Funded Projects

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:

Current diagnostics and treatments of chronic low back pain (cLBP) rely primarily on subjective metrics and do not target all the multidimensional biopsychosocial mechanisms. This multidisciplinary effort will develop and validate a digital health platform and provide meaningful data-driven metrics that enable an integrated approach to clinical evaluation and treatment of cLBP. This platform will facilitate the use of quantitative spinal motion metrics (function), patient-reported outcomes, and patient preference information to enable deep patient phenotyping and inform clinical decision making on personalized treatments in order to improve outcomes. This effort will involve software and hardware development to enable data collection, analysis, and visualization in clinical settings. The outcome of this project will be a digital health platform with data to support regulatory submission for clinical use. At the end of this effort, the researchers will have a validated tool for integration in clinical research studies supported by the BACPAC Consortium.

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

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:

Most opioid misuse begins during adolescence and young adulthood. Adolescence is the best time for prevention interventions in settings like school-based health centers (HCs), yet few programs focus on preventing initiation of opioid misuse. This study harnesses the power of video game interventions and incorporates components of effective substance use prevention programs to develop an evidence-informed intervention to prevent the initiation of opioid misuse in adolescents. In partnership with the national School-Based Health Alliance (SBHA), researchers will develop and test a new video game intervention, PlaySmart. It will build on our previous video game intervention that has demonstrated efficacy in improving attitudes and knowledge related to risk behaviors. The study will evaluate the game in a randomized controlled trial in 10 school-based HCs and examine strategies for implementing PlaySmart in school-based HCs nationally. This research has considerable potential for wide implementation, reach, and impact on high-risk adolescents through school-based HCs.

NOFO Title: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-23-006
Summary:

This project will develop PIDA, which will allow researchers to measure the activity of pain-sensitive human neurons in response to pain stimuli and potential pain treatments. The tool will use automated digital microscopes in the absence or presence of a potential pain medication. Since this tool contains human neurons, it may be more effective at predicting the efficacy of potential pain drugs in human patients than the animal models that are currently used.

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:

Fatal opioid overdose rates are higher among American Indian/Alaska Native populations than among Hispanics, African Americans, and Asian Americans, and are just below non-Hispanic Whites. AI/AN opioid overdose rates vary significantly by state and county; however, tribe-level differences are difficult to ascertain due to decentralized data systems that divide state health data and Indian Health Service data. This study will conduct a two-phase research project that leverages Center for Disease Control funding awarded to the Albuquerque Area Southwest Tribal Epidemiology Center for improving data quality in opioid overdose surveillance in New Mexico. In the first phase, geocoding and data linkages will be studied to address the need in New Mexico for tribe-specific data and analyses on opioid use disorder and opioid overdose. After disseminating analyses to tribal communities and Indian Health Service, Tribal and Urban Indian health facilities, the second phase of the study will establish a collaboration with interested tribes and facilities in a community-based participatory intervention research project to develop and test a culturally centered implementation program for providing medication for opioid use disorders to American Indian people.

NOFO Title: HEAL Initiative: Translational Development of Devices to Treat Pain (U18 Clinical Trial Not Allowed)
NOFO Number: RFA-EB-18-003
Summary:

While traditional epidural spinal cord stimulation (SCS) for intractable pain has been very efficacious for the patients responsive to it, the success rate has held at approximately 55%. Dorsal root ganglion (DRG) stimulation has shown promise in early trials to provide greater pain relief. Although the decrease in back pain at 3 months was significantly greater in the DRG arm vs. SCS, the adverse event rate related to the device or implant procedure was significantly higher in the DRG arm. Researchers will develop the “Injectrode” system to make the procedure simpler and safer by using an alternative to implantation: using an injectable pre-polymer liquid composite that cures quickly after injection adjacent to the DRG. They will compare an Injectrode-based system with traditional electrode stimulation at the DRG as an alternative to opioid administration. Researchers will perform benchtop characterization and refinement as a precursor to a clinical study, use modeling and animal testing to refine the efficiency of energy transfer from a transcutaneous electrical nerve stimulation unit to an Injectrode/Injectrode collector concept, and optimize the procedure for the complex anatomy of the human DRG.

NOFO Title: Discovery of Biomarkers, Biomarker Signatures, and Endpoints for Pain (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-NS-18-041
Summary:

Debilitating pain is the most common complication of sickle cell disease (SCD), but there is significant variability in pain expression in these patients. Currently, there is no plasma biomarker that can prognosticate which patients are likely to experience pain. The overall goal of this proposed research is to develop a biomarker that prognosticates the clinical expression of pain in SCD. Project aims are to (1) derive the inflammatory index for pain by identifying inflammatory and immune regulatory gene probe sets that will distinguish healthy controls, patients with SCD in baseline health, and patients with SCD in acute pain and (2) determine whether co-expressed genes from patients with SCD correlate with clinical pain data. Subsequent aims are to (1) determine the clinically meaningful changes of the index in patients with SCD and (2) investigate the preliminary clinical validity of the index as a prognostic biomarker for pain in patients with SCD.

NOFO Title: HEAL Initiative: Sleep Predictors of Opioid-Use Disorder Treatment Outcomes Program (R01 Clinical Trial Optional)
NOFO Number: RFA-DA-23-059
Summary:

Medications used to treat opioid use disorder (OUD) such as methadone and buprenorphine can cause central sleep apnea—a condition in which an individual momentarily stops breathing during sleep. This project will evaluate whether central sleep apnea, by worsening sleep quality and causing low blood oxygen levels, leads to nighttime arousal and emotional distress, which in turn increases the risk of relapse in individuals receiving treatment for OUD.

NOFO Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trials Not Allowed)
NOFO Number: RFA-NS-19-025
Summary:

The Icahn School of Medicine at Mount Sinai (ISMMS) will support the mission of the Early Phase Pain Investigation Clinical Network (EPPIC-Net), through the ISMMS Department of Neurology as the core of a hub and spokes structure. The study contains four specific aims: (1) to streamline and optimize rapid implementation of EPPIC-Net studies, exceeding the required minimum of 100 subjects recruited per year to EPPIC-Net studies; (2) to ensure access to patient populations with a wide range of pain disorders, including CLBP, using a hub and spokes model to ensure effective recruitment; (3) to provide the highest-quality protocol implementation, deep clinical phenotyping of pain disorders, and accurate and complete data collection; and (4) to work collaboratively with the EPPIC-Net Coordinating Centers and investigators from the NIH HEAL Partnership to assist with development/design of clinical trials. The study team will also increase training opportunities through EPPIC-Net within ISMMS and the larger pain research community, training junior investigators to become future pain clinical trials leaders and increase and disseminate knowledge about pain research throughout the network.

NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Consortium Administrative Core (U24 - Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-022
Summary:

The HEALthy Brain and Child Development National Consortium (HBCD-NC) Administrative Core (HCAC) will coordinate efforts across all sites in the HBCD-NC consortium to ensure that the consortium meets its primary objective to establish a normative model of developmental trajectories over the first 10 years of life. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. The HCAC will oversee study design and monitor the progress of each site’s ability to carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. This administrative core is located at the University of California, San Diego.

NOFO Title: HEAL Initiative: Secondary Analysis and Integration of Existing Data Related to Acute and Chronic Pain Development or Managementin Humans (R21 Clinical Trials Not Allowed)
NOFO Number: RFA-DE-22-011
Summary:

Pain is common, complex, and debilitating in many cancer patients. Although adequate pain management can significantly improve health-related quality of life for these individuals, substantial disparities limit care access, especially among underserved populations. After the 2014 Drug Enforcement Agency policy that raised the risk potential of the opioid hydrocodone (from Schedule III to Schedule II), few studies examined the impact of this policy on pain management strategies and outcomes among cancer patients. This project will use national cancer registry data linked with Medicare claims to assess the change in opioid and non-opioid medication use among older lung cancer patients before and after this policy change. By focusing on older racial/ethnic minority groups dually eligible for both Medicare and Medicaid, the research will also examine disparities in the use of medications for pain management and service use consistent with inadequate pain management.

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:

Despite increased efforts to understand the neurodevelopmental sequelae of in utero opioid and other substance exposure on long-term behavioral, cognitive, and societal outcomes, important questions remain, specifically, 1) How is brain growth disrupted by fetal substance and related pre- and post-natal exposures? and 2) How are these disrupted growth patterns causally related to later cognitive and behavioral outcomes? This project seeks to formulate an approach to addressing these key questions and decipher the individual and cumulative effect of these intertwined pre- and post-natal exposures on child neurodevelopment. First, researchers will address the legal, ethical, and mother-child care and support concerns implicit in this study. Next, they will integrate across our areas of neuroimaging expertise to develop, implement, and harmonize a multi-modal MRI and EEG protocol to assess maturing brain structure, function, and connectivity. Finally, researchers will develop and test advanced statistical approaches to model and analyze this multidimensional and longitudinal data.

NOFO Title: Notice of Special Interest for HEAL Initiative: Request for Administrative Supplements to Existing Grants for Identification and Validation of New Pain and Opioid Use Disorder Targets within the Understudied Druggable Genome
NOFO Number: NOT-TR-20-008
Summary:

This project will establish a rapid research pipeline for linking plant-derived compounds to nociception (pain) and to G Protein-Coupled Receptors (GPCRs) and ion channels in the druggable human genome. As more than 80% of these membrane proteins are conserved in the C. elegans nematodes, the study will screen for compounds and genes affecting nociception as well as to identify novel ligand-receptor pairs using this model organism. The study will test which understudied GPCRs and ion channels are involved in nociception as well as attraction or repulsion behaviors. This research has the potential to reveal novel ligand-receptor pairs that could serve as new entry points for improved or alternative pain treatments.