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) Sort ascending | Location(s) | Year Awarded |
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3PL1HD101059-01S2
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Administrative Supplement to Increase Participant Diversity, Inclusion and Engagement in the ACT NOW OBOE Study | 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 | 2021 |
NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
NOFO Number: NOT-NS-21-025 Summary: The ACT NOW Outcomes of Babies with Opioid Exposure (OBOE) Study – also called the ACT NOW Longitudinal Study – is a longitudinal cohort study to prospectively examine longitudinal outcomes from birth to 2 years of age among infants who were exposed to opioids in utero as compared to matched controls. The objectives of this study are to i) determine the impact of pre-birth opioid exposure on brain structure and connectivity over the first 2 years of life, ii) define medical, developmental, and behavioral outcomes over the first 2 years of life in infants exposed to opioids, and iii) Explore whether and how the home environment, maternal mental health, and parenting affect brain connectivity and neurodevelopment trajectories over the first 2 years of life. This research will use an innovative approach to engage a more diverse study population and thereby improve the generalizability of the research findings. |
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3PL1HD101059-01S1
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Supplement to increase the sample size of the Outcomes of Babies with Opioid Exposure (OBOE) study cohort. | Enhanced Outcomes for Infants and Children Exposed to Opioids | Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) | NICHD | Research Triangle Institute | Bann, Carla | 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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1U01DA055369-01
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14/24 The Healthy Brain & Child Development National Consortium | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | UNIVERSITY OF CALIFORNIA, SAN DIEGO | BANDOLI, GRETCHEN E (contact); GAHAGAN, SHEILA | San Diego, CA | 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. The University of San Diego study site will recruit a diverse cohort of mother-infant pairs, including Hispanic and American Indian individuals. |
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1R34DA050237-01
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6/6 Planning for the HEALthy Early Development Study | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR | BAKHIREVA, LUDMILA NICOLE (contact); LEEMAN, LAWRENCE M; STEPHEN, JULIA MARIE | Albuquerque, NM | 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 Planning for the HEALthy Early Development Study will contribute to the design and recommended protocol for a future large-scale, multi-site research study to prospectively examine human brain, cognitive, behavioral, social, and emotional development of children beginning prenatally through ages 9–10 and to determine the impact of maternal pre- and postnatal substance use on short- and long-term development of children. The planning study will link investigators across 6 research sites who have complementary experience and expertise in the areas that are essential to designing the study. Planning activities will be accomplished using a coordinated set of 10 working groups. By the end of the planning phase, the 6 consortium sites will have produced and tested a recommended protocol for the future multi-site study and will have established feasibility of carrying out the study protocol at each of the 6 linked sites. |
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1U01DA055359-01
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18/24 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 NEW MEXICO HEALTH SCIS CTR | BAKHIREVA, LUDMILA NICOLE (contact); LEEMAN, LAWRENCE M | Albuquerque, NM | 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 template 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 and well curated research dataset to the scientific community at large. 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. The University of New Mexico Health Science Center study site is in a largely rural/mixed state with one of the highest rates of overdose in the nation. This site will enroll diverse mother-infant pairs and partners or caregivers, including Hispanic/Latinx and American Indian individuals. |
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3U01DA055359-03S1
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HBCD Study Biospecimens Administrative Supplement: Resource Generation for Delivery Specimens | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR | BAKHIREVA, LUDMILA NICOLE (contact); LEEMAN, LAWRENCE M | Albuquerque, NM | 2023 |
NOFO Title: Notice of Special Interest (NOSI): HEAL Initiative: Biospecimen Collection in Pregnancy
NOFO Number: NOT-DA-23-005 Summary: Opioid use during pregnancy is associated with adverse outcomes for pregnant individuals and offspring. The mechanisms through which these outcomes arise and the consequences of prenatal opioid exposure on child health and development remain largely unexplored. The HEALthy Brain and Child Development (HBCD) Study is a nationwide longitudinal prospective study of early child development that will assess a broad spectrum of biological, behavioral, social, and health factors among 7,500 pregnant women and their children from pregnancy to mid-childhood. This supplement will expand the biospecimen collection of the HBCD protocol at the University of North Carolina at Chapel Hill to include delivery specimens (placenta, cord tissue, and cord blood). This will provide an unprecedented resource-generating opportunity for the larger scientific community to comprehensively evaluate mechanisms that mediate the connection between substance use during pregnancy and adverse neonatal, infant, and/or maternal health outcomes and inform innovative preventive strategies |
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1R43NR017575-01A1
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Using Virtual Reality Psychological Therapy to Develop a Non-Opioid Chronic Pain Therapy | Cross-Cutting Research | Small Business Programs | NINR | COGNIFISENSE, INC. | BAEUERLE, TASSILO; CEKO, MARTA ; WEBSTER, LYNN | Sunnyvale, CA | 2019 |
NOFO Title: PHS 2017-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])
NOFO Number: PA-17-302 Summary: Chronic pain affects over 100 million Americans, costing society about $600 billion annually. Despite numerous pharmacological and non-pharmacological therapies, over 50% of chronic pain sufferers feel little control over their pain. CognifiSense has developed a patent-pending Virtual Reality Psychological Therapy (VRPT), which is designed to create lasting reduction of chronic pain by addressing the maladaptive learning processes driving pain chronification. VRPT is an experiential learning system, which provides the brain a new set of signals that teaches it that the pain is not as bad as it perceived and that it has greater control over the pain than it perceived. VRPT combines the immersive power and the ability to individualize the therapy of Virtual Reality with well-researched principles of self-distancing, self-efficacy, and extinction to retrain the brain. The goal of this study is to determine the clinical feasibility of VRPT in achieving a lasting reduction of chronic pain, establish brain mechanisms associated with treatment response, and collect comprehensive user feedback to enable further refinement of the current product prototype. CognifiSense's VRPT has the potential to be a significant clinical and business opportunity in the treatment of chronic pain. |
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1U24NS115678-01
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EPPIC-Net Hub at University of Washington | Clinical Research in Pain Management | Early Phase Pain Investigation Clinical Network (EPPIC-Net) | NINDS | University of Washington | BACKONJA, MIROSLAV MISHA (contact); CURATOLO, MICHELE ; STACEY, BRETT | Seattle, WA | 2019 |
NOFO Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-19-036 Summary: The Helping to End Addiction Long-term? (HEAL) Initiative’s Early Phase Pain Investigation Clinical Network (EPPIC-Net) is a unique opportunity to impact the management of pain, through expeditious discovery and validation of biomarkers and analgesic therapies, and in-depth phenotyping. The University of Washington’s (UW) Division of Pain Medicine (UW Pain; “hub”) includes four core clinical sites. Committed spokes include specialty care clinics, primary care clinics, external academic medical centers, and health systems. To achieve the goals of the HEAL Initiative’s EPPIC-Net, the study group will (1) establish UW EPPIC-Net hub and spokes infrastructure, provide scientific leadership and administrative oversight, and apply expertise in design and conduct of high-quality multidisciplinary Phase 2 clinical trials and biomarker validation studies; (2) develop policies and procedures for rapid design, initiation, recruitment, conduct, and closure of high-quality multidisciplinary Phase 2 clinical trials and biomarker validation studies for specific pain conditions at UW Pain EPPIC-Net hub and spokes; and (3) establish mechanisms for communication, education and training, and performance assessment of the UW-EPPIC-Net hub and spokes, to assure efficient and timely utilization of resources to most effectively recruit research participants into EPPIC-Net. |
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3U24NS115678-01S1
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Increasing Diversity and Community Engagement in EPPIC-Net Research at the University of Washington | Clinical Research in Pain Management | Early Phase Pain Investigation Clinical Network (EPPIC-Net) | NINDS | UNIVERSITY OF WASHINGTON | BACKONJA, MIROSLAV MISHA | Seattle, WA | 2021 |
NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
NOFO Number: NOT-NS-21-025 Summary: A main goal of the NIH HEAL Initiative and the Early Phase Pain Intervention Clinical Network (EPPIC-Net) is to improve pain management by discovering and validating biomarkers and non-opioid pain medications. This award will leverage the resources at the University of Washington’s EPPIC-Net’s Specialized Clinical Centers by implementing and evaluating strategies to improve the engagement, recruitment, and retention of individuals from underserved racial/ethnic minority populations to participate in EPPIC-Net clinical trials. The site’s network spans multiple states and specialties, allowing access to geographically and demographically diverse patient populations, including underrepresented and underserved populations. |
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1R41DA050386-01
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Prevention of renarcotization from synthetic opioids | Cross-Cutting Research | Small Business Programs | NIDA | CONSEGNA PHARMA, INC. | AVERICK, SAADYAH | Pittsburgh, PA | 2019 |
NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-019 Summary: While the mu opioid receptor (MOR) antagonist naloxone has proven invaluable as an opioid overdose antidote, naloxone suffers from a very short duration of action (half-life is approximately 1 hour) and has been found to be less effective against newer, long-acting opioids, including fentanyl (half-life is approximately 7–10 hours). This leads to a highly lethal and increasingly prevalent phenomenon known as “renarcotization,” wherein an overdose patient revived with naloxone can re-enter an overdose state from residual fentanyl in the body. Thus, there is a critical need to develop a long-acting MOR antagonist formulation that can address renarcotization by providing multi-hour protection. The goal of this project is to reformulate naloxone using FDA-approved microencapsulation technology into a long-acting injectable (LAI) that can provide 12–24 hours of sustained antagonist activity in vivo. It will employ a proprietary Computational Drug Delivery™ software, called ADSR™, to perform in silico formulation optimization as well as to predict its in vitro dissolution and in vivo pharmacokinetic behavior. |
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3R01MH112148-03S1
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Improving the Identification and Management of Suicide Risk among Patients Using Prescription Opioids | New Strategies to Prevent and Treat Opioid Addiction | Optimizing Care for People with Opioid Use Disorder and Mental Health Conditions | NIMH | UNIVERSITY OF CONNECTICUT SCH OF MED/DNT | ASELTINE, ROBERT H | Farmington, CT | 2020 |
NOFO Title: Notice of Special Interest: HEAL Supplements to Improve the Treatment and Management of Common Co-occurring Conditions and Suicide Risk in People Affected by the Opioid Crisis
NOFO Number: NOT-MH-20-025 Summary: The project will address gaps in both risk identification and clinical management by utilizing comprehensive clinical data from a mature health information exchange containing more than 2.3 million patients across the spectrum of clinical care (hospitals, primary care, specialty care, community health centers, urgent care) to develop a statistically robust method to measure suicide risk associated with prescription opioid use. First, the team will couple data fusion techniques with machine learning-based approaches in identifying the clinical and demographic characteristics associated with elevated risk of suicidal behavior among prescription opioid users. Second, the team will develop clinical profiles of patients with higher risk of suicidal behavior associated with prescription opioids, and to incorporate these profiles in a clinical decision support platform that can be used for identification and intervention at the point of care. The clinical decision support tool developed under this proposal will provide a generalizable platform that could be extended to other more conventional opioid related outcomes such as OUD and overdose. |
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3R42HD088325-02A1S1
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Mobile Augmented Screening Tool to Increase Adolescent HIV Testing and Linkage to Care | Cross-Cutting Research | Small Business Programs | NIDA | DIGITAL HEALTH EMPOWERMENT, INC. | ARONSON, IAN DAVID | BROOKLYN, NY | 2019 |
NOFO Title: PHS 2016-02 Omnibus Solicitation of the NIH, CDC, FDA, and ACF for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])
NOFO Number: PA-16-302 Summary: Adolescents face increased HIV risk, infrequent testing, inconsistent linkage to care, and a lack of prevention-related knowledge. We propose to complete and evaluate the Mobile Augmented Screening (MAS) tool to privately and discretely offer routine HIV testing and counseling, including prevention education, to high-need, diverse adolescent and young adult populations at a low cost. The MAS will consist of a tablet-based intervention including a brief video designed to increase adolescent HIV testing, automated text messages to facilitate linkage to care for those who test positive, and text-based education for those who test negative or decline testing. Phase I was conducted with young emergency department (ED) patients. Preliminary evaluations indicate the video led to significant knowledge increases and encouraged testing. In phase II, we seek to complete intervention development and evaluate through a randomized controlled trial with ED patients, with qualitative interviews for a subset of young patients and ED staff. |
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1R44DA058431-01
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Development of an AI-Empowered Device that Utilizes Multimodal Data-Visualization to Aid in the Diagnosis, and Treatment, of OUD | Cross-Cutting Research | Small Business Programs | NIDA | WAVI COMPANY | ARESE LUCINI, FRANCESCA | Englewood, CO | 2023 |
NOFO Title: Developing Regulated Therapeutic and Diagnostic Solutions for Patients Affected by Opioid and/or Stimulants use Disorders (OUD/StUD) (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-23-021 Summary: There are a lack of clinical tools to effectively identify and monitor opioid use disorder (OUD). This project will develop and test a clinically usable device that uses a range of data inputs and an artificial intelligence (AI) algorithm to help health care providers diagnose and treat OUD. The research aims to help providers choose treatment plans and monitor the timing of release from rehabilitation clinics. |
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1U24AR076730-01
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Back Pain Consortium (BACPAC) Research Program Data Integration, Algorithm Development and Operations Management Center | Clinical Research in Pain Management | Back Pain Consortium Research Program | NIAMS | UNIV OF NORTH CAROLINA CHAPEL HILL | ANSTROM, KEVIN J (contact); IVANOVA, ANASTASIA ; LAVANGE, LISA | Chapel Hill, NC | 2019 |
NOFO Title: HEAL Initiative: Back Pain Consortium (BACPAC) Research Program Data Integration, Algorithm Development and Operations Management Center (U24 Clinical Trial Not Allowed)
NOFO Number: RFA-AR-19-027 Summary: The BACPAC Research Program’s Data Integration, Algorithm Development, and Operations Management Center (DAC) will bring cohesion to research performed by the participating Mechanistic Research Centers, Technology Research Sites, and Phase 2 Clinical Trials Centers. DAC Investigators will share their vision and provide scientific leadership and organizational support to the BACPAC Consortium. The research plan consists of supporting design and conduct of clinical trials with precision interventions that focus on identifying the best treatments for individual patients. The DAC will enhance collaboration and research progress with experienced leadership, innovative design and analysis methodologies, comprehensive research operations support, a state-of-the-art data management and integration system, and superior administrative support. This integrated structure will set the stage for technology assessments, solicitation of patient input and utilities, and the evaluation of high-impact interventions through the innovative design and sound execution of clinical trials, leading to effective personalized treatment approaches for patients with chronic lower back pain. |
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1UG3DA059414-01
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Autonomous Digital CBT Intervention for Opioid Use Disorder in Individuals with Co-Occurring Internalizing Disorders | New Strategies to Prevent and Treat Opioid Addiction | Optimizing Care for People with Opioid Use Disorder and Mental Health Conditions | NIDA | UNIVERSITY OF MINNESOTA | ANKER, JUSTIN JACK (contact); RINEHART, LINDA | Minneapolis, MN | 2023 |
NOFO Title: HEAL Initiative: Therapeutics Development for Opioid Use Disorder in Patients with Co-occurring Mental Disorders (UG3/UH3 - Clinical Trial Optional)
NOFO Number: RFA-DA-23-049 Summary: People who have anxiety and/or depression are particularly susceptible to misusing opioids to avoid negative emotional states. This project aims to develop and test a fully autonomous (no-human operator) cognitive behavioral therapy-based digital therapeutic for people with co-occurring opioid use disorder and anxiety or depression. The goal is to specifically target compulsive opioid use motivated by the relief of unpleasant emotions. The researchers will modify an existing digital therapeutic and test its efficacy in this patient population. |
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1UG3NR019196-01
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Pain Response Evaluation of a Combined Intervention to Cope Effectively (PRECICE) | Clinical Research in Pain Management | Pain Management Effectiveness Research Network (ERN) | NINR | WAKE FOREST UNIVERSITY HEALTH SCIENCES | ANG, DENNIS CHUA | Winston-Salem, NC | 2020 |
NOFO Title: HEAL Initiative: Pain Management Effectiveness Research Network: Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)
NOFO Number: RFA-NS-19-021 Summary: Chronic musculoskeletal pain is common and often severe enough to be disabling. Some treatments such as cognitive behavioral therapies or analgesics may relieve pain for some, but not all patients. Combining effective therapies and providing support to ensure that patients are motivated to adhere to their treatment may prove to be more beneficial to patients than prescribing a drug or recommending a single non-pharmacological treatment. This study aims to evaluate a combination of complementary treatments and Registered Nurse (RN) support to motivate patients to use and maintain combined therapies. Some patients will receive phone-based motivational interviews with an RN to enhance their adherence to pain coping skills learned through web-based cognitive behavioral therapy in combination with duloxetine, a pain-relieving drug. Others will receive both treatments but will not receive support from an RN. The study aims to determine whether motivational nursing support enhances adherence to newly learned pain coping skills, and results in improved pain relief and physical function. |
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1UG1HD107580-01
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UAB Clinical Site HEAL Neonatal Opioid Withdrawal Pharmacological Treatments | Enhanced Outcomes for Infants and Children Exposed to Opioids | Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) | NICHD | UNIVERSITY OF ALABAMA AT BIRMINGHAM (AL) | AMBALAVANAN, NAMASIVAYAM | Birmingham, AL | 2021 |
NOFO Title: HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial - Clinical Sites (UG1 Clinical Trial Required)
NOFO Number: RFA-HD-21-031 Summary: Neonatal Opioid Withdrawal Syndrome (NOWS) is a condition that occurs when newborns are exposed to opioids during pregnancy. Symptoms often include tremors, excessive crying, sleep deprivation, and swallowing difficulties. Cases are rising, with a newborn affected by NOWS approximately every 15 minutes. Currently, healthcare providers in the United States lack standard, evidence-based treatments for NOWS. This project is part of a multi-center, randomized controlled clinical trial that directly compares NOWS treatments—morphine, methadone, and buprenorphine—and takes into account other types of non-drug therapies, such as behavioral interventions. The goal is to generate results that can inform clinical practice guidelines and give newborns with NOWS the best start possible. The University of Alabama at Birmingham routinely treats newborns with NOWS and has been part of NICHD’s Neonatal Research Network (NRN) for more than 25 years. The center has an excellent track record of enrollment in clinical studies, with successful follow-up to 2 years of age and beyond. |
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1R21DA057598-01
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Tracking the Opioid Epidemic with Social Media: An Early Warning System | Cross-Cutting Research | Leveraging Existing and Real-Time Opioid and Pain Management Data | NIDA | STANFORD UNIVERSITY | ALTMAN, RUSS BIAGIO | Redwood City, CA | 2022 |
NOFO Title: HEAL Initiative: Exploratory Data and Methods to Address Urgent Needs to Stem the Opioid Epidemic (R21- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-22-045 Summary: A key component to addressing the current opioid overdose crisis is the ability to track dangerous opioid use in a timely manner so that public health agencies can plan accordingly. Direct reports about drug use and overdoses from social media might provide a useful early warning system that when combined with other sources, can provide policy makers and public health officials with powerful tools for monitoring this public health crisis. This project will explore the usefulness of Twitter and Reddit as a social media component of opioid use surveillance – in particular by monitoring mentions of fentanyl and synthetic opioids at various geographic levels (e.g., local or regional) and over time. |
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1UC2AR082196-01
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Innervation of the Knee and TMJ | Preclinical and Translational Research in Pain Management | Restoring Joint Health and Function to Reduce Pain (RE-JOIN) | NIAMS | UNIVERSITY OF FLORIDA | ALLEN, KYLE D (contact); ALMARZA, ALEJANDRO JOSE; CAUDLE, ROBERT M | Gainesville, FL | 2022 |
NOFO Title: HEAL Initiative: Restoring Joint Health and Function to Reduce Pain Consortium (RE-JOIN) (UC2 Clinical Trial Not Allowed)
NOFO Number: RFA-AR-22-009 Summary: A complex network of different nerve cell subtypes connects to joints in different ways throughout body regions, such as the knee and the temporomandibular joint (TMJ) that connects the lower jaw and skull. This project aims to identify disease-specific pain symptoms using clinically relevant rat models of TMJ and knee osteoarthritis – and compare findings with disease-specific pain symptoms in human patients with the same conditions. This research may lead to a better understanding of how different nerve cell subtypes contribute to joint pain as well as how these nerve cell subtypes change with age and disease. |
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1R44GM140795-01A1
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Non-Opioid Post-Operative Pain Management Using Bupivacaine-loaded Poly(ester urea) Mesh | Cross-Cutting Research | Small Business Programs | NIGMS | 21MEDTECH, LLC | ALFARO, ARTHUR | Durham, NC | 2021 |
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: There is an urgent need for non-opioid post-operative pain management solutions. This research is developing a naturally absorbable polymer film that can release controlled amounts of the non-opioid analgesic bupivacaine – aiming to manage pain for several days following surgery. Project objectives are to optimize the timing of drug release, develop manufacturing standards, determine effective dosage for preserving motor function, and determine safety and efficacy in mouse models of neuropathic pain. Continued development of this film delivery system may lead to a new, non-opioid therapeutic strategy that could be combined with local anesthesia for up to 4 days after surgery to reduce or potentially eliminate opioids use. |
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1R61DA059033-01A1
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Implementing a Patient Navigation Intervention Across a Health System to Address Treatment Entry Inequities | Translation of Research to Practice for the Treatment of Opioid Addiction | Optimizing the Quality, Reach, and Impact of Addiction Services | NIDA | FRIENDS RESEARCH INSTITUTE, INC. | ALEXANDER, KAREN (contact); GRYCZYNSKI, JAN | Baltimore, MD | 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: Significant racial, ethnic, socioeconomic, and geographic disparities affect access to opioid use disorder (OUD) treatment and have thus contributed to the opioid overdose crisis. Patient navigator interventions after hospitalization can improve access to treatment, but challenges prevent full adoption of these strategies. These include lack of coordination across institutions, inadequate data sharing, workforce shortages, and lack of awareness, especially in resource-limited communities. This project aims to develop a hospital system-wide patient navigation protocol that can be scaled up to address OUD treatment linkage and continuity after hospitalization. |
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1R34DA050258-01
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3/3 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 | ALEXANDER, ANDREW L | 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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3R01DE029187-01S2
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LIGHT and Lymphotoxin targeting for the treatment of chronic orofacial pain conditions | Preclinical and Translational Research in Pain Management | Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain | NINDS | UNIVERSITY OF TEXAS HLTH SCIENCE CENTER | AKOPIAN, ARMEN N; RUPAREL, SHIVANI B; TUMANOV, ALEXEI V | San Antonio, TX | 2020 |
NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for PA-18-906 Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: NOT-NS-20-023 Summary: Chronic orofacial pain during Temporomandibular Disorders (TMD) and oral cancer is a significant health problem with scarce non-opioid treatment options. This study aims to validate critical regulators of the balance between protective immunity and immunopathology during chronic inflammatory diseases?tumor necrosis factor alpha superfamily members, LIGHT (TNFSF14) and lymphotoxin-beta (LT?) and their receptors, LT?R and Herpes Virus Entry Mediator (HVEM)?as novel therapeutic targets. The study also seeks to determine whether inhibition of LIGHT and LT? signaling prevents the development and inhibits maintenance of chronic TMD and oral cancer pain via peripheral mechanisms involving plasticity of immune, muscle and tumor cells as well as sensory neurons. The study will define the contribution of LIGHT and LT? signaling to TMD-induced excitability of trigeminal sensory neurons innervating the masseter muscle and joint. New validated therapeutic targets for prevention and treatment of orofacial pain that can be peripherally targeted would reduce side effects of current pain medicates related to drug dependence or tolerance. |
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1UC2AR082195-01
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Comprehensive Functional Phenotyping of Trigeminal Neurons Innervating Temporomandibular Joint (TMJ) Tissues in Male, Female and Aged Mice, Primates, and Humans With and Without TMJ Disorders (TMJD) | Preclinical and Translational Research in Pain Management | Restoring Joint Health and Function to Reduce Pain (RE-JOIN) | NIAMS | UNIVERSITY OF TEXAS HLTH SCIENCE CENTER | AKOPIAN, ARMEN N; BOADA, MARIO DANILO; ERNBERG, MALIN; MACPHERSON, LINDSEY J | San Antonio, TX | 2022 |
NOFO Title: HEAL Initiative: Restoring Joint Health and Function to Reduce Pain Consortium (RE-JOIN) (UC2 Clinical Trial Not Allowed)
NOFO Number: RFA-AR-22-009 Summary: Scientists do not know the details of how the nervous system interacts with the temporomandibular joint (TMJ) that connects the lower jaw with the skull. This project aims to comprehensively explain the functions, types, neuroanatomical distributions, and adaptability (plasticity) of specific nerve cells in the brain (trigeminal neurons) that connect with the TMJ. The research will analyze nerve-TMJ connections associated with chewing muscles and other structures that form the TMJ such as cartilage and ligaments. The project will analyze samples from both sexes of aged mice, primates, and humans with and without painful TMJ disorders. This research aims to uncover potential treatment and prevention targets for managing TMJ pain. |
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1R01DE029187-01
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LIGHT and Lymphotoxin targeting for the treatment of chronic orofacial pain conditions | Preclinical and Translational Research in Pain Management | Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain | NIDCR | UNIVERSITY OF TEXAS HLTH SCIENCE CENTER | AKOPIAN, ARMEN N | San Antonio, TX | 2019 |
NOFO Title: Discovery and Validation of Novel Targets for Safe and Effective Pain Treatment (R01 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-18-043 Summary: Mismanagement of orofacial chronic pain, such as temporomandibular joint and muscle disorders (TMJD) and oral cancer, substantially contributes to opioid overuse; overdose-related deaths; and cardiovascular, renal, and neurological complications at epidemic proportions. The current paradigm implies that orofacial conditions could trigger maladaptation of the immune system and plasticity supporting persistent inflammation, which influences the development and maintenance of orofacial chronic pain. LIGHT (TNFSF14) and Lymphotoxin-beta (LT?), members of the tumor necrosis factor superfamily, provide a balance between protective immunity and immunopathology during chronic inflammatory diseases. This project will test the hypothesis that targeting LIGHT and LT? signaling could prevent the development and inhibit the maintenance of chronic pain produced by TMJD and oral cancer, via peripheral mechanisms involving plasticity of immune, stromal, and tumor cells, as well as sensory neurons. The proposed research is significant as it advances our understanding of mechanisms regulating the development and maintenance of orofacial pain and offers new therapeutic targets and an immunotherapeutic approach for preventing and blocking chronic pain during TMJD and oral cancer. |