Funded Projects

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:

Prior research has shown that chronic pain is common among immigrants and refugees. Cultural preferences for pain management, combined with barriers to healthcare in the United States, result in a lack of effective and accessible pain treatment in these populations. Pain experiences and treatment preferences of non-English-speaking immigrant and refugee communities are poorly understood because of a lack of research conducted in non-English-speaking immigrants’ native languages. This research will develop effective, equitable, and sustainable interventions for individuals with both chronic pain and opioid use disorder: in particular, individuals within Hispanic/Latino and Bhutanese communities.

NOFO Title: Discovery of Biomarkers, Biomarker Signatures, and Endpoints for Pain (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-NS-18-041
Summary:

Neuropathic corneal pain (NCP) causes patients to have severe discomfort and a compromised quality of life (QoL). The lack of signs observed by standard examination has resulted in misdiagnosis as dry eye disease (DED). An optical biopsy using laser in vivo confocal microscopy (IVCM) revealed that microneuromas (bulbs at the ends of severed nerves caused by buildup of molecular constituents) are present in NCP but not DED and may serve as a biomarker for NCP. The aims are to (1) use a database of more than 2,000 DED/NCP subjects and more than 500,000 IVCM images to confirm that the presence of microneuromas is an appropriate biomarker for NCP, (2) provide biological validation of microneuromas, (3) develop a validated artificial intelligence (AI) program for automated identification of microneuromas, and (4) establish the clinical utility of microneuromas observed by IVCM as a biomarker for NCP in a prospective, multicenter study.

NOFO Title: CTSA Network - Trial Innovation Centers (TICs) (U24)
NOFO Number: RFA-TR-15-002

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-23-033
Summary:

Exposure to prescription opioids during pregnancy can alter growth of the fetus and cause persistent neurological problems during childhood. This project will identify biological underpinnings of oxycodone exposure on health of the placenta, brain development of the fetus, and behavioral problems observed in early infancy. This research will also assess whether melatonin supplementation can limit these harmful outcomes. Overall, the research aims to characterize the health effects of oxycodone used during pregnancy, as well as to point to new tools and molecular indicators (biomarkers) for diagnosing, treating, and preventing opioid harm to the fetus and mother.

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:

The current overdose epidemic is being fueled by widespread, non-medical use of opioids prescribed by mostly well-meaning physicians who often lack adequate training on how to properly initiate, monitor, and discontinue opioid therapy. It is very difficult for physicians to fully assess a new patient?s risk of substance misuse and possible future overdose in the limited amount of time of a typical evaluation. The Care Continuity Program (CCP) is a novel, online patient self-assessment used by prescribers of opioids to better identify patient risk factors and therapy benefit. The CCP tool is completed by the patient, outside of the office, using an internet enabled device and follows a compliance-driven protocol. The results are instantly transmitted to the prescriber?s electronic health records (EHR), mitigating the prescriber?s civil and criminal liabilities. The study aims to validate the protocol and delivery system of the CCP by measuring patient outcomes, prescriber confidence, and completeness of documentation in the patient chart in primary care and pain management settings. If successful, this project can significantly expand the benefits of CCP to even a broader network of providers and help mitigate the impact of the opioid crisis

NOFO Title: Limited Competition: International Cooperative Biodiversity Groups (U19)
NOFO Number: RFA-TW-13-001
Summary:

The Philippine Mollusk Symbiont International Cooperative Biodiversity Group harnesses the vast biodiversity of the Philippines to discover new drugs to treat bacterial infections, parasitic infections, pain, and other neurological conditions and cancer, all of which are serious health problems in both the Philippines and the United States. The Republic of the Philippines represents a unique nexus of exceptional biodiversity, dense human population with pressing societal needs, consequent urgent need for conservation, and government commitment to education and technology to harness national human and natural resources for a sustainable future. Mollusks are one of the most diverse groups of marine animals, and their associated bacteria represent an unexplored trove of chemical diversity. Researchers will use an increasing understanding of the interactions between mollusk symbionts and their hosts to discover the most novel and useful molecules. The project will document and describe Philippine mollusk biodiversity and support training and infrastructure that provide the foundation for conservation of Philippine biodiversity.

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: 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:

Current drug-screening immunoassays use benchtop analyzers that require experienced personnel, time, and a laboratory setup. Physicians without access to in-house testing have to send out patient samples for screening, resulting in unacceptable delays in the treatment of patients who are potentially suffering from chronic pain. This project, a partnership with BreviTest Technologies, LLC, aims to develop a low-cost, point-of-care (POC) urine drug testing (UDT) device to detect opioids. The goal is for a portable platform to deliver quantitative performance similar to a standard laboratory test for opioids within a 10-minute run time. If successful, this will provide a technology capable of performing rapid quantifications of urine drug levels in a physician’s office, providing an invaluable tool to render more effective pain management dosing to patients, thus paving the way toward lower toxicity and a better quality of life.

NOFO Title: Notice of Special Interest for HEAL Initiative: Request for Administrative Supplements to Existing Grants for Identification and Validation of New Pain and Opioid Use Disorder Targets within the Understudied Druggable Genome
NOFO Number: NOT-TR-20-008
Summary:

The cannabis plant contains many active compounds known collectively as cannabinoids that have been shown to possess analgesic and anti-inflammatory properties. These compounds exert their biological activity, in part, through the cannabinoid receptor. The cannabinoid receptor is a member of a class of proteins known as G-protein coupled receptors (GPCRs). This study will test whether a GPCR with unknown biological function, called Gpr149, has a role in the activity of cannabinoids. The study will identify and characterize Gpr149 expression in mouse cells, and deeply characterize the action of minor cannabinoids, endocannabinoids and products of inflammation to modulate Gpr149. This research will provide insight into the analgesic and anti-inflammatory action of minor cannabinoids and into the role of Gpr149 in nociception and the sensitization of nociceptors to inflammatory mediators.

NOFO Title: Discovery of Biomarkers, Biomarker Signatures, and Endpoints for Pain (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-NS-18-041
Summary:

Debilitating neuropathic pain occurs in 40 percent to 70 percent of people who suffer from spinal cord injury (SCI). There are no distinguishing characteristics to identify who will develop neuropathic pain. The objective of this research is to develop a biomarker signature prognostic of SCI-induced neuropathic pain (NP). The aims of the project are to (1) identify autoantibodies in plasma samples from acute SCI patients to CNS autoantigens and determine the relationship between autoantibodies levels to the development of NP, (2) identify the autoantibody combination with maximal prognostic accuracy for the development of NP at six months after SCI, and (3) develop and optimize an assay to simultaneously measure several autoantibodies and independently validate the prognostic efficacy for NP using plasma samples collected prospectively. Establishing a panel will refine the prognostic value of these autoantibodies as biomarkers to detect who are vulnerable to NP and may be used to for development of nonaddictive pain therapeutics.

NOFO Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-19-036

NOFO Title: NIMHD Social, Behavioral, Health Services, and Policy Research on Minority Health and Health Disparities (R01)
NOFO Number: RFA-MD-13-006
Summary:

Previous studies found that African American (AA) and low socioeconomic status (SES) patients are less likely to receive guideline-concordant pain care relative to White and high SES patients. According to research and theory, enhancing clinician perspective-taking is a promising strategy for improving the care of AA and low SES patients. We have developed an innovative methodology that utilizes computer-simulated patients and environments to assess, understand, and remediate pain treatment disparities. Our approach allows for the intervention to be individually tailored to each trainee, thereby enhancing its impact. It also allows for individual trainees to gain exposure to a greater range of racially and socioeconomically diverse patients than can normally be obtained in traditional training settings. We hypothesize that our perspective-taking intervention will increase trainees’ knowledge of their own biases, enhance trainees’ empathy toward patients, and reduce trainees’ anxiety/threat toward patients, and that these changes will reduce pain treatment disparities.

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.