Funded Projects

NOFO Title: HEAL Initiative: Justice Community Opioid Innovation Network (JCOIN) Clinical Research Centers (UG1 Clinical Trial Optional)
NOFO Number: RFA-DA-19-025
Summary:

Correctional settings have the potential to serve as key players in linking individuals with opioid use disorder (OUD) to treatment and health services upon release. Many individuals with OUD are being treated with medications, but these efforts will be ineffective if they fail to connect people to OUD treatment upon release. The Transitions Clinic Network (TCN) program provides enhanced primary care and OUD treatment for people recently released from incarceration. In TCN, formerly incarcerated community health workers are embedded within primary care teams and address social determinants of OUD, provide social support, help patients build trust in the health system, and advocate in interactions with the criminal justice system. This study will assess the effectiveness of the TCN: Post Incarceration Addiction Treatment, Healthcare, and Social Support (TCN PATHS) intervention versus referral to standard primary care on opioid treatment cascade outcomes and whether housing, food access, criminal justice contact, and social support mediate this association.

NOFO 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
NOFO Number: NOT-NS-21-025
Summary:

The emergency department is an ideal venue to reach and intervene with adolescents and young adults at risk for opioid misuse, particularly as young adults may disconnect from primary care when transitioning out of care in pediatric settings. This study will evaluate the efficacy of interventions of varying type and intensity to prevent or reduce opioid misuse or opioid use disorder. The research leverages technology that is appealing to youth to facilitate intervention delivery by health coaches. In this study, adolescents and young adults in the emergency department screening positive for opioid use or misuse will be randomly assigned to one of four intervention conditions with outcomes measured at 4, 8, and 12 months. Technology-driven, scalable interventions delivered via health coaches allow for real-time tailoring to the rapidly changing opioid epidemic, with the potential to prevent an increase in opioid misuse among adolescents and young adults.  Black/African American youth are at increased risk for opioid and other substance use, but they often do not participate in research studies. As a result, it is not known how well prevention interventions work with Black/African American people. This supplement will focus on increasing participant diversity and inclusion by recruiting additional Black/African American participants for this ongoing randomized controlled study of technology-driven prevention interventions.

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.

NOFO Title: HEAL Initiative: Back Pain Consortium (BACPAC) Research Program Technology Research Sites (UH2/UH3 Clinical Trial Optional)
NOFO Number: RFA-AR-19-028
Summary:

A primary factor contributing to acute or recurrent back injury is overexertion via excessive peak and cumulative forces on the back and the primary factors involved in the progression of acute low back injury to chronic low back pain (cLBP) include maladaptive motor control strategies, muscle hyperactivity, reduced movement variability, and the development of fear cognitions. This project will focus on the development of robotic apparel with integrated biofeedback components that can reduce exertion; encourage safe, varied movement strategies; and promote recovery. Robotic apparel will be capable of providing supportive forces to the back and hip joints through adaptive control algorithms that respond to dynamic movements and becoming fully transparent when assistance is no longer needed. This technology can be used to prevent cLBP caused by overexertion and provide a new tool to physical therapists and the clinical community to enhance rehabilitation programs.

NOFO Title: NIH Research Project Grant (Parent R01)
NOFO Number: PA-16-160
Summary:

Morbidity and mortality related to prescription opioids are accelerating in the United States. Identifying the factors that lead to new opioid dependence among opioid naïve patients is a critical opportunity to reduce prescription opioid dependence and unintended diversion. In the United States, the majority of individuals who become opioid dependent receive their first opioid prescription following surgical procedures, yet there are no clinical guidelines to inform appropriate postoperative opioid use. We will examine the patient factors that are associated with postoperative pain and opioid consumption among a cohort of patients undergoing common elective abdominal procedures. We will identify the provider characteristics in postoperative opioid prescribing practices, and design and implement a provider-directed intervention to optimize postoperative opioid prescribing. Findings will inform patients and providers regarding the risk of opioid dependence following surgery, and will establish a patient-centered data infrastructure that yields continuous feedback to providers regarding appropriate opioid prescribing practices.

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:

Though prenatal exposure to opioids and other substances have adverse effects on neurodevelopment, advances in neuroimaging and developmentally sensitive phenotypic measurement now enable characterization of typical and atypical brain-behavior pathways on an unprecedented scale. The Brains Begin Before Birth (B4) Midwest Consortium, a partnership of neuroscience, substance use, perinatal mental health, and child welfare scientists at Washington University School of Medicine (WUSM) and neuroscience, bioethics, pediatric population health, maternal-fetal, and addiction scientists at Northwestern University (NU). This regional consortium will leverage the contrasting approaches of Illinois (punitive) and Missouri (non-punitive) to prenatal opioid use, providing a platform for examining the impact of jurisdictional variations on science and practice. The consortium provide a framework for addressing three major areas of challenge: (1) legal/ethical, (2) recruitment/retention, and (3) imaging/assessment methods.

NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)
NOFO Number: PA-18-573
Summary:

 Non-Invasive Brain Stimulation (NIBS) has been successfully applied for the treatment of chronic pain (CP) in some disease states, where treatment induced changes in brain activity revert maladaptive plasticity associated with the perception/sensation of CP [25-28]. However, the most common NIBS methods, e.g., transcranial direct current stimulation, have shown limited, if any, efficacy in treating neuropathic pain. It has been postulated that limitations in conventional NIBS techniques’ focality, penetration, and targeting control limit their therapeutic efficacy . Electrosonic Stimulation (ESStim™) is an improved NIBS modality that overcomes the limitations of other technologies by combining independently controlled electromagnetic and ultrasonic fields to focus and boost stimulation currents via tuned electromechanical coupling in neural tissue . This proposal is focused on evaluating whether our noninvasive ESStim system can effectively treat CP in carpal tunnel syndrome (CTS), both as a lone treatment and in conjunction with physical therapy (PT). Investigators hypothesize ESStim can be provided synergistically with PT, as both can encourage plasticity-dependent changes which could maximally improve a CTS patient’s pain free mobility. In parallel with the CTS treatments, the team will build multivariate linear and generalized linear regression models to predict the CTS patient outcomes related to pain, physical function, and psychosocial assessments as a function of baseline disease characteristics. The computational work will be used to develop an optimized CTS ESStim dosing model. 

NOFO Title: HEAL Initiative: Harm Reduction Policies, Practices, and Modes of Delivery for Persons with Substance Use Disorders (R01 Clinical Trial Optional)
NOFO Number: RFA-DA-22-046
Summary:

While some people who use drugs do not carry or use naloxone, others respond to multiple overdoses over short periods of time. This project aims to identify characteristics and experiences of these individuals, known as “overdose responders,” toward better understanding barriers to naloxone use. The research will also test interventions to support the well-being of responders and to increase the number of community members ready and willing to give naloxone to reverse overdose. 

NOFO Title: HEAL Initiative: Human Pain-associated Genes & Cells Data Coordination and Integration Center (U24 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-22-021
Summary:

The primary goal of the PRECISION Human Pain network and its participating centers is to generate comprehensive datasets of molecular signatures and cellular function phenotypes or signatures of various cell types that underlie transmission and processing of pain signals in humans. To maximize the impact of the data generated through this effort, it is vital to standardize and integrate all data generated by the various centers and make these data available in a meaningful way to the larger scientific community. As the Data Coordination and Integration Center, this project will support the network to curate, harmonize, and effectively integrate center-generated datasets as well as provide operational support for the network and conduct educational and outreach efforts.

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-23-032
Summary:

Exposure of the developing fetus to opioids during pregnancy in women with opioid use disorder can lead to inefficient placenta function and impaired fetal brain development and neurodevelopmental outcomes. This project will measure molecules that circulate within maternal blood to identify specific indicators (biomarkers) of maternal health such as inflammation and changes in placental gene activity. The research will include a focus on specialized molecules released from the placenta called exosomes that carry information about the health of the placenta. These data will be combined with neurodevelopmental measures of infants at 1 year of age. Together, these studies will provide new molecular predictors (biomarkers) of placenta and fetal health.

NOFO Title: Notice of Special Interest (NOSI): Encourage Eligible NIH HEAL Initiative Awardees to Apply for Administrative Supplements to Support Career Enhancement Related to Clinical Research on Pain
NOFO Number: NOT-NS-22-087
Summary:

This project supports a post-doctoral trainee to develop the skills and knowledge needed to pursue a career in clinical pain research. The research will involve optimizing a GetActive mind-body activity program to overcome barriers that prevent disadvantaged older adult populations in community health clinics from access to non-pharmacological pain management strategies. The research will include qualitative analysis of secondary data, a literature review to evaluate methods, and feasibility for establishing a community advisory board for the GetActive project.

NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020
Summary:

The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first 10 years of life. This study will be conducted at Johns Hopkins University in Baltimore, Maryland, and researchers will recruit diverse participants from a range of backgrounds.