Funded Projects

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.

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.

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.

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.

NOFO Title: HEAL Initiative: HEAL Data2Action – Innovation and Acceleration Projects, Phased Awards (R61/R33, Clinical Trial Optional)
NOFO Number: RFA-DA-23-057
Summary:

Health services for the treatment of opioid use disorder (OUD) are fragmented in west Chicago, an epicenter for overdose deaths. This project will develop a data-driven opioid response plan involving key partners. These include local health departments, community organizations, health care systems, and people with lived experience. The research will develop a digital screening tool for OUD that can be used in hospitals and their emergency departments. The tool will be built from machine learning of data from electronic health records, the prescription drug monitoring program, and patient-reported measures. The research will test the value of the screening tool for connecting people to treatment and preventing fatal overdoses mortality in local neighborhoods.

NOFO Title: The National Drug Abuse Treatment Clinical Trials Network (UG1 Clinical Trial Optional)
NOFO Number: RFA-DA-19-008
Summary:

The Great Lakes Node of the NIDA-supported Drug Abuse Clinical Trials Network (CTN) represents all of the major academic medical centers in the Greater Chicago and Wisconsin areas and serves as a vital Midwestern hub for the CTN. This project supports a scientist from a group underrepresented in biomedicine to expand the work of this CTN node on research in several areas. These include mHealth, eHealth, artificial intelligence, natural language processing, and telehealth interventions; focus on youth/adolescent health and seniors/aging; health disparities; and professional education about opioid and substance treatment.

NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
NOFO Number: RFA-DA-19-002
Summary:

Opioids have been significantly over-prescribed and are associated with numerous deaths, resulting in the nation’s current opioid crisis. The FDA recently approved the ?2 adrenergic agonist lofexidine as a non-addictive, non-opioid treatment for opioid use disorder (OUD), but there is a continued, urgent need to develop additional pharmacological alternatives to address both pain and OUD. The psychoactive, natural product, Mitragyna speciosa (kratom), has triggered significant interest in this space because Mitragynine, its main alkaloid, can interact with both mu opioid and ?2 receptors, offering a totally new approach for treating OUD. This project involves the synthesis and research of a series of Mitragynine analogs to better understand the pharmacological mechanisms that underlie Mitragynine’s opioid and adrenergic activities. If successful, this project will result in templates for the design of novel opioid receptor ligands. This advance would greatly improve the knowledge of interactions of these structurally novel compounds with opioid receptors and facilitate the development of these ligands as treatments for OUD.

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:

The project will address gaps in both risk identification and clinical management by utilizing comprehensive clinical data from a mature health information exchange containing more than 2.3 million patients across the spectrum of clinical care (hospitals, primary care, specialty care, community health centers, urgent care) to develop a statistically robust method to measure suicide risk associated with prescription opioid use. First, the team will couple data fusion techniques with machine learning-based approaches in identifying the clinical and demographic characteristics associated with elevated risk of suicidal behavior among prescription opioid users. Second, the team will develop clinical profiles of patients with higher risk of suicidal behavior associated with prescription opioids, and to incorporate these profiles in a clinical decision support platform that can be used for identification and intervention at the point of care. The clinical decision support tool developed under this proposal will provide a generalizable platform that could be extended to other more conventional opioid related outcomes such as OUD and overdose.

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:

Currently available treatments for opioid use disorder (OUD) are insufficient for many patients. Novel compounds that can promote alterations in brain connections (i.e., neural plasticity) possess enormous potential for improving substance use disorder (SUD) treatments. Psychedelic compounds induce neural plasticity and can elicit long-lasting, beneficial impacts on a wide variety of SUDs. However, these compounds have significant side effects, including hallucinations and cardiotoxicity. Researchers have developed a novel, synthetic derivative of the psychedelic ibogaine, called tabernanthalog, that does not have these side effects. This compound has demonstrated both short- and long-term therapeutic effects in a preclinical model of OUD. This research study will determine the molecular and neural mechanisms through which tabernanthalog affects opioid seeking. It will also evaluate whether the effects are specific to opioids and do not alter response to natural rewards and will examine the efficacy of tabernanthalog in a preclinical model of comorbid opioid and alcohol use disorder.

NOFO Title: Notice of Special Interest(NOSI): HEAL Initiative: Social Network Analyses to Reduce American Indian and Alaska Native Opioid Use Disorder and Related Risks for Suicide and Mental Health Disorders
NOFO Number: NOT-DA-20-033
Summary:

American Indian and Alaska Native (AI/AN) youth and young adults experience disproportionately high rates of suicide, mental health disorders, traumatic life events, and substance use disorder. More effective, culturally informed interventions are needed that are tailored to the specific needs of this population. This supplement will examine how a person?s social network contributes to their behavioral health (suicide risk, mental health, substance use) status and how this network can be leveraged to improve the uptake of prevention interventions. The long-term goal is to disseminate and translate the lessons learned into practical policy, organizational changes, and preventive innovations that optimize patient-centered health outcomes and ultimately reduce or eliminate the dramatic and tragic suicide-related health disparities among urban AI/AN YYAs.

NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Community pharmacies are optimal—yet underutilized—settings for identifying individuals with opioid use disorder (OUD) and increasing their access to treatment. Approximately 93 percent of individuals in the U.S. live within 5 miles of a community pharmacy. The most common opioid-related tool available to pharmacists is the prescription drug monitoring program (PDMP), which provides highly limited information and support for clinical decision making. Appriss Health, the largest U.S. PDMP vendor, covering 42 states, has developed an opioid risk measure, the NarxScore. This study will clinically validate the NarxScore metric and identify high, moderate and low opioid risk thresholds to inform OUD care management within urban and rural community pharmacies. This is a prospective cross-sectional comprehensive OUD risk and behavioral/physical health survey administered electronically with patients (n = 1,523) filling opioid medications in urban/rural community pharmacies in Ohio (pharmacy sites: n = 12) and Indiana (pharmacy sites: n = 3), states that continue to have disproportionately high rates of overdose and opioid prescribing. Correlation, regression and kappa statistics will be calculated for validation; receiver operating curves with sensitivity/specificity values will be employed for threshold identification (with >95 percent power to detect an area of 0.7 under the curve value).

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.