Funded Projects

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. 

NOFO Title: Notice of Special Interest (NOSI): Encourage Eligible NIH HEAL Initiative Awardees to Apply for Administrative Supplements to Support Career Enhancement Related to Clinical Research on Pain
NOFO Number: NOT-NS-22-087
Summary:

Understanding the mechanisms underlying the transition to chronic pain is key to mitigating the dual epidemics of chronic pain and opioid use in the United States. As part of the National Institutes of Health-funded Acute to Chronic Pain Signatures Program, the Data Integration and Resource Center aims to This project will support a post-doctoral trainee to develop the skills and knowledge needed to pursue a successful career in clinical pain research. The research will involve integrating imaging, physiology, -omics, behavioral, and clinical data to develop biosignatures for the transition from acute to chronic pain, toward understanding how the nervous and immune systems affect post-surgical pain and opioid use.

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.

NOFO Title: HEAL Initiative: Discovery of Biomarkers and Biomarker Signatures to Facilitate Clinical Trials for Pain Therapeutics (UG3/UH3 Clinical Trial Optional)
NOFO Number: RFA-NS-22-050
Summary:

Neuropathic pain is a chronic and difficult to treat condition that affects people in different ways. This project aims to personalize treatments based on individual pain profiles. The research will develop an inexpensive test using a technique called quantitative sensory testing to predict how a patient will respond to two common pain medications. The research will also look for other factors in blood that enhance the accuracy of these predictions.

NOFO Title: HEAL Initiative: Translational Development of Diagnostic and Therapeutic Devices (R18 Clinical Trial Not Allowed)
NOFO Number: RFA-EB-22-002
Summary:

People with sickle cell disease often experience episodes of severe pain (vaso-occlusive crisis) that are caused by the abnormal red blood cells and frequently result in opioid use. Tools that can identify and measure the degree of such a crisis early on could allow clinicians to pre-emptively disrupt this process. This project aims to develop a rapid, automated screening technology for evaluating red blood cells that allows assessment of patients at risk of pain crisis right in their health care provider’s office.

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:

Myofascial pain syndrome is a prevalent and debilitating condition and can aggravate other conditions such as sickle cell disease. This project will use total body imaging using positron emission tomography/computed tomography (TB-PET/CT) to identify and monitor this pain syndrome and potential treatments over time. The research will use TB-PET/CT to assess myofascial tissue effects of chronic low back pain and sickle cell disease pain. The first phase of the project will assess health changes observed by TB-PET/CT imaging in painful and non-painful myofascial tissues compared to healthy myofascial tissue. The second phase of the research will be a randomized, controlled longitudinal interventional study to evaluate the effectiveness of acupuncture on myofascial pain syndrome, using TB-PET/CT imaging to assess changes.

NOFO Title: HEAL Initiative: Secondary Analysis and Integration of Existing Data Related to Acute and Chronic Pain Development or Managementin Humans (R21 Clinical Trials Not Allowed)
NOFO Number: RFA-DE-22-011
Summary:

Pain is common, complex, and debilitating in many cancer patients. Although adequate pain management can significantly improve health-related quality of life for these individuals, substantial disparities limit care access, especially among underserved populations. After the 2014 Drug Enforcement Agency policy that raised the risk potential of the opioid hydrocodone (from Schedule III to Schedule II), few studies examined the impact of this policy on pain management strategies and outcomes among cancer patients. This project will use national cancer registry data linked with Medicare claims to assess the change in opioid and non-opioid medication use among older lung cancer patients before and after this policy change. By focusing on older racial/ethnic minority groups dually eligible for both Medicare and Medicaid, the research will also examine disparities in the use of medications for pain management and service use consistent with inadequate pain management.

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-22-066
Summary:

Fibromyalgia is a chronic pain condition characterized by widespread musculoskeletal pain, tenderness, stiffness, fatigue, and sleep disturbance. The FAST trial (Fibromyalgia Activity Study with transcutaneous electrical nerve stimulation [TENS]) was the first study to conclusively demonstrate the clinical value of TENS for treating musculoskeletal pain. While physical therapists are trained in the use of TENS, it is underused in clinical practice. This project will test TENS in fibromyalgia patients receiving physical therapy in a real-world physical therapy practice setting. This research will determine if adding TENS to physical therapy reduces pain, increases adherence to physical therapy and allows fibromyalgia patients to reach their self-defined functional goals with less use of medication.

NOFO Title: HEAL Initiative: Secondary Analysis and Integration of Existing Data Related to Acute and Chronic Pain Development or Managementin Humans (R21 Clinical Trials Not Allowed)
NOFO Number: RFA-DE-22-011
Summary:

Chronic pain is a persistent source of disability and reduced quality of life for aging adults. Chronic pain-related outcomes are disproportionately worse for aging African Americans, who report greater pain severity and worse pain-related disability compared to White peers. A significant pain risk factor for African Americans is chronic stress (including family-related stress), which is worsened by structural inequities that affect this population. Although many African Americans identify family support as critical for pain self-management, this influence has not been studied thoroughly. This project will study how pain conditions develop and persist for aging African Americans by analyzing existing data from African American participants in two large aging studies: Midlife in the U.S. (721 participants) and the Health and Retirement Study (2,698 participants). The research aims to determine how family emotional climate affects pain risk, taking into account structural factors like discrimination, socioeconomic disparity, and the influence of various neighborhood settings.

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-22-066
Summary:

Chronic pain is a debilitating medical condition that affects roughly 50 million people in the United States. Current diagnostics and treatments rely primarily on subjective metrics and do not target the unique biological, psychological, and social factors that contribute to an individual’s pain. This project is part of the NIH Back Pain Consortium (BACPAC) program, a patient-centered effort to address the need for effective and personalized therapies for chronic low back pain. This research will enhance patient diversity within the BACPAC research participant population.

NOFO Title: HEAL Initiative: Data and Methods to Address Urgent Needs to Stem the Opioid Epidemic (R01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-22-044
Summary:

Effective overdose prevention requires timely, location-specific data to efficiently direct resources and interventions as well as to inform healthcare policy. However, rarely is such information available, resulting in responses that are frequently too late. This project will partner with local government agencies from Los Angeles County, California, to rapidly acquire and analyze information in near real-time from multiple sources to identify overdose hotspots and determine overdose metrics. This information will be used to develop a publicly available Rapid Overdose Surveillance Los Angeles online dashboard with built-in analytics. The dashboard will help determine the scope and specifics of overdose and opioid use in Los Angeles County to help target response and guide mobile addiction treatment and harm reduction services.

NOFO Title: HEAL Initiative: Harm Reduction Policies, Practices, and Modes of Delivery for Persons with Substance Use Disorders (R01 Clinical Trial Optional)
NOFO Number: RFA-DA-22-046
Summary:

People who use drugs often have other medical problems that cause them to visit an emergency department frequently. This project will develop and test an intervention aimed at reducing health risk among Black people who use drugs that visit an urban emergency department for care. The intervention will be delivered by people with lived experience of drug use and tailored to meet the unique needs of Black people who use drugs.

NOFO Title: HEAL Initiative: Data and Methods to Address Urgent Needs to Stem the Opioid Epidemic (R01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-22-044
Summary:

Effective responses to the highly dynamic overdose crisis require accurate and timely information about the timing and location of drug overdoses, which is currently reported mainly through death certificates that take time to become available and thus limit life-saving responses. This project will comprehensively evaluate, optimize, and assess barriers and facilitators to adoption of a surveillance tool developed by the New York City Office of the Chief Medical Examiner. The tool uses data routinely collected during death investigations to predict in near real-time whether a death was due to an unintentional drug overdose. The findings will inform drug overdose mortality surveillance efforts in other states.