Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
1U01DA047982-01
Long-acting buprenorphine vs. naltrexone opioid treatments in CJS-involved adults Translation of Research to Practice for the Treatment of Opioid Addiction Justice Community Opioid Innovation Network (JCOIN) NIDA NEW YORK UNIVERSITY SCHOOL OF MEDICINE LEE, JOSHUA D; FARABEE, DAVID J; MARSCH, LISA A; SCHWARTZ, ROBERT P; SPRINGER, SANDRA ANN; WADDELL, ELIZABETH NEEDHAM New York, NY 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:

This study will assess the implementation of an evidence-based treatment in correctional settings by comparing the effectiveness of two medications used to treat opioid use disorder—extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX)—among adults currently incarcerated in U.S. jails and prisons at five distinct trial sites. This study will allow providers, correctional and public health authorities, payers, and policymakers’ timely and relevant data to assess the effectiveness of these medications as potentially useful re-entry treatment options. Findings from this study have implications for expanding public safety and limiting the societal costs of heroin, fentanyl, and prescription opioid addictions.
1U24NS114416-01
Duke Pain Early-phase Research Clinical Center (PERC) Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS DUKE UNIVERSITY LIMKAKENG, ALEXANDER TAN (contact); PORTER, LAURA S Durham, NC 2019
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:

Managing persistent pain has long been a difficult challenge, one that is heightened by the recent opioid crisis. Although many potential solutions may exist, demonstrating their efficacy in a multicenter trial is a considerable obstacle. There is broad consensus that a nationwide clinical research network is necessary to promote innovation. A hub-spoke complex of academic medical centers with considerable experience in pain management clinical trials and biomarker validation will leverage existing resources to make clinical trial execution efficient and rapid. Together, spokes will provide maximum flexibility, ready to accommodate studies in any well-characterized pain condition.
1R44DA049630-01
Opioid-Sparing pain management for Chronic Low Back Pain patients using TMC-CP01 - A VANISH (Virtual Autonomic Neuromodulation Induced Systemic Healing) based program Cross-Cutting Research Small Business Programs NIDA TAMADÉ, LLC TIEN, CELINE (contact); LUCAS, GALE ; MAHAJAN, AMAN Pasadena, CA 2019
NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-019
Summary:

Opioids have been found to be ineffective for chronic lower back pain (CLBP), yet they are still commonly prescribed. TAMADÉ, LLC aims to leverage a novel and validated technology based on virtual reality (VR) to provide therapy to CLBP patients on a daily opioid dosage with an opioid-sparing pain management tool aiming to increase pain management efficacy and decrease health complications. The intervention uses VR to stimulate patients’ visual, auditory, and haptic fields in order to simultaneously distract and actively engage patients in biofeedback therapy, where patients consciously self-regulate their nervous system by paring down their sympathetic tone through exercises in controlling respiration and heart rate. The study will compare patients receiving the proposed VR-based intervention with a group receiving either just opioids or opioids with sham VR. All groups will receive the same opioid tapering guidelines.
1UG3TR003148-01
Multi-organ-on-chip device for modeling opioid reinforcement and withdrawal, and the negative affective component of pain: a therapeutic screening tool. Preclinical and Translational Research in Pain Management Translational Research to Advance Testing of Novel Drugs and Human Cell-Based Screening Platforms to Treat Pain and Opioid Use Disorder NCATS UNIVERSITY OF CALIFORNIA LOS ANGELES MAIDMENT, NIGEL T (contact); ASHAMMAKHI, NUREDDIN ; SEIDLITS, STEPHANIE KRISTIN; SVENDSEN, CLIVE NIELS Los Angeles, CA 2019
NOFO Title: HEAL Initiative: Tissue Chips to Model Nociception, Addiction, and Overdose (UG3/UH3 Clinical Trial Not Allowed)
NOFO Number: RFA-TR-19-003
Summary:

Researchers will develop multi-organ, microphysiological systems (MPSs) based on human induced pluripotent stem cell-derived midbrain-fated dopamine (DA)/gamma-aminobutyric acid neurons on a three-dimensional platform that incorporates microglia, blood–brain barrier (BBB), and liver metabolism. RNA sequencing and metabolomics analyses will complement the primary DA release measure to identify novel mechanisms contributing to chronic opioid-induced plasticity in DA responsiveness. The chronic pain-relevant aspect of the model will be realized by examination of aversive kappa-mediated opioid effects on DA transmission in addition to commonly abused mu opioid receptor agonists, and by incorporation of inflammatory-mediating microglia. Incorporation of BBB and liver metabolism modules into the microphysiologic system platform will permit screening of drugs. Throughput will be increased by integration of online sensors for online detection of DA and other analytes. Researchers will use a curated set of 100 chemical genomics probes.
1UH2AR076729-01
The Spine Phenome Project: Enabling Technology for Personalized Medicine Clinical Research in Pain Management Back Pain Consortium Research Program NIAMS OHIO STATE UNIVERSITY MARRAS, WILLIAM STEVEN (contact); KHAN, SAFDAR N; WEAVER, TRISTAN E Columbus, OH 2019
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.