Funded Projects

NOFO Title: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: PA-21-071
Summary:

Although there are effective prevention and treatment programs and services to address opioid misuse, opioid use disorder, and overdose, gaps remain between those needing and those receiving prevention and treatment. There is a need to better understand how to make these programs and services most effective at a local level, a problem being addressed by the HEALing Communities Study. This project supports a scientist from a group underrepresented in biomedicine to continue ongoing work to test the impact of an integrated set of evidence-based practices across health care, behavioral health, justice, and other community-based settings.

NOFO Title: Emergency Awards: HEAL Initiative- New Innovator Award (DP2 Clinical Trial Not Allowed)
NOFO Number: RFA-TR-22-013
Summary:

Endometriosis is a gynecologic disorder characterized by severe pelvic pain, affecting 10% of reproductive aged women and adolescents worldwide. These individuals are at an increased risk for chronic opioid use, dependence, and overdose. Adolescents and young adults in particular are understudied in endometriosis research. This project will conduct a longitudinal study of adolescent endometriosis. The research will identify novel biomarkers and biological pathways involved in the transition of acute to chronic pain. The research aims to improve non-surgical endometriosis diagnosis, risk, and treatment. 

NOFO Title: Notice of Special Interest (NOSI): Availability of Administrative Supplements for Helping to End Addiction Long-term (HEAL) Initiative awardees to make data Findable, Accessible, Interoperable, and Reusable (FAIR) through the HEAL Data Ecosystem
NOFO Number: NOT-OD-22-110
Summary:

This research provides support to strengthen data management, data sharing, and data readiness efforts within the HEAL Initiative. This support further fosters collaboration among HEAL awardees and enables maximal data discoverability, interoperability, and reuse by aligning with the FAIR (Findable, Accessible, Interoperable, and Reusable) principles. It also provides an opportunity for existing HEAL Initiative award recipients to increase data “FAIR”-ness, participate in coordinated HEAL Initiative activities to build community around data sharing, and foster sustainability of HEAL Initiative digital assets.

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

NOFO Title: PHS 2017-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])
NOFO Number: PA-17-302
Summary:

Chronic pain affects over 100 million Americans, costing society about $600 billion annually. Despite numerous pharmacological and non-pharmacological therapies, over 50% of chronic pain sufferers feel little control over their pain. CognifiSense has developed a patent-pending Virtual Reality Psychological Therapy (VRPT), which is designed to create lasting reduction of chronic pain by addressing the maladaptive learning processes driving pain chronification. VRPT is an experiential learning system, which provides the brain a new set of signals that teaches it that the pain is not as bad as it perceived and that it has greater control over the pain than it perceived. VRPT combines the immersive power and the ability to individualize the therapy of Virtual Reality with well-researched principles of self-distancing, self-efficacy, and extinction to retrain the brain. The goal of this study is to determine the clinical feasibility of VRPT in achieving a lasting reduction of chronic pain, establish brain mechanisms associated with treatment response, and collect comprehensive user feedback to enable further refinement of the current product prototype. CognifiSense's VRPT has the potential to be a significant clinical and business opportunity in the treatment of chronic 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:

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

Chemokines (hormones of the immune system that mediate innate immune inflammation) enhance pain, reduce opioid analgesia, and promote drug-seeking behavior and addiction, giving them a central role at the crossroads of chronic pain and the opioid crisis. Blocking chemokines (rather than opioid receptors) provides an exciting treatment opportunity for both pain and opioid use disorder. This research continues previous work studying the efficacy of RAP-103, a small, orally stable chemokine receptor blocker. The previous research has shown that RAP-103 is safety and effective in preclinical models that mimic human drug-taking. This research will now optimize the dose required to achieve decreased motivation to maintain opioid use, establish manufacturing scale-up feasibility, provide RAP-103 for safety testing in animals, and conduct stability testing of RAP-103 toward the goal of submitting an Investigational New Drug application to the FDA.

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: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
NOFO Number: PA-18-575
Summary:

 Chronic persistent post-operative pain (CPOP) is a devastating outcome from any type of surgical procedure. Its incidence is anywhere between 20-85% depending on the type of surgery, with thoracotomies showing one of the highest annual incidences of 30-60%. Given that millions of patients (approximately 23 million yearly based on incidence) are affected by CPOP, the results are increased direct medical costs, increased indirect medical costs due to decreased productivity, and associated negative effects on an individual’s physical functioning, psychological state, and quality of life. Given these extensive public health and economic consequences there is a resurgence of research in the area of preventative analgesia.  The goal of this project is to evaluate a novel small molecule antagonist of MD2-TLR4, DT-001 in preclinical models of surgical pain representative of persistent post-operative pain. In collaboration with University of California, San Diego, DT-001 will be evaluated for its ability to block the development of neuropathic pain states. These studies will evaluate dose escalating efficacy of DT001 in rats in formalin and spinal nerve injury (SNI) models using both intrathecal and intravenous routes of administration. Tissues will be preserved to assess functional effects on relevant pain centers for analysis by Raft. With demonstration of efficacy, these studies will determine the optimal dose and route of administration of DT001 and guide a development path to IND and eventually clinical trials.

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:

It is unclear if long-term use of opioids by head and neck cancer patients affects risk for depression, which is higher in this population compared to people without cancer. This knowledge could inform interventions such as increased opioid prescription safety or alternative pain management approaches and could thus help reduce the risk for depression-related outcomes. This project will use data from a national cancer database linked to Medicare claims and a Veterans Administration database to determine whether people with head and neck cancer that take opioid medications for more than 90 days have increased risk for new-onset or worsening depression or suicide death.

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: 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:

This project will develop and refine a wearable device (forearm bracelet) designed to rapidly sense and report the presence of opioids in the wearer. This research will optimize this device to provide ultra-high sensitivity, enhanced drug specificity, long-term durability, low power consumption, and cost-effective production. The findings could support a path toward commercialization of this new device.

NOFO Title: PHS 2016-02 Omnibus Solicitation of the NIH, CDC, FDA, and ACF for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])
NOFO Number: PA-16-302
Summary:

Since 2002, persons with opioid use disorders who desire medication-assisted treatment can be treated with buprenorphine, which has been shown to be efficacious. Buprenorphine treatment can occur in any medical office-based setting, is prescribed by any physician who seeks to become waivered, and is taken by patients at home unsupervised. However, without visual confirmation of medication ingestion, providers remain unsure if patients divert part or all of their buprenorphine medication. This project will develop the technical and logistical workflow needed to implement a video-­based application, miDOT, for office-­based buprenorphine monitoring during the initial months of care, which will allow health care providers to monitor whether patients ingest the drug and adhere to treatment. The project will configure a video-based DOT platform, evaluate its effectiveness in securing medication ingestion and care retention for illicit opiate users, and solidify routes of sustainable commercial viability with commercial partners.