Funded Projects

NOFO Title: HEAL Initiative: Research to Foster an Opioid Use Disorder Treatment System Patients Can Count On (RM1 - Clinical Trial Optional)
NOFO Number: RFA-DA-23-046
Summary:

Medicaid covers the cost of treatment for opioid use disorder (OUD) for most individuals who need it, including minoritized populations and those with risk factors related to low income, education, and employment. The Medicaid Outcomes Distributed Research Network has supported efforts to improve OUD treatment by developing novel measures of treatment quality and examining effects of treatment quality on overdoses. Using this network, this project will leverage university-state partnerships in 12 states to inform quality improvement initiatives and Medicaid policy. The research will develop provider-level quality measures for OUD using Medicaid administrative data and measure patient-reported outcomes. The research will also look for approaches to use claims-based quality measures and practice-level quality improvement strategies to improve treatment outcomes for people with OUD.

NOFO Title: HEAL Initiative: Oral Complications Arising from Pharmacotherapies to Treat Opioid Use Disorders (R21 Clinical Trial Not Allowed)
NOFO Number: RFA-DE-23-016
Summary:

Buprenorphine is used for treatment of opioid use disorder (OUD), and patients often take it for many years by slowly dissolving it in the mouth. In 2022, the U.S. Food and Drug Administration warned about possible oral complications from buprenorphine use, including tooth decay, oral infections, and tooth loss. However, this warning was largely based on small studies with no comparison group and no assessment of other risk factors such as limited dental care. This project will follow two groups of individuals with OUD who take either sublingual buprenorphine or methadone, to compare their oral health and understand barriers and facilitators of dental care. The results will be used to plan an intervention for preventing and treating oral diseases in this patient group.

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:

Osteoarthritis is a degenerative joint disease marked by progressively worsening chronic joint pain that affects function and quality of life. Non-opioid, alternative medications are needed for people with this condition. Joint inflammation, damage, and pain involve signaling through the interleukin-6/glycoprotein 130 pathway. This project will test blocking this pathway in rodents with a new molecule with improved drug-like properties, toward developing an oral medication for osteoarthritis. 

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:

This project supports a post-doctoral trainee to develop the skills and knowledge needed to pursue a career in clinical pain research. The research will involve optimizing a GetActive mind-body activity program to overcome barriers that prevent disadvantaged older adult populations in community health clinics from access to non-pharmacological pain management strategies. The research will include qualitative analysis of secondary data, a literature review to evaluate methods, and feasibility for establishing a community advisory board for the GetActive project.

NOFO Title: HEAL Initiative: Planning Studies for Initial Analgesic Development [Small Molecules and Biologics] (R61 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-21-029
Summary:

Common chronic pain syndromes such as fibromyalgia, temporomandibular disorder, and low back pain, are significant health conditions for which safe and effective treatments are needed. Previous studies have identified the adrenergic receptor beta-3 (Adrb3) as a novel target for chronic pain, but past attempts to block this receptor have not worked. This project aims to identify and develop new molecules to attach selectively and block Adrb3 without entering the brain and spinal cord. The research will test these molecules in rodent animal models to determine their ability to block pain without significant side effects.

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.

NOFO Title: HEAL Initiative: Oral Complications Arising from Pharmacotherapies to Treat Opioid Use Disorders (R01 Clinical Trial Not Allowed)
NOFO Number: RFA-DE-23-015
Summary:

Buprenorphine is commonly used in medication-assisted treatment of opioid use disorders. The U.S. Food and Drug Administration recently issued a warning that the drug may lead to serious tooth damage in some patients. It is thought that high concentrations of the drug in saliva may contribute to tooth damage and decay. This project will use a mouse model of dental caries to explore the mechanism leading to high buprenorphine concentrations in saliva and examine ways to reduce concentrations in the mouth but not the rest of the body; it will also examine buprenorphine’s effects on the bacteria that lead to caries development.

NOFO Title: HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)
NOFO Number: RFA-NS-21-010
Summary:

Neuropathic pain is a debilitating and complex medical condition for which safe and non-addictive treatment options are urgently needed. Preliminary studies have found that lysophosphatidic acid receptor 5 (LPA5) is present in areas of the body that signal pain, including at high levels in rodent models of neuropathic pain. This project will use genetic and pharmacological approaches to determine whether blocking LPA5 signaling reduces neuropathic pain toward future testing in humans.  

NOFO Title: HEAL Initiative: Career Development Awards in Implementation Science for Substance Use Prevention and Treatment (K01 - Clinical Trial Required)
NOFO Number: PAS-22-206
Summary:

This project provides protected time for training and research activities that are required for an independent scientific career in the development, testing, and implementation of cutting-edge digital therapies and tools (such as smartphone apps and other web-based resources) that can promote health equity in treatment of opioid use disorder (OUD). The research will adapt and test digital overdose prevention and recovery support interventions for Black Americans with co-occurring OUD and mental illness. 

NOFO Title: HEAL Initiative: Planning Studies for Initial Analgesic Development [Small Molecules and Biologics] (R61 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-21-029
Summary:

Natural products, which are substances found in nature and made by living organisms, have been used in the past as good sources for developing new medications. Natural products isolated from marine bacteria that attach to the pain-signaling protein sigma-2 receptor (also known as transmembrane protein 97 [TMEM97]), may serve as a starting point to create new, non-opioid pain medications. This project will use chemistry and biology approaches to refine such natural products as a treatment for neuropathic pain.

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:

Significant racial, ethnic, socioeconomic, and geographic disparities affect access to opioid use disorder (OUD) treatment and have thus contributed to the opioid overdose crisis. Patient navigator interventions after hospitalization can improve access to treatment, but challenges prevent full adoption of these strategies. These include lack of coordination across institutions, inadequate data sharing, workforce shortages, and lack of awareness, especially in resource-limited communities. This project aims to develop a hospital system-wide patient navigation protocol that can be scaled up to address OUD treatment linkage and continuity after hospitalization.

NOFO Title: HEAL Initiative: Oral Complications Arising from Pharmacotherapies to Treat Opioid Use Disorders (R01 Clinical Trial Not Allowed)
NOFO Number: RFA-DE-23-015
Summary:

Recently, concerns have been voiced that medications to treat opioid use disorder (OUD) may contribute to dental problems, including cavities and tooth loss. These concerns may contribute to barriers preventing use of these medications. A better understanding of the effects of these medications on oral complications is critical. This project will use national databases to link dental, medical, and pharmacy claims data for Medicaid- or commercially-insured new users of various medications for OUD to determine and compare oral health outcomes. The project will also examine the perspectives and experiences of people with OUD on oral health.

NOFO Title: HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)
NOFO Number: RFA-NS-21-010
Summary:

Neuropathic pain is a debilitating and complex medical condition for which safe and non-addictive treatment options are urgently needed. This project aims to develop new strategies for treating neuropathic pain by controlling the activity of transmembrane protein 97 (TMEM97), also known as the sigma 2 receptor, which has been shown to relieve pain in an animal model of neuropathic pain. The research aims to develop a new molecule that increases TMEM97 activity and is safe for human use, toward obtaining approval from the U.S. Food and Drug Administration for Phase I clinical testing.