Funded Projects

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:

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. 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. 

NOFO Title: HEAL Initiative: Career Development Awards in Implementation Science for Substance Use Prevention and Treatment (K23 - Clinical Trial Required)
NOFO Number: PAS-22-207
Summary:

This project provides protected time for training and research activities that are required for an independent scientific career in delivering evidence-based treatments for people with opioid use disorder. The increasing presence of fentanyl in the drug supply creates challenges for the use of buprenorphine, because both patients and physicians want to avoid causing withdrawal. This research will interview both patients and physicians to understand their concerns and experiences and work with them to develop a buprenorphine induction toolkit to help balance the advantages of buprenorphine treatment against concerns about the potential presence of unknown fentanyl. 

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:

Oral cancer pain is debilitating and difficult to treat, in part because even the most effective available pain remedies are limited by side effects. Opioid-based pain medications have several side effects including dependence and tolerance, in which the body gets used to a medicine so that either more medicine is needed or different medicine is needed. Another side effect is hyperalgesia, in which people taking opioids become more sensitive to certain painful stimuli and may misuse the drugs and risk addiction. This project will evaluate lab-made versions of cannabinoid molecules known to block pain signals in nerve cells, but which cannot enter the brain to cause neurological side effects. The research aims to advance promising versions of the molecules to testing in human research participants.

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:

The overdose crisis has expanded rapidly among adolescent populations in recent years, largely due to illicit substances containing lethal amounts of the highly potent synthetic opioid fentanyl. However, a provider shortage limits access to effective treatment for adolescents with opioid use disorder and other substance use disorders (SUD). Although primary care is a promising setting for expanding delivery of SUD treatment to adolescents, many primary care providers lack the training, resources, and support systems to deliver these services confidently and effectively. This project will leverage a large-scale rollout of integrated behavioral health care in a statewide health system. The research will test whether embedding behavioral health specialists into primary care visits, introducing case management and electronic clinical decision support tools, and reducing stigma will increase delivery of SUD treatment to adolescents.

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.