Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
1R21DA057598-01
Tracking the Opioid Epidemic with Social Media: An Early Warning System Cross-Cutting Research Leveraging Existing and Real-Time Opioid and Pain Management Data NIDA STANFORD UNIVERSITY ALTMAN, RUSS BIAGIO Redwood City, CA 2022
NOFO Title: HEAL Initiative: Exploratory Data and Methods to Address Urgent Needs to Stem the Opioid Epidemic (R21- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-22-045
Summary:

A key component to addressing the current opioid overdose crisis is the ability to track dangerous opioid use in a timely manner so that public health agencies can plan accordingly. Direct reports about drug use and overdoses from social media might provide a useful early warning system that when combined with other sources, can provide policy makers and public health officials with powerful tools for monitoring this public health crisis. This project will explore the usefulness of Twitter and Reddit as a social media component of opioid use surveillance – in particular by monitoring mentions of fentanyl and synthetic opioids at various geographic levels (e.g., local or regional) and over time.
2R44NS086343-04
IND-ENABLING STUDIES ON NOVEL CAV3 T-CHANNEL MODULATORS FOR TREATMENT OF NEUROPATHIC PAIN Cross-Cutting Research Small Business Programs NINDS AFASCI, INC. XIE, XINMIN SIMON REDWOOD CITY, CA 2018
NOFO Title: NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Pre-Clinical Research (R44)
NOFO Number: PAR-17-480
Summary:

We discovered a class of non-opioid modulators of the T-type Cav3.2 channel that could treat neuropathic pain. In vivo pharmacokinetic and pharmacodynamic studies and preliminary toxicological studies identified AFA-279 and other candidates, which did not produce observable side-effects and showed greater analgesic effects than other neuropathic pain medications in rodent models. The goal of this proposed project is to submit the IND application on our Cav3.2 modulator to the Food and Drug Administration (FDA). We will produce AFA-279 under Good Manufacturing Practice (GMP)–like conditions using chemical manufacturing controls for Good Laboratory Practice (GLP) nonclinical toxicity studies and GMP clinical batch future Phase 1 clinical trials, complete toxicological and safety studies to establish the safety profile of AFA-279, prepare and submit the IND application, and then initiate early clinical trials. Our ultimate goal is to deliver a safer, more effective, non-opioid Cav3.2 channel modulator to patients suffering from neuropathic pain.
1U2CDA057717-01
HD2A Research Adoption Support Center (RASC) Cross-Cutting Research Translating Data 2 Action to Prevent Overdose NIDA STANFORD UNIVERSITY MCGOVERN, MARK P (contact); BECKER, SARA J; BECKER, WILLIAM C; BROWN, C HENDRICKS Redwood City, CA 2022
NOFO Title: HEAL Initiative: HEAL Data2Action Research Adoption Support Center (U2C Clinical Trial Optional)
NOFO Number: RFA-DA-22-050
Summary:

This project creates the HEAL Data2Action Research Adoption Support Center to support the HEAL Data2Action Innovation Projects. It will provide supportive evidence for prevention and treatment practices, form implementation strategies, assess outcomes, obtain feedback from the projects, and assess readiness for scalability. This center will offer on-demand technical assistance, host a learning collaborative, harmonize dissemination and implementation data, provide implementation support, and help with stakeholder engagement. The research will also catalogue evidence-based and emerging opioid use disorder and pain management practices as a resource to the field. The center will address timely, high-priority implementation challenges.
1K23DA058785-01
Addressing the Readiness Gap: An eHealth Intervention to Increase Patient Motivation for Evidence-Based Chronic Pain Interventions and Reduced Opioid Reliance Cross-Cutting Research Training the Next Generation of Researchers in HEAL NIDA VIRGINIA COMMONWEALTH UNIVERSITY CROUCH, TAYLOR BERENS Richmond, VA 2023
NOFO Title: Career Development Awards in Implementation Science for Substance Use Prevention and Treatment (K23 - Clinical Trial Required)
NOFO Number: PAS-22-207
Summary:

Evidence-based behavioral treatments for pain are among the most effective and safe approaches, but they are underused, especially among patients taking opioids long-term. Despite known risks to long-term opioid therapy (including opioid use disorder and overdoses), patients may be reluctant to try something different to manage their pain. This project brings together two evidence-based behavior change interventions—motivational interviewing and contingency management—into an online format. The research will test whether web-based tools or mobile apps influence a patient’s willingness to consider using non-medication treatments for pain. The research will assess feasibility, acceptability to patients and providers, and broad-scale implementation.
1R21DE032583-01
Predicting Pediatric Sickle Cell Disease Acute Pain Using Mathematical Models Based on mHealth Data Cross-Cutting Research Leveraging Existing and Real-Time Opioid and Pain Management Data NIDCR VIRGINIA COMMONWEALTH UNIVERSITY VALRIE, CECELIA R (contact); MCGEE, REGINALD Richmond, VA 2022
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:

Sickle cell disease is an inherited blood disorder affecting about 100,000 Americans and more than 20 million people worldwide. It is caused by a mutation in the gene for beta-globin that results in the characteristic sickled shape of red blood cells, life-long severe pain, and shortened lifespan. Sickle cell disease pain episodes are usually unanticipated, making it hard for people with the condition to manage their pain and putting them at risk for increased use of opioids and poor health outcomes. This project will use existing real-time health data to identify factors that can predict onset, severity, and worsening of daily pain in children with sickle cell disease.
1R42DA049448-01
Reward-based technology to improve opioid use disorder treatment initiation after an ED visit Cross-Cutting Research Small Business Programs NIDA Q2I, LLC BOUDREAUX, EDWIN D Rindge, NH 2019
NOFO Title: Loyalty and Reward-Based Technologies to Increase Adherence to Substance Use Disorder Pharmacotherapies (R41/R42 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-015
Summary:

Medication-assisted treatment (MAT) for opioid use disorder (OUD) is highly efficacious, but only a fraction of people with OUD access MAT, and treatment non-adherence is common and associated with poor outcomes. This project aims to increase rates of Suboxone (buprenorphine/naloxone) treatment initiation and adherence among OUD patients recruited from emergency and inpatient acute care by enhancing the Opioid Addiction Recovery Support (OARS)—an existing Q2i company technology—with a new evidence-based reward, contingency management (CM) function that allows for the automatic calculation, delivery, and redemption of rewards contingent on objective evidence of Suboxone initiation and adherence.
1R41DA048689-01
BEST-OUD: Behavioral Economic Screening Tool of Opioid Use Disorder for use in clinical practice Cross-Cutting Research Small Business Programs NIDA BEAM DIAGNOSTICS, INC SNIDER, SARAH EMILY Roanoke, VA 2019
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
NOFO Number: PA-18-575
Summary:

A critical line of defense against opioid use disorder (OUD), one of the nation’s leading preventable causes of death, must be standardized screening provided by the patient’s primary care physician, psychiatrist, and/or counselor. Standardized screening methods for opioids, however, are simply inferior and no gold standards exist. This project aims to develop a validated, theoretically guided tool that provides clinicians with information beyond OUD symptoms using reinforcer pathology, a measure of severity derived from the synergy between excessive delay discounting and high behavioral economic demand. The Behavioral Economic Screening Tool (BEST-OUD) will use these combined measures in a mobile tablet application to enable clinicians to screen for OUD.
2R44DA048689-02
Beacon-OUD: Behavioral Economic Screening Tool of Opioid Use Disorder (OUD) for Use in Clinical Practice Cross-Cutting Research Small Business Programs NIDA BEAM DIAGNOSTICS, INC. SNIDER, SARAH EMILY Roanoke, VA 2023
NOFO Title: PHS 2021-2 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-21-259
Summary:

Current clinical screening measures for opioid misuse are underused and susceptible to bias. This project will develop Beacon-OUD, a digital opioid misuse assessment. The tool generates an automated, standardized score, preventing potential judgements related to patient’s status and circumstances, limiting stigma. The research will further advance Beacon-OUD into a commercial product for use both as a stand-alone tool and as an electronic health record-integrated solution to encourage objective opioid misuse screening in large health care systems. 
1K01DA058750-01
Leveraging mHealth to Increase Health Equity Among Black Individuals with OUD and Commonly Occurring Mental Health Disorders Cross-Cutting Research Training the Next Generation of Researchers in HEAL NIDA WASHINGTON UNIVERSITY SZLYK, HANNAH Saint Louis, MO 2023
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. 
1K01DA059641-01
Adapting and Implementing a Chronic Disease Self-Management Program for Primary Care Patients with Opioid Use Disorder and Serious Mental Illness Cross-Cutting Research Training the Next Generation of Researchers in HEAL NIDA UNIVERSITY OF UTAH SIANTZ, ELIZABETH Salt Lake City, UT 2023
NOFO Title: Career Development Awards in Implementation Science for Substance Use Prevention and Treatment (K01 - Clinical Trial Required) 
NOFO Number: PAS-22-206
Summary:

Many people with opioid use disorder (OUD) also have a serious mental illness and other chronic conditions, which can be difficult for individuals and primary care providers to manage. A chronic disease self-management program is an established health care model in which peers help to educate patients about their condition(s) and build problem-solving skills to manage their health. Such programs have been effective in other populations and settings, but they have not been adapted for primary care patients who have OUD and SMI. This project will adapt and test a chronic disease self-management program for this population to understand its feasibility, acceptability, impact, and how best to put such programs into place widely in primary care settings.
1R44DA058467-01
Development of a Novel Calcium Channel Therapeutic for Opioid Use Disorder Cross-Cutting Research Small Business Programs NIDA VIVREON BIOSCIENCES, LLC GREENBERG, MILTON L San Diego, CA 2023
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:

Hospitalized patients often receive opioids for pain and sleep management, which can contribute to opioid dependence and continued use after leaving the hospital. Even when hospital stays are extended to wean people from opioids, these patients remain at increased risk for opioid use disorder and withdrawal.  This project will develop a novel small molecule medication that blocks nerve inflammation to prevent opioid dependence in hospitalized patients receiving opioids. 
1R42NS132622-01
Targeting TLR4-lipid rafts to prevent postoperative pain Cross-Cutting Research Small Business Programs NINDS RAFT PHARMACEUTICALS, LLC DOUGHERTY, PATRICK M (contact); KOGAN, YAKOV San Diego, CA 2023
NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R41/R42 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-20-009
1R43NS112088-01A1
Repression of Sodium Channels via a Gene Therapy for Treatment of Chronic Neuropathic Pain Cross-Cutting Research Small Business Programs NINDS NAVEGA THERAPEUTICS, INC. MORENO, ANA MARIA; ALEMAN GUILLEN, FERNANDO San Diego, CA 2019
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. 
1R43TR004743-01
The Pain in a Dish Assay (PIDA): A High Throughput System Featuring Human Stem Cell-Derived Nociceptors and Dorsal Horn Neurons to Test Compounds for Analgesic Activity Cross-Cutting Research Small Business Programs NCATS VALA SCIENCES, INC. MCDONOUGH, PATRICK M San Diego, CA 2023
NOFO Title: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-23-006
Summary:

This project will develop PIDA, which will allow researchers to measure the activity of pain-sensitive human neurons in response to pain stimuli and potential pain treatments. The tool will use automated digital microscopes in the absence or presence of a potential pain medication. Since this tool contains human neurons, it may be more effective at predicting the efficacy of potential pain drugs in human patients than the animal models that are currently used.
1R44NS119036-01
Development of a novel analgesic for mixed inflammatory and neuropathic pain states Cross-Cutting Research Small Business Programs NINDS ANABIOS CORPORATION GHETTI, ANDREA San Diego, CA 2021
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:

As prescription opioid drug abuse and overdose-related deaths continue to skyrocket in the United States, the need for new and more effective non-addictive pain drugs to treat chronic pain remains critical. This research is conducting studies in animal models of a small molecule that has high potential to treat chronic pain conditions associated with neuropathy and/or inflammation. The goal of this project is to conduct dosing and other studies leading up to an animal model study of the potential drug in a toxicology study for 28 days. Results may lead to Investigative New Drug regulatory clearance to begin clinical studies to validate the potential drug’s efficacy and safety.
1R43DE029379-01
Therapeutic in Situ Analgesic Implant for improved Oral-Facial Post-Operative Pain Outcomes Cross-Cutting Research Small Business Programs NIDCR EPIGEN BIOSCIENCES, INC. FRIEDMAN, CRAIG; CAUDLE, ROBERT M San Diego, CA 2019
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:

Analgesia for post-operative populations remains a significant health need that calls for innovative therapies which improve both safety and outcome measures. Recent FDA drug safety warnings and studies focusing on post-operative analgesia have highlighted the imperative need for new approaches that can be utilized for common clinical scenarios. Accordingly, novel treatment options that are safe and afford additional benefit in relief of pain are needed. In this proposal, the development of an innovative surgical sealant technology is proposed that functions at the level of the surgical wound bed and actively delivers local pharmacologic agents to therapeutically address post-operative pain. New formulations of several analgesic regimens will be assessed for their ability to seal wounds and provide appropriate pain management.
1R43DA047722-01
PERIPHERALLY-RESTRICTED AND LONG-ACTING MAS1(LA-MAS1) AGONISTS FOR PAIN Cross-Cutting Research Small Business Programs NIDA Peptide Logic, LLC Riviere, Pierre SAN DIEGO, CA 2019
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.
2R44DA045410-02
Peripherally-Restricted Long-Acting Somatostatin Receptor 4 (LA-SSTR4) Agonists for Pain Cross-Cutting Research Small Business Programs NIDA PEPTIDE LOGIC, LLC RIVIERE, PIERRE San Diego, CA 2019
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:

The proposed SBIR Phase II program seeks to select a first-in-class, peripherally-restricted, and long-acting somatostatin receptor 4 (LA-SSTR4) agonist clinical candidate for development as a novel non-addictive analgesic able to replace opioids for the treatment of moderate-to-severe chronic pain. The program is based on strong scientific evidence showing that activation of peripheral SSTR4 produces broad spectrum analgesic activity and pursues a unique therapeutic strategy.   Unlike opioids, SSTR4 agonists do not induce constipation, respiratory depression, dependence, addiction, or abuse. Finally, unlike SSTR2 and SSTR5, SSTR4 expression in the pituitary and pancreas is very low, supporting that selective SSTR4 agonists are unlikely to perturb peripheral endocrine functions. The preceding SBIR Phase I program has already established the feasibility of conjugating a short-acting, potent, and selective peptide SSTR4 agonist to the antibody carrier. The resulting LA-SSTR4 agonist lead series has high agonist potency and selectivity for SSTR4 and has demonstrated antinociceptive activity in an animal pain model. The proposed SBIR Phase II program seeks to: optimize the existing lead series and select a clinical candidate for development,  validate and prioritize the indication(s) for clinical development using disease-relevant mouse pain models, and characterize the pharmacokinetics and safety/toxicology profile of the clinical candidate in rat and non-human primates to help design subsequent investigational new drug (IND)-enabling studies.
1R43DA050380-01
Neurofeedback-EEG-VR (NEVR) System for Non-opioid Pain Therapy Cross-Cutting Research Small Business Programs NIDA QUASAR, INC. ROBERTS, BROOKE San Diego, CA 2019
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:

Pain is one of the most common and debilitating symptoms of a wide range of injuries and diseases. Safe and effective alternatives for treating pain that reduce dependence on opioids are, therefore, a primary goal of the NIH. This project proposes a non-invasive, non-pharmacological alternative to treat pain by combining an innovative electroencephalography (EEG)-based Neurofeedback (NF) solution in an immersive virtual reality (VR) environment. NF and VR have been shown to independently produce ameliorative effects on pain, and it is hypothesized that an NF training in VR would have synergistic effects, as VR would distract from pain perception to improve patient compliance in more engaging NF protocols that improve their ability to control pain perception. In the scope of this project, we will initially focus our work on chronic low back pain (cLBP), as this is a growing segment of chronic pain sufferers with a 39 percent worldwide lifetime prevalence, and whose sufferers have historically been heavy users of opiates; later stages of this project will expand this application to address other forms of pain.
1R41NS113717-01
Pre-clinical evaluation of DT-001, a small molecule antagonist of MD2-TLR4 for utility in the treatment of pain Cross-Cutting Research Small Business Programs NINDS DOULEUR THERAPEUTICS, INC. YAKSH, TONY L; CHAKRAVARTHY, KRISHNAN San Diego, CA 2019
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.
1R44CA271904-01A1
Novel Biologic to Treat Chemotherapy-Induced Neuropathic Pain Cross-Cutting Research Small Business Programs NCI RAFT PHARMACEUTICALS, LLC KOGAN, YAKOV San Diego, CA 2022
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 conduct studies to investigate the safety and tolerability of a novel strategy to treat neuropathic pain: modifying the activity of the dorsal root ganglia, which are nerve cells in the spinal cord that communicate pain signals to and from the brain.
9SB1NS137964-04
Advancing precision pain medicines to the clinic Cross-Cutting Research Small Business Programs NINDS NAVEGA THERAPEUTICS, INC. MORENO, ANA MARIA (contact); ALEMAN GUILLEN, FERNANDO San Diego, CA 2023
NOFO Title: HEAL Commercialization Readiness Pilot (CRP) Program: Embedded Entrepreneurs for Small Businesses in Pain Management (SB1 Clinical Trial Not Allowed)
NOFO Number: PAR-23-069
3UH3AR076724-04S1
Technology Research Site for Advanced, Faster Quantitative Imaging for BACPAC Cross-Cutting Research Training the Next Generation of Researchers in HEAL NIAMS UNIVERSITY OF CALIFORNIA, SAN FRANCISCO MAJUMDAR, SHARMILA San Francisco, CA 2022
NOFO Title: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: PA-20-222
Summary:

Despite the significance of spine disorders, there are few reliable methods to determine appropriate patient care and evaluate intervention effectiveness. The Back Pain Consortium Research Program
(BACPAC) is developing machine learning-based methods to obtain disease-related features from biological images. This project supports a scientist from a group underrepresented in biomedicine to expand ongoing research to improve ways to interpret medical data about spine disorders and associated pain.
1R43DA049623-01
Non-invasive Neuromodulation Device for Decreasing Withdrawal Symptoms and Craving during Treatment of Opioid Use Disorder Cross-Cutting Research Small Business Programs NIDA THERANOVA, LLC JAASMA, MICHAEL San Francisco, CA 2019
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:

Opioid use disorder (OUD) can be lethal, with opioid overdose causing more than 115 deaths in the U.S. each day. Although medications are effective at reducing illicit opioid use and overdose deaths, it is well-established that withdrawal and craving are highest in the initial weeks, making this a high-risk period for treatment dropout, relapse, and overdose. Adjunct therapies that can reduce early opioid withdrawal and craving may improve retention in treatment with buprenorphine-naloxone, and recent research has shown that stimulation of a peripheral nerve significantly modulates withdrawal- and craving-related responses for opioids and other drugs. This project will test the effectiveness of the EMPOWER Neuromodulation System, a portable, non-invasive transcutaneous electrical nerve stimulation (TENS) device developed by TheraNova for the treatment of OUD.
1R43NS113726-01
Pharmacokinetic and toxicology studies of AYX2, a transcription factor decoy, non-opioid, disease modifying drug candidate for the long-term treatment of chronic pain Cross-Cutting Research Small Business Programs NINDS ADYNXX, INC. MAMET, JULIEN San Francisco, CA 2019
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.