameters needed to maximally improve outcome inference and emotion regulation in OUD.</p>
</div>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35066"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9906080" target="_blank">1R44DA050339-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Transforming smartphones into active sonar systems to detect opioid overdose </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">SOUND LIFE SCIENCES, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">GILLESPY, THURMAN (contact); GOLLAKOTA, SHYAMNATH ; SUNSHINE, JACOB </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Seattle, WA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: Americas Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-019.html" target="_blank">RFA-DA-19-019</a>
<br>
<strong>Summary:</strong>
<br>
<p>Deaths from opioid overdose are highly preventable with early detection and administration of naloxone, but overdose victims often die because they are alone or among untrained or impaired bystanders and thus do not receive timely resuscitation. There is an urgent, unmet need for a low-barrier, easily scalable solution that can identify opioid overdoses in real time and rapidly connect victims to naloxone therapy. This proposal seeks to commercialize an innovative overdose detection software product that can be downloaded on any commodity smartphone and can detect opioid- induced respiratory failure (i.e., overdose) and summon help. The software-only product, SecondChance, converts a smartphone into a short-range active sonar system capable of monitoring breathing and detecting overdose.</p>
</div>
</td>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35411"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?icde=0&amp;aid=9845846" target="_blank">2R44DA045410-02</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Peripherally-Restricted Long-Acting Somatostatin Receptor 4 (LA-SSTR4) Agonists for Pain </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">PEPTIDE LOGIC, LLC </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">RIVIERE, PIERRE </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">San Diego, CA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-574.html" target="_blank">PA-18-574</a>
<br>
<strong>Summary:</strong>
<br>
<p>The proposed SBIR Phase II program seeks to select a first-in-class, peripherally-restricted, and long-acting somatostatin receptor 4 (LA-SSTR4) agonist clinical candidate for development as a novel non-addictive analgesic able to replace opioids for the treatment of moderate-to-severe chronic pain. The program is based on strong scientific evidence showing that activation of peripheral SSTR4 produces broad spectrum analgesic activity and pursues a unique therapeutic strategy.&nbsp;&nbsp; Unlike opioids, SSTR4 agonists do not induce constipation, respiratory depression, dependence, addiction, or abuse. Finally, unlike SSTR2 and SSTR5, SSTR4 expression in the pituitary and pancreas is very low, supporting that selective SSTR4 agonists are unlikely to perturb peripheral endocrine functions. The preceding SBIR Phase I program has already established the feasibility of conjugating a short-acting, potent, and selective peptide SSTR4 agonist to the antibody carrier. The resulting LA-SSTR4 agonist lead series has high agonist potency and selectivity for SSTR4 and has demonstrated antinociceptive activity in an animal pain model. The proposed SBIR Phase II program seeks to: optimize the existing lead series and select a clinical candidate for development,&nbsp; validate and prioritize the indication(s) for clinical development using disease-relevant mouse pain models, and characterize the pharmacokinetics and safety/toxicology profile of the clinical candidate in rat and non-human primates to help design subsequent investigational new drug (IND)-enabling studies.</p>
</div>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35641"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9778453&amp;amp;icde=44817712" target="_blank">2R44DA043288-02</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">MINDFULNESS MOBILE APP TO REDUCE ADOLESCENT SUBSTANCE USE </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">Oregon Research Behavioral Intervention Strategies </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Smith, Dana K </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Eugene, OR </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> PHS 2018-02 Omnibus Solicitation of the NIH for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-573.html" target="_blank">PA-18-573</a>
<br>
<strong>Summary:</strong>
<br>
<p>Adolescents in the juvenile justice system demonstrate very high rates of tobacco, alcohol, and other drug use (ATOD), with rates that are estimated to be three times higher than non-justice-involved youth. Substance-abusing youth are at higher risk than nonusers for mental health problems, including depression, conduct problems, personality disorders, suicidal thoughts, attempted suicide, and completed suicide, as well as detrimental effects on neural development related to substance use. This project aims to adapt and test the feasibility and efficacy of a smartphone application (app) intervention prototype that would help adolescent substance users reduce or quit their substance use. The program, entitled Rewire, is based on the primary substance use cessation components tested in previous work with juvenile justice-involved adolescents and on intervention components shown to be central to smoking cessation, and applies a mindfulness approach as the guiding framework for the intervention.</p>
</div>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-36061"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9622261&amp;amp;icde=41497838" target="_blank">2R44NS086343-04</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">IND-ENABLING STUDIES ON NOVEL CAV3 T-CHANNEL MODULATORS FOR TREATMENT OF NEUROPATHIC PAIN </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NINDS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">AFASCI, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">XIE, XINMIN SIMON </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">REDWOOD CITY, CA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2018 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Pre-Clinical Research (R44)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PAR-17-480.html" target="_blank">PAR-17-480</a>
<br>
<strong>Summary:</strong>
<br>
<p>We discovered a class of non-opioid modulators of the T-type Cav3.2 channel that could treat neuropathic pain. In vivo pharmacokinetic and pharmacodynamic studies and preliminary toxicological studies identified AFA-279 and other candidates, which did not produce observable side-effects and showed greater analgesic effects than other neuropathic pain medications in rodent models. The goal of this proposed project is to submit the IND application on our Cav3.2 modulator to the Food and Drug Administration (FDA). We will produce AFA-279 under Good Manufacturing Practice (GMP)like conditions using chemical manufacturing controls for Good Laboratory Practice (GLP) nonclinical toxicity studies and GMP clinical batch future Phase 1 clinical trials, complete toxicological and safety studies to establish the safety profile of AFA-279, prepare and submit the IND application, and then initiate early clinical trials. Our ultimate goal is to deliver a safer, more effective, non-opioid Cav3.2 channel modulator to patients suffering from neuropathic pain.</p>
</div>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-33831"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9848027&amp;icde=48650353&amp;ddparam=&amp;ddvalue=&amp;ddsub=&amp;cr=1&amp;csb=default&amp;cs=ASC&amp;pball=" target="_blank">1R44DA049631-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Addressing Opioid Use Disorder with an External Multimodal Neuromodulation Device: Development and Clinical Evaluation of DuoTherm for Opioid-Sparing in Acute and Chronic Low Back Pain. </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">MMJ LABS, LLC </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">BAXTER, AMY LYNN </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Atlanta, GA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: Americas Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-019.html" target="_blank">RFA-DA-19-019</a>
<br>
<strong>Summary:</strong>
<br>
<p>Acute and chronic low back pain are among the most common sources of short- and long-term disability. Fear of pain and disability, or “catastrophizing,” increases opioid use, but is reduced when patients have effective options and feel control over pain. The goal of this project is to develop an opioid-sparing therapeutic consumer device for low back pain, with multiple patient-controlled effective neuromodulatory pain relief options, including vibration, pressure, cold, and heat. After proving that providing a multimodal device is effective for pain, the project will determine whether the availability of an effective home therapy device reduces opioid use for patients with acute and chronic low back pain.</p>
</div>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-34206"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9608089&amp;amp;icde=43814406" target="_blank">1R43DA046998-01</a>
</span>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">DEVELOPMENT OF A MULTIPLEX PEPTIDE ARRAY TO IDENTIFY PATIENTS WITH AN AUTOANTIBODY SIGNATURE FOR CHRONIC PAIN </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">Affinergy, LLC </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Darby, Martyn </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Durham, NC </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> Development of a Device to Objectively Measure Pain (R43/R44)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-18-012.html" target="_blank">RFA-DA-18-012</a>
<br>
<strong>Summary:</strong>
<br>
<p>One of the most widely used treatments for chronic pain is opioid analgesics. Importantly, there is evidence of a pathological interaction between opioids and the immune system that can contribute to both opioid tolerance and elevated levels of pain. Chronic pain conditions for which opioids are most often prescribed have been shown to involve dysregulation of the immune system, which may contribute to pathological effects of opioid use in these patients. To address this unmet need, this study aims to develop a reliable, cost-effective, and non-invasive in vitro diagnostic assay for chronic pain with an underlying inflammatory pathology, as a blood test available in primary care settings, with the hope that doctors can use the test to identify which patients might benefit less from opioids and be more likely to become addicted.</p>
</div>
</td>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-34656"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?icde=0&amp;aid=9678382" target="_blank">1R43NS110117-01</a>
</span>
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<td headers="view-title-table-column" class="views-field views-field-title">Development of a novel anti-migraine therapeutics </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NINDS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">ADEPTHERA, LLC </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">HSU, SHEAU-YU TEDDY </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Palo Alto, CA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-574.html" target="_blank">PA-18-574</a>
<br>
<strong>Summary:</strong>
<br>
<p>New approaches that can effectively ameliorate acute and chronic migraine pain are urgently needed. Due to its critical roles in inducing migraine pain, CGRP and its receptor complex, the calcitonin receptor-like receptor (CLR) and receptor activity-modifying protein 1 (RAMP1) have been targeted for migraine treatment. A new strategy for targeting the CGRP-mediated signaling pathway is needed to meet the medical need of migraine patients. The team developed a group of long-acting CGRP/RAMP1-specific peptide super-antagonists that form gels in situ in aqueous solution. Based on this exciting finding, the investigators propose to develop and identify the most potent antagonistic analog candidates (Aim 1), and characterize the pharmacokinetics of gel depots made of the selected candidates in vivo (Aim 2). This feasibility study is needed to explore the translational potential of these newly invented super-antagonists for the treatment of chronic migraine in combination with conventional migraine agents.&nbsp;</p>
</div>
</td>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-34816"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9907601" target="_blank">1R41DA050364-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Optimization of Betulinic Acid analogs for T-type calcium channel inhibition for non-addictive relief of chronic pain </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">REGULONIX, LLC </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">KHANNA </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Tucson, AZ </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: Americas Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-019.html" target="_blank">RFA-DA-19-019</a>
<br>
<strong>Summary:</strong>
<br>
<p>The increase in prevalence of cancer coupled with an increase in the cancer survival rates due to chemotherapy regimens is transforming cancer pain into a large, unmet medical problem. Chemotherapy-induced peripheral neuropathy (CIPN) is a common and potentially dose-limiting side effect of many cancer drug treatment regimens and is caused in part by alterations in ion channels; blocking or depleting Cav3.2 channels in dorsal root ganglion (DRG) neurons should thus mediate analgesic effects. This proposal aims to develop and test potent, orally available, and selective Cav3.2 channel antagonists, building on the structure of a medicinal plant product—betulinic acid (BA)—that has been identified to be Cav3.2-selective and antinociceptive in CIPN. Such compounds could reduce the reliance on opioids in cancer patients.</p>
</div>
</td>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-34941"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9848425" target="_blank">1R43DA049617-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">At-Home Virtual Reality Guided Imagery Intervention for Chronic Pain </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">LIMBIX HEALTH, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">LEWIS, BENJAMIN (contact); RICHEIMER, STEVEN H </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Palo Alto, CA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: Americas Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-019.html" target="_blank">RFA-DA-19-019</a>
<br>
<strong>Summary:</strong>
<br>
<p>Chronic pain affects more than 100 million adults in the United States, resulting in disability, loss of work productivity, and overall reductions in health, making chronic pain a major public health problem with an economic burden estimated at $560635 billion annually. Opioids, the most frequently prescribed class of drugs to control pain, lack evidence supporting their long-term efficacy and carry a 15% to 26% risk of misuse and abuse among pain patients. Guided imagery (GI) is an effective non-pharmacological intervention for reducing pain, but its effectiveness is limited by patients imaging abilities. This project will develop and assess the feasibility of an at-home virtual reality system, Limbix VR Kit, to reduce chronic pain and opioid reliance, as well as improve other functional outcomes, by delivering an immersive GI experience.</p>
</div>
</td>
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<tr class="even">
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35241"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?icde=0&amp;aid=9909162" target="_blank">1R43NS115294-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Developing EXP-1801 as an imaging agent to quantify pain and analgesia </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NINDS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">EXPESICOR, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">NORWOOD, BRAXTON </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Kalispell, MT </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-574.html" target="_blank">PA-18-574</a>
<br>
<strong>Summary:</strong>
<br>
<p>The use of a pain imaging technology would allow for objective efficacy data (both pre-clinically and in clinical trials), and reduce costs by enabling smaller sample sizes due to more homogeneous populations; i.e. with a particular “pain signal,” and more accurate measurement of analgesic effects. This research team recently invented a novel positron emission tomography (PET) imaging agent as a tool to address these issues in pain care and therapy development. Although the ability of PET to detect pathological changes for (early) disease detection is widely used in cancer and neurological diseases, it has not yet been used for pain indications. The goals of this project are: 1) to change the evaluation of (experimental) pain therapies, and 2) the standard of care in pain assessment through molecular imaging. The proposed study is designed to determine the feasibility of our imaging agent to objectively measure pain in rodents. This will set the stage for a Phase II study that further develops this agent into a tool for quantifying pain/analgesia.</p>
</div>
</td>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35496"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9908597" target="_blank">1R43DA050349-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">A Novel Chemokine Receptor Antagonist to Block Opioid Reinforcement, Relapse and Physical Dependence </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">CREATIVE BIO-PEPTIDES, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">RUFF, MICHAEL </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Potomac, MD </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<tr id="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> HEAL Initiative: Americas Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-019.html" target="_blank">RFA-DA-19-019</a>
<br>
<strong>Summary:</strong>
<br>
<p>Current agonist treatments for opioid use disorder (OUD) are not adequate to address the opioid crisis and have abuse liability concerns. Chemokines (hormones of the immune system that mediate innate immune inflammation) enhance pain, reduce opioid analgesia, and promote drug-seeking behavior and addiction—giving them a central role at the crossroads of chronic pain and the opioid crisis. So blocking chemokines (rather than opioid receptors) provides an exciting and untested treatment opportunity for pain and OUD. This proposal will assess, in animal self-administration models that mimic human drug-taking, whether a chemokine antagonist peptide R103 reduces morphine intake, as well as if R103 will prevent or blunt naloxone-precipitated withdrawal signs in morphine-dependent rats and stop relapse.</p>
</div>
</td>
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<tr class="even">
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35766"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?icde=0&amp;aid=9908680" target="_blank">1R41NS115460-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Minimally Invasive Intercostal Nerve Block Device to Treat Severe Pain and Reduce Usage of Opiates </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NINDS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">TAI, CHANGFENG; POPIELARSKI, STEVE </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">THERMAQUIL, INC. </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Philadelphia, PA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-575.html" target="_blank">PA-18-575</a>
<br>
<strong>Summary:</strong>
<br>
<p>Most of the 200k Americans who undergo thoracotomy each year receive opiates to reduce postoperative pain because clinicians have few non-addictive, cost-effective choices to control the severe pain patients often experience in the first two weeks after surgery. Managing pain post-thoracotomy is critical to enable patients to take deep breaths and remove (via coughing) lung secretions that otherwise significantly increase risk of pneumonia and collapsed lung, hospital re-admission and morbidity. The most severe pain associated with thoracotomy is transmitted along the intercostal nerves, but no long-term analgesic or nerve block device exists that can provide safe and effective long-term reduction of pain. A reversible, patient-controlled, non- addictive, intercostal nerve block device would reduce suffering due to thoracotomy, broken ribs and herpes zoster. In this Phase I project, the team will develop a minimally invasive thermal nerve block device that can control nerve conduction by gently warming and cooling a short nerve segment between room temperature and warm water temperature. This novel approach is based on the discovery that warm and cool temperature mechanisms of nerve block are different and additive, enabling moderate-temperature nerve block by cycling neural tissues slightly above and below body temperature. Reversible thermal nerve blocks represent a completely new approach to managing pain.&nbsp;&nbsp;</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-36121"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9848378&amp;amp;icde=46470772" target="_blank">1R43DA049620-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">NeoGUARD: An easy-to-use, low-cost brain monitor for objective screening and treatment of opioid-exposed infants </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">NEUROWAVE SYSTEMS, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Zikov, Tatjana None </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Cleveland Hights, OH </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: Americas Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-019.html" target="_blank">RFA-DA-19-019</a>
<br>
<strong>Summary:</strong>
<br>
<p>Neonatal Opioid Withdrawal Syndrome (NOWS) affects a growing number of neonates each year due to the ongoing opioid epidemic ravaging the United States. Complex neurobehavioral observation of newborns is the primary modality used. It is subjective and time-consuming by nature, requires significant expertise, and can lead to delays in treatment. The goal of this project is to develop an innovative, low-cost, non-invasive, and easy-to-use brain monitor to objectively assess the severity of withdrawal symptoms in newborns exposed to opioids and provide evidence-based decision support to care providers to improve both short- and long-term developmental outcomes. This device, referred to as NeoGUARD, is based on the continuous, automated, and real-time monitoring of brain function to detect EEG abnormalities shown to be related to NOWS and determine severity to guide pharmacological intervention. This study will focus on the initial prototyping and refinement of the hardware and software, as well as initial evaluations of its use.</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-33971"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9912141" target="_blank">1R43DA050397-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Development of cannabinoid-opioid combination with opioid sparing and synergistic analgesic effects to prevent opioid use disorder and overdose. </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">BDH PHARMA, LLC </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">BRIONES, MARISA </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Valley Village, CA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> HEAL Initiative: Americas Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-019.html" target="_blank">RFA-DA-19-019</a>
<br>
<strong>Summary:</strong>
<br>
<p>With the entwined crises of opioid use and chronic pain, there is a need for alternative, safe therapies to manage opioid use disorder, opioid withdrawal symptoms, chronic pain, and/or associated anxiety and depression. A proof-of-concept preclinical study has already been conducted of a cannabinoid-opioid combination that demonstrated opioid-sparing and synergistic analgesic effects, with the combination providing greater analgesia in a rodent model of chronic pain than a standard dose of the opioid alone. This proposal aims to develop a fixed-dose combination (FDC) of the cannabinoid-opioid that may have improved analgesia with lower opioid doses and thereby lower the risk of dependence, withdrawal, diversion, abuse, and overdose. Preclinical pharmacokinetic and ?in vivo ?safety studies will help determine if co-administration alters the pharmacokinetics and/or respiratory depression related to either compound in rodents.</p>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-34441"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?icde=0&amp;aid=9909401" target="_blank">1R43DE029379-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">Therapeutic in Situ Analgesic Implant for improved Oral-Facial Post-Operative Pain Outcomes </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDCR </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">EPIGEN BIOSCIENCES, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">FRIEDMAN, CRAIG; CAUDLE, ROBERT M </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">San Diego, CA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
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<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> PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-574.html" target="_blank">PA-18-574</a>
<br>
<strong>Summary:</strong>
<br>
<p>Analgesia for post-operative populations remains a significant health need that calls for innovative therapies which improve both safety and outcome measures. Recent FDA drug safety warnings and studies focusing on post-operative analgesia have highlighted the imperative need for new approaches that can be utilized for common clinical scenarios. Accordingly, novel treatment options that are safe and afford additional benefit in relief of pain are needed. In this proposal, the development of an innovative surgical sealant technology is proposed that functions at the level of the surgical wound bed and actively delivers local pharmacologic agents to therapeutically address post-operative pain. New formulations of several analgesic regimens will be assessed for their ability to seal wounds and provide appropriate pain management.</p>
</div>
</td>
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<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-34721"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?icde=0&amp;aid=9908492" target="_blank">1R43DE029369-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">A Novel Opioid-Free Targeted Pain Control Method for Acute Post-Operative Localized Pain Related to Oral Surgical Procedures </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDCR </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">LAUNCHPAD MEDICAL, LLC </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">JADIA, RAHUL; KAY, GEORGE </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Boston, MA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
</tr> <!-- closing head of time -->
<tr id="summary20" class="summary collapse even fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-574.html" target="_blank">PA-18-574</a>
<br>
<strong>Summary:</strong>
<br>
<p>There is a compelling need to develop a front line, non-opioid-based acute pain management strategy for outpatient oral surgical procedures. LaunchPad Medical has developed Tetranite® (TN), a novel bone regenerative mineral-organic self-setting adhesive biomaterial. TN has been extensively studied in vivo in a canine jaw model and shown to be effective and well-tolerated. In this project, researchers will demonstrate that drug-loaded TN can be a novel route to providing localized and time release pain medication following wisdom tooth extraction by determining the release profile of various pain medications from TN at different concentrations. The ability to release pain therapeutics in a controlled fashion and directly at the site of injury offers improved pain control following oral surgical procedures without exposing the patient to opioids. This novel approach to pain management can be extended to more invasive orthopedic procedures such as joint replacement, spinal fusions or reconstructive trauma surgery. In Phase II the team will conduct an in vivo study to assess efficacy of medicated TN to address post-operative pain following wisdom tooth odontectomy, optimize incorporation and release of medications in TN formulations, develop cGMP manufacturing process for the compounded product, and ultimately conduct clinical trials for bone void filler using medicated TN.</p>
</div>
</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-34866"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9927826&amp;amp;icde=45111461" target="_blank">3R44DA044083-03S1</a>
</span>
<br>
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Show Summary
</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">CLINICAL DATA INTELLIGENCE &amp;amp; ADVANCED ANALYTICS TO REDUCE DRUG DIVERSION ACROSS THE CARE DELIVERY CYCLE AND DRUG SUPPLY CHAIN IN HEALTH SYSTEMS </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">Invistics Corporation </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Knight, Thomas </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Peachtree Corners, GA </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
</tr> <!-- closing head of time -->
<tr id="summary21" class="summary collapse odd fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> PHS 2016-02 Omnibus Solicitation of the NIH, CDC, FDA, and ACF for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-16-302.html" target="_blank">PA-16-302</a>
<br>
<strong>Summary:</strong>
<br>
<p>There are alarming rates of substance abuse and diversion in hospitals, with multiple studies finding that roughly 10% of our nations nurses, anesthesiologists, and pharmacists are currently diverting drugs in their workplaces. Diversion continues even though most hospitals already lock addictive drugs in Automated Dispensing Machines (ADMs) and run monthly “anomalous usage” computer reports to try to detect diversion. This SBIR project will research mechanisms to detect when health care workers (HCWs) in hospitals steal or “divert” legal drugs, either to abuse themselves or to illegally sell to others, by building a computer system with (a) automated data feeds from multiple existing hospital computer systems and (b) advanced analytics to flag potential diversion for investigation. This research has the potential to reduce injuries to HCWs who are becoming addicted, destroying their careers, jeopardizing their patients safety, and increasingly dying from drug diversion overdoses.</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-35016"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9608532" target="_blank">1R43DA046974-01</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">IMPACT-Instrument to Measure Pain and Assess Correlation to Treatment. Create a smartphone pupillometry to objectively determine the presence of acute pain, evaluate opioid as the treatment for pain. </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">BENTEN TECHNOLOGIES, INC </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">MA, TONY XUYEN </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Manassa, 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="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 a Device to Objectively Measure Pain (R43/R44)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-18-012.html" target="_blank">RFA-DA-18-012</a>
<br>
<strong>Summary:</strong>
<br>
<p>While patient self-report of pain is the gold standard of pain measurement, this may not be feasible in critically ill patients who are sedated and intubated, unconscious, or unable to verbally communicate. Pupillary dilation (PD) is a reliable indicator of acute pain, and measurement of pupil size changes may be useful in determining the intensity of pain experienced as well as the efficacy of an analgesia. Research also demonstrates that pupillary unrest under ambient light (PUAL) is an objective marker of sensitivity to opioids, and facial expression analysis can help detect pain. Benten Technologies, Inc. aims to develop and validate IMPACT, a device that uses pupillometry with a proprietary algorithm to measure both PD and PUAL and conduct facial expression analysis using computer vision. The project team will then demonstrate the feasibility of IMPACT in helping clinicians objectively determine pain and assess opioid efficacy and compare results obtained to pain scores reported by patients.</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-35381"> <a href="https://projectreporter.nih.gov/project_info_details.cfm?aid=9545385&amp;amp;icde=45111948" target="_blank">1R44DA046151-01</a>
</span>
<br>
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</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">RAE (REALIZE, ANALYZE, ENGAGE)- A DIGITAL BIOMARKER BASED DETECTION AND INTERVENTION SYSTEM FOR STRESS AND CRAVING DURING RECOVERY FROM SUBSTANCE ABUSE DISORDERS </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">ContinueYou, LLC </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Reinhardt, Megan Rois </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Bristol, ME </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> Wearable to Track Recovery and Relapse Factors for People w/ Addiction (R43/R44)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-18-010.html" target="_blank">RFA-DA-18-010</a>
<br>
<strong>Summary:</strong>
<br>
<p>For many individuals in recovery from a substance use disorder, certain cues—including stress and drug-related cues—can trigger a physiological state in which they are more likely to relapse. In this SBIR project, the investigators intend to deploy a system—consisting of a wearable sensor, a smartphone app, and a clinical portal—to provide individuals in recovery and their treatment providers with an opportunity to identify moments of high risk for relapse and to access real-time intervention opportunities. The sensors will identify signals of stress or drug use, interface with a smartphone app, and provide options for annotations, stress-reduction techniques, or contact with an individuals support system and treatment providers, as well as log and encourage healthy behaviors. This study will deploy and optimize the system, as well as test its effects on addiction-related outcomes, such as rate of relapse.</p>
</div>
</td>
</tr> <!-- summary-->
<tr class="even">
<td headers="view-field-reporter-number-table-column" class="views-field views-field-field-reporter-number">
<span id="project-title-35571"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?aid=9980028" target="_blank">3R44DA044053-03S1</a>
</span>
<br>
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</a>
</td>
<td headers="view-title-table-column" class="views-field views-field-title">DEVELOPMENT AND EVALUATION OF VIDEO-BASED DIRECTLY OBSERVED THERAPY FOR OFFICE-BASED TREATMENT OF OPIOID USE DISORDERS WITH BUPRENORPHINE </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NIDA </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">emocha Mobile Health, Inc. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">Seiguer, Sebastian </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Owings Mills, MD </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
</tr> <!-- closing head of time -->
<tr id="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> PHS 2016-02 Omnibus Solicitation of the NIH, CDC, FDA, and ACF for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-16-302.html" target="_blank">PA-16-302</a>
<br>
<strong>Summary:</strong>
<br>
<p>Since 2002, persons with opioid use disorders who desire medication-assisted treatment can be treated with buprenorphine, which has been shown to be efficacious. Buprenorphine treatment can occur in any medical office-based setting, is prescribed by any physician who seeks to become waivered, and is taken by patients at home unsupervised. However, without visual confirmation of medication ingestion, providers remain unsure if patients divert part or all of their buprenorphine medication. This project will develop the technical and logistical workflow needed to implement a video-­based application, miDOT, for office-­based buprenorphine monitoring during the initial months of care, which will allow health care providers to monitor whether patients ingest the drug and adhere to treatment. The project will configure a video-based DOT platform, evaluate its effectiveness in securing medication ingestion and care retention for illicit opiate users, and solidify routes of sustainable commercial viability with commercial partners.</p>
</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-35876"> <a href="https://projectreporter.nih.gov/project_info_description.cfm?icde=0&amp;aid=9905086" target="_blank">1R44NS115196-01</a>
</span>
<br>
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</td>
<td headers="view-title-table-column" class="views-field views-field-title">A single dose long-acting non-addictive polymer conjugate formulation of buprenorphine that provides immediate and prolonged analgesia for post-operative pain </td>
<td headers="view-field-research-focus-area-table-column" class="views-field views-field-field-research-focus-area"><a href="/research/cross-cutting-research" hreflang="en">Cross-Cutting Research</a> </td>
<td headers="view-field-research-program-table-column" class="views-field views-field-field-research-program"><a href="/research/cross-cutting-research/small-business-programs" hreflang="en">Small Business Programs</a> </td>
<td headers="view-field-administering-ics-table-column" class="views-field views-field-field-administering-ics">NINDS </td>
<td headers="view-field-institutions-table-column" class="views-field views-field-field-institutions">SERINA THERAPEUTICS, INC. </td>
<td headers="view-field-investigators-table-column" class="views-field views-field-field-investigators">VIEGAS, TACEY XAVIER; MOREADITH, RANDALL W </td>
<td headers="view-field-locations-table-column" class="views-field views-field-field-locations">Huntsville, AL </td>
<td headers="view-field-year-awarded-table-column" class="views-field views-field-field-year-awarded">2019 </td>
</tr> <!-- closing head of time -->
<tr id="summary25" class="summary collapse odd fullSummary">
<td colspan="9">
<div class="offset-xl-1 offset-lg-1 offset-md-1 col-10 db-summary">
<strong>NOFO Title:</strong> PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
<br>
<strong>NOFO Number:</strong> <a href="https://grants.nih.gov/grants/guide/pa-files/PA-18-574.html" target="_blank">PA-18-574</a>
<br>
<strong>Summary:</strong>
<br>
<p>SER-227 is a long-acting polymer pro-drug of buprenorphine that is being developed to treat post- operative pain following major surgeries such as bunionectomy, abdominoplasty, thoracotomy and knee and hip surgery. The ultimate goal is to demonstrate that SER-227 can be manufactured and tested preclinically to show that it is safe for use in a Phase I clinical study. Aims include 1.SER-227 chemistry and process optimization to generate a technical package, 2. SER-227 manufactured under current Good Manufacturing Practices, 3. Evaluated in formal toxicology studies in rodent and non-rodent animals so that justifications can be made to support a first-in-man study, and 4. Submission of an Investigational New Drug application (IND) along with a Phase I clinical&nbsp; protocol in normal volunteers to measure the safety, tolerability and pharmacokinetics of&nbsp; buprenorphine that is released from SER-227.&nbsp;</p>
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