Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
4R33DA057683-02
Leveraging regulatory flexibility for methadone take-home dosing to improve retention in treatment for opioid use disorder: A stepped-wedge randomized trial to facilitate clinic level changes Cross-Cutting Research HEAL Data2Action (HD2A) NIDA NEW YORK UNIVERSITY SCHOOL OF MEDICINE NEIGHBORS, CHARLES J (contact); BAO, YUHUA; RAMSEY, KELLY S New York, NY 2023
NOFO Title: HEAL Initiative: HEAL Data2Action Innovation Projects (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-DA-22-051
1K01DA059641-01
Adapting and Implementing a Chronic Disease Self-Management Program for Primary Care Patients with Opioid Use Disorder and Serious Mental Illness Cross-Cutting Research NIDA UNIVERSITY OF UTAH SIANTZ, ELIZABETH Salt Lake City, UT 2023
NOFO Title: Career Development Awards in Implementation Science for Substance Use Prevention and Treatment (K01 - Clinical Trial Required) 
NOFO Number: PAS-22-206
Summary:

Many people with opioid use disorder (OUD) also have a serious mental illness and other chronic conditions, which can be difficult for individuals and primary care providers to manage. A chronic disease self-management program is an established health care model in which peers help to educate patients about their condition(s) and build problem-solving skills to manage their health. Such programs have been effective in other populations and settings, but they have not been adapted for primary care patients who have OUD and SMI. This project will adapt and test a chronic disease self-management program for this population to understand its feasibility, acceptability, impact, and how best to put such programs into place widely in primary care settings.
1K23DA058785-01
Addressing the Readiness Gap: An eHealth Intervention to Increase Patient Motivation for Evidence-Based Chronic Pain Interventions and Reduced Opioid Reliance Cross-Cutting Research NIDA VIRGINIA COMMONWEALTH UNIVERSITY CROUCH, TAYLOR BERENS Richmond, VA 2023
NOFO Title: Career Development Awards in Implementation Science for Substance Use Prevention and Treatment (K23 - Clinical Trial Required)
NOFO Number: PAS-22-207
Summary:

Evidence-based behavioral treatments for pain are among the most effective and safe approaches, but they are underused, especially among patients taking opioids long-term. Despite known risks to long-term opioid therapy (including opioid use disorder and overdoses), patients may be reluctant to try something different to manage their pain. This project brings together two evidence-based behavior change interventions—motivational interviewing and contingency management—into an online format. The research will test whether web-based tools or mobile apps influence a patient’s willingness to consider using non-medication treatments for pain. The research will assess feasibility, acceptability to patients and providers, and broad-scale implementation.
1K99AR083486-01
Novel Models to Study Dorsal Root Ganglion Neurons in Knee Osteoarthritis Pain Cross-Cutting Research NIAMS STANFORD UNIVERSITY BREWER, CHELSIE L Stanford, CA 2023
NOFO Title: HEAL Initiative Advanced Postdoctoral-to-Independent Career Transition Award in PAIN and SUD Research (K99/R00 Independent Clinical Trial Not Allowed)
NOFO Number: RFA-NS-22-022
Summary:

Knee osteoarthritis (OA) is a frequent cause of disability and chronic pain. Treatment often relies on analgesics like opioids to manage OA pain, with all the associated risks; other approaches to treat OA are often invasive and inaccessible to patients. Therefore, novel analgesic strategies are needed to reduce the high burden of knee OA-induced pain. This project aims to study in detail and target the sensory neurons that drive OA pain to assist in the development of more effective pain therapeutics.
1K99NS134965-01
Lymphocyte Antigen 6 (Ly6) Proteins: New Players in Chronic Pain Cross-Cutting Research NINDS NEW YORK UNIVERSITY GOMEZ, KIMBERLY New York, NY 2023
NOFO Title: HEAL Initiative Advanced Postdoctoral-to-Independent Career Transition Award in PAIN and SUD Research to Promote Diversity (K99/R00 Independent Clinical Trial Not Allowed)
NOFO Number: RFA-NS-22-025
Summary:

Neuropathic pain—a debilitating form of chronic pain affecting millions of people—responds poorly to current analgesic treatment approaches. By better understanding the cellular mechanisms and compounds involved in neuropathic pain, researchers will be able to develop more targeted therapeutic approaches. This project will investigate the role that two proteins—Ly6e and Lynx1—play in various processes involved in the development of neuropathic pain, such as the activity of pain-triggering sensory neurons, interactions between neurons and immune cells, and the activity of an ion channel that has been implicated in the generation of pain signals.
1K99AT012658-01
A Role for Peripheral NAAA-Regulated Lipid Signaling in the Control of Hyperalgesic Priming Cross-Cutting Research NCCIH UNIVERSITY OF CALIFORNIA-IRVINE FOTIO, YANNICK Irvine, CA 2023
NOFO Title: HEAL Initiative Advanced Postdoctoral-to-Independent Career Transition Award in PAIN and SUD Research (K99/R00 Independent Clinical Trial Not Allowed)
NOFO Number: RFA-NS-22-022
Summary:

Chronic pain remains a significant global heath challenge. Development of novel safe and effective treatments requires a deeper understanding of the molecular and cellular mechanisms that underlie the development of chronic pain. One protein that has been implicated in controlling the transition from acute to chronic pain is N-acylethanolamine acid amidase (NAAA). This project will evaluate how NAAA controls pain susceptibility after an acute insult and how this affects the emergence of chronic pain.
1K99AR083482-01
Elucidating the Neuroimmune Mechanisms Underlying Pain and Inflammation in Autoimmune Arthritis Cross-Cutting Research NIAMS BOSTON CHILDREN'S HOSPITAL JAIN, AAKANKSHA Boston, MA 2023
NOFO Title: HEAL Initiative Advanced Postdoctoral-to-Independent Career Transition Award in PAIN and SUD Research (K99/R00 Independent Clinical Trial Not Allowed)
NOFO Number: RFA-NS-22-022
Summary:

Rheumatoid arthritis is an autoimmune disease characterized by episodes of joint inflammation and pain. There are currently no safe and effective treatments that achieve long-term remission of the condition or the associated pain. Many patients use opioid medications to manage the pain and are at increased risk of developing opioid use disorder; therefore, additional treatment options are needed. In rheumatoid arthritis, pain-triggering sensory neurons interact with immune cells in the joints. This project aims to dissect the neuroimmune crosstalk underlying pain and inflammation in arthritic joints and uncover novel therapeutic avenues for this painful condition.
2SB1NS119103-04
Novel non-narcotic analgesic for acute and chronic pain Cross-Cutting Research Small Business Programs NINDS SOUTH RAMPART PHARMA, LLC NAISMITH, ROBERT New Orleans, LA 2023
NOFO Title: HEAL Commercialization Readiness Pilot (CRP) Program: Embedded Entrepreneurs for Small Businesses in Pain Management (SB1 Clinical Trial Not Allowed)
NOFO Number: PAR-23-069
9SB1NS137964-04
Advancing precision pain medicines to the clinic Cross-Cutting Research Small Business Programs NINDS NAVEGA THERAPEUTICS, INC. MORENO, ANA MARIA (contact); ALEMAN GUILLEN, FERNANDO San Diego, CA 2023
NOFO Title: HEAL Commercialization Readiness Pilot (CRP) Program: Embedded Entrepreneurs for Small Businesses in Pain Management (SB1 Clinical Trial Not Allowed)
NOFO Number: PAR-23-069
2R44DE029369-02
A Novel Opioid-Free Targeted Pain Control Method for Acute Post-Operative Localized Pain Related to Oral Surgical Procedures Cross-Cutting Research Small Business Programs NINDS REVBIO, INC. JADIA, RAHUL (contact); KAY, GEORGE Lowell, MA 2023
NOFO Title: PHS 2022-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
NOFO Number: PA-22-176
1R43HL167661-01A1
Improving Analgesic Effectiveness and Safety with Proactive Precision Pain Management in Thoracic Surgical Patients with Lung Lesions Cross-Cutting Research Small Business Programs NHLBI OPALGENIX, INC. PLUMP, STEVEN R (contact); SADHASIVAM, SENTHILKUMAR Indianapolis, IN 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
1R42NS132622-01
Targeting TLR4-lipid rafts to prevent postoperative pain Cross-Cutting Research Small Business Programs NINDS RAFT PHARMACEUTICALS, LLC DOUGHERTY, PATRICK M (contact); KOGAN, YAKOV San Diego, CA 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-20-009
1SB1AR083748-01
Commercial Readiness in CTS Pain Management Cross-Cutting Research Small Business Programs NIAMS HIGHLAND INSTRUMENTS, INC. WAGNER, TIMOTHY ANDREW (contact); DIPIETRO, LAURA Cambridge, MA 2023
NOFO Title: HEAL Commercialization Readiness Pilot (CRP) Program: Embedded Entrepreneurs for Small Businesses in Pain Management (SB1 Clinical Trial Not Allowed)
NOFO Number: PAR-23-069
1R43HL167661-01A1
Improving Analgesic Effectiveness and Safety with Proactive Precision Pain Management in Thoracic Surgical Patients with Lung Lesions Cross-Cutting Research Small Business Programs NHLBI OPALGENIX, INC. PLUMP, STEVEN R (contact); SADHASIVAM, SENTHILKUMAR Carmel, IN 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:

Thoracic (chest) surgeries often cause both short-term (acute) and long-term (chronic) pain and long-term opioid use. Unique genetic and clinical risk factors affect individual responses to surgical pain and pain medications. Current trial-and-error approaches to managing post-surgical pain and opioid prescribing are not ideal. This project will develop predictive software within a medical device that takes into account an individual’s genetic and clinical information to predict the likelihood of chronic pain following thoracic surgery. 
2R44MD015912-03
Clinical Optimization of Ultrasonic Drug Delivery Technologies for Underserved Minority U.S. Veterans in Chronic Pain Cross-Cutting Research Small Business Programs NIMHD ZETROZ SYSTEMS, LLC LEWIS, GEORGE KENNETH Trumbull, CT 2023
NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Required)
NOFO Number: RFA-NS-20-010
Summary:

Osteoarthritis is one of the most common joint diseases affecting Americans. Osteoarthritis is particularly high among veterans with a service-related disability. This project will develop and refine a wireless ultrasound device that increases the penetration of over-the-counter pain medications into the body, which is expected to reduce pain. The research will conduct safety and clinical testing toward commercializing this technology. 
1R43NS132623-01
Optogenetic Pain Modulator for Non-Opioid Chronic Pain Management Cross-Cutting Research Small Business Programs NINDS OPSIN BIOTHERAPEUTICS, INC. NARCISSE, DARRYL Bedford, TX 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:

Optogenetics is a method of controlling nerve or brain activity using light-sensitive cell receptors (opsins). Optogenetics has been used in brain research for decades, allowing researchers to understand the brain and its associated disorders by selectively turning on and off specific nerve cells. This project will develop and refine use of an opsin and a light-stimulation device to control nerve cells contributing to the sensation of pain. 
1R43HD111082-01A1
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. 
1R43DA058614-01
Combination Therapeutic for Chronic Opioid Use Disorder Relapse Cross-Cutting Research Small Business Programs NIDA APHIOS CORPORATION CASTOR, TREVOR P Woburn, MA 2023
NOFO Title: PHS 2022-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
NOFO Number: PA-22-176
Summary:

Side effects from taking the opioid receptor blocker naltrexone make it difficult for patients to adhere to treatment with this medication for opioid use disorder. Cannabidiol (CBD), a bioactive ingredient of cannabis, is not an opioid and is non-psychoactive. Previous research shows that CBD blocks opioid-seeking behaviors, craving, and withdrawal. This project will develop tiny particles containing CBD and low-dose naltrexone. The research will determine if this combined version of CBD and naltrexone helps people stay in treatment and prevents relapse without problematic side effects. 
1R44DA058467-01
Development of a Novel Calcium Channel Therapeutic for Opioid Use Disorder Cross-Cutting Research Small Business Programs NIDA VIVREON BIOSCIENCES, LLC GREENBERG, MILTON L San Diego, CA 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:

Hospitalized patients often receive opioids for pain and sleep management, which can contribute to opioid dependence and continued use after leaving the hospital. Even when hospital stays are extended to wean people from opioids, these patients remain at increased risk for opioid use disorder and withdrawal.  This project will develop a novel small molecule medication that blocks nerve inflammation to prevent opioid dependence in hospitalized patients receiving opioids. 
1R44DA058474-01
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. 
2R44DA053078-02
Developing and Testing the Opioid Rapid Response System Cross-Cutting Research Small Business Programs NIDA REAL PREVENTION, LLC HECHT, MICHAEL (contact); CHOI, HYE JEONG Clifton, NJ 2023
NOFO Title: PHS 2022-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)
NOFO Number: PA-22-177
Summary:

Reversing an opioid overdose requires a rapid response not available through standard emergency procedures. The Opioid Rapid Response System recruits and trains citizen responders to reverse overdoses with naloxone. It uses widely disseminated smart phone apps linking responders to an overdose through the 911 system. This project will complete the development of this system, test how well it works to reverse an opioid overdose, and prepare to share it widely. 
1R41NS127637-01A1
Protease-Activated-Receptor-2 Antagonists for Treatment of Migraine Pain Cross-Cutting Research Small Business Programs NINDS PARMEDICS, INC. DEFEA, KATHRYN (contact); DUSSOR, GREGORY O Temecula, CA 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-20-009
Summary:

There is a need for additional effective treatments for migraine, which affects more than 36 million people in the United States. This project will develop an oral medication to disrupt the biological processes that drive migraine pain, which include nerve inflammation in response to pain signals. 
1DP2HD112176-01
Identifying Plasma Proteomic Profiles of Chronic Pain Development in Endometriosis From Adolescence to Adulthood Cross-Cutting Research NICHD BRIGHAM AND WOMEN'S HOSPITAL SASAMOTO, NAOKO Boston, MA 2023
NOFO Title: Emergency Awards: HEAL Initiative- New Innovator Award (DP2 Clinical Trial Not Allowed)
NOFO Number: RFA-TR-22-013
Summary:

Endometriosis is a gynecologic disorder characterized by severe pelvic pain, affecting 10% of reproductive aged women and adolescents worldwide. These individuals are at an increased risk for chronic opioid use, dependence, and overdose. Adolescents and young adults in particular are understudied in endometriosis research. This project will conduct a longitudinal study of adolescent endometriosis. The research will identify novel biomarkers and biological pathways involved in the transition of acute to chronic pain. The research aims to improve non-surgical endometriosis diagnosis, risk, and treatment. 
1R43DA058430-01
Predicting and Preventing Adverse Maternal and Child Outcomes of Opioid Use Disorder in Pregnancy Cross-Cutting Research Small Business Programs NIDA OPALGENIX, INC. PLUMP, STEVEN R (contact); SADHASIVAM, SENTHILKUMAR Carmel, IN 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 is an urgent and unmet clinical need for a reliable technology to prevent maternal opioid use relapse and neonatal opioid withdrawal syndrome (NOWS) in their infants. This project aims to assess risk for these outcomes based on individual genetic and clinical factors. The research will expand previous studies of genetic and clinical predictors of opioid-related adverse outcomes. The goal is to develop a risk predictor algorithm and software tool for use in an electronic health record, toward personalized risk assessment and prevention of maternal relapse and NOWS. 
1R44DA058531-01
BoostPrime, A Novel Digital Therapeutic for Craving Mitigation in Opioid Use Disorder Cross-Cutting Research Small Business Programs NIDA NXTECH, INC. PATEL, SALIL Patchogue, NY 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:

Cravings and impulsivity are key contributors that lead people to return to opioid misuse, but are not addressed by currently available treatments and tools. This project will develop and validate BoostPrime, a customized digital therapeutic software tool that delivers novel cognitive training exercises. The tool aims to help address cravings and strengthen momentary self-control for people with opioid use disorder by incorporating.