Funded Projects

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Project # Sort descending	Project Title	Research Focus Area	Research Program	Administering IC	Institution(s)	Investigator(s)	Location(s)	Year Awarded
1U01HL150568-01	Effects of experimental sleep disruption and fragmentation on cerebral Mu-opioid receptor function, Mu-opioid receptor agonist analgesia, and abuse liability.	New Strategies to Prevent and Treat Opioid Addiction	Sleep Dysfunction as a Core Feature of Opioid Use Disorder and Recovery	NHLBI	Johns Hopkins University	Smith, Michael T	Baltimore, MD	2019
NOFO Title: HEAL Initiative: Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder (OUD) and Response to Medication Assisted Treatment (MAT) (U01 Clinical Trial Optional) NOFO Number: RFA-HL-19-029 Summary: Chronic pain and opioid use disorders (OUD) are burgeoning interrelated epidemics. Sleep disturbances are prevalent, treatable, and increasingly recognized as risk factors for both chronic pain and OUD. Sleep disruption impairs endogenous pain inhibition, linked to analgesic efficacy and rewarding properties of mu-opioid receptor (MOR) agonists. It is not known, however, whether sleep disturbance causally alters mechanisms that contribute to OUD risk. Sleep continuity disruption (SCD) and/or sleep fragmentation (SF) may alter cerebral MOR availability, and these forms of sleep disruption may increase OUD risk. This study aims to 1) evaluate whether experimental SCD and/or SF alter resting or pain-evoked MOR binding potential (BP) in brain regions associated with pain inhibition; 2) examine whether SCD and/or SF alters the analgesic response; and 3) determine whether MOR BP in brain regions of interest are associated with analgesia and abuse liability.
1U01HL150596-01	The Collaboration Linking Opioid Use Disorder and Sleep ("CLOUDS") Study	New Strategies to Prevent and Treat Opioid Addiction	Sleep Dysfunction as a Core Feature of Opioid Use Disorder and Recovery	NHLBI	Yale University	YAGGI, HENRY KLAR (contact); BARRY, DECLAN T; REDEKER, NANCY S; SCHEINOST, DUSTIN	New Haven, CT	2019
NOFO Title: HEAL Initiative: Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder (OUD) and Response to Medication Assisted Treatment (MAT) (U01 Clinical Trial Optional) NOFO Number: RFA-HL-19-029 Summary: Opioid use disorder (OUD) is a chronic and relapsing brain disease that affects over 2 million Americans. Despite effective evidence-based treatments in the form of behavioral interventions and FDA-approved medication for addiction treatment (MAT), relapse rates are high. The Collaboration Linking Opioid Use Disorder and Sleep Study will investigate patients on MAT to elucidate potential causal mechanisms between sleep deficiency and OUD. The aims of this study are to 1) test whether there are different neurocognitive connectivity patterns between patients with adequate vs. deficient sleep in brain systems involved in addiction and assess the extent to which these “neural fingerprints” predict ongoing opioid use; 2) evaluate the potential biologic, psychiatric, and pharmacologic mechanisms that explain the causal pathway between sleep deficiency and opioid use; and 3) test ecologic factors such as psychosocial, family, and neighborhood contextual factors associated with OUD and their contribution to sleep deficiency among patients in MAT.
1U01HL150835-01	Evaluating the Role of the Orexin System in Circadian Rhythms of Sleep and Stress in Persons on Medication-Assisted Treatments for Opioid Use Disorder	New Strategies to Prevent and Treat Opioid Addiction	Sleep Dysfunction as a Core Feature of Opioid Use Disorder and Recovery	NHLBI	Johns Hopkins University	HUHN, ANDREW S (contact); FINAN, PATRICK	Baltimore, MD	2019
NOFO Title: HEAL Initiative: Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder (OUD) and Response to Medication Assisted Treatment (MAT) (U01 Clinical Trial Optional) NOFO Number: RFA-HL-19-029 Summary: For individuals with moderate to severe opioid use disorder (OUD), medication-assisted treatments (MATs) such as oral methadone and extended-release naltrexone (XR-NTX) are the gold standard in initiating and maintaining long-term recovery. Still, many patients struggle with persistent sleep disturbance and stress reactivity in the early stages of recovery, which drive relapse behaviors. This proposal constitutes a novel mechanistic approach to understanding the role of the orexin system in sleep disturbance and circadian rhythms of stress in OUD patients who are maintained on MATs and are early in recovery. This study will determine whether the FDA-approved sleep medication suvorexant (SUVO) improves sleep continuity and decreases diurnal measures of stress, and whether improvement of sleep/stress processes translates to improved OUD treatment outcomes. Its findings will fill critical gaps in our understanding of the role of the orexin system in sleep disturbance and circadian rhythms of stress that impact OUD recovery.
1U18EB029251-01	The Injectrode - A Truly Injectable Electrode for Dorsal Root Ganglion Stimulation to Treat Pain	Preclinical and Translational Research in Pain Management	Translating Discoveries into Effective Devices to Treat Pain	NIBIB	UNIVERSITY OF WISCONSIN-MADISON	LUDWIG, KIP A (contact); WEBER, DOUGLAS J	Madison, WI	2019
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.
1U18EB029257-01	Temporal Patterns of Spinal Cord Stimulation	Preclinical and Translational Research in Pain Management	Translating Discoveries into Effective Devices to Treat Pain	NIBIB	DUKE UNIVERSITY	GRILL, WARREN M	Durham, NC	2019
NOFO Title: HEAL Initiative: Translational Development of Devices to Treat Pain (U18 Clinical Trial Not Allowed) NOFO Number: RFA-EB-18-003 Summary: This project will design and test optimized temporal patterns of stimulation to improve the efficacy of commercially available spinal cord stimulation (SCS) systems to treat chronic neuropathic pain. Researchers will build upon a validated biophysical model of the effects of SCS on sensory signal processing in neurons within the dorsal horn of the spinal cord to better understand how to improve the electrical stimulus patterns applied to the spinal cord. They will use sensitivity analyses to determine the robustness of stimulation patterns to variations in electrode positioning, selectivity of stimulation, and biophysical properties of the dorsal horn neural network. Researchers will demonstrate improvements from these new stimulus patterns by 1) measuring their effects on pain-related behavioral outcomes in a rat model of chronic neuropathic pain and by 2) quantifying the effects of optimized temporal patterns on spinal cord neuron activity. The outcome will be mechanistically derived and validated stimulus patterns that are significantly more efficacious than the phenomenologically derived standard of care patterns; these patterns could be implemented with either a software update or minor hardware modifications to existing SCS products.