Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
3UG1DA013720-19S3
Individual Level Predictive Modeling of Opioid Use Disorder Treatment Outcome 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 MIAMI SCHOOL OF MEDICINE SZAPOCZNIK, JOSE; FEASTER, DANIEL J CORAL GABLES, FL 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

A persistent problem in the dissemination of medications for opioid use disorder (MOUD) is patient dropout, and matching patients to suitable medication early has the potential to minimize dropout. The overall objective of this secondary data analysis study is to develop and disseminate individual level risk prediction models using harmonized data collected from three multi-site clinical trials from the CTN, in order to predict specific clinical outcomes (e.g., dropout, relapse) for patients treated with MOUD, including methadone, buprenorphine or extended-release depot naltrexone. The relative importance of predictors in the best predictive models will be estimated, which may facilitate refinement of common data elements for future OUD studies. The comprehensive, harmonized database of treatment data created in this study can be used for future secondary data analysis studies and will provide a replicable data pipeline to process and validate OUD data in future protocols.
3UG1DA013720-20S2
Medication treatment for Opioid-dependent expecting Mothers (MOMs): A Pragmatic Randomized Trial Comparing Extended-Release and Daily Buprenorphine Formulations (CTN-0080) 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 MIAMI SCHOOL OF MEDICINE SZAPOCZNIK, JOSE; FEASTER, DANIEL J CORAL GABLES, FL 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

The growing opioid use epidemic in the U.S. has been associated with a significant increase in the prevalence of pregnant opioid-dependent women and neonatal abstinence syndrome, which is associated with adverse health effects for the infant and with costly hospitalizations. Maintenance with sublingual (SL) buprenorphine (BUP) is efficacious for opioid use disorder but has disadvantages that may be heightened in pregnant women, including the potential for poor adherence, treatment dropout, and negative maternal/fetal effects associated with daily BUP peak-trough cycles. Extended release (XR) formulations may address some of these disadvantages. The primary objective of CTN-0080 is to evaluate the impact of treating opioid use disorder in pregnant women (n = 300) with BUP-XR, compared to BUP-SL, on maternal-infant outcomes. Other objectives include testing a conceptual model of the mechanisms by which BUP-XR may improve maternal-infant outcomes, relative to BUP-SL; determining the economic value of BUP-XR, compared with BUP-SL, to treat OUD in pregnant women; and evaluating the impact of BUP-XR, relative to BUP-SL, on neurodevelopment when the infant/child is approximately 12 and 24 months of age. Ultimately, this study will help in increasing access to treatment as well as provide quality care for pregnant/postpartum women.
3UG1DA013720-20S3
Individual Level Predictive Modeling of Opioid Use Disorder Treatment Outcome 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 MIAMI SCHOOL OF MEDICINE SZAPOCZNIK, JOSE; FEASTER, DANIEL J CORAL GABLES, FL 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

A persistent problem in the dissemination of medications for opioid use disorder (MOUD) is patient dropout, and matching patients to suitable medication early has the potential to minimize dropout. The overall objective of this secondary data analysis study is to develop and disseminate individual level risk prediction models using harmonized data collected from three multi-site clinical trials from the CTN, in order to predict specific clinical outcomes (e.g., dropout, relapse) for patients treated with MOUD, including methadone, buprenorphine or extended-release depot naltrexone. The relative importance of predictors in the best predictive models will be estimated, which may facilitate refinement of common data elements for future OUD studies. The comprehensive, harmonized database of treatment data created in this study can be used for future secondary data analysis studies and will provide a replicable data pipeline to process and validate OUD data in future protocols.
3U54EB020404-05S1
CENTER OF EXCELLENCE FOR MOBILE SENSOR DATA-TO-KNOWLEDGE (MD2K) - OVERALL New Strategies to Prevent and Treat Opioid Addiction NIBIB University of Memphis KUMAR, SANTOSH MEMPHIS, TN 2018
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Rapid technological advances are leading to field-deployable mobile sensing devices that can quantify complex dynamics of key physical, biological, behavioral, social, and environmental factors, enabling us to understand causation in complex disorders. Significant new investment is needed to develop and disseminate data analytics tools. The Center of Excellence for Mobile Sensor Data-to-Knowledge (MD2K) will generate generalizable theory, methods, tools, and software to address major barriers to processing complex mobile sensor data and its use in biomedical knowledge discovery and just-in-time care delivery. We will develop and implement a standards-based, interoperable, extensible, and open-source big data software platform for efficient implementation of MD2K data analytics. MD2K will demonstrate the feasibility, utility, and generalizability of this approach by implementing the entire MD2K data analytics system in the context of two biomedical applications: reducing relapse among abstinent daily smokers and reducing readmission among congestive heart failure patients
3R01MH112138-03S3
A SYSTEM OF SAFETY (SOS): PREVENTING SUICIDE THROUGH HEALTHCARE SYSTEM TRANSFORMATION New Strategies to Prevent and Treat Opioid Addiction NIMH University of Massachusetts Medical School, Worcester BOUDREAUX, EDWIN D; KIEFE, CATARINA I. WORCESTER, MA 2018
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

The System of Safety (SOS) represents an opportunity to study the implementation of best practice suicide-related care processes that embody the Zero Suicide Essential Elements of Care across emergency departments, inpatient medical and behavioral health units, and primary care clinics associated with a large healthcare system. This effectiveness trial will use a stepped wedge design across a total of 39 clinical units. Aim 1 will measure suicide risk screening and screening's impact on risk identification. Aim 2 will measure the effective implementation of clinician-administered interventions, such as safety planning with means restriction counseling, on suicide, suicide attempts, and suicide-related acute healthcare. Exploratory aims will examine mechanisms of action, moderators, economics, and population effects of the intervention. This study's innovative approach positions it for a significant impact on the fields of suicide prevention, CQI, and effectiveness trial design and analysis.
1R01MH128904-01
Supporting Treatment Access and Recovery for Co-Occurring Opioid Use and Mental Health Disorders (STAR-COD) New Strategies to Prevent and Treat Opioid Addiction Optimizing Care for People with Opioid Use Disorder and Mental Health Conditions NIMH University of Massachusetts Medical School SMELSON, DAVID A (contact); GONZALEZ, GERARDO ; LI, WENJUN ; OLMSTEAD, TODD ALDEN Worcester, MA 2021
NOFO Title: HEAL Initiative: Optimizing Multi-Component Service Delivery Interventions for People with Opioid Use Disorder, Co-Occurring Conditions, and/or Suicide Risk (R01 Clinical Trials Optional)
NOFO Number: RFA-MH-21-145
Summary:

Opioid use disproportionally affects people with co-occurring mental health disorders. Although medication for opioid use disorder (MOUD) is the gold standard of care, engagement rates are low. Also, it is unclear whether addition of one or more behavioral interventions improves outcomes of MOUD treatment, particularly in patients with co-occurring mental health disorders. This project evaluates the effectiveness of the “Maintaining Independence and Sobriety through Systems Integration, Outreach and Networking (MISSION)” intervention—a multi-component, cross-disciplinary, team-based treatment approach that combines three evidence-based practices with MOUD—in people with co-occurring mental health disorders. The 4-year, five-arm, randomized controlled clinical trial will determine the therapeutic benefit of adding MISSION to MOUD and identify the MISSION components that yield the largest clinical improvement and offer the greatest return on investment.
1R01DA057443-01
Peer-Delivered, Behavioral Activation Intervention to Improve Polysubstance Use and Retention in Mobile Telemedicine OUD Treatment in an Underserved, Rural Area Translation of Research to Practice for the Treatment of Opioid Addiction Improving Delivery of Healthcare Services for Polysubstance Use NIDA UNIVERSITY OF MARYLAND, COLLEGE PARK MAGIDSON, JESSICA F (contact); KATTAKUZHY, SARAH M College Park, MD 2022
NOFO Title: HEAL Initiative: Understanding Polysubstance Use and Improving Service Delivery to Address Polysubstance Use (R01 Clinical Trial Optional)
NOFO Number: DA22-047
Summary:

Polysubstance use, especially use of both opioids and stimulants, is compounding the already devastating effects of the opioid crisis in underserved rural areas. This project builds on a previously established treatment model for opioid use disorder that uses telehealth and mobile treatment units, which seeks to engage people in activities they enjoy, to help them avoid negative behaviors such as drug use. This research will evaluate the effectiveness of a behavioral treatment approach delivered by peer recovery support specialists in rural areas and using mobile treatment units. The project will measure the intervention’s effect on treatment retention and polysubstance use – as well as evaluate the intervention’s feasibility, acceptability, adoption, and economic value.
1R21DE032532-01
Secondary Analysis and Integration of Existing Data Related to Chronic Orofacial Pain and Placebo Effects Cross-Cutting Research Leveraging Existing and Real-Time Opioid and Pain Management Data NIDCR UNIVERSITY OF MARYLAND, BALTIMORE COLLOCA, LUANA (contact); DORSEY, SUSAN G Baltimore, MD 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:

Temporomandibular joint (TMJ) disorders, which affect the joint connecting the lower jaw and the skull, are common and difficult chronic pain conditions. Pain management strategies that harness the body’s own pain relief mechanisms (including placebo effects in which pain relief cannot be attributed to a specific treatment), can reduce the severity and duration of TMJ-related chronic pain. Although research suggests that placebo effects may have a genetic basis, few, if any, genetic studies have examined this possibility in individuals with TMJ disorders. This project will use in-depth genetic, sociodemographic, clinical, and psychological data collected from adults with chronic TMJ disorders to better understand how the placebo effect works.
1R21AG082345-01
Assessing Chronic Pain Using Brain Entropy Mapping Cross-Cutting Research Leveraging Existing and Real-Time Opioid and Pain Management Data NIA UNIVERSITY OF MARYLAND, BALTIMORE WANG, ZE Baltimore, MD 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:

Chronic pain affects millions of Americans and remains poorly understood and challenging to manage. Researchers do not fully understand brain processes involved in chronic pain, which can vary considerably from person to person. This project will analyze brain function using magnetic resonance imaging (MRI) in individuals with and without chronic pain. The research will also directly determine the degree of pain-related brain imaging changes by using a large database of brain imaging data.
1R61NS113269-01
Validation of a novel cortical biomarker signature for pain Preclinical and Translational Research in Pain Management Discovery and Validation of Biomarkers, Endpoints, and Signatures for Pain Conditions NINDS University of Maryland, Baltimore SEMINOWICZ, DAVID Baltimore, MD 2019
NOFO Title: Discovery of Biomarkers, Biomarker Signatures, and Endpoints for Pain (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-NS-18-041
Summary:

Chronic pain is a major health burden associated with immense economic and social costs. Predictive biomarkers that can identify individuals at risk of developing severe and persistent pain, which is associated with worse disability and greater reliance on opioids, would promote aggressive, early intervention that could halt the transition to chronic pain. The applicant’s team uncovered evidence of a unique cortical biomarker signature that predicts pain susceptibility (severity and duration). This biomarker signature could be capable of predicting the severity of pain experienced by an individual minutes to months in the future, as well as the duration of pain (time to recovery). Analytical validation of this biomarker will be conducted in healthy participants using a standardized model of the transition to sustained myofascial temporomandibular pain. Specifically the biomarker signature will be tested for its ability to predict an individual’s pain sensitivity, pain severity, and pain duration and will perform initial clinical validation.
1R01NS116759-01
Validating ASCT2 for the Treatment of Chronic Postsurgical Pain Preclinical and Translational Research in Pain Management Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain NINDS UNIVERSITY OF MARYLAND BALTIMORE MELEMEDJIAN, OHANNES KEVORK Baltimore, MD 2020
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:

Pain associated with surgery is experienced by millions of patients every year. Although post-surgical pain usually resolves as the surgical site heals, up to half of the patients develop chronic pain after surgery. Opioids remain the mainstay treatment for post-surgical pain which are fraught with serious side-effects and abuse liabilities. The endogenous mechanism that leads to the resolution of post-surgical pain remain unclear, specifically the effects of surgery on the metabolism of sensory neurons and how those changes influence the resolution of post-surgical pain are not known. Preliminary findings suggest that surgical trauma suppresses pyruvate oxidation while increased glutamine catabolism was associated with the resolution of post-surgical pain. This project will test the hypothesis that tissue incision and surgery disrupt the expression of the glutamine transporter ASCT2, which then prevents the resolution of post-incisional pain and aims to validate ASCT2 as a therapeutic target. This project will also employ pharmacological, genetic and animal pain model studies test a novel RNA expression-based strategy to enhance ASCT2 expression in DRG sensory neurons and alleviate postoperative pain in animal model systems. Successful completion of this project would validate ASCT2 as a novel endogenous non-opioid and non-addictive mechanism-based target for the resolution of postoperative pain.
1R01DE029074-01A1
Novel Target Identification for Treatment of Chronic Overlapping Pain Using Multimodal Brain Imaging Preclinical and Translational Research in Pain Management Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain NINDS UNIVERSITY OF MARYLAND BALTIMORE TRAUB, RICHARD J; MELEMEDJIAN, OHANNES KEVORK Baltimore, MD 2020
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:

As many as 64% of patients with Temporomandibular Joint Disorders (TMJDs) report symptoms consistent with Irritable Bowel Syndrome (IBS). However the underlying connection between these comorbid conditions is unclear and treatment options are poor. As such, pain management for these Chronic Overlapping Pain Conditions (COPCs) is a challenge for physicians and patients. This project will determine whether the convergence of pain from different peripheral tissues and perceived stress occurs in the brain and elicits a change in central neural processing of painful stimuli. This project will identify and validate specific lipids, enzymes and metabolic pathways that change expression in the brain during the transition from acute to chronic overlapping pain that can be therapeutically targeted to treat COPCs. Multi-disciplinary approaches will be used to combine brain imaging, visualization of spatial distribution of molecules, genetics, pharmacological and behavioral research techniques.
1R24DA051975-01
Innovations in Recovery through Infrastructure Support (IRIS) Translation of Research to Practice for the Treatment of Opioid Addiction Recovery Research Networks NIDA UNIVERSITY OF MARYLAND BALTIMORE UNICK, GEORGE J Baltimore, MD 2020
NOFO Title: Research Networks for the Study of Recovery Support Services for Persons Treated with Medications for Opioid Use Disorder (R24 Clinical Trial Optional)
NOFO Number: RFA-DA-20-014
Summary:

The opioid epidemic in the United States is associated with alarming rates of overdose and overdose deaths. Medication Assisted Treatment (MAT), in combination with psychosocial intervention, is the most effective treatment for OUD; however, many individuals are unable to access treatment, are not sufficiently retained in treatment, or experience barriers that prohibit their participation in treatment. A multipronged approach is needed that includes 1) development of integrated networks of care, both formal and informal, to better address the needs of individuals with OUDs and 2) measures of the efficacy of these integrated networks for addressing the needs of individuals with OUD. This project will build a learning collaborative to address gaps in knowledge about the delivery, sustainability, and assessment of recovery service for individuals on MAT. The collaborative will foster collaboration and communication between stakeholders and with the larger community of research and providers interested in improving the delivery of OUD recovery support services. This community-academic partnership will address the lack of evidence regarding effective recovery support services.
1R01CA249939-01
Identification of Novel Targets for the Treatment of Chemotherapy-Induced Painful Peripheral Neuropathy Preclinical and Translational Research in Pain Management Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain NINDS UNIVERSITY OF MARYLAND BALTIMORE MELEMEDJIAN, OHANNES KEVORK Baltimore, MD 2020
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:

Chemotherapy-induced painful peripheral neuropathy (CIPN) is the most common toxicity associated with widely used chemotherapeutics. CIPN accounts for significant dose reductions and/or discontinuation of these life-saving treatments. Unfortunately CIPN can also persist in cancer-survivors, adversely affecting their quality of life. CIPN is not well-managed with existing pain therapeutics. Recent preliminary findings suggest that the transcription factor hypoxia-inducible factor alpha (HIF1A) is the target for the chemotherapeutic bortezomib, a proteasome inhibitor. This project will test the hypothesis that bortezomib chemotherapy-induced expression of HIF1A, PDHK1 and LDHA constitute an altered metabolic state known as aerobic glycolysis (AG) that leads to the initiation and maintenance of peripheral neuropathy and pain using a novel tumor-bearing animal model of CIPN. This project aims to validate HIF1A as a therapeutic target for the prevention of CIPN, as well as validate PDHK1 and LDHA as non-opioid therapeutic targets for chronic or established CIPN in animal models.
1R61AT010799-01
Peer-Delivered Behavioral Activation Intervention to Improve Adherence to MAT Among Low-Income, Minority Individuals With OUD Translation of Research to Practice for the Treatment of Opioid Addiction Behavioral Research to Improve Medication-Based Treatment NCCIH University of Maryland MAGIDSON, JESSICA F College Park, MD 2019
NOFO Title: HEAL Initiative: Behavioral Research to Improve MAT: Behavioral and Social Interventions to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-AT-19-006
Summary:

Poor medication-assisted treatment (MAT) retention disproportionately affects low-income racial/ethnic minority individuals with opioid use disorder (OUD) and increases risk for relapse; therefore, evidence-based interventions are needed to improve MAT retention. Peer recovery coaches (PRCs), trained individuals with experiences with substance use disorder, may be uniquely suited to address common MAT retention barriers among underserved populations, including stigma, challenges navigating services, housing instability, and other structural and psychosocial factors. Preliminary work by the research team suggests that behavioral activation (BA) by PRCs may be a feasible, scalable reinforcement-based approach for improving MAT retention for low-income minority OUD individuals. The study builds upon the research team’s formative work to adapt and evaluate the effectiveness and implementation of a PRC-delivered BA intervention (Peer Activate) to improve MAT retention for low-income, minority individuals with OUD.
1UG1HD107649-01
Neonatal Opioid Withdrawal Syndrome (NOWS) in Kentucky: Improving Outcomes for Infants Enhanced Outcomes for Infants and Children Exposed to Opioids Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) NICHD UNIVERSITY OF LOUISVILLE  (KY) DEVLIN-PHINNEY, LORI ANN (contact); TELANG, SUCHETA Louisville, KY 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 Louisville serves a large, diverse population that is disproportionately affected by the opioid crisis. Mothers and infants treated by the university’s healthcare team live in rural
and urban underserved regions where the frequency of opioid use during pregnancy is among the highest in the country, with a rate estimated at 3 times the national average.
1R01DA056646-01
Ghrelin Deacylase as a Treatment for Opioid Polysubstance Abuse Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA University of Kentucky Research Foundation ZHAN, CHANG-GUO (contact); ZHENG, FANG Lexington, KY 2022
NOFO Title: HEAL Initiative: Novel Targets for Opioid Use Disorders and Opioid Overdose (R01 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-22-031
Summary:

There is an urgent need for novel substance use disorder treatments aimed at treating polysubstance use disorders, such as opioid and methamphetamine co-use. One promising new target is the peptide ghrelin, which recent studies have implicated in drug- and reward-relevant behaviors. This research project will investigate the recently identified enzyme, ghrelin deacylase, that affects the activity of ghrelin to attenuate the rewarding and reinforcing effects of fentanyl and heroin in combination with methamphetamine. The researchers will also design and test new, long-acting forms of ghrelin deacylase that may be potential therapeutic candidates for the treatment of polysubstance use disorders.
1R01DA057605-01
Rapid Actionable Data for Opioid Response in Kentucky (RADOR-KY) Cross-Cutting Research Leveraging Existing and Real-Time Opioid and Pain Management Data NIDA UNIVERSITY OF KENTUCKY SLAVOVA, SVETLA STEFANOVA (contact); TALBERT, JEFFERY C Lexington, KY 2022
NOFO Title: HEAL Initiative: Data and Methods to Address Urgent Needs to Stem the Opioid Epidemic (R01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-22-044
Summary:

To respond quickly and effectively to the constantly changing dynamics of the opioid crisis, public health agencies and organizations need timely state and local data to make critical decisions about where to allocate resources and target responses. This project creates the Rapid Actionable Data for Opioid Response in Kentucky system, a near real-time statewide surveillance system. This resource will combine data from multiple state agencies to provide actionable and timely information to support opioid overdose prevention, harm reduction, evidence-based treatment, and recovery services. The project will also develop user-driven reporting and visualization tools (mobile and web-based apps) that provide immediate access to near real-time community or state level data, reports, and visual analytics.
1R01DA059152-01
POPI: Placenta, Opioids and Perinatal Implications Enhanced Outcomes for Infants and Children Exposed to Opioids The Biology of Opioid Exposure During Pregnancy and Effects on Early Neuro-Behavioral Development NIDA UNIVERSITY OF KENTUCKY MESSAOUDI, ILHEM (contact); O'BRIEN, JOHN M Lexington, KY 2023
NOFO Title: HEAL Initiative: Opioid Exposure and Effects on Placenta Function, Brain Development, and Neurodevelopmental Outcomes (R01 Clinical Trial Not Allowed)
NOFO Number: RFA-HD-23-034
Summary:

Opioid use during pregnancy is associated with harmful health outcomes for infants including preterm birth, neonatal opioid withdrawal syndrome, and brain-related problems. This project will carry out an in-depth investigation of the effects of opioid use during pregnancy including changes to health of the placenta, inflammation in the fetus, as well as behavioral and movement-related outcomes during the first year of life. This research will contribute to fundamental knowledge about how the placenta and brain work together as well as identify new strategies for diagnosing, treating, and preventing opioid harm to the fetus and mother.   
1UG1DA050069-01
Kentucky Womens Justice Community Opioid Innovation Network (WJCOIN) Translation of Research to Practice for the Treatment of Opioid Addiction Justice Community Opioid Innovation Network (JCOIN) NIDA UNIVERSITY OF KENTUCKY STATON, MICHELE STATON Lexington, KY 2019
NOFO Title: HEAL Initiative: Justice Community Opioid Innovation Network (JCOIN) Clinical Research Centers (UG1 Clinical Trial Optional)
NOFO Number: RFA-DA-19-025
Summary:

Women are disproportionately affected by the opioid crisis due to increased pain sensitivity, physician prescribing practices, and self-medication, as well as a faster trajectory from opioid exposure to the development of opioid use disorder (OUD). The University of Kentucky proposes to establish the Women’s Clinical Research Center as part of the NIDA Justice Community Opioid Innovation Network (W-JCOIN), with the overall goal of increasing initiation and maintenance of medications for OUD among high-risk justice-involved women in the transition from jail to the community to reduce opioid relapse and overdose. The KY W-JCOIN has the potential for significant impact on the OUD treatment field by contributing empirical evidence on the effectiveness and implementation of innovative technologies to increase initiation and maintenance of life-saving medications during a critical, high-risk time of community re-entry among vulnerable, justice-involved women in both urban and rural communities.
3R01DA057605-01S1
Diversity Supplement - Rapid Actionable Data for Opioid Response in Kentucky (RADOR-KY) Cross-Cutting Research Increasing Participant Diversity, Inclusion, and Engagement in HEAL Research NIDA UNIVERSITY OF KENTUCKY SLAVOVA, SVETLA STEFANOVA (contact); TALBERT, JEFFERY C Lexington, KY 2023
NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for PA-20-222: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: NOT-NS-20-107
Summary:

RADOR-KY is a near real-time, state-wide surveillance system to monitor prevention and treatment services for opioid use disorder (OUD). This project will fill gaps in this system by capturing data from agencies receiving state funding to provide treatment and support services for people with OUD. Access to the additional data will help expand and improve surveillance dashboards being used to coordinate and target resources for preventing overdose deaths.
1R01DE033318-01
Understanding the Association Between Sublingual Buprenorphine and Oral Health Outcomes Novel Therapeutic Options for Opioid Use Disorder and Overdose Oral Complications Arising From Pharmacotherapies to Treat Opioid Use Disorders NIDCR UNIVERSITY OF KENTUCKY ROJAS RAMIREZ, MARCIA VANESSA (contact); OYLER, DOUGLAS Lexington, KY 2023
NOFO Title: HEAL Initiative: Oral Complications Arising from Pharmacotherapies to Treat Opioid Use Disorders (R01 Clinical Trial Not Allowed)
NOFO Number: RFA-DE-23-015
Summary:

Sublingual buprenorphine is a standard treatment for opioid use disorder and is considered safe and effective. However, in 2022 the U.S. Food and Drug Administration advised that buprenorphine is linked to oral disease. However, the underlying studies did not measure when oral disease started, how it progressed, or if other risk factors were present. How sublingual buprenorphine may impact oral health also remains unclear. This project will follow adults in two U.S. states who take sublingual buprenorphine or other medications for opioid use disorder to understand if and how these medications increase the extent, onset, and progression of oral disease, accounting for other risk factors.
1R01DA057686-01
Fast and Fine: NLP Methods for Near Real-Time and Fine-Grained Overdose Surveillance Cross-Cutting Research Leveraging Existing and Real-Time Opioid and Pain Management Data NIDA UNIVERSITY OF KENTUCKY KAVULURU, VENKATA NAGA RAMAKANTH Lexington, KY 2022
NOFO Title: HEAL Initiative: Data and Methods to Address Urgent Needs to Stem the Opioid Epidemic (R01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-22-044
Summary:

Timely and accurate surveillance of fatal and non-fatal overdoses is necessary in light of the worsening overdose crisis, but data is rarely available in real-time. Tracking non-fatal overdoses is especially important because patients who overdose once are likely to experience additional and potentially fatal overdoses. This project aims to increase the quality and timeliness of non-fatal overdose data estimates by analyzing clinicians’ notes rather than clinical codes from emergency department and emergency medical services records. The datasets and models produced from this research will be used to build an interactive dashboard with up-to-date, county-level overdose-surveillance estimates for use by Kentucky first responders to aid in rapid allocation of resources.
1R61NS127271-01A1
Planning Study for the Development of Sigma 2 Ligands as Analgesics Preclinical and Translational Research in Pain Management Development and Optimization of Non-Addictive Therapies to Treat Pain NINDS UNIVERSITY OF KENTUCKY TIDGEWELL, KEVIN JOSEPH (contact); KOLBER, BENEDICT J Lexington, KY 2023
NOFO Title: HEAL Initiative: Planning Studies for Initial Analgesic Development [Small Molecules and Biologics] (R61 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-21-029
Summary:

Natural products, which are substances found in nature and made by living organisms, have been used in the past as good sources for developing new medications. Natural products isolated from marine bacteria that attach to the pain-signaling protein sigma-2 receptor (also known as transmembrane protein 97 [TMEM97]), may serve as a starting point to create new, non-opioid pain medications. This project will use chemistry and biology approaches to refine such natural products as a treatment for neuropathic pain.
1UM1DA049406-01
HEALing Communities Study - Kentucky Translation of Research to Practice for the Treatment of Opioid Addiction HEALing Communities Study NIDA UNIVERSITY OF KENTUCKY WALSH, SHARON L Lexington, KY 2019
NOFO Title: HEALing Communities Study: Developing and Testing an Integrated Approach to Address the Opioid Crisis (Research Sites) (UM1 - Clinical Trial Required)
NOFO Number: RFA-DA-19-016
Summary:

Although there are effective prevention and treatment programs and services to address opioid misuse, opioid use disorder (OUD), and overdose, gaps remain between those needing and those receiving prevention and treatment, in part because of a need to better understand how to make these programs and services most effective at a local level. The National Institutes of Health (NIH) and the Substance Abuse and Mental Health Services Administration (SAMHSA) launched the HEALing Communities Study to generate evidence about how tools for preventing and treating opioid misuse and OUD are most effective at the local level. This multisite implementation research study will test the impact of an integrated set of evidence-based practices across health care, behavioral health, justice, and other community-based settings. The goal of the study is to reduce opioid-related overdose deaths by 40 percent over three years. The University of Kentucky is partnering with academic institutions in three other states to study the impact of these efforts in 67 highly affected communities. The study will also look at the effectiveness of coordinated systems of care designed to increase the number of individuals receiving medication to treat OUD, increase the distribution of naloxone, and reduce high-risk opioid prescribing.