Funded Projects

Project # Project Title Research Focus Area Research Program Administering IC(s) Institution(s) Investigator(s) Location(s) Year Awarded
5R24DA051950-02
Building a Lasting Foundation to Advance Actionable Research on Recovery Support Services for High Risk Individuals with Opioid Use Disorder: The Initiative for Justice and Emerging Adult Populations Translation of Research to Practice for the Treatment of Opioid Addiction Recovery Research Networks NIDA OREGON SOCIAL LEARNING CENTER, INC. SHEIDOW, ASHLI J Eugene, OR 2021
FOA Title: Building a Lasting Foundation to Advance Actionable Research on Recovery Support Services for High Risk Individuals with Opioid Use Disorder: The Initiative for Justice and Emerging Adult Populations
FOA Number: RFA-DA-20-014
5R24DA051973-02
Studies to Advance Recovery Supports (STARS) in Central Appalachia Translation of Research to Practice for the Treatment of Opioid Addiction Recovery Research Networks NIDA EAST TENNESSEE STATE UNIVERSITY PACK, ROBERT P Johnson City, Tennessee 2021
FOA Title: Research Networks for the Study of Recovery Support Services for Persons Treated with Medications for Opioid Use Disorder (R24 Clinical Trial Optional)
FOA Number: RFA-DA-20-014
5R24DA051988-02
Advancing the science on recovery community centers to support persons treated with medications for opioid use disorder Translation of Research to Practice for the Treatment of Opioid Addiction Recovery Research Networks NIDA MASSACHUSETTS GENERAL HOSPITAL KELLY, JOHN F. Boston, MA 2021
FOA Title: Research Networks for the Study of Recovery Support Services for Persons Treated with Medications for Opioid Use Disorder (R24 Clinical Trial Optional)
FOA Number: RFA-DA-20-014
3UG1DA049467-03S2
HEAL Diversity Supplement: Great Lakes Nodes Clinical Trials Network Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA RUSH UNIVERSITY MEDICAL CENTER KARNIK, NIRANJAN Chicago, IL 2021
FOA 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)
FOA Number: NOT-NS-20-107
Summary:

Negative Affect (NA) and stress are key features of Opioid Use Disorder (OUD) and often lead to drug use and relapse. The Autonomic Nervous System (ANS) dominates physiological responses to emotions and stress, yet its function and how it unfolds over time and in real-world settings remains understudied in the context of OUD. With new wearable technologies, ANS function can be measured through heart rate variability (HRV) and can be recorded continuously via wearable sensors, providing a non-invasive method to examine physiological mechanisms underlying stress and NA in real-world settings and in real-time. The present research will serve as a pilot study to assess 1. The role of autonomic function (indexed by HRV) as a marker of NA and stress in people with OUD 2. Participants’ adherence to wearing sensor devices and response rates to daily questionnaires. To achieve these objectives, we will monitor participants for 14 days and quantify self-reports measures of stress, overall daytime HRV patterns, and the magnitude, frequency, and duration of reduced HRV instances. Our findings can help advance technologies to address the opioid epidemic, and our understanding of physiological markers as objective measures and predictors of NA and stress in OUD.

2R44DA050397-02
Development of cannabinoid-opioid combination with opioid sparing and synergistic analgesic effects to prevent opioid use disorder and overdose Novel Therapeutic Options for Opioid Use Disorder and Overdose NIDA BDH PHARMA, LLC BRIONES, MARISA Valley Village, CA 2021
FOA Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional
FOA Number: RFA-DA-19-019
3UG1DA049467-03S3
Quantifying How Cocaine Users Respond to Fentanyl Contamination in Cocaine Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA RUSH UNIVERSITY MEDICAL CENTER KARNIK, NIRANJAN Chicago, IL 2021
FOA 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)
FOA Number: NOT-NS-20-107
Summary:

The increased presence of fentanyl in cocaine has drastically increased cocaine-related overdoses, yet there is no research quantifying how cocaine users respond to fentanyl adulteration. In this online study, a modification of a behavioral economics measure, the Cocaine Purchase Task, will quantify for the first time how cocaine users respond to fentanyl contamination in cocaine. This study aims to 1) Determine how possible fentanyl adulteration affects cocaine demand, and 2) Determine which individual characteristics moderate the relationship between fentanyl adulteration and cocaine demand. Determining how possible fentanyl adulteration affects cocaine demand can help inform the development of effective harm reduction interventions for people who use cocaine to address the worsening crisis of opioid related deaths.

2R44DA049300-02
Prapela™ SVS: A cost-effective stochastic vibrotactile stimulation device to improve the clinical course of infants with neonatal abstinence syndrome Enhanced Outcomes for Infants and Children Exposed to Opioids NIDA PRAPELA, INC. KONSIN, JOHN PHILLIP Biddeford, ME 2021
FOA Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
FOA Number: RFA-DA-19-019
Summary:

Infants exposed to opioids in the womb may suffer from neonatal opioid withdrawal syndrome (NOWS). They experience symptoms such as excessive crying, irritability, rapid breathing, elevated heart rates, tremors, and sometimes seizures. There is no accepted standard treatment for NOWS; infants are treated with pharmacological (opioid administration and gradual weaning) and nonpharmacological measures. Nonpharmacological care such as swaddling, rocking, frequent feedings, and skin contact, are time consuming, placing a substantial burden on hospitals with limited resources. Prapela, Inc. previously developed a hospital bassinette pad that, using stochastic vibrotactile stimulation (SVS) technology, very gently rocks infants with NOWS to reduce irritability and other symptoms without disturbing sleep patterns. This project will conduct an additional clinical study to determine the SVS bassinette pad’s efficacy in reducing breathing and heart rate, its safety, and its acceptability with clinical staff and parents caring for infants with NOWS.

3R33AT010606-03S1
Adapting the HOPE Online Support Intervention to Increase MAT Uptake Among OUD Patients Translation of Research to Practice for the Treatment of Opioid Addiction Behavioral Research to Improve Medication-Based Treatment NCCIH UNIVERSITY OF CALIFORNIA-IRVINE YOUNG, SEAN Irvine, CA 2021
FOA 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
FOA Number: NOT-NS-21-025
Summary:

Effective medications for opioid use disorder (MOUD) are approved by the Food and Drug Administration for the treatment of people with opioid use disorder; however, only a small fraction of patients who would benefit from these medications actually use them. Several reasons contribute to low MOUD use, including lack of insurance; lack of knowledge about the medications, both among patients and providers; stigma associated with MOUD; and social norms. Innovative methods are needed to help increase MOUD use. One such option is peer-led interventions that might increase patients’ interest in MOUD. One existing peer-led intervention is the Harnessing Online Peer Education (HOPE) online community intervention that has been designed to reduce stigma and increase health behavior change among stigmatized populations, such as people living with HIV. This project will investigate whether and how HOPE can be adapted for people with opioid use disorder. It will assess whether HOPE can effectively increase MOUD requests, MOUD uptake, and sustained adherence to MOUD as well as reduce overdose rates.  

3UG1DA049468-03S3
Exploring Health Beliefs for Community Engagement and Diversity in Clinical Trials Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR PAGE, KIMBERLY Albuquerque, NM 2021
FOA 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
FOA Number: NOT-NS-21-025
Summary:

Including all population subgroups in clinical research is important to ensure that research results apply to the entire population and can be implemented effectively. However, many communities are underrepresented in health research due to individual, cultural, or structural reasons. This project aims to develop a Health Beliefs Toolkit that will be a readily accessible resource for researchers, providers, and community groups to help them engage diverse and minority populations in clinical research, particularly regarding substance use disorders. The project will examine, adapt, and test existing materials and resources targeting individual and structural barriers to research engagement. The toolkit will also assess individuals’ knowledge of health as well as health-related personal values and beliefs to enhance health and research “literacy.” The toolkit will be targeted to primary care providers, community health workers, peer counselors, agency representatives, and patient and non-patient groups to enhance practice-based research in underserved communities.

2R44DA050360-02
Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Treatment for Neonatal Opioid Withdrawal Syndrome Enhanced Outcomes for Infants and Children Exposed to Opioids NIDA SPARK BIOMEDICAL, INC. KHODAPARAST, NAVID Friendswood, TX 2021
FOA Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
FOA Number: RFA-DA-19-019
3UH3AT010621-03S2
Group-Based Mindfulness for Patients with Chronic Low Back Pain in the Primary Care Clinical Research in Pain Management NCCIH BOSTON MEDICAL CENTER MORONE, NATALIA E Boston, MA 2021
FOA 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
FOA Number: NOT-NS-21-025
Summary:

Mindfulness has been shown to be effective in treating chronic low back pain, but it has not been embedded into routine clinical care. The OPTIMUM study (Optimizing Pain Treatment In Medical settings Using Mindfulness) will address barriers to delivering mindfulness in primary care and determine the effectiveness in this setting. This project extends the stakeholder engagement efforts of the OPTIMUM study by increasing the size and responsibilities of the Community Advisory Board, adding focus groups for participants in both study arms, and collecting stories from study nonparticipants about their experience seeking care for chronic low back pain and their views on participating in research. This expanded effort will optimize recruitment of a diverse and underrepresented sample, maximize retention, and prepare for future implementation and dissemination.

3PL1HD101059-01S3
Administrative Supplement for ACT NOW OBOE Longitudinal Study Enhanced Outcomes for Infants and Children Exposed to Opioids Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) NICHD RESEARCH TRIANGLE INSTITUTE (NC) BANN, CARLA M Research Triangle Park, NC 2021
FOA Title:
FOA Number: PA-20-272
3U24NS113844-03S1
EPPIC-NET DCC Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS NEW YORK UNIVERSITY SCHOOL OF MEDICINE PETKOVA, EVA New York, NY 2021
FOA 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)
FOA Number: NOT-NS-20-107
Summary:

There is a clear public health imperative to improve the care and outcomes of people who experience severe acute and chronic pain. The Early Phase Pain Investigation Clinical Network (EPPIC-Net) is charged with conducting deep phenotyping and biomarker studies for specific pain conditions – and with conducting high-quality phase II clinical trials to test novel non-opioid pain treatments with academic and industry partners. This research will extend EPPIC-Net’s current portfolio to develop novel and efficient data-analytic methodologies for complex medical data, such as those that are expected to be generated by the clinical trials conducted by EPPIC-Net.

3UH3AT010739-03S1
Improving Diversity, Inclusion, and Retention in BackinAction/AcuOA Clinical Research in Pain Management NCCIH KAISER FOUNDATION RESEARCH INSTITUTE SHERMAN, KAREN J Oakland, CA 2021
FOA 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
FOA Number: NOT-NS-21-025
Summary:

Participants in many clinical trials do not represent the U.S. population. Racial/ethnic minorities are often underrepresented, as are people with lower socioeconomic status and lower education levels, who face additional barriers, such as lack of transportation or childcare. Thus, both recruitment and retention of such populations is challenging, particularly for complementary and integrative health trials. This project proposes to enhance diversity, inclusion, and retention of participants in an ongoing study by creating a patient and caregiver Diversity, Recruitment, and Retention Advisory Board as well as adding a recruitment and retention specialist to coordinate the advisory board and implement necessary activities. The project will also provide evidence-based recruitment tools and will conduct structured interviews with patients who choose not to participate in a study as well as those who are at risk of dropping out to enhance understanding of the barriers and factors contributing to trial recruitment, loss to follow-up, and successful completion.

3U19AR076737-01S2
REACH Participant Diversity Program Clinical Research in Pain Management Back Pain Consortium Research Program NIAMS UNIVERSITY OF CALIFORNIA, SAN FRANCISCO LOTZ, JEFFREY C San Francisco, CA 2021
FOA 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
FOA Number: NOT-NS-21-025
Summary:

The University of California, San Francisco, as part of the Back Pain Consortium (BACPAC) Research Program, has established a Core Center for Patient-centric Mechanistic Phenotyping in Chronic Low Back Pain (REACH). The main goal of REACH is to define different subtypes (phenotypes) of chronic low back pain as well as to identify underlying pain mechanisms that can lead to effective, personalized treatments for patients across all population subgroups. To achieve this goal, REACH is, or will be, participating in several clinical trials, and it is imperative that the patients participating in these trials reflect the diversity of the U.S. population. Therefore, this project seeks to adapt methods that have successfully improved minority participation in other settings as well as to develop and deploy digital strategies that can promote recruitment and engagement of patients from marginalized populations.

3UG1CA189824-08S1
Wake Forest NCORP Research Base Clinical Research in Pain Management Pain Management Effectiveness Research Network NCI WAKE FOREST UNIVERSITY HEALTH SCIENCES LESSER, GLENN J Winston-Salem, NC 2021
FOA 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)
FOA Number: NOT-NS-20-107
Summary:

Cancer remains a leading cause of death among Hispanic/Latino populations in the United States. Compared with non-Hispanic Whites, Hispanic/Latino cancer patients are more likely to experience poor quality of life and inadequate cancer-related care, including less effective pain relief and poor patient‒provider communication. Additionally, Hispanic/Latino populations often have inadequate access to pain treatment, due to both social disparities and language barriers. However, most behavioral and psychosocial oncology research continues to focus on non-Hispanic Whites, and empirically validated and effective treatment interventions, particularly psychosocial interventions, are often not available in Spanish. This project will generate a Spanish-language version of the painTRAINER internet-based coping skills training program that is both linguistically and culturally sensitive and will evaluate its feasibility and acceptability in Hispanic/Latino patients with persistent cancer-related pain.

1OT2OD031940-01
A Strategy for HEAL Federated Data Ecosystem OD UNIV OF NORTH CAROLINA CHAPEL HILL AHALT, STANLEY CARLTON Chapel Hill, NC 2021
FOA Number: OTA-21-002
Summary:

The HEAL Initiative is establishing a HEAL Data Ecosystem to help investigators manage and share HEAL-generated data. A key principle underlying the HEAL Data Ecosystem strategy is to make those data findable, accessible, interoperable, and reusable (FAIR). Renascence Computing Institute at the University of North Carolina Chapel Hill (RENCI) and RTI, International (RTI) [RENCI/RTI] are serving as the HEAL Data Stewardship Group to guide HEAL investigators as they prepare their data to connect to the HEAL Platform, a secure data access and computing environment that will leverage metadata query to provide access to data and digital assets stored in various disparate repositories. The HEAL Data Stewardship Group is engaging HEAL investigators to understand and enhance data management needs, provide tools, training, and best practices for making data FAIR, and understand and support valuable uses and reuses of HEAL data sharing via the Platform The HEAL Data Stewardship Group will collaborate closely with the HEAL Platform team at the University of Chicago to meet the needs and goals of the HEAL Data Ecosystem.

3UH3AR076573-03S1
Improving representation of non-Hispanic Black and Hispanic study participants in a trial of virtual reality for chronic lower back pain Clinical Research in Pain Management Back Pain Consortium Research Program NIAMS CEDARS-SINAI MEDICAL CENTER SPIEGEL, BRENNAN Los Angeles, CA 2021
FOA 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
FOA Number: NOT-NS-21-025
Summary:

Digital health interventions, such as virtual reality (VR) applications, have become available for the treatment and monitoring of numerous health conditions, including pain management. A current HEAL-funded study is evaluating the role of a therapeutic VR approach for chronic low back pain. However, racial and ethnic disparities exist in patient access and response to such VR applications, as well as in the incidence and reporting of pain. For example, non-Hispanic Blacks and Hispanics are more likely to report severe pain than non-Hispanic Whites, yet are less likely to have access to digital health information and interventions. To address these disparities, this project will develop a framework to advance diversity and inclusion in digital health trials and will seek to increase the proportion of non-Hispanic Black and Hispanic participants in the ongoing VR trial by tailoring recruitment materials and using novel artificial intelligence-driven cohort building tools.

1OT2NS122680-01
A 24-week Week Study to Evaluate the Safety and Efficacy of CNTX-6970 in Subjects with Moderate to Severe Knee Osteoarthritis Pain. Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS Massachussetts General Hospital FAVA, MAURIZIO Boston, MA 2021
FOA Title: HEAL Initiative: EPPIC-Net Pain Research Asset Application (OT2)
FOA Number: OTA-20-008
Summary:

This award funds EPPIC-NET’s first phase 2 clinical trial, testing the novel oral drug CNTX-6970 in patients with moderate to severe knee osteoarthritis pain. It will include 150 participants at EPPIC-Net sites across the United States. Preclinical studies of CNTX-6970, which binds effectively and dose-proportionally to C-C chemokine type 2 (CCR2) receptors, have demonstrated potent analgesia in multiple pain models, with no emergent safety issues. CNTX-6970 has effects both at an affected joint, as well as on neural signaling. Participants will be randomized to receive CNTX-6970, placebo, or a third pain medication and will be followed for 24 weeks.

1U18EB030609-01
Novel Implantable Device to Negate Post-Amputation Pain Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NIBIB NOVAFLUX, INC. LABIB, MOHAMED E Princeton, NJ 2021
FOA Title: HEAL Initiative: Translational Development of Devices to Treat Pain (U18 Clinical Trial Not Allowed)
FOA Number: RFA-EB-18-003
Summary:

Approximately 3.6 million Americans live with an amputated extremity, and the majority of these individuals are likely to suffer from chronic post-amputation pain. There is no consensus as to a recommended therapy for such pain, and many treatments do not provide sufficient pain control. Some studies have shown effective pain suppression from delivering an anesthetic agent directly to an injured nerve. This research aims to develop a device that can be implanted near the injured nerves of an amputated limb to deliver an anesthetic. Findings from this preclinical study will optimize design and delivery features to maximize its effect on pain control for as long as possible without needing a drug refill. The research is expected to advance eligibility for further testing in large animals and humans.

3U44NS115111-03S1
High-Resolution, Spinal Cord Stimulation for Non-Opioid Treatment of Neuropathic Pain Preclinical and Translational Research in Pain Management NINDS MICRO-LEADS, INC. MCLAUGHLIN, BRYAN L Somerville, MA 2021
FOA 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)
FOA Number: NOT-NS-20-107
Summary:

This research seeks to develop a high-resolution spinal cord stimulation therapy for treating chronic neuropathic pain of the lower extremities, groin, and lower back. Systems that use wireless communication methods require robust strategies to prevent various forms of cyberattacks on implantable devices. The focus of this project's research will be to develop a new cybersecurity risk-reduced architecture for Bluetooth low-energy implant communication.

3R01DE029951-01S1
Targeting Endosomal Receptors for Treatment of Chronic Pain Preclinical and Translational Research in Pain Management Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain NIDCR NEW YORK UNIVERSITY BUNNETT, NIGEL W New York, NY 2021
FOA 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)
FOA Number: NOT-NS-20-107
Summary:

G protein-coupled receptors (GPCRs) are the largest family of transmembrane signaling proteins and play important roles in inflammation and pain. GPCR signaling is fast and temporary, making it hard to measure in clinical studies of potential drugs to interfere with the signaling. This research is using selectively designed nanoparticles to stimulate or block GPCRs toward identifying new treatments for oral cancer pain. This award will use a new nanoformulation approach to understand how nanoparticles affect nerve function by i) testing the effects of continuous release of a GPCR inhibitor in an oral cancer microenvironment and ii) investigating the influence of various physicochemical characteristics of nanoparticles on nerve function in an oral cancer microenvironment.

3U24NS113784-01S1
University of Rochester Hub and Spokes for the EPPIC Network - Specialized Clinical Center Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS UNIVERSITY OF ROCHESTER MARKMAN, JOHN DOUGLAS Rochester, NY 2021
FOA 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)
FOA Number: NOT-NS-21-048
Summary:

Improving pain treatment for is a major goal of the NIH HEAL Initiative. This award supports an early career physician toward achieving a future in clinical pain research and in conducting phase II clinical trials focused on pain. Research activities will provide this individual with the skills needed to serve as a primary investigator for future clinical trials in chronic pain and will help to answer a key question that could improve the design of analgesic clinical trials for neurogenic intermittent claudication, a distinct form of chronic low back pain for which no available treatment exists.

1UG3NS123964-01
Disease Modifying Analgesia with CA8 Gene Therapy Preclinical and Translational Research in Pain Management Development and Optimization of Non-Addictive Therapies to Treat Pain NINDS UNIVERSITY OF MIAMI SCHOOL OF MEDICINE LEVITT, ROY C Coral Gables, FL 2021
FOA Title: HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)
FOA Number: RFA-NS-21-010
Summary:

Efforts to identify non-opioid analgesics for treatment of chronic pain have identified a protein, carbonic anhydrase-8 (CA8), in pain-sensing nerve cells in the spinal cord (dorsal root ganglion cells) whose expression regulates analgesic responses. Gene therapy delivering CA8 to dorsal root ganglion cells through clinically relevant routes of administration functions as a “local anesthetic” that induces long-lasting pain relief in animal models of chronic pain. This project will further develop CA8 gene therapy with the goal of treating chronic knee osteoarthritis pain. It will assess several gene therapy constructs to determine the doses needed, safety, efficacy, and specificity to nerve cells for each construct. It will then select the safest and most effective construct that can be administered via the least invasive route for further development. The project will include all steps necessary to identify one candidate gene therapy construct that will be suitable to begin clinical trials in patients with chronic knee osteoarthritis pain.

1R43NS120410-01A1
Optimization of a Gene Therapy for Chronic Pain in Human DRGs Preclinical and Translational Research in Pain Management NINDS NAVEGA THERAPEUTICS, INC. MORENO, ANA MARIA La Jolla, CA 2021
FOA Title: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Not Allowed)
FOA Number: NS-20-011
Summary:

To avoid the reliance on opioids for treatment of pain, researchers are investigating alternative approaches to disrupt the transmission of pain signals by specialized neurons in the body, such as dorsal root ganglion neurons in the spinal cord. Molecules called voltage-gated sodium channels that are located in the membranes of dorsal root ganglion neurons are essential for transmission of the pain signals. People carrying a specific variant of these channels, NaV1.7, are insensitive to pain; therefore, strategies to block this particular channel might help in the development of non-addictive pain treatment approaches. Navega Therapeutics is developing an innovative gene therapy that specifically targets NaV1.7. Using studies in human cell lines, they will identify the best designs to then test this gene therapy approach in human dorsal root ganglion neurons.