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) Sort descending | Investigator(s) | Location(s) | Year Awarded |
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1R01DA057645-01
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Mobile Health Strategies to Support Longitudinal Engagement in Harm Reduction Services | Translation of Research to Practice for the Treatment of Opioid Addiction | Harm Reduction Approaches to Reduce Overdose Deaths | NIDA | UNIVERSITY OF WISCONSIN-MADISON | WESTERGAARD, RYAN PATRICK (contact); SEAL, DAVID W | Madison, WI | 2022 |
NOFO Title: HEAL Initiative: Harm Reduction Policies, Practices, and Modes of Delivery for Persons with Substance Use Disorders (R01 Clinical Trial Optional)
NOFO Number: RFA-DA-22-046 Summary: Research is needed to better understand how to make life-saving harm reduction services more accessible to populations that are hard to reach. This project will identify the physical and psychological factors that make harm reduction services most effective. The findings will then be used to inform the development, implementation, and testing of an innovative strategy consisting of several internet- and smartphone-based tools designed to improve access to harm reduction services for people who are hard to reach. |
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1R34DA050270-01
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1/3 Promoting Resilience in Children: Protocol Development for a Birth Cohort Study To Assess Factors Impacting Neurodevelopment | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | UNIVERSITY OF WISCONSIN-MADISON | GOLDSTEIN, ELLEN (contact); ZGIERSKA, ALEKSANDRA EWA | Madison, WI | 2019 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (Collaborative R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-029 Summary: The first ten years of life are accompanied by rapid changes to the developing brain and cognitive abilities. Complex interacting factors including genetics, early-life exposure to substances, family and social interactions, and home and community environments can affect brain and cognitive development. Three linked projects aim to develop effective research protocols to lay a foundation for a future HEALthy Brain and Cognitive Development (HBCD) birth cohort study. Project 1 will develop protocols for recruitment and retention of a diverse sample of pregnant and postpartum women with oversampling of mothers with prenatal opioid use. Project 2 will identify ethical, legal, and regulatory challenges for investigations in this vulnerable population and define effective solutions to enable recruitment and study of these participants. Project 3 will develop and evaluate protocols for acquiring high-quality, quantitative neuroimaging measures with magnetic resonance imaging and functional near infrared spectroscopy and assess effective strategies for measuring cognitive performance in young children, including those exposed to opioids. |
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1R61DA059897-01
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Testing a Video and Text Messaging Intervention to Reduce PTSD and Opioid Misuse Among Sexual Violence Survivors | Translation of Research to Practice for the Treatment of Opioid Addiction | Optimizing the Quality, Reach, and Impact of Addiction Services | NIDA | UNIVERSITY OF WISCONSIN-MADISON | WALSH, KATIE L | Madison, WI | 2023 |
NOFO Title: HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-DA-23-053 Summary: People who survive sexual violence are at increased risk for posttraumatic stress disorder (PTSD) and opioid misuse. Emergency departments are often the first, and in some cases only, contact with the medical care system for survivors of sexual violence. This makes them a suitable setting to initiate interventions to address the risk of PTSD and opioid misuse in these individuals. This project will develop and test a brief, low-cost video and text message intervention that can be initiated in the emergency department to prevent onset or escalation of PTSD and opioid misuse among people who survive sexual violence. |
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1U18EB029251-01
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The Injectrode - A Truly Injectable Electrode for Dorsal Root Ganglion Stimulation to Treat Pain | Preclinical and Translational Research in Pain Management | Translating Discoveries into Effective Devices to Treat Pain | NIBIB | UNIVERSITY OF WISCONSIN-MADISON | LUDWIG, KIP A (contact); WEBER, DOUGLAS J | Madison, WI | 2019 |
NOFO Title: HEAL Initiative: Translational Development of Devices to Treat Pain (U18 Clinical Trial Not Allowed)
NOFO Number: RFA-EB-18-003 Summary: While traditional epidural spinal cord stimulation (SCS) for intractable pain has been very efficacious for the patients responsive to it, the success rate has held at approximately 55%. Dorsal root ganglion (DRG) stimulation has shown promise in early trials to provide greater pain relief. Although the decrease in back pain at 3 months was significantly greater in the DRG arm vs. SCS, the adverse event rate related to the device or implant procedure was significantly higher in the DRG arm. Researchers will develop the “Injectrode” system to make the procedure simpler and safer by using an alternative to implantation: using an injectable pre-polymer liquid composite that cures quickly after injection adjacent to the DRG. They will compare an Injectrode-based system with traditional electrode stimulation at the DRG as an alternative to opioid administration. Researchers will perform benchtop characterization and refinement as a precursor to a clinical study, use modeling and animal testing to refine the efficiency of energy transfer from a transcutaneous electrical nerve stimulation unit to an Injectrode/Injectrode collector concept, and optimize the procedure for the complex anatomy of the human DRG. |
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1U01DA055370-01
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21/24 Healthy Brain and Child Development National Consortium | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | UNIVERSITY OF WISCONSIN-MADISON | DEAN III, DOUGLAS CARL (contact); POEHLMANN-TYNAN, JULIE A | Madison, WI | 2021 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020 Summary: The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first 10 years of life. This study will take place at the University of Wisconsin, Madison, where researchers will have access to a diverse group of people, including women with criminal justice involvement. |
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1R34DA050263-01
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2/3 Promoting Resilience in Children: Protocol Development for a Birth Cohort Study To Assess Factors Impacting Neurodevelopment | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | UNIVERSITY OF WISCONSIN-MADISON | OSSORIO, PILAR N | Madison, WI | 2019 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (Collaborative R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-029 Summary: The first ten years of life are accompanied by rapid changes to the developing brain and cognitive abilities. Complex interacting factors including genetics, early-life exposure to substances, family and social interactions, and home and community environments can affect brain and cognitive development. Three linked projects aim to develop effective research protocols to lay a foundation for a future HEALthy Brain and Cognitive Development (HBCD) birth cohort study. Project 1 will develop protocols for recruitment and retention of a diverse sample of pregnant and postpartum women with oversampling of mothers with prenatal opioid use. Project 2 will identify ethical, legal, and regulatory challenges for investigations in this vulnerable population and define effective solutions to enable recruitment and study of these participants. Project 3 will develop and evaluate protocols for acquiring high-quality, quantitative neuroimaging measures with magnetic resonance imaging and functional near infrared spectroscopy and assess effective strategies for measuring cognitive performance in young children, including those exposed to opioids. |
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1UG3DA054799-01
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Development of Lofexidine as a First-line Non-Opioid Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | USWM, LLC | GULLO, KRISTEN LEANN | Louisville, KY | 2021 |
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: The nation’s opioid epidemic remains a public health emergency, marked by high rates of opioid use and misuse among adults and a correlated rising incidence of neonatal opioid withdrawal syndrome (NOWS) in infants exposed to opioids before they are born. There are currently no pharmacotherapies approved by the Food and Drug Administration (FDA) for the treatment of NOWS. This research will complete manufacturing and clinical trial activities to evaluate and support FDA approval of a pediatric-appropriate formulation of lofexidine, a non-opioid medication approved for mitigation of opioid withdrawal symptoms in adults, as a first line-therapy in NOWS patients through two clinical trials to (1) identify an optimal dosing regimen of lofexidine for treatment of NOWS, and (2) evaluate the risks and benefits of its use in improving withdrawal symptoms, limiting infant exposure to other off-label narcotic medications and shortening the infant’s overall stay in the hospital. |
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1R21AG082344-01
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Using Secondary Analyses to Test Novel Pathways Linking Family Stress and Pain Incidence and Persistence Among African Americans | Cross-Cutting Research | Leveraging Existing and Real-Time Opioid and Pain Management Data | NIA | UT SOUTHWESTERN MEDICAL CENTER | WOODS, SARAH B | Dallas, TX | 2022 |
NOFO Title: HEAL Initiative: Secondary Analysis and Integration of Existing Data Related to Acute and Chronic Pain Development or Managementin Humans (R21 Clinical Trials Not Allowed)
NOFO Number: RFA-DE-22-011 Summary: Chronic pain is a persistent source of disability and reduced quality of life for aging adults. Chronic pain-related outcomes are disproportionately worse for aging African Americans, who report greater pain severity and worse pain-related disability compared to White peers. A significant pain risk factor for African Americans is chronic stress (including family-related stress), which is worsened by structural inequities that affect this population. Although many African Americans identify family support as critical for pain self-management, this influence has not been studied thoroughly. This project will study how pain conditions develop and persist for aging African Americans by analyzing existing data from African American participants in two large aging studies: Midlife in the U.S. (721 participants) and the Health and Retirement Study (2,698 participants). The research aims to determine how family emotional climate affects pain risk, taking into account structural factors like discrimination, socioeconomic disparity, and the influence of various neighborhood settings. |
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1R43HD111082-01A1
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Novel Venous Device for the Treatment of Chronic Pelvic Pain | Cross-Cutting Research | Small Business Programs | NICHD | V-FLOW MEDICAL, INC. | BRENNEMAN, RODNEY | San Juan Capistrano, CA | 2023 |
NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Not Allowed)
NOFO Number: RFA-NS-20-011 Summary: Pelvic venous compression is a common cause of chronic pelvic pain in women. Because many women do not receive an accurate diagnosis for the cause of their pelvic pain, some take opioids to help manage their symptoms. This project will further develop a new diagnostic system specifically designed to treat limited blood flow in pelvic region. This system visualizes pelvic veins toward development of a method to relieve pressure that causes pain. |
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1R43TR004743-01
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The Pain in a Dish Assay (PIDA): A High Throughput System Featuring Human Stem Cell-Derived Nociceptors and Dorsal Horn Neurons to Test Compounds for Analgesic Activity | Cross-Cutting Research | Small Business Programs | NCATS | VALA SCIENCES, INC. | MCDONOUGH, PATRICK M | San Diego, CA | 2023 |
NOFO Title: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-23-006 Summary: This project will develop PIDA, which will allow researchers to measure the activity of pain-sensitive human neurons in response to pain stimuli and potential pain treatments. The tool will use automated digital microscopes in the absence or presence of a potential pain medication. Since this tool contains human neurons, it may be more effective at predicting the efficacy of potential pain drugs in human patients than the animal models that are currently used. |
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1UG3NS116218-01
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Novel mGlu5 negative allosteric modulators as first-in-class non-addictive analgesic therapeutics | Preclinical and Translational Research in Pain Management | Development and Optimization of Non-Addictive Therapies to Treat Pain | NINDS | VANDERBILT UNIVERSITY | ROOK, JERRI MICHELLE; CONN, P JEFFREY; GEREAU, ROBERT W; LINDSLEY, CRAIG | Nashville, TN | 2019 |
NOFO Title: Optimization of Non-addictive Therapies [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-19-010 Summary: An extensive literature provides compelling evidence that selective antagonists or negative allosteric modulators (NAMs) of the metabotropic glutamate (mGlu) receptor, mGlu5, have exciting potential as a novel approach for treatment of multiple pain conditions that could provide sustained antinociceptive activity without the serious adverse effects and abuse liability associated with opioids. Researchers have developed a novel series of highly selective mGlu5 NAMs that are structurally unrelated to previous compounds, have properties for further development, and avoid the formation of toxic metabolites that were associated with previous mGlu5 NAMs. Based on existing preclinical models, as well as clinical trial data showing efficacy of an mGlu5 NAM in migraine patients, researchers anticipate that their compounds will have broad-spectrum analgesic activity in patients with a variety of chronic pain conditions. |
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1U01DA055347-01
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6/6 HBCD Prenatal Experiences and Longitudinal Development (PRELUDE) Consortium Vanderbilt | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | VANDERBILT UNIVERSITY | CUTTING, LAURIE E (contact); OSMUNDSON, SARAH SCHEIDERICH | Vanderbilt, TN | 2021 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020 Summary: The objective of the HBCD PRELUDE (Prenatal Experiences and Longitudinal Development) multi-site consortium is to characterize typical brain development from birth through childhood. All sites in this consortium will measure the influence of key biological and environmental factors on child social, cognitive, and emotional development. Researchers will assess how prenatal exposure to opioids and other substances, as well as other adverse environmental factors, affect brain development and other child health outcomes. The Vanderbilt University site will enroll a diverse sample of mother-infant dyads reflective of the racial, ethnic, and economic composition of the demographics of Tennessee, including rural areas dramatically affected by the opioid crisis. |
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3UH3NS116218-02S1
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Novel mGlu5 Negative Allosteric Modulators as First-in-Class Non-Addictive Analgesic Therapeutic | Preclinical and Translational Research in Pain Management | Development and Optimization of Non-Addictive Therapies to Treat Pain | NINDS | Vanderbilt University | ROOK, JERRI MICHELLE | Nashville, TN | 2022 |
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements. Parent Grant: HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)
NOFO Number: Supplement: PA-20-272; Parent NOFO: NS-21-010 Summary: Negative allosteric modulators (NAMs) of the metabotropic glutamate (mGlu) receptor, mGlu5, have shown promise for treatment of multiple pain conditions without the serious adverse effects and safety concerns associated with opioids. This project will develop and test a novel series of highly selective mGlu5 NAMs that are structurally unrelated to earlier failed compounds and do not form toxic byproducts as with previous mGlu5 NAMs. A lead candidate is now being characterized in several studies to assess readiness for testing in Phase I clinical studies. |
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3U24TR001579-04S1
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TIN Supplement | Clinical Research in Pain Management | Pain Management Effectiveness Research Network (ERN) | NCATS | Vanderbilt University | Harris, Paul A | Nashville, TN | 2019 |
NOFO Title: Clinical and Translational Science Award (CTSA) Network Recruitment Innovation Centers (RICs)(U24)
NOFO Number: RFA-TR-15-004 |
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1UG3NS135551-01
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Translating an MR-guided focused ultrasound system for first-in-human precision neuromodulation of pain circuits | Preclinical and Translational Research in Pain Management | Translating Discoveries into Effective Devices to Treat Pain | NINDS | VANDERBILT UNIVERSITY MEDICAL CENTER | CASKEY, CHARLES F (contact); CHEN, LI MIN | Nashville, TN | 2023 |
NOFO Title: Blueprint MedTech Translator (UG3/UH3 - Clinical Trial Optional)
NOFO Number: PAR-21-315 |
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3R01LM010685-09S1
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BEYOND PHEWAS: RECOGNITION OF PHENOTYPE PATTERNS FOR DISCOVERY AND TRANSLATION - ADMINISTRATIVE SUPPLEMENT | Preclinical and Translational Research in Pain Management | NLM | VANDERBILT UNIVERSITY MEDICAL CENTER | Denny, Joshua C. | NASHVILLE, TN | 2018 | |
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591 Summary: Genomic medicine offers hope for improved diagnostic methods and for more effective, patient-specific therapies. Genome-wide associated studies (GWAS) elucidate genetic markers that improve clinical understanding of risks and mechanisms for many diseases and conditions and that may ultimately guide diagnosis and therapy on a patient-specific basis. Previous phenome-wide association studies (PheWAS) established a systematic and efficient approach to identifying novel disease-variant associations and discovering pleiotropy using electronic health records (EHRs). This proposal will develop novel methods to identify associations based on patterns of phenotypes using a phenotype risk score (PheRS) methodology to systematically search for the influence of Mendelian disease variants on common disease. By doing so, it also creates a way to assess pathogenicity for rare variants and will identify patients at highest risk of having undiagnosed Mendelian disease. The project is enabled by large DNA biobanks coupled to de-identified copies of EHR. |
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1U18EB029351-01
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Development of an MRgFUS system for precision-targeted neuromodulation of pain circuits with simultaneous functional MRI | Preclinical and Translational Research in Pain Management | Translating Discoveries into Effective Devices to Treat Pain | NIBIB | VANDERBILT UNIVERSITY MEDICAL CENTER | CASKEY, CHARLES F (contact); CHEN, LI MIN ; GRISSOM, WILLIAM A | Nashville, Tennessee | 2019 |
NOFO Title: HEAL Initiative: Translational Development of Devices to Treat Pain (U18 Clinical Trial Not Allowed)
NOFO Number: RFA-EB-18-003 Summary: This project aims to develop a next-generation noninvasive neuromodulation system for non-addictive pain treatments. The research team will build an integrated system that uses magnetic resonance image-guided focused ultrasound (MRgFUS) stimulation to target pain regions and circuits in the brain with high precision. The system will use MR imaging to locate three pain targets commonly used in clinical pain treatments, to stimulate those targets with ultrasound, and to monitor responses of nociceptive pain circuits using a functional MRI readout. Three collaborating laboratories will tackle the goals of this project: (Aim 1) Develop focused ultrasound technology for neuromodulation in humans, compatible with the high magnetic fields in an MRI scanner. (Aim 2) Develop MRI technology to find neuromodulation targets, compatible with focused ultrasound transducers. (Aim 3) Validate the complete MRgFUS neuromodulation system in brain pain regions in nonhuman primates. By the end of the project, the research team will have a fully developed and validated MRgFUS system that is ready for pilot clinical trials in pain management. |
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1U01DK123821-01
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Vanderbilt-West Virginia (VWV) Collaborative: A HOPE Consortium Clinical Center | Clinical Research in Pain Management | Integrated Approach to Pain and Opioid Use in Hemodialysis Patients | NIDDK | VANDERBILT UNIVERSITY MEDICAL CENTER | CAVANAUGH, KERRI (contact); EDWARDS, DAVID ALLAN | Nashville, TN | 2019 |
NOFO Title: HEAL Initiative: Integrated Approach to Pain and Opioid Use in Hemodialysis Patients: The Hemodialysis Opioid Prescription Effort (HOPE) Consortium - Clinical Centers (U01 Clinical Trial Required)
NOFO Number: RFA-DK-18-030 Summary: This study will collaborate with diverse stakeholders to design and conduct a multisite trial evaluating innovative strategies to reduce opioid dosing and improve quality of life and experience with care specific to pain management among adults receiving in-center hemodialysis. A pragmatic parallel arm trial will test the impact of adding a 12-week interactive video cognitive behavioral therapy (IV-CBT) intervention program, compared with CDC guideline-concordant shared decision-making (SDM) for NCCP pharmacotherapy management. The specific aims are to (1) conduct a multisite randomized trial to receive IV-CBT and SDM versus SDM alone over 15 months; (2) investigate and describe barriers and facilitators of the implementation of IV-CBT and also SDM among patients, clinicians, and dialysis staff; and (3) create a collaborative network of investigators and dialysis facilities for efficient recruitment and for dissemination of successful strategies to optimize pain care in dialysis. |
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1R41NS132625-01A1
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Opioid-Sparing Non-Surgical, Bioresorbable Nerve Stimulator for Pain Relief | Cross-Cutting Research | Small Business Programs | NINDS | VANISH THERAPEUTICS INC. | CUI, XINYAN TRACY | Mars, PA | 2023 |
NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R41/R42 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-23-007 Summary: Nerve stimulators are devices surgically implanted near a peripheral nerve or on the spinal cord that use electrical signals to reduce the perception of pain. Although these devices can provide effective pain relief to patients, many have high complication rates, resulting from the wire moving, breaking, not working, or the implantable battery pack or permanent wire causing new pain. This project will support the development and animal testing of a peripheral nerve stimulator to treat chronic pain which can be implanted without surgery. Once injected, the device will provide pain relief through electrical stimulation and then be safely degraded and resorbed by the body. |
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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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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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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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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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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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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. |