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 descending | Location(s) | Year Awarded |
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1R01DA059321-01
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Multimodal Fetal and Placental Imaging and Biomarkers of Clinical Outcomes in Opioid Use Disorder | Enhanced Outcomes for Infants and Children Exposed to Opioids | The Biology of Opioid Exposure During Pregnancy and Effects on Early Neuro-Behavioral Development | NIDA | INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS | RADHAKRISHNAN, RUPA | Indianapolis, IN | 2023 |
NOFO Title: HEAL Initiative: Opioid Exposure and Effects on Placenta Function, Brain Development, and Neurodevelopmental Outcomes (R01 Clinical Trial Not Allowed)
NOFO Number: RFA-HD-23-035 Summary: Opioid use during pregnancy is associated with significant harmful health outcomes for infants including preterm birth, neonatal opioid withdrawal syndrome, and impaired brain-related problems. This project will combine advanced imaging of the fetal brain and placenta, genetics, and tissue and blood samples from the placenta to determine how opioid use during pregnancy affects development of the fetal brain and placenta. This research will provide novel and early molecular indicators (biomarkers) to as well as identify new strategies for diagnosing, treating, and preventing opioid harm to the fetus and mother. |
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1R61AT012279-01
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Quantifying and Treating Myofascial Dysfunction in Post Stroke Shoulder Pain | Clinical Research in Pain Management | Discovery and Validation of Biomarkers, Endpoints, and Signatures for Pain Conditions | NCCIH | JOHNS HOPKINS UNIVERSITY | RAGHAVAN, PREETI | Baltimore, MD | 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: Shoulder pain occurs in many patients who are recovering from a stroke. In addition to impairments in the ability to move, persistent shoulder pain contributes to depression, and often reduces quality of life. Although the cause of post-stroke shoulder pain is complex and not completely understood, it is thought to arise in part to damage of muscles and surrounding connective tissues (myofascial tissues) in the shoulder. This project will use advanced medical imaging techniques to create biomarkers of that can reliably identify myofascial tissues. The research will then test the ability of these biomarkers to monitor, and ultimately predict treatment responses in patients with post-stroke shoulder pain in the context of a randomized controlled clinical trial. |
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1R21AT012304-01
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Erythrocyte Autophagy Proteins as Potential Non-Opioid Novel Targets for Pain in Sickle Cell Disease | Preclinical and Translational Research in Pain Management | Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain | NCCIH | UNIVERSITY OF ILLINOIS, CHICAGO | RAMASAMY, JAGADEESH | Chicago, IL | 2022 |
NOFO Title: Emergency Awards: HEAL Initiative-Early-Stage Discovery of New Pain and Opioid Use Disorder Targets Within the Understudied Druggable Proteome (R21 Clinical Trial Not Allowed)
NOFO Number: TR22-011 Summary: Sickle cell disease is an inherited blood disorder affecting about 100,000 Americans and over 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. Painful episodes that require hospitalization and, in many cases, opioid treatment, are a hallmark of sickle cell disease. The source of these painful episodes remains unclear, and it is also unknown why pain severity varies so much among affected individuals. This project will identify novel, non-opioid targets to reduce sickle cell-related pain and search for biomarkers to help clinicians predict which individuals are at risk for increased pain, thereby improving health outcomes for people with sickle cell disease. |
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3R21DA045092-01A1S1
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EVALUATING COGNITIVE AND DEVELOPMENTAL RISK FACTORS FOR OPIOID MISUSE AMONG ADOLESCENT CANNABIS USERS | New Strategies to Prevent and Treat Opioid Addiction | Preventing Opioid Use Disorder | NIDA | University of Washington | RAMIREZ, JASON | Seattle, WA | 2019 |
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591 Summary: The opioid epidemic continues unabated in the United States, and despite the rapid expansion of this crisis, the nature of the risk factors that contribute to opioid misuse remain poorly understood compared with other substances of abuse. The goal of this project is to examine cannabis use and cannabis identification measures as risk factors for opioid misuse while also developing and evaluating novel implicit measures of opioid associations as risk factors for opioid misuse among an at-risk sample of adolescents. Findings from the proposed research are intended to improve the prediction of opioid misuse among adolescents and to potentially identify novel targets for prevention and intervention strategies that aim to combat the opioid epidemic. |
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3S06GM123552-02S1
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NATIVE TRANSFORMATIONS OPIATE PROJECT | New Strategies to Prevent and Treat Opioid Addiction | NIGMS | Northwest Indian College | RASMUS, STACY M; CALDWELL, SHEILA | BELLINGHAM, WA | 2018 | |
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591 Summary: Abuse of opioids constitutes a national public health crisis. Data from the Lummi Nation show that for the 18 Tribal member deaths occurring in the first seven months of 2016, five were opioid related, with the average age of the deceased being 29 years. The proposed Native Transformations Opioid Project (NTOP) seeks to develop research capacity at Northwest Indian College and its surrounding tribal communities to develop effective and culturally congruent strategies to reduce the burden of death from opioid and other drug-related overdoses in tribal communities in the Pacific Northwest. The primary aim of the proposed project is to identify the strengths and behavioral strategies in successful recovery from OUD in three Coast Salish communities. The ultimate goal of the proposed research is to identify Coast Salish recovery factors from OUD to develop a data-driven, culturally congruent intervention to reduce OUD and OUD overdose deaths. |
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1R44DA058474-01
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Development of the OpiAID Strength Band Platform | Cross-Cutting Research | Small Business Programs | NIDA | OPIAID, INC. | REESER, DAVID (contact); MACQUEEN, DAVID ALDERSON; WASHINGTON, WENDY DONLIN | Wilmington, NC | 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: Although medications for opioid use disorder are effective and available, providers currently lack methods to monitor patients and thus inform improved dosing. This project will develop Strength Band Platform, an innovative artificial intelligence-based digital platform. The wearable device will collect patient physiological characteristics to detect relapse and withdrawal during treatment with medications for opioid use disorder in real-world settings. |
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1UG3DA058553-01
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Development of Sigma Receptor/DAT Dual-Targeting Compounds to Treat Stimulant Use Disorder | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | SPARIAN BIOSCIENCES, INC. | REICH, JEFFREY | New York, NY | 2023 |
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: An increasing number of Americans use multiple drugs at the same time, and overdose deaths from stimulants have increased. However, there are no available treatments for stimulant use disorder. This project aims to develop new treatment (SBS-518) for cocaine use disorder. Previous research using animal models showed that SBS-518 decreases stimulant self-administration without being rewarding itself. The research will continue the development of SBS-518 toward testing in human research participants. |
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1R01DA051067-01
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Hub and Spoke Opioid Treatment Networks: 2nd Generation Approaches to Improve Medication Treatment for Opioid Use Disorders | Translation of Research to Practice for the Treatment of Opioid Addiction | Behavioral Research to Improve Medication-Based Treatment | NIDA | Brandeis University | REIF, SHARON | Waltham, MA | 2019 |
NOFO Title: HEAL Initiative Limited Competition: Behavioral Research to Improve MAT: Ancillary Studies to Enhance Behavioral or Social Interventions to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders (R01 Clinical Trial Optional)
NOFO Number: RFA-AT-19-007 Summary: Washington state used federal Opioid-STR funding to develop the Washington State Hub and Spoke Model (H&S), an integrated care model to expand access to OUD medications by incorporating primary care and substance use treatment programs, referral organizations, nurse care managers, and care navigators. Based on the initial success, Washington provided more funding and developed a second-generation, low-barrier H&S model, to place medication initiation sites in nontraditional settings, such as emergency departments, syringe exchanges, jails, and homeless shelters, and to have community partners offer OUD medication maintenance. The study will determine the implementation and effectiveness of the new H&S model, maintaining a hybrid effectiveness-implementation approach, and utilizing social network analysis to understand how H&S networks develop to serve the OUD population. The findings will demonstrate what makes the H&S model effective for increasing OUD medication treatment, improving outcomes for people with OUD, and reaching individuals who may not seek treatment. |
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3R01DA051067-01S1
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Treatment of Co-Occurring Opioid Use Disorder with Alcohol, Other Drug, and/or Mental Disorders: The Role of Innovative Models and Integrated Care | New Strategies to Prevent and Treat Opioid Addiction | Optimizing Care for People with Opioid Use Disorder and Mental Health Conditions | NIDA | BRANDEIS UNIVERSITY | REIF, SHARON | Waltham, MA; | 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: People with opioid use disorders (OUD) have high rates of co-occurring alcohol, stimulant and other drug disorders, as well as mental disorders. Traditionally, treatment for OUD has been ?siloed? even though these high rates of co-occurring conditions emphasize the need for comprehensive treatment to address holistic needs. As the opioid crisis continues, attention to the whole person and access to comprehensive mental health and substance use treatment as well as primary care is needed. This study aims to better understand co-occurring mental health disorders, alcohol use disorders, and/or other substance use disorders among people with OUD, in the context of innovative integrated care networks for people with OUD. This study examines how innovative OUD treatment models work for individuals with co-occurring mental health and substance use by 1) assessing mental health treatment quality measures and outcomes; 2) testing how these innovative treatment models compare to other OUD treatment for people who have OUD and other substance use disorders; and 3) considering the ways people with OUD access co-occurring disorder care. The findings from this study will provide needed information to improve mental health, alcohol, and other substance use treatment for individuals with OUD, whether or not they are in OUD treatment and may provide information to help move the system from siloed efforts to truly integrated care |
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1R43NS120335-01
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Closed-Loop Micromagnetic Neuromodulation as a Non-Opioid Treatment for Neuropathic Pain | Cross-Cutting Research | Small Business Programs | NINDS | QUANTUM NANOSTIM | REILLY, THOMAS | Treasure Island, FL | 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: Spinal cord stimulation (SCS) has been shown to provide effective relief for most people with chronic pain and eliminated the need for opioid therapy in more than half of those treated. However, traditional SCS approaches have encountered problems when glial cells coat the stimulation electrodes that distance the device from targeted neurons. This project will develop a novel hybrid Closed Loop Omnidirectional Neuromodulation with Electromagnetic fields (CLONE) system that is combined with magnetic-based stimulation to overcome glial coating of SCS electrodes, better target neurons in dorsal spine tissue, which may lead to better treatment of chronic neuropathic neck and low back pain. |
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1R44DA046151-01
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RAE (REALIZE, ANALYZE, ENGAGE)- A DIGITAL BIOMARKER BASED DETECTION AND INTERVENTION SYSTEM FOR STRESS AND CRAVING DURING RECOVERY FROM SUBSTANCE ABUSE DISORDERS | Cross-Cutting Research | Small Business Programs | NIDA | ContinueYou, LLC | Reinhardt, Megan Rois | Bristol, ME | 2019 |
NOFO Title: Wearable to Track Recovery and Relapse Factors for People w/ Addiction (R43/R44)
NOFO Number: RFA-DA-18-010 Summary: For many individuals in recovery from a substance use disorder, certain cues—including stress and drug-related cues—can trigger a physiological state in which they are more likely to relapse. In this SBIR project, the investigators intend to deploy a system—consisting of a wearable sensor, a smartphone app, and a clinical portal—to provide individuals in recovery and their treatment providers with an opportunity to identify moments of high risk for relapse and to access real-time intervention opportunities. The sensors will identify signals of stress or drug use, interface with a smartphone app, and provide options for annotations, stress-reduction techniques, or contact with an individual’s support system and treatment providers, as well as log and encourage healthy behaviors. This study will deploy and optimize the system, as well as test its effects on addiction-related outcomes, such as rate of relapse. |
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1R61DA059892-01
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Data-Driven Approaches for Opioid Use Disorder Treatment, Recovery, and Overdose Prevention in Rural Communities via Mobile Health Clinics and Peer Support Services | Translation of Research to Practice for the Treatment of Opioid Addiction | Optimizing the Quality, Reach, and Impact of Addiction Services | NIDA | CLEMSON UNIVERSITY | RENNERT, LIOR (contact); LITWIN, ALAIN HARRIS | Clemson, SC | 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: Although medication-based treatment for opioid use disorder (OUD) can effectively reduce overdose risk and improve health outcomes, most people discontinue treatment too soon. Peer support specialists, who are individuals with direct experience with a substance use disorder, can offer social support to help individuals with OUD overcome barriers to treatment and recovery. This project will develop, deliver, and evaluate an innovative peer support specialist intervention to help individuals begin and stay in a treatment program. The research will focus on rural populations and underserved communities, using a dynamic modeling framework to prioritize at-risk communities for treatment offered through mobile health clinics. |
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1U19NS130617-01
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Harvard PRECISION Human Pain Center | Preclinical and Translational Research in Pain Management | Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain | NINDS | BRIGHAM AND WOMEN'S HOSPITAL | RENTHAL, WILLIAM RUSSELL (contact); WOOLF, CLIFFORD J | Boston, MA | 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 use state-of-the-art technologies to analyze individual cells to characterize how human pain receptors communicate pain between the human dorsal root ganglia and the brain – including how the signals vary across diverse populations. This research will generate useful, high-quality human data about pain for further analysis and re-use by other scientific teams, toward identifying and prioritizing novel therapeutic targets for pain. |
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3UH3DA047714-04S1
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Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory 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 | WEST VIRGINIA UNIVERSITY | REZAI, ALI R | Morgantown, WV | 2023 |
NOFO Title: Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder
NOFO Number: PA-20-272 Summary: Novel treatments for opioid use disorder are critically needed as the addiction and overdose crises continue. Neuromodulation is a promising supplemental treatment to standard care. The overarching project seeks to evaluate low-intensity focused ultrasound that targets the nucleus accumbens, a primary component of the brain’s reward neurocircuitry. This supplement will expand the number of participants in part of the study and will increase the project’s overall impact consistent with the original objectives and aims of the parent grant. |
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5UG3DA047714-02
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Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory 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 | WEST VIRGINIA UNIVERSITY | Rezai, Ali R | Morgantown, WV | 2019 |
NOFO Title: Device-Based Treatments for Substance Use Disorders (UG3/UH3, Clinical Trial Optional)
NOFO Number: PAR-18-494 |
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3R21DA044443-02S1
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DAT-OPTIMIZING THE IMPACT OF MEDICATION ASSISTED TREATMENT INTERVENTIONS IN PRISON AND JAIL SETTINGS | Translation of Research to Practice for the Treatment of Opioid Addiction | NIDA | MIRIAM HOSPITAL | RICH, JOSIAH D | Providence, RI | 2018 | |
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591 Summary: We propose to estimate the impact of expanded access to medication-assisted treatment (MAT) in prisons and jails on post-release rates of overdose. Our approach will use agent-based modeling, data collected through the parent study, existing surveillance data, and recently published data from similar settings to understand how different MAT interventions in the prison and jail setting impact overdose death post-release. We will examine the impact of standard of care/no intervention, providing access to depot-naltrexone alone, providing access to all three MATs to only those who were prescribed it prior to incarceration, and comprehensive provision of all three MATs on post-release rates of overdose. These models will incorporate advanced methodological techniques that will allow for the investigation of engaged treatment, program attrition, and other complex events on a population level. This study’s findings may be used by health agencies, policymakers, and correctional systems to inform their efforts to expand MAT access. |
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1R43NS120617-01A1
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Chemokine-receptor profiling for painful diabetic neuropathy in biological samples from human clinical trials | Cross-Cutting Research | Small Business Programs | NINDS | PLUMERIA THERAPEUTICS, INC. | RICHARDSON, THOMAS P (contact); WANG, YIPING | Plainsboro, NJ | 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: Chronic pain is a major healthcare burden. However, the types and underlying mechanisms of pain vary greatly, as do patient responses to currently available pain medications. Inflammation in the nervous system (neuroinflammation) is involved in several types of pain, and targeting key molecules involved in neuroinflammation is therefore a promising treatment approach. The chemokine receptor system, a complex network of more than 20 different receptors and more than 80 molecules that bind to these receptors, has a central role in neuroinflammation. Researchers do not yet fully understand the functioning of this network and how specific receptors vary in different chronic pain conditions. Therefore, this project aims to further characterize the expression of one specific receptor, using samples collected from participants in clinical trials evaluating a compound that interferes with the receptor’s function. This information should allow researchers to classify pain patients and identify those most likely to benefit from a treatment with compounds targeting the receptor. |
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1U18EB030607-01
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Non-invasive Nonpharmaceutical Treatment for Neck Pain: Development of Cervical Spine-specific MR-guided Focused Ultrasound System | Preclinical and Translational Research in Pain Management | Translating Discoveries into Effective Devices to Treat Pain | NINDS | UNIVERSITY OF UTAH | RIEKE, VIOLA | Salt Lake City, UT | 2020 |
NOFO Title: HEAL Initiative: Translational Development of Devices to Treat Pain (U18 Clinical Trial Not Allowed)
NOFO Number: RFA-EB-18-003 Summary: Neck pain is the fourth leading cause of disability and also a significant cause of cervicogenic headaches. Many of the currently available neck pain treatments are invasive with associated risks and complications, particularly because of the complex anatomy. Magnetic resonance guided focused ultrasound, a novel, completely noninvasive technique, can precisely target spinal facet joints to help ameliorate neck pain, potentially transforming the current practices. The goal of this study is to develop a cervical spine-specific device and demonstrate its safety and efficacy on targeting cervical sensory fibers and the third occipital nerve. The results of these studies will provide an understanding on how to best use this technology for chronic neck pain as well as a basis for translation into human use. |
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1UH2AR076736-01
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Focused Ultrasound Neuromodulation of Dorsal Root Ganglion for Noninvasive Mitigation of Low Back Pain | Clinical Research in Pain Management | Back Pain Consortium Research Program | NIAMS | UNIVERSITY OF UTAH | RIEKE, VIOLA (contact); SHAH, LUBDHA | Salt Lake City, UT | 2019 |
NOFO Title: HEAL Initiative: Back Pain Consortium (BACPAC) Research Program Technology Research Sites (UH2/UH3 Clinical Trial Optional)
NOFO Number: RFA-AR-19-028 Summary: This project's goal is to develop a completely noninvasive, precise, and durable treatment option for low back pain (LBP). Focused ultrasound (FUS) is a lower-risk, completely noninvasive modality that enables the delivery of spatially confined acoustic energy to a small tissue region (dorsal root ganglion [DRG]) under magnetic resonance (MR) imaging guidance to treat axial low back pain by neuromodulation. The central goal of this study is to demonstrate neuromodulation of the DRG with FUS to decrease nerve conduction; this treatment can be used to attenuate pain sensation. This exploratory study will demonstrate FUS neuromodulation of the DRG in pigs as assessed by somatosensory evoked potential and perform unique behavioral assessments indicative of supraspinal pain sensation, with the ultimate goal of translating this technology to patients with LBP. FUS could potentially replace current invasive or systemically detrimental treatment modalities. |
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3U01DE027441-02S1
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DE-IMPLEMENTING OPIOID USE AND IMPLEMENTING OPTIMAL PAIN MANAGEMENT FOLLOWING DENTAL EXTRACTIONS | Clinical Research in Pain Management | NIDCR | HealthPartners Institute | RINDAL, D. BRAD | MINNEAPOLIS, MN | 2018 | |
NOFO Title: Implementation Science Research to Improve Dental, Oral and Craniofacial Health (U01)
NOFO Number: RFA-DE-18-001 Summary: The primary objective of this project is to de-implement the use of opioid analgesics for the management of postoperative pain following dental extractions and to implement effective alternative pain management. We propose a cluster-randomized trial designin which dental practitioners are randomly assigned to one of three conditions: 1) standard practice as a control condition; 2) a clinical decision support (CDS) tool that will extract patient history and interface with the state prescription drug monitoring program to provide personalized recommendations for analgesic prescribing and offer language for discussing non-opioid pain management; 3) an enhanced version of the CDS (CDS-E) that will also include information regarding optimal, evidence-based non-opioid pain management delivered to the patient both before and following the dental extraction visit. We will examine opioid and non-opioid prescribing data from the electronic health record across study arms as well as other provider- and patient-focused outcomes using mixed methods. |
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2R44DA045410-02
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Peripherally-Restricted Long-Acting Somatostatin Receptor 4 (LA-SSTR4) Agonists for Pain | Cross-Cutting Research | Small Business Programs | NIDA | PEPTIDE LOGIC, LLC | RIVIERE, PIERRE | San Diego, CA | 2019 |
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
NOFO Number: PA-18-574 Summary: The proposed SBIR Phase II program seeks to select a first-in-class, peripherally-restricted, and long-acting somatostatin receptor 4 (LA-SSTR4) agonist clinical candidate for development as a novel non-addictive analgesic able to replace opioids for the treatment of moderate-to-severe chronic pain. The program is based on strong scientific evidence showing that activation of peripheral SSTR4 produces broad spectrum analgesic activity and pursues a unique therapeutic strategy. Unlike opioids, SSTR4 agonists do not induce constipation, respiratory depression, dependence, addiction, or abuse. Finally, unlike SSTR2 and SSTR5, SSTR4 expression in the pituitary and pancreas is very low, supporting that selective SSTR4 agonists are unlikely to perturb peripheral endocrine functions. The preceding SBIR Phase I program has already established the feasibility of conjugating a short-acting, potent, and selective peptide SSTR4 agonist to the antibody carrier. The resulting LA-SSTR4 agonist lead series has high agonist potency and selectivity for SSTR4 and has demonstrated antinociceptive activity in an animal pain model. The proposed SBIR Phase II program seeks to: optimize the existing lead series and select a clinical candidate for development, validate and prioritize the indication(s) for clinical development using disease-relevant mouse pain models, and characterize the pharmacokinetics and safety/toxicology profile of the clinical candidate in rat and non-human primates to help design subsequent investigational new drug (IND)-enabling studies. |
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1R43DA047722-01
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PERIPHERALLY-RESTRICTED AND LONG-ACTING MAS1(LA-MAS1) AGONISTS FOR PAIN | Cross-Cutting Research | Small Business Programs | NIDA | Peptide Logic, LLC | Riviere, Pierre | SAN DIEGO, CA | 2019 |
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
NOFO Number: PA-18-574 Summary: This project seeks to develop a first-in-class (FIC), peripherally restricted and long-acting drug with potential to reduce or replace opioid for moderate to severe pain, and that will be non-addictive, safe, and convenient to use. The program is based on strong scientific evidence showing that activation of a receptor called MAS1 produces opioid-independent and peripheral pain relieving activity in a wide range of animal models of chronic pain, including inflammatory, neuropathic, and bone cancer pain. This project focuses on the development of potent, stable, and specific molecules that stimulate MAS1. Researchers will then attach peptides that stimulate MAS to antibody carriers that make them last longer and selectively affect only the peripheral nervous system, which could allow for once a week or twice a month dosing while maintaining the drug’s efficacy and reducing potential side effects, and test the resulting molecule in animal models. |
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1R43DA050380-01
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Neurofeedback-EEG-VR (NEVR) System for Non-opioid Pain Therapy | Cross-Cutting Research | Small Business Programs | NIDA | QUASAR, INC. | ROBERTS, BROOKE | San Diego, CA | 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: Pain is one of the most common and debilitating symptoms of a wide range of injuries and diseases. Safe and effective alternatives for treating pain that reduce dependence on opioids are, therefore, a primary goal of the NIH. This project proposes a non-invasive, non-pharmacological alternative to treat pain by combining an innovative electroencephalography (EEG)-based Neurofeedback (NF) solution in an immersive virtual reality (VR) environment. NF and VR have been shown to independently produce ameliorative effects on pain, and it is hypothesized that an NF training in VR would have synergistic effects, as VR would distract from pain perception to improve patient compliance in more engaging NF protocols that improve their ability to control pain perception. In the scope of this project, we will initially focus our work on chronic low back pain (cLBP), as this is a growing segment of chronic pain sufferers with a 39 percent worldwide lifetime prevalence, and whose sufferers have historically been heavy users of opiates; later stages of this project will expand this application to address other forms of pain. |
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1U24NS113849-01
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The Icahn School of Medicine at Mount Sinai (ISMMS) EPPIC-Net Specialized Clinical Center | Clinical Research in Pain Management | Early Phase Pain Investigation Clinical Network (EPPIC-Net) | NINDS | ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI | ROBINSON-PAPP, JESSICA | New York, 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 Icahn School of Medicine at Mount Sinai (ISMMS) will support the mission of the Early Phase Pain Investigation Clinical Network (EPPIC-Net), through the ISMMS Department of Neurology as the core of a hub and spokes structure. The study contains four specific aims: (1) to streamline and optimize rapid implementation of EPPIC-Net studies, exceeding the required minimum of 100 subjects recruited per year to EPPIC-Net studies; (2) to ensure access to patient populations with a wide range of pain disorders, including CLBP, using a hub and spokes model to ensure effective recruitment; (3) to provide the highest-quality protocol implementation, deep clinical phenotyping of pain disorders, and accurate and complete data collection; and (4) to work collaboratively with the EPPIC-Net Coordinating Centers and investigators from the NIH HEAL Partnership to assist with development/design of clinical trials. The study team will also increase training opportunities through EPPIC-Net within ISMMS and the larger pain research community, training junior investigators to become future pain clinical trials leaders and increase and disseminate knowledge about pain research throughout the network. |
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1OT2NS122680-01
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of 80 mg o.d. of NRD135S.El Versus Placebo in Adult and Elderly Subjects with Painful Diabetic Peripheral Neuropathy (SERENDIPITY-I) | Clinical Research in Pain Management | Early Phase Pain Investigation Clinical Network (EPPIC-Net) | NINDS | ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI | ROBINSON-PAPP, JESSICA | New York, NY | 2021 |
NOFO Title: HEAL Initiative: EPPIC-Net Pain Research Asset Application (OT2)
NOFO Number: OTA-20-008 Summary: People with diabetes are at risk for painful diabetic peripheral neuropathy. This pain may be experienced as burning, aching, hypersensitivity to touch, or simply as pain, and there are no currently FDA-approved medications that reduce its symptoms. This phase 2 clinical trial, through the EPPIC-NET program, will test a potential new treatment for painful diabetic peripheral neuropathy. The molecule, NRD135S.E1, is a lab-made version of a natural substance traditionally used to brew tea to treat a variety of indications, including pain, in a village in Siberia. In clinical studies, NRD135S.E1 was well tolerated by patients and showed clinically relevant pain relief. Testing within EPPIC-Net will use a master protocol, an innovative study design in which multiple treatments can be tested at the same time with fewer research participants. |