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: 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:

There is an urgent and unmet clinical need for a reliable technology to prevent maternal opioid use relapse and neonatal opioid withdrawal syndrome (NOWS) in their infants. This project aims to assess risk for these outcomes based on individual genetic and clinical factors. The research will expand previous studies of genetic and clinical predictors of opioid-related adverse outcomes. The goal is to develop a risk predictor algorithm and software tool for use in an electronic health record, toward personalized risk assessment and prevention of maternal relapse and NOWS. 

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 overdose prevention requires timely, location-specific data to efficiently direct resources and interventions as well as to inform healthcare policy. However, rarely is such information available, resulting in responses that are frequently too late. This project will partner with local government agencies from Los Angeles County, California, to rapidly acquire and analyze information in near real-time from multiple sources to identify overdose hotspots and determine overdose metrics. This information will be used to develop a publicly available Rapid Overdose Surveillance Los Angeles online dashboard with built-in analytics. The dashboard will help determine the scope and specifics of overdose and opioid use in Los Angeles County to help target response and guide mobile addiction treatment and harm reduction services.

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:

While the mu opioid receptor (MOR) antagonist naloxone has proven invaluable as an opioid overdose antidote, naloxone suffers from a very short duration of action (half-life is approximately 1 hour) and has been found to be less effective against newer, long-acting opioids, including fentanyl (half-life is approximately 7–10 hours). This leads to a highly lethal and increasingly prevalent phenomenon known as “renarcotization,” wherein an overdose patient revived with naloxone can re-enter an overdose state from residual fentanyl in the body. Thus, there is a critical need to develop a long-acting MOR antagonist formulation that can address renarcotization by providing multi-hour protection. The goal of this project is to reformulate naloxone using FDA-approved microencapsulation technology into a long-acting injectable (LAI) that can provide 12–24 hours of sustained antagonist activity in vivo. It will employ a proprietary Computational Drug Delivery™ software, called ADSR™, to perform in silico formulation optimization as well as to predict its in vitro dissolution and in vivo pharmacokinetic behavior.

NOFO Title: HEAL Initiative: Secondary Analysis and Integration of Existing Data Related to Acute and Chronic Pain Development or Management in Humans (R21 Clinical Trials Not Allowed)
NOFO Number: RFA-DE-22-011
Summary:

Fifty million Americans experience chronic pain, including about 25 million who report pain that substantially interferes with daily activities and reduces quality of life. Mental health problems, including depression, anxiety, and post-traumatic stress disorder, increase risk for severe chronic pain. This project will use genetic data, information about observable characteristics (phenotypic data), and neuroimaging data from three large databases to identify psychosocial factors that predict chronic pain, assess differences across diverse U.S. populations, and determine whether risk profiles predict post-surgical chronic pain.

NOFO Title: Wearable to Track Recovery and Relapse Factors for People w/ Addiction (R43/R44)
NOFO Number: RFA-DA-18-010
Summary:

For many individuals in recovery from a substance use disorder, certain cues—including stress and drug-related cues—can trigger a physiological state in which they are more likely to relapse. In this SBIR project, the investigators intend to deploy a system—consisting of a wearable sensor, a smartphone app, and a clinical portal—to provide individuals in recovery and their treatment providers with an opportunity to identify moments of high risk for relapse and to access real-time intervention opportunities. The sensors will identify signals of stress or drug use, interface with a smartphone app, and provide options for annotations, stress-reduction techniques, or contact with an individual’s support system and treatment providers, as well as log and encourage healthy behaviors. This study will deploy and optimize the system, as well as test its effects on addiction-related outcomes, such as rate of relapse.

NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for Administrative Supplements to Support Career Enhancement Related to Clinical Research on Pain (Admin Supp – Clinical Trial Not Allowed)
NOFO Number: NOT-NS-22-087
Summary:

This research is measuring patient-reported outcomes, unique physical and behavioral characteristics, and opioid use in individuals with chronic low back pain who are using virtual reality (VR) therapy. This project expands the clinical pain workforce by enhancing the ability of an early career clinician to conduct mixed-methods research involving patients using VR technology. This research will contribute new information about barriers to implementing VR technologies across diverse populations, patient preferences for using VR for relief of chronic low back pain.

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:

Lumbar spinal surgery, an increasingly common surgery in adults with severe chronic back pain, is associated with acute post-surgical pain, costly postoperative opioid-related adverse effects, long hospital stays, high-risk for chronic post-surgical back pain, and persistent opioid use and dependence. Each individual responds differently to opioids based on their unique genetic and clinical factors, and the current trial-and-error approach to opioid use and prescribing promotes excessive opioid use, costly adverse outcomes, and poor surgical pain management. To address this issue, this research project will develop a preoperative diagnostic test that will use genetic and clinical information to proactively assess each person’s risk for opioid-related adverse events and chronic post-operative pain. The results will help clinicians provide personalized pain management to maximize pain relief while minimizing opioid-related safety risks, including opioid dependence.

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:

Voltage-gated sodium channels are responsible for the transmission of pain signals. Nine genes have been identified, each having unique properties and tissue distribution patterns. Genetic studies have correlated a hereditary loss-of-function mutation in one human Na+ channel isoform – ?Na?V?1.7 – with a rare genetic disorder known as Congenital Insensitivity to Pain (CIP). Individuals with CIP are not able to feel pain without any significant secondary alteration. Thus, selective inhibition of ?Na?V?1.7 in normal humans could recapitulate the phenotype of CIP. This research team developed a non-permanent gene therapy to target pain that is non-addictive (because it targets a non-opioid pathway), highly specific (only targeting the gene of interest), and long-term lasting (around 3 weeks in preliminary assays in mice). During this Phase I , the team will 1) test additional pain targets ?in vitro?, and 2) evaluate the new targets ?in vivo ?in mice models of inflammatory and neuropathic pain. 

NOFO Title: HEAL Initiative: Secondary Analysis and Integration of Existing Data Related to Acute and Chronic Pain Development or Management in Humans (R21 Clinical Trials Not Allowed)
NOFO Number: RFA-DE-22-011
Summary:

Musculoskeletal pain is common, costly, and affects millions of Americans. Clinical guidelines strongly recommend complementary and integrative treatments such as physical therapy, but nearly half of people receiving physical therapy for musculoskeletal pain seek additional care. Additional treatments such as medication and surgery are more aggressive and carry higher risk. This project will use data from a large physical therapy dataset and nationwide medical claims data to investigate why some people do not respond well to physical therapy for musculoskeletal pain, toward finding safe and effective options for these individuals.

NOFO Title: HEAL Initiative: Secondary Analysis and Integration of Existing Data Related to Acute and Chronic Pain Development or Management in Humans (R21 Clinical Trials Not Allowed)
NOFO Number: RFA-DE-22-011
Summary:

Temporomandibular joint (TMJ) disorders, which affect the joint connecting the lower jaw and the skull, are common and difficult chronic pain conditions. Pain management strategies that harness the body’s own pain relief mechanisms (including placebo effects in which pain relief cannot be attributed to a specific treatment), can reduce the severity and duration of TMJ-related chronic pain. Although research suggests that placebo effects may have a genetic basis, few, if any, genetic studies have examined this possibility in individuals with TMJ disorders. This project will use in-depth genetic, sociodemographic, clinical, and psychological data collected from adults with chronic TMJ disorders to better understand how the placebo effect works.

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; PA-21-071
Summary:

The Early Phase Pain Investigation Clinical Network (EPPIC-Net) conducts comprehensive analyses of observable traits (deep phenotyping) and aims to identify molecular and physiological signatures to help characterize specific pain conditions. To achieve these goals, researchers collect complex data using technologies such as magnetic resonance imaging of the brain, actigraphy, and electroencephalography. There is a need to train researchers to be able to extract key information from high-powered computing resources now widely available.  This research will complement the goals of EPPIC-Net by enhancing development of novel statistical methods to analyze complex data generated by EPPIC-Net pain studies.

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:

Black/African American and Hispanic/Latino individuals suffer a disproportionate burden of co-occurring substance use and mental illness, in part due to reduced access to culturally responsive quality healthcare, compared to other racial/ethnic groups. In addition, Black/African American and Hispanic/Latino individuals are not well represented in clinical trials that could help reduce these health disparities. This research aims to improve the recruitment of Black/African American and Hispanic/Latino individuals to participate in clinical research related to co-occurring substance use and mental illness. The project will conduct community engagement and community-based participatory research, establishing a bidirectional partnership between researchers and community members.