Funded Projects
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.
Project # | Project Title | Research Focus Area | Research Program | Administering IC | Institution(s) | Investigator(s) | Location(s) Sort ascending | Year Awarded |
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1U24NS113784-01
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University of Rochester Hub and Spokes for the EPPIC Network - Specialized Clinical Center | Clinical Research in Pain Management | Early Phase Pain Investigation Clinical Network (EPPIC-Net) | NINDS | UNIVERSITY OF ROCHESTER | MARKMAN, JOHN DOUGLAS (contact); GEWANDTER, JENNIFER | Rochester, NY | 2019 |
NOFO Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trials Not Allowed)
NOFO Number: RFA-NS-19-025 Summary: The NIH’s HEAL Initiative aims to support collaboration between clinical research experts in academia and industry to accelerate the development of highly efficacious, nonaddictive analgesics for well-defined chronic pain syndromes. The University of Rochester (UR), and its leadership for the UR Hub and Spokes within Early Phase Pain Investigation Clinical Network (EPPIC-Net), will recruit subjects with a broad range of pain conditions, with a focus on leveraging clinical trial infrastructure to support patient recruitment and retention, timely and accurate data entry, and regulatory documentation, as well as recruit additional Spoke sites through a national network of analgesic researchers. |
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3U24NS113784-01S1
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University of Rochester Hub and Spokes for the EPPIC Network - Specialized Clinical Center | Clinical Research in Pain Management | Early Phase Pain Investigation Clinical Network (EPPIC-Net) | NINDS | UNIVERSITY OF ROCHESTER | MARKMAN, JOHN DOUGLAS | Rochester, NY | 2021 |
NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for Administrative Supplements to Support Career Enhancement Related to Clinical Research on Pain (Admin Supp – Clinical Trial Not Allowed)
NOFO Number: NOT-NS-21-048 Summary: Improving pain treatment for is a major goal of the NIH HEAL Initiative. This award supports an early career physician toward achieving a future in clinical pain research and in conducting phase II clinical trials focused on pain. Research activities will provide this individual with the skills needed to serve as a primary investigator for future clinical trials in chronic pain and will help to answer a key question that could improve the design of analgesic clinical trials for neurogenic intermittent claudication, a distinct form of chronic low back pain for which no available treatment exists. |
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1K24NS126861-01
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Promoting high-quality chronic pain treatment trials through mentorship of junior investigators: A focus on study conduct and method development | Clinical Research in Pain Management | NINDS | UNIVERSITY OF ROCHESTER | Gewandter, Jennifer | Rochester, NY | 2021 | |
NOFO Title: Midcareer Investigator Award in Patient-Oriented Research (Parent K24 Independent Clinical Trial Required)
NOFO Number: PA-20-193 Summary: Enhancing the workforce of pain investigators and practitioners is a key goal of the NIH HEAL Initiative. This mentoring award leverages the resources at one of EPPIC-Net’s Specialized Clinical Centers to encourage interest in clinical pain management, in particular through multidisciplinary pain research projects. A selected investigator will train early career clinical researchers on how to develop and validate relevant pain measures and outcomes in chronic pain conditions, including chemotherapy-induced peripheral neuropathy and neuropathic chronic low back pain. Mentoring activities will include formal research and analysis, active inclusion in EPPIC-Net working groups, and collaborative writing experiences. |
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1R61CA278594-01
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Achieving Equity through SocioCulturally-Informed, Digitally-Enabled Cancer Pain managemeNT" (ASCENT) Clinical Trial | Clinical Research in Pain Management | Advancing Health Equity in Pain Management | NCI | Mayo Clinic | CHEVILLE, ANDREA LYNNE (contact); DOUBENI, CHYKE ABADAMA | Rochester, MN | 2022 |
NOFO Title: HEAL Initiative: Advancing Health Equity in Pain Management (R61/R33 Clinical Trial Required)
NOFO Number: NS22-002 Summary: Cancer pain treatment disparities are associated with a decreased ability to tolerate treatment, as well as increased rates of disability, unemployment, institutionalization, and early death. The Achieving Equity through SocioCulturally-informed, Digitally-Enabled Cancer Pain managemeNT (ASCENT) clinical trial will test whether a novel digitally enabled, collaborative approach to team-based pain management can improve clinical outcomes and reduce long-standing and devastating disparities among rural dwelling and Hispanic/Latinx cancer survivors. A major focus of the randomized, effectiveness clinical trial is to test the hypothesis that the ASCENT intervention will reduce pain and unplanned healthcare use, while improving function, mood, sleep, and quality of life. |
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1R61AT012185-01
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MRI-Based Quantitative Characterization of Impaired Myofascial Interface Properties in Myofascial Pain Syndrome | Clinical Research in Pain Management | Discovery and Validation of Biomarkers, Endpoints, and Signatures for Pain Conditions | NCCIH | MAYO CLINIC ROCHESTER | YIN, ZIYING (contact); BAUER, BRENT A | Rochester, MN | 2022 |
NOFO Title: HEAL Initiative: Developing Quantitative Imaging and Other Relevant Biomarkers of Myofascial Tissues for Clinical Pain Management
NOFO Number: RFA-AT-22-003 Summary: Pain in the muscles and surrounding connective tissue (myofascial pain) is a significant health concern affecting hundreds of millions of Americans. Understanding and managing myofascial pain has been limited due to a lack of tools to help clinicians diagnose and treat this disorder. While past efforts to understand myofascial pain have focused on impairments in how connective tissues connect to other tissues in the body, this project will use a new imaging technique to study myofascial tissue physical properties, including how they move in the body and their structural stiffness. This research will identify an imaging biomarker to be used in a randomized controlled clinical trial to predict patient responses to a myofascial pain treatment. |
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1UG3AG067593-01
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Non-pharmacological Options in postoperative Hospital-based And Rehabilitation pain Management (NOHARM) pragmatic clinical trial | Clinical Research in Pain Management | Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) | NIA | MAYO CLINIC ROCHESTER | CHEVILLE, ANDREA LYNNE (contact); TILBURT, JON C | Rochester, MN | 2019 |
NOFO Title: HEAL Initiative: Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM)(UG3/UH3 Clinical Trial Optional)
NOFO Number: RFA-AT-19-004 Summary: Prescriptions for narcotic pain relief after surgery result in unintended prolonged opioid use for hundreds of thousands of Americans. Nonpharmacological pain care is effective and recommended by guidelines for perioperative pain while offering a more favorable risk-benefit ratio. However, nonpharmacological pain care is rarely used as first or second-line therapy after surgery. Patient and clinician decision support interventions are effective in encouraging patient-centered and guideline-concordant care, but these strategies have not been tested pragmatically as a bundle in everyday postoperative pain care. The NOHARM trial will first confirm the feasibility of patient-facing and clinician-facing decision support components of an EHR-embedded evidence-based bundle. The investigators will test the bundle in a stepped-wedge cluster randomized trial. They will test a sustainable system strategy that could change the paradigm of perioperative pain management toward nonpharmacological options in a manner that preserves patient function, honors patient values, and maintains availability of opioids as a last resort. |
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2R44DA048689-02
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Beacon-OUD: Behavioral Economic Screening Tool of Opioid Use Disorder (OUD) for Use in Clinical Practice | Cross-Cutting Research | Small Business Programs | NIDA | BEAM DIAGNOSTICS, INC. | SNIDER, SARAH EMILY | Roanoke, VA | 2023 |
NOFO Title: PHS 2021-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
NOFO Number: PA-21-259 Summary: Current clinical screening measures for opioid misuse are underused and susceptible to bias. This project will develop Beacon-OUD, a digital opioid misuse assessment. The tool generates an automated, standardized score, preventing potential judgements related to patient’s status and circumstances, limiting stigma. The research will further advance Beacon-OUD into a commercial product for use both as a stand-alone tool and as an electronic health record-integrated solution to encourage objective opioid misuse screening in large health care systems. |
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1R41DA048689-01
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BEST-OUD: Behavioral Economic Screening Tool of Opioid Use Disorder for use in clinical practice | Cross-Cutting Research | Small Business Programs | NIDA | BEAM DIAGNOSTICS, INC | SNIDER, SARAH EMILY | Roanoke, VA | 2019 |
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
NOFO Number: PA-18-575 Summary: A critical line of defense against opioid use disorder (OUD), one of the nation’s leading preventable causes of death, must be standardized screening provided by the patient’s primary care physician, psychiatrist, and/or counselor. Standardized screening methods for opioids, however, are simply inferior and no gold standards exist. This project aims to develop a validated, theoretically guided tool that provides clinicians with information beyond OUD symptoms using reinforcer pathology, a measure of severity derived from the synergy between excessive delay discounting and high behavioral economic demand. The Behavioral Economic Screening Tool (BEST-OUD) will use these combined measures in a mobile tablet application to enable clinicians to screen for OUD. |
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1R42DA049448-01
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Reward-based technology to improve opioid use disorder treatment initiation after an ED visit | Cross-Cutting Research | Small Business Programs | NIDA | Q2I, LLC | BOUDREAUX, EDWIN D | Rindge, NH | 2019 |
NOFO Title: Loyalty and Reward-Based Technologies to Increase Adherence to Substance Use Disorder Pharmacotherapies (R41/R42 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-015 Summary: Medication-assisted treatment (MAT) for opioid use disorder (OUD) is highly efficacious, but only a fraction of people with OUD access MAT, and treatment non-adherence is common and associated with poor outcomes. This project aims to increase rates of Suboxone (buprenorphine/naloxone) treatment initiation and adherence among OUD patients recruited from emergency and inpatient acute care by enhancing the Opioid Addiction Recovery Support (OARS)—an existing Q2i company technology—with a new evidence-based reward, contingency management (CM) function that allows for the automatic calculation, delivery, and redemption of rewards contingent on objective evidence of Suboxone initiation and adherence. |
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1UG3DA054785-01A1
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Development of Specific Mu Opioid Receptor Antagonists to Reverse the Acute and Chronic Toxicity of Fentanyls | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | Virginia Commonwealth University | ZHANG, YAN | Richmond, Virginia | 2022 |
NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
NOFO Number: PAR-20-092 Summary: Fentanyl and its analogs are synthetic opioids that are 100 to 10,000 times more potent than morphine. Overdose from these opioids is extremely dangerous due to their ultra-potency and longer half-life than naloxone, the front-line treatment for fentanyl overdose. This research study will develop novel mu opioid receptor antagonists that bind to the same receptor as the opioid drugs and specifically counteract fentanyl and its analogs, thereby reversing the drugs’ acute toxicity more effectively and with fewer side effects than current treatments. The researchers will characterize novel fentanyl derivatives, identify promising compounds, and pursue preclinical development of these compounds as novel reversal agents against the acute toxicity of fentanyl. The goal is to file an Investigational New Drug application with the U.S. Food and Drug Administration. |
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1R61NS127287-01
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Initial Development of AEG-1 Inactivation as a Possible Strategy for Pain Treatment | Preclinical and Translational Research in Pain Management | Development and Optimization of Non-Addictive Therapies to Treat Pain | NINDS | Virginia Commonwealth University | DAMAJ, M IMAD (contact); SARKAR, DEVANAND | Richmond, Virginia | 2022 |
NOFO Title: HEAL Initiative: Planning Studies for Initial Analgesic Development [Small Molecules and Biologics] (R61 Clinical Trial Not Allowed)
NOFO Number: NS21-029 Summary: There is a continued need to discover and validate new targets for potential therapeutic strategies for effective and safe treatment of pain. This project focuses on the protein metadherin, also known as astrocyte elevated gene-1 protein (AEG-1), as a possible new target for pain treatment. Preliminary studies have shown that mice genetically engineered to lack metadherin had significantly lower inflammation and chronic pain-related behaviors. This project aims to further validate AEG-1 as a pain target and test whether reducing levels in white blood cells called macrophages might work as a therapeutic strategy to reduce chronic inflammatory and/or neuropathic pain using an innovative nanoparticle approach to target specific cells. |
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1R61NS133217-01
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A Novel Assay to Improve Translation in Analgesic Drug Development | Preclinical and Translational Research in Pain Management | Development and Optimization of Non-Addictive Therapies to Treat Pain | NINDS | VIRGINIA COMMONWEALTH UNIVERSITY | NEGUS, SIDNEY S | Richmond, VA | 2023 |
NOFO Title: Development and Validation of Pain-Related Models and Endpoints to Facilitate Non-Addictive Analgesic Discovery
NOFO Number: NOT-NS-22-095 Summary: Effective development of non-addictive therapies for pain requires animal models that reflect the human condition. Unfortunately, currently used models have limitations and have not always done a good job of predicting what will work in human patients. This project will refine a new way of measuring pain-related behaviors in mice that takes advantage of more natural mouse behavior and is less influenced by experimenter biases and artifacts. The research will verify that the promising results hold up in several different types of pain and that different classes of clinically used pain medications are effective. They will also make sure the data can be reproduced by an outside laboratory. If successful, this will support the use of this new read-out for future pain therapy development. |
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1K23DA058785-01
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Addressing the Readiness Gap: An eHealth Intervention to Increase Patient Motivation for Evidence-Based Chronic Pain Interventions and Reduced Opioid Reliance | Cross-Cutting Research | Training the Next Generation of Researchers in HEAL | NIDA | VIRGINIA COMMONWEALTH UNIVERSITY | CROUCH, TAYLOR BERENS | Richmond, VA | 2023 |
NOFO Title: Career Development Awards in Implementation Science for Substance Use Prevention and Treatment (K23 - Clinical Trial Required)
NOFO Number: PAS-22-207 Summary: Evidence-based behavioral treatments for pain are among the most effective and safe approaches, but they are underused, especially among patients taking opioids long-term. Despite known risks to long-term opioid therapy (including opioid use disorder and overdoses), patients may be reluctant to try something different to manage their pain. This project brings together two evidence-based behavior change interventions—motivational interviewing and contingency management—into an online format. The research will test whether web-based tools or mobile apps influence a patient’s willingness to consider using non-medication treatments for pain. The research will assess feasibility, acceptability to patients and providers, and broad-scale implementation. |
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1UG3DA050311-01
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Mu Opioid Receptor Modulator Development to Treat Opioid Use Disorder | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | Virginia Commonwealth University | Zhang, Yan | Richmond, VA | 2019 |
NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
NOFO Number: RFA-DA-19-002 Summary: There is a need to develop a mu-opioid receptor (MOR) treatment with enhanced therapeutic effects and reduced undesirable effects. Recently, several highly selective and potent MOR modulators have been identified as novel leads for opioid use disorder treatment. They all showed more promising pharmacological profiles compared to other known drugs in this category. The current proposal will focus on further development of these leads for preclinical IND-enabling studies and dynamic drug discovery and development pipeline construction. This project plans to further validate therapeutic profiles of the current leads with self-administration and pharmacokinetic studies and expand the small-molecule library to build a dynamic drug discovery and development pipeline. Preclinical IND-enabling studies on the identified lead(s) will be conducted, and in vivo pharmacokinetics and pharmacodynamics profiles of the new hits will be compared with current leads to define the next generation of lead compound(s). |
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3U54DA038999-05S1
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MEDICATION DEVELOPMENT CENTER FOR COCAINE USE DISORDER | Novel Therapeutic Options for Opioid Use Disorder and Overdose | NIDA | VIRGINIA COMMONWEALTH UNIVERSITY | MOELLER, FREDERICK GERARD | Richmond, VA | 2018 | |
NOFO Title: Medications Development Centers of Excellence Cooperative Program (U54)
NOFO Number: RFA-DA-15-003 Summary: This U54 Center will use translational research from brain to bedside as a tool for medication development in cocaine use disorder. Preclinical and early phase I clinical PK/PD data will provide information for go/no-go decisions on phase II–III clinical trials with medications that show promise for cocaine use disorder. The overall goal of this research is to create a center that can provide important preclinical and early phase I clinical data to NIDA and pharmaceutical industry partners on novel compounds for cocaine use disorder. The aims related to the theme of the center will be achieved through two cores and three projects: The Administrative Core serves as a general resource for the other projects and the Educational Core, including oversight of fiscal and compliance matters, and will oversee interactions with outside entities, including NIDA and the pharmaceutical industry. The Educational Core will focus on training translational researchers for medication development for addictions across the two institutions. |
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1UG3DA048768-01A1
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Novel LAAM formulations to treat Opioid Use Disorder | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | Virginia Commonwealth University | Xu, Qingguo | Richmond, VA | 2019 |
NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
NOFO Number: RFA-DA-19-002 Summary: Levo-alpha-acetylmethadol (LAAM) offers numerous behavioral and clinical advantages for select opioid use disorder (OUD) patients who do not respond to standard treatment. While LAAM was withdrawn from the market despite being approved for OUD treatment, this project seeks to develop novel, patentable, convenient dosage forms of LAAM, including novel LAAM oral dosage formulations and novel buccal film formulations of LAAM. Morphology, mechanical property, drug release kinetics, and stability of the oral dosage and buccal film formulations will be characterized to determine the instant release or steady release of LAAM, respectively. The two lead LAAM formulations with adequate release and stability profiles will be chosen through optimization studies both in vitro and in vivo. A human pharmacokinetic/pharmacodynamic study will then be carried out on the two selected formulations. |
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1U01DA057846-01
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Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | VIRGINIA COMMONWEALTH UNIVERSITY | BJORK, JAMES M; ARIAS, ALBERT JOSEPH | Richmond, VA | 2022 |
NOFO Title: Grand Opportunity in Medications Development for Substance-Use Disorders (U01)
NOFO Number: PAR-19-327 Summary: Currently no medications are approved by the U.S. Food and Drug Administration to treat cocaine use disorder, which compromises cognitive function associated with achieving goals such as working memory, the ability to update information, and mental flexibility. This project will test whether stimulating dopamine activity in the brain with the drug rotigotine (approved to treat Parkinson’s disease) is effective for treating cocaine use disorder. Past research has also shown that rotigotine can improve nerve cell and cognitive function in Alzheimer’s disease. This project will conduct a clinical trial to test whether treatment with rotigotine combined with cognitive behavioral therapy can reduce cocaine use in people with cocaine use disorder. |
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1R21DE032583-01
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Predicting Pediatric Sickle Cell Disease Acute Pain Using Mathematical Models Based on mHealth Data | Cross-Cutting Research | Leveraging Existing and Real-Time Opioid and Pain Management Data | NIDCR | VIRGINIA COMMONWEALTH UNIVERSITY | VALRIE, CECELIA R (contact); MCGEE, REGINALD | Richmond, VA | 2022 |
NOFO Title: HEAL Initiative: Secondary Analysis and Integration of Existing Data Related to Acute and Chronic Pain Development or Management in Humans (R21 Clinical Trials Not Allowed)
NOFO Number: RFA-DE-22-011 Summary: Sickle cell disease is an inherited blood disorder affecting about 100,000 Americans and more than 20 million people worldwide. It is caused by a mutation in the gene for beta-globin that results in the characteristic sickled shape of red blood cells, life-long severe pain, and shortened lifespan. Sickle cell disease pain episodes are usually unanticipated, making it hard for people with the condition to manage their pain and putting them at risk for increased use of opioids and poor health outcomes. This project will use existing real-time health data to identify factors that can predict onset, severity, and worsening of daily pain in children with sickle cell disease. |
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3R01NS093990-04S1
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S1P RECEPTOR MECHANISMS IN NEUROPATHIC PAIN | Preclinical and Translational Research in Pain Management | NINDS | VIRGINIA COMMONWEALTH UNIVERSITY | SIM-SELLEY, LAURA J; HAUSER, KURT F; LICHTMAN, ARON H; SELLEY, DANA E | RICHMOND, VA | 2018 | |
NOFO Title: Mechanisms, Models, Measurement, & Management in Pain Research (R01)
NOFO Number: PA-13-118 Summary: Chronic pain diminishes the quality of life for millions of patients, and new drugs that have better efficacy and/or fewer side effects are needed. A promising target is the sphingosine-1-phosphate (S1P) receptor system, which mediates central nervous system (CNS) neuromodulatory functions. FTY720-phosphate, the active metabolite of FTY720 (FTY), acts as an agonist at four of the five S1P receptors (S1P1, 3, 4, 5). We propose that the S1P1 receptor is a target for treatment of neuropathic pain. We will test whether S1P1 receptors mediate anti-hyperalgesic effects in a mouse neuropathic pain model. The specific aims are to: 1) determine the role of S1P1Rs in alleviation of neuropathic pain by S1PR ligands; 2) determine the role of FTY-induced S1PR adaptation in FTY-mediated reversal of neuropathic pain; and 3) determine the role of S1P and S1P1 receptors in spinal glia in CCI-induced neuropathic pain and its reversal by FTY. |
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1U19NS130608-01
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Human Nociceptor and Spinal Cord Molecular Signature Center | Preclinical and Translational Research in Pain Management | Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain | NINDS | UNIVERSITY OF TEXAS DALLAS | PRICE, THEODORE J (contact); CURATOLO, MICHELE; DOUGHERTY, PATRICK M | Richardson, TX | 2023 |
NOFO Title: Notice of Special Interest (NOSI): Encourage Eligible NIH HEAL Initiative Awardees to Apply for Administrative Supplements to Support Career Enhancement Related to Clinical Research on Pain
NOFO Number: NOT-NS-22-087 Summary: This project supports a post-baccalaureate trainee develop skills needed to pursue a career in clinical pain research. The research will use molecular tools to study nerve, joint, muscle, and fascia tissues from individuals with chronic low back pain who had spine surgery. The research will include working with patients, designing clinical studies, and sharing results. |
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1U19NS130608-01
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Human Nociceptor and Spinal Cord Molecular Signature Center | Preclinical and Translational Research in Pain Management | Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain | NINDS | UNIVERSITY OF TEXAS DALLAS | PRICE, THEODORE J (contact); CURATOLO, MICHELE ; DOUGHERTY, PATRICK M | Richardson, TX | 2022 |
NOFO Title: HEAL Initiative: Discovery and Functional Evaluation of Human Pain-associated Genes and Cells (U19 Clinical Trial Not Allowed)
NOFO Number: NS22-018 Summary: This project will identify molecular characteristics of human sensory neurons and non-neuronal cells from the human dorsal root ganglia. This structure located outside the spinal cord is integrally involved in communicating pain signals to and from the brain. The research will use molecular approaches to characterize tissues obtained from organ donors and in patients who experience chronic pain. The findings will also help generate a connectivity map, or “connectome,” of nerve cell connections between the dorsal root ganglia of the spinal cord and the brain. |
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3R01NS098826-02S1
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PROTEASE ACTIVATED RECEPTOR TYPE 2 TARGETING FOR MIGRAINE PAIN | Preclinical and Translational Research in Pain Management | NINDS | UNIVERSITY OF TEXAS DALLAS | PRICE, THEODORE J; BOITANO, SCOTT; DUSSOR, GREGORY O; VAGNER, JOSEF | RICHARDSON, TX | 2018 | |
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591 Summary: Migraine is the most common neurological disorder. Currently available treatments fail to effectively manage migraine in most patients. Development of new therapeutics has been slow due in large part to a poor understanding of the underlying pathology of migraine. Endogenous proteases, released in the meninges by resident mast cells, have been proposed as a potential driver of migraine pain via an action on protease activated receptor type 2 (PAR2). The central hypothesis is that PAR2 expression in nociceptors that project to the meninges plays a key role in the pathogenesis of migraine pain. The aims are to: 1) use the established PAR2 development pipeline to design new PAR2 antagonists with improved drug-like properties; 2) use pharmacological tools in a novel mouse migraine model to further understand the potential role of PAR2 in migraine; and 3) use mouse genetics to study the cell type–specific role of PAR2 in migraine pain. |
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1UM1DA049394-01
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HEALing Communities Study Data Coordinating Center | Translation of Research to Practice for the Treatment of Opioid Addiction | HEALing Communities Study | NIDA | RTI International | WILLIAMS, RICK L | Research Triangle, NC | 2019 |
NOFO Title: HEALing Communities Study: Developing and Testing an Integrated Approach to Address the Opioid Crisis (Data Coordinating Center) (UM1- Clinical Trials Not Allowed)
NOFO Number: RFA-DA-19-017 Summary: Although there are effective prevention and treatment programs and services to address opioid misuse, opioid use disorder (OUD), and overdose, gaps remain between those needing and those receiving prevention and treatment, in part because of a need to better understand how to make these programs and services most effective at a local level. The National Institutes of Health (NIH) and the Substance Abuse and Mental Health Services Administration (SAMHSA) launched the HEALing Communities Study to generate evidence about how tools for preventing and treating opioid misuse and OUD are most effective at the local level. This multisite implementation research study will test the impact of an integrated set of evidence-based practices across health care, behavioral health, justice, and other community-based settings. The goal of the study is to reduce opioid-related overdose deaths by 40 percent over three years. As the Data Coordinating Center, RTI will provide coordination and facilitate communications to unite the HEALing Communities Study research centers into a cohesive research cooperative. |
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3U24HD095254-03S1
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DATA COORDINATING CENTER FOR THE NICHD NEONATAL RESEARCH NETWORK (U24) | Enhanced Outcomes for Infants and Children Exposed to Opioids | Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) | NICHD | Research Triangle Institute | Abhik Das | Research Triangle Park, NC | 2020 |
NOFO Number: PA-18-591
Summary: Neonatal opioid withdrawal syndrome (NOWS) has emerged as a tragic by-product of the opioid epidemic. Newborns whose mothers used opioids while pregnant can experience symptoms of opioid withdrawal in the days following birth, such as tremors, irritability, seizures, sleep, digestive, and feeding problems. However, little is known about the effect of antenatal opioid exposure on longer-term infant development over time. To address this gap in understanding, the ACT NOW Longitudinal study is examining a crucial developmental period from birth to two years of life through a comprehensive battery of assessments, including MRI imaging, neurodevelopmental behavioral assessments, and family report measures. This longitudinal cohort study is projected to include a total of 375 infants, 250 who were exposed to opioids and 125 matched controls. |
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1PL1HD101059-01
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HEAL Initiative: Antenatal Opioid Exposure Longitudinal Study Consortium | Enhanced Outcomes for Infants and Children Exposed to Opioids | Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) | NICHD | RESEARCH TRIANGLE INSTITUTE | BANN, CARLA M | Research Triangle Park, NC | 2019 |
NOFO Title: HEAL Initiative: Antenatal Opioid Exposure Longitudinal Study Consortium (PL1 Clinical Trial Not Allowed)
NOFO Number: RFA-HD-19-025 Summary: The incidence of Neonatal Opioid Withdrawal Syndrome (NOWS) in the United States has increased more than fivefold since 2004 to almost 7 per 1,000 hospital births. It is unknown how these effects are modulated by associated maternal, neonatal, and environmental factors and how the environment, maternal health, and parenting styles modify trajectories of brain connectivity and neurodevelopment. This study leverages the established infrastructure and longstanding collaborations of four clinical sites and the data coordinating center of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network to address current critical knowledge gaps in childhood brain structure and connectivity and on medical, developmental, and behavioral trajectories in early childhood. The study will analyze a well-characterized observational cohort using clinical and neuroimaging measures to improve understanding of the structural and functional sequelae resulting from prenatal opioid exposure and NOWS and their interactions with the maternal-infant dyad. |