Funded Projects

NOFO Title: HEAL Initiative: HEAL Data2Action – Innovation and Acceleration Projects, Phased Awards (R61/R33, Clinical Trial Optional)
NOFO Number: RFA-DA-23-057
Summary:

Health services for the treatment of opioid use disorder (OUD) are fragmented in west Chicago, an epicenter for overdose deaths. This project will develop a data-driven opioid response plan involving key partners. These include local health departments, community organizations, health care systems, and people with lived experience. The research will develop a digital screening tool for OUD that can be used in hospitals and their emergency departments. The tool will be built from machine learning of data from electronic health records, the prescription drug monitoring program, and patient-reported measures. The research will test the value of the screening tool for connecting people to treatment and preventing fatal overdoses mortality in local neighborhoods.

NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R41/R42 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-23-007
Summary:

Nerve stimulators are devices surgically implanted near a peripheral nerve or on the spinal cord that use electrical signals to reduce the perception of pain. Although these devices can provide effective pain relief to patients, many have high complication rates, resulting from the wire moving, breaking, not working, or the implantable battery pack or permanent wire causing new pain. This project will support the development and animal testing of a peripheral nerve stimulator to treat chronic pain which can be implanted without surgery. Once injected, the device will provide pain relief through electrical stimulation and then be safely degraded and resorbed by the body.

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. 

NOFO Title: HEAL Initiative: Multilevel Interventions to Reduce Harm and Improve Quality of Life for Patients on Long Term Opioid Therapy (MIRHIQL) (R01 Clinical Trial Required)
NOFO Number: RFA-DA-23-041
Summary:

Decreasing opioid dosing faster than advised by clinical recommendations often leaves chronic pain unaddressed and may increase the risk of overdose and suicide compared to continuing long-term opioid treatment. Continued, long-term use of opioids after surgery by individuals who use opioids increases the risk of postoperative complications, opioid use disorder, and death. Surgery is a critical point-of-care moment for health care providers to interact with patients who use opioids about continued opioid use when harms outweigh benefits. This project will test of the Motivational Interviewing and guided Opioid Tapering support (MI-Opioid Taper) strategy, with or without a medication that reduces anxiety and relieves pain, at four geographically diverse hospitals across the nation.

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-23-036
Summary:

The number of women misusing opioids during pregnancy has more than quadrupled in recent years, with fentanyl use rising to an all-time high. The exposure puts the fetus at serious risk for opioid withdrawal, as well as developmental and behavioral effects during infancy and childhood. This project will study the effects of fentanyl use during pregnancy on maternal physiology and stress, function of the placenta, pregnancy outcomes, as well as infant withdrawal symptoms, development, and stress. This research aims to identify new strategies for diagnosing, treating, and preventing opioid harm to the fetus and mother.

NOFO Title: Development of Medications to Prevent and Treat Opioid and/or Stimulant Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)
NOFO Number: PAR-22-200
Summary:

Buprenorphine is an effective treatment for opioid use disorder, but its use is limited due to the need for frequent dosing. This project will optimize the molecular features of an injectable, biodegradable, long-acting (3-month) buprenorphine implant that would not require surgical removal. The research aims to advance toward testing in human research participants.

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:

Managing the risks and benefits of opioid medications can be difficult. Although prescription opioids alleviate pain for some patients, serious adverse effects include opioid use disorder. There is a critical, unmet need for new technologies that significantly minimize the opioid doses needed for effective relief from moderate to severe pain. This project will develop a novel combination treatment containing a small amount of morphine along with pramipexole, a drug approved by the U.S. Food and Drug Administration for Parkinson’s disease and restless legs syndrome that reduces the reward-seeking behavior associated with opioids. The research will conduct safety studies to enable testing in human research participants.

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.

NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for PA-20-222: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: NOT-NS-20-107
Summary:

RADOR-KY is a near real-time, state-wide surveillance system to monitor prevention and treatment services for opioid use disorder (OUD). This project will fill gaps in this system by capturing data from agencies receiving state funding to provide treatment and support services for people with OUD. Access to the additional data will help expand and improve surveillance dashboards being used to coordinate and target resources for preventing overdose deaths.

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: HEAL Data2Action – Innovation and Acceleration Projects, Phased Awards (R61/R33, Clinical Trial Optional)
NOFO Number: RFA-DA-23-057
Summary:

Emergency departments (EDs) are key settings for identifying and treating opioid use disorder (OUD), but EDs are underused for this purpose. This project aims to develop a data system that automates and integrates electronic health record and administrative data from EDs into the Clinical Emergency Department Registry, partnering with the American College of Emergency Physicians. The research will assess the digital readiness of ED systems before developing and deploying the enhanced ED OUD data infrastructure. This research aims to guide near-real time hospital quality improvement initiatives, toward development of a web-based, near-real time dashboard that can be used in EDs across the country.

NOFO Title: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-23-006
Summary:

Pelvic pain (PP) includes more than 20 different painful and debilitating conditions, such as urinary tract infections, menstrual cramps, endometriosis, overactive bladder, and interstitial cystitis, and affects millions of people. Globally, pelvic pain affects 1 in 5 women and 1 in 12 men. This project will develop an instrument to monitor and treat pain-associated temperature changes in the pelvic region to reduce chronic pelvic pain. This novel system is intended to be used at home with personalized settings.

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: RFA-TR-22-011
Summary:

Chronic post-traumatic headache (PTH) is highly debilitating, poorly understood, and difficult to treat. This project aims to identify proteins located in the membrane of certain neurons that are critical for the development, maintenance, and/or resolution of PTH. These proteins may be targets for novel treatment approaches that are nonaddictive and have minimal side effects.