Funded Projects

NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 – Clinical Trial Not Allowed)
NOFO Number: RFA-NS-20-011
Summary:

Some chemotherapy treatments damage nerves outside the brain and spinal cord. This condition, chemotherapy-induced peripheral neuropathy, involves tingling, burning, weakness, or numbness in hands and/or feet and affects nearly 70% of cancer patients receiving chemotherapy. Common pain medications, including opioids, can relieve pain for short intervals but are not suitable for long-term therapy. This project will develop and test a new type of treatment (reduced size cyclic analogs) for this condition. The research will evaluate the ability of this therapy to reduce inflammation and pain, as well as to repair nerve damage.

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:

Maternal use and addiction to opioids or other drugs has resulted in an unprecedented rise in drug withdrawal complications in newborns known as neonatal abstinence syndrome (NAS). While there is no accepted standard for treating NAS, non-pharmacological bundles are recommended as an initial course of treatment. Unfortunately, non-pharmacological care (swaddling, rocking, frequent feedings, and skin contact) require significant use of human resources. This project studies the technical feasibility of a stochastic vibrotactile stimulation (SVS) technology incorporated into the hospital bassinet pad, which provides gentle vibrating sensory stimulation to soothe infants with NAS. Building on preliminary evidence that this type of stimulation calms NAS infants without altering their sleep, this study aims to develop a commercially viable bassinet pad that could be used in a hospital setting.

NOFO Title: HEAL Initiative: Pragmatic Randomized Controlled Trial of Acupuncture for Management of Chronic Low Back Pain in Older Adults (UG3/UH3 Clinical Trial Required)
NOFO Number: RFA-AT-19-005
Summary:

Acupuncture has been found to be effective in treating chronic lower back pain (cLBP) in adults. Yet trials have rarely included older adults, who have more comorbidities and may respond differently from typical trial participants. To fill this gap, the study team will conduct a three-arm trial of 828 adults ?65 years of age with cLBP to evaluate acupuncture versus usual care. They will compare a standard 12-week course of acupuncture with an enhanced course of acupuncture (12-week standard course, plus 12-week maintenance course) to usual medical care for cLBP. If successful, this pragmatic RCT will offer clear guidance about the value of acupuncture for improving functional status and reducing pain intensity and pain interference for older adults with cLBP.

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-21-025

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-23-034
Summary:

Opioid use during pregnancy is associated with harmful health outcomes for infants including preterm birth, neonatal opioid withdrawal syndrome, and brain-related problems. This project will carry out an in-depth investigation of the effects of opioid use during pregnancy including changes to health of the placenta, inflammation in the fetus, as well as behavioral and movement-related outcomes during the first year of life. This research will contribute to fundamental knowledge about how the placenta and brain work together as well as identify new strategies for diagnosing, treating, and preventing opioid harm to the fetus and mother.   

NOFO Title: HEAL Initiative: Discovery and Validation of Novel Targets for Safe and Effective Pain Treatment (R01 Clinical Trial Not Allowed)
NOFO Number: NS22-034
Summary:

Chronic visceral pain disorders, such as interstitial cystitis/bladder pain syndrome, are among the most difficult types of pain to treat. This project will conduct a detailed analysis of an enzyme thought to be involved with the disorder (purine nucleoside phosphorylase, or PNPase) as a target for new nonopioid pain medications to treat interstitial cystitis/bladder pain syndrome. The research will lay the groundwork for developing targeted treatments for visceral pain disorders.

NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-036
Summary:

Prevalence rates of opioids misuse in Los Angeles County (LA) are particularly high among individuals of childbearing age and in already-vulnerable populations including African American females. These data highlight a pressing need for a systematic study of the effects of prenatal drug exposures (PDE) in the unique sociodemographic LA County area. In this project, researchers aim to establish the feasibility for the large-scale Phase II HEALthy BCD study in the Los Angeles area with three specific aims: (1) build a broad interdisciplinary team of investigators capable of a multi-faceted study of brain and behavioral development in both typically developing and at-risk infants/children; (2) establish a set of highly executable recruitment and retention strategies for both drug-free and drug-exposed infants/children; and (3)establish comprehensive study protocols that will help address the three key research objectives of the Phase II study.

NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
NOFO Number: RFA-DA-19-002
Summary:

Opioid use disorder (OUD) is a serious public health problem that is associated with high rates of morbidity and mortality. The proposed Phase 1a/1b studies are designed to evaluate a novel treatment strategy for OUD. Specifically, the safety, immunogenicity and preliminary efficacy of a vaccine (OXY-KLH) targeted against oxycodone (Study 1) and a vaccine (M-KLH) targeted against heroin/morphine (Study 2) will be evaluated in participants diagnosed with OUD.

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:

Withdrawal symptoms associated with current opioid use disorder treatments, such as naltrexone or buprenorphine, can be serious obstacles to successful treatment. This project aims to develop a U.S. Food and Drug Administration-approved sedative medication (dexmedetomidine) as an under-the-tongue film to treat opioid withdrawal symptoms at doses that have minimal ill effects on blood pressure and heart rate. This research will compare the safety and efficacy of dexmedetomidine to lofexidine, which is currently approved to treat opioid withdrawal.

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:

Chronic focal neuropathic pain, which includes pain etiologies such as radiculopathy and radiculitis, focal peripheral neuropathies, and low back pain, affects as many as 25 million patients annually in the United States. Chronic focal neuropathic pain is maintained by genome-wide transcription regulation in the dorsal root ganglia (DRG) / spinal cord network. The transcription factors driving this regulation constitute a promising class of targets with the potential to alter the course of pain with a single treatment. DNA decoys are oligonucleotides that specifically inhibit the activity of certain transcription factors. AYX2 binds and inhibits Krüppel-like transcription factors (KLF) in the DRG-spinal cord. The goal of this Phase 1 proposal is to advance AYX2 toward an IND submission, allowing for human clinical trials. We propose in Aim 1 to characterize AYX2 pharmacokinetics in the cerebrospinal fluid and plasma and its distribution in the DRG, spinal cord and brain following an IT injection. With this information, AYX2 will be tested in a panel of complementary toxicology studies in Aim 2 to allow for final IND-enabling studies, supported by Phase 2 of the grant. This research will accelerate development of AYX2 as a novel drug candidate for the non-opioid treatment of pain.

NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
NOFO Number: RFA-DA-19-002
Summary:

Several abuse-deterrent opioid products (primarily formulations) are currently marketed or in clinical development, but they fall short of being resistant to abuse. Rather than abuse-deterrent formulations, this project, in partnership with Ensyce Biosciences, has created two complementary, novel technologies that control the release of known opioids. One technology delivers prodrugs — drugs that are not active until they have been exposed to the right conditions within the body, at which point they are gradually converted into active drugs, making them difficult to tamper with and reducing the potential for misuse. Another technology makes it so that taking increasing numbers of pills inhibits the process of converting prodrug into active drug, reducing the potential for overdose. This project aims to refine the development of these two technologies and work to combine them, and to translate promising animal results into human use.

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:

The number of drug overdoses in New York continues to rise. In response, the New York State Office of Addiction Services and Supports (OASAS) is promoting approaches that embrace person-centered care, evidence-based practices, equitable treatment, and harm-reduction principles. In this project, researchers will partner with OASAS to build a quality measurement and management research center that provides performance feedback to support and encourage leadership and staff of treatment clinics to improve practice. The center will also publicize quality measures to ensure public accountability.

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:

This project seeks to develop a first-in-class (FIC), peripherally restricted and long-acting drug with potential to reduce or replace opioid for moderate to severe pain, and that will be non-addictive, safe, and convenient to use. The program is based on strong scientific evidence showing that activation of a receptor called MAS1 produces opioid-independent and peripheral pain relieving activity in a wide range of animal models of chronic pain, including inflammatory, neuropathic, and bone cancer pain. This project focuses on the development of potent, stable, and specific molecules that stimulate MAS1. Researchers will then attach peptides that stimulate MAS to antibody carriers that make them last longer and selectively affect only the peripheral nervous system, which could allow for once a week or twice a month dosing while maintaining the drug’s efficacy and reducing potential side effects, and test the resulting molecule in animal models.