Funded Projects

Explore our currently funded projects. You may search with all three fields, then focus your results by applying any of the dropdown filters. After customizing your search, you may download results and even save your specific search for later.

Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Sort descending Location(s) Year Awarded
1R61DA057660-01
Fatal Overdose Review Teams – Research to Enhance Surveillance Systems (FORTRESS) Cross-Cutting Research Translating Data 2 Action to Prevent Overdose NIDA INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS AALSMA, MATTHEW (contact); RAY, BRADLEY ; REDA, KHAIRI Indianapolis, IN 2022
NOFO Title: HEAL Initiative: HEAL Data2Action Innovation Projects (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-DA-22-051
Summary:

Overdose fatality review teams review cases of overdose deaths to identify system gaps and innovative prevention and intervention strategies. With the rise in overdose deaths, these multidisciplinary teams require more timely population-level data to inform their recommendations. This project will develop the Overdose Touchpoints Dashboard that uses real-time data and records from multiple sources to help visualize common “overdose touchpoints” for harm reduction services and treatment opportunities. This research will compare use of the dashboard to standard overdose fatality review practices. The project will assess multiple aspects related to use of the dashboard, including process, staff attitudes, implementation successes, and usability.

1DP2NS130454-01
Using Mouse Pain Scales to Discover Unusual Pain Sensitivity and New Pain Targets Cross-Cutting Research Training the Next Generation of Researchers in HEAL NINDS COLUMBIA UNIV NEW YORK MORNINGSIDE ABDUS-SABOOR, ISHMAIL JOHN New York, NY 2022
NOFO Title: Emergency Awards: HEAL Initiative- New Innovator Award (DP2 Clinical Trial Not Allowed)
NOFO Number: RFA-TR-22-013
Summary:

Acute and chronic pain vary widely across patients, due in large part to genetic differences between individuals. The same variation occurs in preclinical animal models with diverse genetic backgrounds. The development of automated mouse “pain scales” using high-speed videography, machine learning, and custom software allows pain to be assessed in a quantitative manner in nonverbal animals. This technology will be used to identify genetically different mice with high or low pain sensitivity, which will facilitate the development of new therapeutic strategies to treat pain and reduce reliance on opioids.

3U24HD095254-03S1
DATA COORDINATING CENTER FOR THE NICHD NEONATAL RESEARCH NETWORK (U24) Enhanced Outcomes for Infants and Children Exposed to Opioids Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) NICHD Research Triangle Institute Abhik Das Research Triangle Park, NC 2020
NOFO Number: PA-18-591
Summary:

Neonatal opioid withdrawal syndrome (NOWS) has emerged as a tragic by-product of the opioid epidemic. Newborns whose mothers used opioids while pregnant can experience symptoms of opioid withdrawal in the days following birth, such as tremors, irritability, seizures, sleep, digestive, and feeding problems. However, little is known about the effect of antenatal opioid exposure on longer-term infant development over time. To address this gap in understanding, the ACT NOW Longitudinal study is examining a crucial developmental period from birth to two years of life through a comprehensive battery of assessments, including MRI imaging, neurodevelopmental behavioral assessments, and family report measures. This longitudinal cohort study is projected to include a total of 375 infants, 250 who were exposed to opioids and 125 matched controls.

3UG3DA047793-01S1
tDCS to decrease opioid relapse Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA BUTLER HOSPITAL (PROVIDENCE, RI) Abrantes, Ana M Providence, RI 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Neurostimulation techniques, such as transcranial direct current stimulation (tDCS), have been used as interventions for substance use disorders. This is a supplement to the currently NIDA-funded UG3 DA047793, “tDCS to Decrease Opioid Relapse,” which will measure behavioral and brain responses following tDCS stimulation delivered during tasks that use a particular brain network involved in cognitive control, and utilizing FMRI to assess the effects. This supplement allows the researchers to add an EEG measurement to the study, to get a complete picture of how tDCS might affect the function of key brain networks in ways that could be helpful for SUDs.

1UG3DA047793-01
TDCS TO DECREASE OPIOID RELAPSE New Strategies to Prevent and Treat Opioid Addiction Translational Research to Advance Testing of Novel Drugs and Human Cell-Based Screening Platforms to Treat Pain and Opioid Use Disorder NIDA Butler Hospital ABRANTES, ANA M.; STEIN, MICHAEL D PROVIDENCE, RI 2018
NOFO Title: Device-Based Treatments for Substance Use Disorders (UG3/UH3, Clinical Trial Optional)
NOFO Number: PAR-18-494
Summary:

Neurostimulation techniques, such as transcranial direct current stimulation (tDCS), have been used as interventions for substance use disorders. This is a supplement to the currently NIDA-funded UG3 DA047793, “tDCS to Decrease Opioid Relapse,” which will measure behavioral and brain responses following tDCS stimulation delivered during tasks that use a particular brain network involved in cognitive control, and utilizing FMRI to assess the effects. This supplement allows the researchers to add an EEG measurement to the study, to get a complete picture of how tDCS might affect the function of key brain networks in ways that could be helpful for SUDs.

1R24DA055306-01
Wake Forest IMPOWR Dissemination Education and Coordination Center (IDEA-CC) Clinical Research in Pain Management Reducing Opioid-Related Harms to Treat Chronic Pain (IMPOWR and MIRHIQL) NIDA WAKE FOREST UNIVERSITY HEALTH SCIENCES ADAMS, MEREDITH C B Winston-Salem, NC 2021
NOFO Title: HEAL Initiative: Integrative Management of Chronic Pain and OUD for Whole Recovery (IMPOWR): Coordination and Dissemination Center (R24 Clinical Trial Optional)
NOFO Number: RFA-DA-21-029
Summary:

The IMPOWR (Integrative Management of Chronic Pain and OUD for Whole Recovery) Dissemination, Education, and Coordination Center (IDEA-CC) will develop infrastructure to amplify and create momentum for the findings of the IMPOWR initiative and other linked research networks. This center will i) rapidly deploy a communication framework to link IMPOWR clinical sites with each other and the larger HEAL research frameworks; ii) develop an educational infrastructure addressing stigma and health disparities in patients with co-morbid chronic pain and opioid misuse/disorder; iii) disseminate research findings effectively to targeted audiences; iv) develop a novel composite screening tool for chronic pain and opioid misuse/disorder; and v) harmonize processes for data collection and common data elements of chronic pain and opioid misuse/disorder measures across the IMPOWR research centers, providing a coordinated platform for gathering data from these studies. This center will rapidly disseminate key findings to stakeholders, clinicians, and patients to improve the health and wellbeing of individuals with co-occurring chronic pain and opioid misuse/disorder.

1U24DA057612-01
WF DISC: Navigating Data Solutions for Chronic Pain and Opioid Use Disorder Cross-Cutting Research Translating Data 2 Action to Prevent Overdose NIDA WAKE FOREST UNIVERSITY HEALTH SCIENCES ADAMS, MEREDITH C B Winston-Salem, NC 2022
NOFO Title: HEAL Initiative: HEAL Data2Action Data Infrastructure Support Center (U24 Clinical Trial Optional)
NOFO Number: RFA-DA-22-052
Summary:

This project creates the HEAL Data2Action Data Infrastructure Support Center that will conduct research as well as support the HEAL Data2Action Innovation Projects with analytics and support for navigating electronic health records and other “big data” sources, as well as logistical processes related to privacy and ethics. The center will help plan for data collection and assessing outcomes, as well as provide data visualization efforts for various stakeholders. Key support mechanisms include courses, seminars, conferences, trainings, and on-demand technical assistance.

R24DA055306-01
Wake Forest IMPOWR Dissemination Education and Coordination Center (IDEA-CC) NIDA Wake Forest University Health Sciences ADAMS, MEREDITH C B Winston-Salem, NC 2022
NOFO Title: Administrative Supplements to Support Collaborations to Improve the AI/ML-Readiness of NIH-Supported Data
NOFO Number: NOT-OD-22-067
Summary:

This research is intended to create multidisciplinary team science collaborations to develop effective interventions, best models of care for delivery of services, and sustainable implementation strategies for access to quality care for complex patients with chronic pain and opioid use disorder or opioid misuse. To allow comparison and analysis of data created in nine unique clinical trials funded across four centers, common data elements (CDEs) were selected to assess all aspects of a patient’s condition and experience. The purpose of this project is to make the IMPOWR CDE data more FAIR (Findable, Accessible, Interoperable, Reusable) by building a tool that will automate the mapping/conversion of HEAL-related data to the Observational Medical Outcomes Partnership data model that allows for systematic analysis of data from different databases. Upon completion, this tool would be shared with the HEAL research community as a new resource to enable broader harmonization and secondary data analysis.

3R24DA055306-01S1
Wake Forest IMPOWR Dissemination Education and Coordination Center (IDEA-CC) Cross-Cutting Research Leveraging Existing and Real-Time Opioid and Pain Management Data NIDA WAKE FOREST UNIVERSITY HEALTH SCIENCES ADAMS, MEREDITH C B Winston-Salem, NC 2022
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-20-272
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.

1U24DA058606-01
MIRHIQL Resource Center (MRC) for Improving Quality of Life with Chronic Pain Clinical Research in Pain Management Reducing Opioid-Related Harms to Treat Chronic Pain (IMPOWR and MIRHIQL) NIDA WAKE FOREST UNIVERSITY HEALTH SCIENCES ADAMS, MEREDITH C B (contact); HURLEY, ROBERT WILLSON Winston-Salem, NC 2023
NOFO Title: HEAL Initiative: Multilevel Interventions to Reduce Harm and Improve Quality of Life for Patients on Long Term Opioid Therapy (MIRHIQL): Resource Center (U24- Clinical Trial Optional)
NOFO Number: RFA-DA-23-042
Summary:

Decreasing opioid dosing faster than advised by clinical recommendations often leaves chronic pain unaddressed and may increase the risk of overdose and suicide compared to continuing long-term opioid treatment. Clinical and research communities are uncertain about how to assess and manage long-term opioid therapy, despite having diagnostic and treatment frameworks for chronic pain and opioid use disorder. Because of this undefined space, health policy, institutions, and practitioners lack clear advice on long-term opioid prescribing in chronic pain. The goal of the MRC is to provide infrastructure support for the network; create a risk-benefit decision tool to assist providers in determining when opioids should be continued as prescribed, tapered, or tapered/discontinued; and develop and validate a clinical definition for this population (name, identifying associated symptoms/behaviors, and generating a screening tool). This project will leverage big data analytics in administrative datasets, natural language processing approaches in electronic health records, and cohort modeling techniques to accomplish these key responsibilities. These efforts will complement the qualitative data collection approaches in the Becker Resource Center. 

1OT2OD031940-01
A Strategy for HEAL Federated Data Ecosystem OD UNIV OF NORTH CAROLINA CHAPEL HILL AHALT, STANLEY CARLTON Chapel Hill, NC 2021
NOFO 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.

3U01MH114087-02S1
Patient perspectives on clinical approaches to prevent opioid related suicide attempts New Strategies to Prevent and Treat Opioid Addiction Optimizing Care for People with Opioid Use Disorder and Mental Health Conditions NIMH Henry Ford Health System AHMEDANI, BRIAN KENNETH Detroit, MI 2020
NOFO Title: Notice of Special Interest: HEAL Supplements to Improve the Treatment and Management of Common Co-occurring Conditions and Suicide Risk in People Affected by the Opioid Crisis
NOFO Number: NOT-MH-20-025
Summary:

This study will evaluate the implementation of the Zero Suicide framework across six health systems serving over nine million people in collaboration with the Mental Health Research Network. The project will incorporate the voice of the patient and provider stakeholders as part of the implementation of the Zero Suicide framework in three health settings from the NIMH-funded parent award as well as the Southcentral Foundation which is an Alaska Native-owned, nonprofit health care organization serving nearly 65,000 American Indian/Alaskan Native people living in and around Anchorage, Alaska. The team will first systematically engage patients, providers, national consumer advocacy groups, and MHRN scientists in formulating research questions to address the prevention of opioid-related overdoses in people with Opioid Use Disorders (OUD) or people without diagnosed OUD who are using opioids for pain management. Next, the team will utilize semi-structured interviews to determine how people with OUD or people without diagnosed OUD who are using opioids for pain management are experiencing the implementation of the Zero Suicide framework in four diverse health systems. Experiences will be recorded using 80 semi-structured phone interviews in a diverse sample of patients who have survived an opioid-related overdose (50% intentional; 50% unintentional), as well as 20 Addiction Medicine, Primary Care, and/or Specialty Pain Medicine providers.

3U01MH114087-02S2
EVALUATING THE IMPACT OF CHANGES IN OPIOID PRESCRIBING ACROSS HEALTH SYSTEMS IMPLEMENTING ZERO SUICIDE New Strategies to Prevent and Treat Opioid Addiction Sleep Dysfunction as a Core Feature of Opioid Use Disorder and Recovery NIMH Henry Ford Health System AHMEDANI, BRIAN KENNETH; SIMON, GREGORY E. DETROIT, MI 2018
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

This supplement supports the goals of the current award, “An Evaluation of the National Zero Suicide Model Across Learning Healthcare Systems” (U01MH114087). Safety planning is a highly recommended practice within the Zero Suicide framework, but little is known about the effectiveness of the individual elements that can make up a safety plan, such as lethal means assessment, identification of supportive contacts, coping skills, warning signs, and sources of distraction. All of the documentation lives in text-based clinical narratives. This supplement will support development of new metrics using natural language processing to determine baseline rates, from which we can quantify the change in safety planning and lethal means assessment practice longitudinally after implementation of new safety planning templates using our Zero Suicide main award.

1UG3DA050189-01
Using SMART Design to Identify an Effective and Cost-Beneficial Approach to Preventing OUD in Justice-Involved Youth New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA Seattle Children’s Hospital AHRENS, KYM R (contact); HAGGERTY, KEVIN P Seattle, WA 2019
NOFO Title: HEAL Initiative: Preventing Opioid Use Disorder in Older Adolescents and Young Adults (ages 16–30) (UG3/UH3 Clinical Trial Required
NOFO Number: RFA-DA-19-035
Summary:

Adolescents and young adults in justice settings (AYAJS) have some of the highest rates of opioid use disorder (OUD), with national rates approaching 20%. Multiple studies have established effectiveness of the Adolescent Community Reinforcement Approach with Assertive Continuing Care (ACRA/ACC) in reducing non-opioid substance use disorder (SUD); however, none have evaluated it as an OUD prevention strategy. SUD is common and costly among AYAJS; thus, ACRA/ACC-based approaches are likely to be effective and cost-beneficial OUD prevention strategies for this group. However, the optimal intensity of an ACRA/ACC-based OUD prevention intervention for AYAJS with and without non-opioid SUD is not known, as these groups are likely to have differing prevention needs. Seattle Children’s Hospital (SCH), University of Washington (UW), and Washington State Juvenile Rehabilitation (WSJR) will collaboratively evaluate ACRA/ACC-based OUD prevention strategies of different intensity levels among SUD and non-SUD youth.

1UG3NS115637-01
Clinical Translation of Ultrasonic Ketamine Uncaging for Non-Opioid Therapy of Chronic Pain Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NINDS STANFORD UNIVERSITY AIRAN, RAAG D (contact); WILLIAMS, NOLAN R Stanford, CA 2019
NOFO Title: HEAL Initiative: Translational Devices to Treat Pain (UG3/UH3 Clinical Trial Optional)
NOFO Number: RFA-NS-19-016
Summary:

The research team has developed ultrasonic drug uncaging for neuroscience, in which neuromodulatory agents are uncaged from ultrasound-sensitive biocompatible and biodegradable drug-loaded nanocarriers. This project will clinically translate ultrasonic ketamine uncaging for chronic pain therapy. In the UG3 phase, the research team will scale our nanoparticle production processes to human scales and adapt them to pharmaceutical standards. In the UH3 phase, they will complete a first-in-human evaluation of the safety and efficacy of ultrasonic ketamine uncaging by quantifying how much ketamine is released relative to the ultrasound dose and assessing whether the uncaged ketamine can modulate the sensitivity and affective response to pain, in patients suffering from chronic osteoarthritic pain. This project aims to yield a novel, noninvasive, non-opioid therapy for chronic pain that maximizes the therapeutic efficacy of ketamine over its side effects, by targeting its action to a critical hub of pain processing.

1RF1NS130481-01
Immune Modulating Therapies to Treat Complex Regional Pain Syndrome Preclinical and Translational Research in Pain Management Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain NINDS DREXEL UNIVERSITY AJIT, SEENA Philadelphia, PA 2022
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:

Complex regional pain syndrome is a difficult-to-treat chronic condition that causes excess and prolonged pain and inflammation after injury to an arm or leg and includes damage to skin of affected limbs. Although it is known that aberrant immune system function plays a role in this condition, the details remain unclear about how this occurs – in particular, through the adaptive immune system that relies on specialized immune cells and antibodies to protect the body from harm.  This project will study the role of certain immune cells (T cells) that circulate throughout the body or reside in bone using both rat or human bone samples from patients with complex regional pain syndrome.

1R01DE029187-01
LIGHT and Lymphotoxin targeting for the treatment of chronic orofacial pain conditions Preclinical and Translational Research in Pain Management Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain NIDCR UNIVERSITY OF TEXAS HLTH SCIENCE CENTER AKOPIAN, ARMEN N San Antonio, TX 2019
NOFO Title: Discovery and Validation of Novel Targets for Safe and Effective Pain Treatment (R01 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-18-043
Summary:

Mismanagement of orofacial chronic pain, such as temporomandibular joint and muscle disorders (TMJD) and oral cancer, substantially contributes to opioid overuse; overdose-related deaths; and cardiovascular, renal, and neurological complications at epidemic proportions. The current paradigm implies that orofacial conditions could trigger maladaptation of the immune system and plasticity supporting persistent inflammation, which influences the development and maintenance of orofacial chronic pain. LIGHT (TNFSF14) and Lymphotoxin-beta (LT?), members of the tumor necrosis factor superfamily, provide a balance between protective immunity and immunopathology during chronic inflammatory diseases. This project will test the hypothesis that targeting LIGHT and LT? signaling could prevent the development and inhibit the maintenance of chronic pain produced by TMJD and oral cancer, via peripheral mechanisms involving plasticity of immune, stromal, and tumor cells, as well as sensory neurons. The proposed research is significant as it advances our understanding of mechanisms regulating the development and maintenance of orofacial pain and offers new therapeutic targets and an immunotherapeutic approach for preventing and blocking chronic pain during TMJD and oral cancer.

1UC2AR082195-01
Comprehensive Functional Phenotyping of Trigeminal Neurons Innervating Temporomandibular Joint (TMJ) Tissues in Male, Female and Aged Mice, Primates, and Humans With and Without TMJ Disorders (TMJD) Preclinical and Translational Research in Pain Management Restoring Joint Health and Function to Reduce Pain (RE-JOIN) NIAMS UNIVERSITY OF TEXAS HLTH SCIENCE CENTER AKOPIAN, ARMEN N; BOADA, MARIO DANILO; ERNBERG, MALIN; MACPHERSON, LINDSEY J San Antonio, TX 2022
NOFO Title: HEAL Initiative: Restoring Joint Health and Function to Reduce Pain Consortium (RE-JOIN) (UC2 Clinical Trial Not Allowed)
NOFO Number: RFA-AR-22-009
Summary:

Scientists do not know the details of how the nervous system interacts with the temporomandibular joint (TMJ) that connects the lower jaw with the skull. This project aims to comprehensively explain the functions, types, neuroanatomical distributions, and adaptability (plasticity) of specific nerve cells in the brain (trigeminal neurons) that connect with the TMJ. The research will analyze nerve-TMJ connections associated with chewing muscles and other structures that form the TMJ such as cartilage and ligaments. The project will analyze samples from both sexes of aged mice, primates, and humans with and without painful TMJ disorders. This research aims to uncover potential treatment and prevention targets for managing TMJ pain.

3R01DE029187-01S2
LIGHT and Lymphotoxin targeting for the treatment of chronic orofacial pain conditions Preclinical and Translational Research in Pain Management Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain NINDS UNIVERSITY OF TEXAS HLTH SCIENCE CENTER AKOPIAN, ARMEN N; RUPAREL, SHIVANI B; TUMANOV, ALEXEI V San Antonio, TX 2020
NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for PA-18-906 Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: NOT-NS-20-023
Summary:

Chronic orofacial pain during Temporomandibular Disorders (TMD) and oral cancer is a significant health problem with scarce non-opioid treatment options. This study aims to validate critical regulators of the balance between protective immunity and immunopathology during chronic inflammatory diseases?tumor necrosis factor alpha superfamily members, LIGHT (TNFSF14) and lymphotoxin-beta (LT?) and their receptors, LT?R and Herpes Virus Entry Mediator (HVEM)?as novel therapeutic targets. The study also seeks to determine whether inhibition of LIGHT and LT? signaling prevents the development and inhibits maintenance of chronic TMD and oral cancer pain via peripheral mechanisms involving plasticity of immune, muscle and tumor cells as well as sensory neurons. The study will define the contribution of LIGHT and LT? signaling to TMD-induced excitability of trigeminal sensory neurons innervating the masseter muscle and joint. New validated therapeutic targets for prevention and treatment of orofacial pain that can be peripherally targeted would reduce side effects of current pain medicates related to drug dependence or tolerance.

1R34DA050258-01
3/3 Promoting Resilience in Children: Protocol Development for a Birth Cohort Study To Assess Factors Impacting Neurodevelopment Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA UNIVERSITY OF WISCONSIN-MADISON ALEXANDER, ANDREW L Madison, WI 2019
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (Collaborative R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-029
Summary:

The first ten years of life are accompanied by rapid changes to the developing brain and cognitive abilities. Complex interacting factors including genetics, early-life exposure to substances, family and social interactions, and home and community environments can affect brain and cognitive development. Three linked projects aim to develop effective research protocols to lay a foundation for a future HEALthy Brain and Cognitive Development (HBCD) birth cohort study. Project 1 will develop protocols for recruitment and retention of a diverse sample of pregnant and postpartum women with oversampling of mothers with prenatal opioid use. Project 2 will identify ethical, legal, and regulatory challenges for investigations in this vulnerable population and define effective solutions to enable recruitment and study of these participants. Project 3 will develop and evaluate protocols for acquiring high-quality, quantitative neuroimaging measures with magnetic resonance imaging and functional near infrared spectroscopy and assess effective strategies for measuring cognitive performance in young children, including those exposed to opioids.

1R61DA059033-01A1
Implementing a Patient Navigation Intervention Across a Health System to Address Treatment Entry Inequities Translation of Research to Practice for the Treatment of Opioid Addiction Optimizing the Quality, Reach, and Impact of Addiction Services NIDA FRIENDS RESEARCH INSTITUTE, INC. ALEXANDER, KAREN (contact); GRYCZYNSKI, JAN Baltimore, MD 2023
NOFO Title: HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-DA-23-053
Summary:

Significant racial, ethnic, socioeconomic, and geographic disparities affect access to opioid use disorder (OUD) treatment and have thus contributed to the opioid overdose crisis. Patient navigator interventions after hospitalization can improve access to treatment, but challenges prevent full adoption of these strategies. These include lack of coordination across institutions, inadequate data sharing, workforce shortages, and lack of awareness, especially in resource-limited communities. This project aims to develop a hospital system-wide patient navigation protocol that can be scaled up to address OUD treatment linkage and continuity after hospitalization.

1R44GM140795-01A1
Non-Opioid Post-Operative Pain Management Using Bupivacaine-loaded Poly(ester urea) Mesh Cross-Cutting Research Small Business Programs NIGMS 21MEDTECH, LLC ALFARO, ARTHUR Durham, NC 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:

There is an urgent need for non-opioid post-operative pain management solutions.  This research is developing a naturally absorbable polymer film that can release controlled amounts of the non-opioid analgesic bupivacaine – aiming to manage pain for several days following surgery. Project objectives are to optimize the timing of drug release, develop manufacturing standards, determine effective dosage for preserving motor function, and determine safety and efficacy in mouse models of neuropathic pain. Continued development of this film delivery system may lead to a new, non-opioid therapeutic strategy that could be combined with local anesthesia for up to 4 days after surgery to reduce or potentially eliminate opioids use.

1UC2AR082196-01
Innervation of the Knee and TMJ  Preclinical and Translational Research in Pain Management Restoring Joint Health and Function to Reduce Pain (RE-JOIN) NIAMS UNIVERSITY OF FLORIDA ALLEN, KYLE D (contact); ALMARZA, ALEJANDRO JOSE; CAUDLE, ROBERT M Gainesville, FL 2022
NOFO Title: HEAL Initiative: Restoring Joint Health and Function to Reduce Pain Consortium (RE-JOIN) (UC2 Clinical Trial Not Allowed)
NOFO Number: RFA-AR-22-009
Summary:

A complex network of different nerve cell subtypes connects to joints in different ways throughout body regions, such as the knee and the temporomandibular joint (TMJ) that connects the lower jaw and skull. This project aims to identify disease-specific pain symptoms using clinically relevant rat models of TMJ and knee osteoarthritis – and compare findings with disease-specific pain symptoms in human patients with the same conditions. This research may lead to a better understanding of how different nerve cell subtypes contribute to joint pain as well as how these nerve cell subtypes change with age and disease.

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.

1UG1HD107580-01
UAB Clinical Site HEAL Neonatal Opioid Withdrawal Pharmacological Treatments Enhanced Outcomes for Infants and Children Exposed to Opioids Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) NICHD UNIVERSITY OF ALABAMA AT BIRMINGHAM  (AL) AMBALAVANAN, NAMASIVAYAM   Birmingham, AL 2021
NOFO Title: HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial - Clinical Sites (UG1 Clinical Trial Required)
NOFO Number: RFA-HD-21-031
Summary:

Neonatal Opioid Withdrawal Syndrome (NOWS) is a condition that occurs when newborns are exposed to opioids during pregnancy. Symptoms often include tremors, excessive crying, sleep deprivation, and swallowing difficulties. Cases are rising, with a newborn affected by NOWS approximately every 15 minutes. Currently, healthcare providers in the United States lack standard, evidence-based treatments for NOWS. 

This project is part of a multi-center, randomized controlled clinical trial that directly compares NOWS treatments—morphine, methadone, and buprenorphine—and takes into account other types of non-drug therapies, such as behavioral interventions. The goal is to generate results that can inform clinical practice guidelines and give newborns with NOWS the best start possible. 

The University of Alabama at Birmingham routinely treats newborns with NOWS and has been part of NICHD’s Neonatal Research Network (NRN) for more than 25 years. The center has an excellent track record of enrollment in clinical studies, with successful follow-up to 2 years of age and beyond.