Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
3UG1DA040317-05S2
Medication treatment for Opioid-dependent expecting Mothers (MOMs): A Pragmatic Randomized Trial Comparing Extended-Release and Daily Buprenorphine Formulations (CTN-0080) Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA DUKE UNIVERSITY WU, LI-TZY T Durham, NC 2019
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.
5R01AI132030-02
MINING REAL-TIME SOCIAL MEDIA BIG DATA TO MONITOR HIV: DEVELOPMENT AND ETHICAL ISSUES Translation of Research to Practice for the Treatment of Opioid Addiction NIAID UNIVERSITY OF CALIFORNIA LOS ANGELES YOUNG, SEAN Los Angeles, CA 2018
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Social big data analysis of publicly available user data on social media platforms is a promising approach for attaining organic observations of behavior that can monitor and predict real-world public health problems, such as HIV incidence. In preliminary research, our team identified and collected tweets suggesting HIV risk behaviors (e.g., drug use, high-risk sexual behaviors), modeled them alongside CDC statistics on HIV diagnoses, and found a significant positive relationship between HIV-related tweets and county-level HIV cases. We propose to create a single automated platform that collects social media data, identifies and labels tweets that suggest HIV-related behaviors, and predicts regional HIV incidence. We will interview staff and participants at local and regional HIV organizations to understand ethical issues associated with mining people’s data. The software developed from this application will be shared with HIV researchers and health care workers to combat the spread of HIV.
1UG3DA050189-01
Using SMART Design to Identify an Effective and Cost-Beneficial Approach to Preventing OUD in Justice-Involved Youth New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA Seattle Children’s Hospital AHRENS, KYM R (contact); HAGGERTY, KEVIN P Seattle, WA 2019
NOFO Title: HEAL Initiative: Preventing Opioid Use Disorder in Older Adolescents and Young Adults (ages 16–30) (UG3/UH3 Clinical Trial Required
NOFO Number: RFA-DA-19-035
Summary:

Adolescents and young adults in justice settings (AYAJS) have some of the highest rates of opioid use disorder (OUD), with national rates approaching 20%. Multiple studies have established effectiveness of the Adolescent Community Reinforcement Approach with Assertive Continuing Care (ACRA/ACC) in reducing non-opioid substance use disorder (SUD); however, none have evaluated it as an OUD prevention strategy. SUD is common and costly among AYAJS; thus, ACRA/ACC-based approaches are likely to be effective and cost-beneficial OUD prevention strategies for this group. However, the optimal intensity of an ACRA/ACC-based OUD prevention intervention for AYAJS with and without non-opioid SUD is not known, as these groups are likely to have differing prevention needs. Seattle Children’s Hospital (SCH), University of Washington (UW), and Washington State Juvenile Rehabilitation (WSJR) will collaboratively evaluate ACRA/ACC-based OUD prevention strategies of different intensity levels among SUD and non-SUD youth.
1R43NR017575-01A1
Using Virtual Reality Psychological Therapy to Develop a Non-Opioid Chronic Pain Therapy Cross-Cutting Research Small Business Programs NINR COGNIFISENSE, INC. BAEUERLE, TASSILO; CEKO, MARTA ; WEBSTER, LYNN Sunnyvale, CA 2019
NOFO Title: PHS 2017-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])
NOFO Number: PA-17-302
Summary:

Chronic pain affects over 100 million Americans, costing society about $600 billion annually. Despite numerous pharmacological and non-pharmacological therapies, over 50% of chronic pain sufferers feel little control over their pain. CognifiSense has developed a patent-pending Virtual Reality Psychological Therapy (VRPT), which is designed to create lasting reduction of chronic pain by addressing the maladaptive learning processes driving pain chronification. VRPT is an experiential learning system, which provides the brain a new set of signals that teaches it that the pain is not as bad as it perceived and that it has greater control over the pain than it perceived. VRPT combines the immersive power and the ability to individualize the therapy of Virtual Reality with well-researched principles of self-distancing, self-efficacy, and extinction to retrain the brain. The goal of this study is to determine the clinical feasibility of VRPT in achieving a lasting reduction of chronic pain, establish brain mechanisms associated with treatment response, and collect comprehensive user feedback to enable further refinement of the current product prototype. CognifiSense's VRPT has the potential to be a significant clinical and business opportunity in the treatment of chronic pain.
3UG1DA040316-05S4
Exemplar Hospital Initiation Trial to Enhance Treatment Engagement (EXHIT ENTRE) Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA HENNEPIN HEALTHCARE RESEARCH INSTITUTE BART, GAVIN; JOSEPH, ANNE Minneapolis, MN 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Hospital inpatient stays due to opioid-related health problems are a reachable moment for increasing access to treatment with medications for opioid use disorder (MOUD). Hospitalized patients with opioid use disorder (OUD) are at particularly high risk for morbidity, mortality, and high medical costs in the U.S. This study will substantially inform the care management of OUD in hospitalized patients. The project includes a comparative effectiveness research trial and an implementation research trial, which will lead to models of broad dissemination for treatment approaches to this largely unaddressed population. They will examine whether (1) in hospitals with addiction medicine consultation services, hospital-initiated extended-release buprenorphine (XR-BUP), compared with other OUD medications, results in increased engagement in treatment with MOUD following hospital discharge and (2) training hospitals without such consultation services on best practices for initiating MOUD using consultation service hubs improves medication uptake in hospitals and increased MOUD treatment engagement following discharge.
3U24TR001608-04S1
TIN Supplement Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NCATS Duke University Benjamin, Daniel K. Durham, NC 2019
NOFO Title: CTSA Network - Trial Innovation Centers (TICs) (U24)
NOFO Number: RFA-TR-15-002
1UG3TR003149-01
hiPSC-based DRG Tissue Mimics on Multi-well Microelectrode Arrays as a Tissue Chip Model of Acute and Chronic Nociception 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 TEXAS DALLAS BLACK, BRYAN JAMES Dallas, TX 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 an innovative three-dimensional (3D) model of acute and chronic nociception using human induced pluripotent stem cell (hiPSC) sensory neurons and satellite glial cell surrogates. They will develop a tissue chip for modeling acute and chronic nociception based on 3D hiPSC-based dorsal root ganglion tissue mimics and a high-content, moderate-throughput microelectrode array. Researchers will demonstrate stable spontaneous and noxious stimulus-evoked behavior in response to thermal, chemical, and electrical stimulation challenges. They aim to demonstrate sensitivity to translational control via ligand receptor interactions between neuronal and non-neuronal cell types. They also will demonstrate the quantitative efficiency and preclinical efficacy of our system by detecting known ligand-based modulators of translational control and voltage-gated ion channel antagonists in a sensitized model of chronic nociception. Researchers will leverage the high-throughput nature of our tissue chip model to screen Food and Drug Administration–approved bioactive compounds.
3UG1DA013727-20S1
CTN Workforce Development Program Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA Medical University of South Carolina Brady, Kathleen Charleston, SC 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

The opioid epidemic has increased the demand for a research workforce with the necessary expertise and skills to conceptualize and carry out studies to expand and improve treatment options for opioid use disorders (OUDs). In particular, as the NIDA-funded Clinical Trials Network (CTN) expands the number of nodes and takes on additional studies as part of the HEAL Initiative, the need for an increasing number of staff who are familiar with the CTN research environment is amplified, and opportunities to provide a platform for training new investigators interested in the OUD area are increased. The CTN Research workforce development and dissemination program will provide multi-modal training, including didactic, experiential, and mentoring, to prepare research staff (regulatory personnel, study coordinators, project managers), post-doctoral fellows and faculty from a variety of disciplines (MD, PhD, PharmD, Nurse Practitioners, etc.) to participate in HEAL Initiative studies being conducted within the CTN.
1R43CA233371-01A1
Inhibiting soluble epoxide hydrolase as a treatment for chemotherapy inducedperipheral neuropathic pain Cross-Cutting Research Small Business Programs NCI EICOSIS, LLC BUCKPITT, ALAN R Davis, CA 2019
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 Not Allowed)
NOFO Number: PA-18-574
Summary:

 Investigating the broader efficacy of sEH inhibition and specifically our IND candidate, EC5026, has indicated that it is efficacious against chemotherapy induced peripheral neuropathy (CIPN). This painful neuropathy develops from chemotherapy treatment, is notoriously difficult to treat, and can lead to discontinuation of life-prolonging cancer treatments. Thus, new therapeutic approaches are urgently needed. The research team will investigate if EC5026 has potential drug-drug interaction with approved chemotherapeutics or alters immune cells function, and assess the effects of sEHI on the lipid metabolome and probe for changes in endoplasmic reticulum stress and axonal outgrowth in neurons. The team proposes to more fully characterize the analgesic potential of our compound and investigate on and off target actions in CIPN models and model systems relevant to cancer therapy.
3UG1DA040314-05S5
Determining the Optimal Duration of Buprenorphine Treatment to Reduce the Risk of Relapse, Overdose, and Mortality Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA KAISER FOUNDATION RESEARCH INSTITUTE CAMPBELL, CYNTHIA I; BRADLEY, KATHARINE ANTHONY; WEISNER, CONSTANCE M. Oakland, CA 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

This study seeks to address the priority of the optimal duration of buprenorphine treatment to reduce the risk of relapse, overdose and mortality outcomes using observational data. Answering this question with a randomized trial raises ethical concerns. Observational studies with large datasets can address these important questions relatively quickly. At the same time, observational studies pose their own methodologic challenges related to confounding, misclassification of exposure and outcome, and informative loss to follow-up. This study will identify and quantify the potential for these sources of bias and then conduct analyses to address the questions of interest (risk of relapse, overdose and mortality).
1U18EB029351-01
Development of an MRgFUS system for precision-targeted neuromodulation of pain circuits with simultaneous functional MRI Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NIBIB VANDERBILT UNIVERSITY MEDICAL CENTER CASKEY, CHARLES F (contact); CHEN, LI MIN ; GRISSOM, WILLIAM A Nashville, Tennessee 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 aims to develop a next-generation noninvasive neuromodulation system for non-addictive pain treatments. The research team will build an integrated system that uses magnetic resonance image-guided focused ultrasound (MRgFUS) stimulation to target pain regions and circuits in the brain with high precision. The system will use MR imaging to locate three pain targets commonly used in clinical pain treatments, to stimulate those targets with ultrasound, and to monitor responses of nociceptive pain circuits using a functional MRI readout. Three collaborating laboratories will tackle the goals of this project: (Aim 1) Develop focused ultrasound technology for neuromodulation in humans, compatible with the high magnetic fields in an MRI scanner. (Aim 2) Develop MRI technology to find neuromodulation targets, compatible with focused ultrasound transducers. (Aim 3) Validate the complete MRgFUS neuromodulation system in brain pain regions in nonhuman primates. By the end of the project, the research team will have a fully developed and validated MRgFUS system that is ready for pilot clinical trials in pain management.
3R21MD011767-02S1
SUPPLEMENT TO OPIOID PRESCRIBING DISPARITIES IN A PUBLIC HEALTH CRISIS Clinical Research in Pain Management NIMHD Research at Nationwide Children's - Nationwide Children's Hospital CHISOLM, DEENA; DEANS, KATHERINE J Columbus, OH 2018
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

African American adults are less likely to receive analgesics, particularly opioids. Research in the pediatric surgical population is limited, but the pattern of disparate use of opioids appears consistent with adults. Furthermore, adolescent access to prescribed opioids has increased, both through physician prescribing and misuse of medications prescribed to family members or friends. This study will explore the interrelated impacts of policy, clinical need, and sociodemographic factors by combining Medicaid claims and electronic health record data with findings from a statewide opioid policy inventory. We will focus on discharge prescribing of opioids in three high-volume pediatric surgical procedures: tonsillectomy/adenoidectomy, supracondylar fracture, and appendectomy. We aim to 1) determine the extent of racial disparities in postoperative discharge opioid prescribing since the 2011 onset of enhanced opioid prescription reduction activities and 2) develop an expanded model to assess the linkage between differential opioid use for pediatric postoperative pain and opioid use-related outcomes.
1UG3AR077360-01
A sequenced-strategy for improving outcomes in patients with knee osteoarthritis pain Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NIAMS JOHNS HOPKINS UNIVERSITY COHEN, STEVEN P (contact); CAMPBELL, CLAUDIA MICHELLE; CASTILLO, RENAN C Baltimore, MD 2019
NOFO Title: HEAL Initiative: Pain Management Effectiveness Research Network: Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)
NOFO Number: RFA-NS-19-021
Summary:

The goal of this proposal is to conduct a randomized controlled trial to evaluate the comparative effectiveness of conservative behavioral and nonopioid pharmacological treatments (Phase I) and, among nonresponders, the benefits of nonsurgical procedural interventions (Phase II). Aim 1 will evaluate the effectiveness of individual and combined online cognitive behavioral therapy (painTRAINER) and pharmacologic treatment (duloxetine) in improving pain and function for knee osteoarthritis (KOA) patients compared with standard of care. Aim 2 will determine if genicular nerve radiofrequency ablation or intra-articular injection of hyaluronic acid and steroid is more effective in improving outcomes than local anesthetic nerve block or standard of care and help establish the role of these interventional treatments in the overall management of pain in KOA patients. Aim 3 will test whether clinical and psychosocial phenotypes predict short- and long-term treatment response.
1UG3DA050317-01
Targeting the Ghrelin System for Novel Opioid Use Disorder Therapeutics Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA The University of Texas Medical Branch at Galveston Cunningham, Kathryn Galveston, TX 2019
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:

To address the need for novel therapeutics for opioid use disorder (OUD), this research group identified ghrelin as an endogenous regulator of the mesocorticostriatal circuit, which contributes to the enhanced motivational attributes of addictive drugs and drug-associated cues. Ghrelin binds to the growth hormone secretagogue receptor 1? (GHS1?R) to transduce several physiological and behavioral processes, including the reward-related effects of opioid agonists. Systemic administration of a GHS1?R antagonist/inverse agonist dose-dependently attenuated self-administration of the addictive opioid analgesic oxycodone as well as oxycodone-seeking. This project proposes to employ a suite of validated rodent OUD models to define the preclinical profile for PF5190457, a selective GHS1?R antagonist/inverse agonist. PF5190457’s abuse liability, ability to suppress withdrawal and relapse-like behaviors, drug metabolism and pharmacokinetics, and brain penetrability in rats will be assessed. Phase 1 clinical studies in non–treatment seeking OUD participants will follow to assess the safety and tolerability of PF5190457.
3U01DE025633-03S1
INVESTIGATION AND MODULATION OF THE MU-OPIOID MECHANISM IN CHRONIC TMD (IN VIVO) Preclinical and Translational Research in Pain Management NIDCR UNIVERSITY OF MICHIGAN AT ANN ARBOR DASILVA, ALEXANDRE ANN ARBOR, MI 2018
NOFO Title: Biology of the Temporomandibular Joint in Health and Disease (R01)
NOFO Number: PA-14-358
Summary:

Initial studies using positron emission tomography (PET) with [11C] carfentanil, a selective radiotracer for ?-opioid receptor (?OR), have demonstrated that there is a decrease in thalamic µOR availability (non-displaceable binding potential BPND) in the brains of TMD patients during masseteric pain compared to healthy controls. ?-opioid neurotransmission is arguably one of the mechanisms most centrally involved in pain regulation and experience. The main goals of our study are: first, to exploit the ?-opioidergic dysfunction in vivo in TMD patients compared to healthy controls; second, to determine whether 10 daily sessions of non-invasive and precise M1 HD-tDCS have a modulatory effect on clinical and experimental pain measures in TMD patients; and third, to investigate whether repetitive active M1 HD-tDCS induces/reverts ?OR BPND changes in the thalamus and other pain-related regions and whether those changes are correlated with TMD pain measures.
3R01LM010685-09S1
BEYOND PHEWAS: RECOGNITION OF PHENOTYPE PATTERNS FOR DISCOVERY AND TRANSLATION - ADMINISTRATIVE SUPPLEMENT Preclinical and Translational Research in Pain Management NLM VANDERBILT UNIVERSITY MEDICAL CENTER Denny, Joshua C. NASHVILLE, TN 2018
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Genomic medicine offers hope for improved diagnostic methods and for more effective, patient-specific therapies. Genome-wide associated studies (GWAS) elucidate genetic markers that improve clinical understanding of risks and mechanisms for many diseases and conditions and that may ultimately guide diagnosis and therapy on a patient-specific basis. Previous phenome-wide association studies (PheWAS) established a systematic and efficient approach to identifying novel disease-variant associations and discovering pleiotropy using electronic health records (EHRs). This proposal will develop novel methods to identify associations based on patterns of phenotypes using a phenotype risk score (PheRS) methodology to systematically search for the influence of Mendelian disease variants on common disease. By doing so, it also creates a way to assess pathogenicity for rare variants and will identify patients at highest risk of having undiagnosed Mendelian disease. The project is enabled by large DNA biobanks coupled to de-identified copies of EHR.
1RF1NS113883-01
Sympathetic-mediated sensory neuron cluster firing as a novel therapeutic target for neuropathic pain Preclinical and Translational Research in Pain Management Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain NINDS JOHNS HOPKINS UNIVERSITY DONG, XINZHONG Baltimore, MD 2019
NOFO Title: Discovery and Validation of Novel Targets for Safe and Effective Pain Treatment (R01 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-18-043
Summary:

An important component of neuropathic pain is spontaneous or ongoing pain, such as burning pain or intermittent paroxysms of sharp and shooting pain, which may result from abnormal spontaneous activity in sensory nerves. However, due to technical limitations, spontaneous activity in sensory neurons in vivo has not been well studied. Using in vivo imaging in genetically-modified mice, preliminary findings identified spontaneously-firing clusters of neurons formed within the dorsal root ganglia (DRG) after traumatic nerve injury that exhibits increased spontaneous pain behaviors. Furthermore, preliminary evidence has been collected that cluster firing may be related to abnormal sympathetic sprouting in the sensory ganglia. This project will test the hypothesis that cluster firing is triggered by abnormal sympathetic inputs to sensory neurons, and that it underpins spontaneous paroxysmal pain in neuropathic pain models. Findings from this project will identify potential novel therapeutic targets for the treatment of neuropathic pain.
1UM1DA049415-01
HEALing Communities Study - New York Translation of Research to Practice for the Treatment of Opioid Addiction HEALing Communities Study NIDA COLUMBIA UNIV NEW YORK MORNINGSIDE EL-BASSEL, NABILA New York, NY 2019
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. Columbia University 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.
3R01DA044778-02S1
EXTENSION OF RISK FOR PRESCRIPTION OPIOID MISUSE IN ADOLESCENTS WITH THE FULL AGE SPECTRUM OF ADOLESCENCE THROUGH EMERGING ADULTHOOD New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA Oregon Health & Science University Feldstein Ewing, Sarah W.; Wilson, Anna Camille (contact) Portland, OR 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Current rates of prescription opioid misuse are rising to epidemic levels among adults. These rates may be even higher among adolescents and young adults (AYAs), who have elevated levels of substance exploration and misuse during this precise developmental period. AYAs who are exposed to opioids via legitimate prescriptions by age 18 are at increased risk for misuse after high school. However, there is a substantial gap in our knowledge of what factors might contribute to the development of misuse and related poor outcomes in these high-risk youth. Identifying factors that convey risk for increasing opioid use and problematic use would inform AYA models of opioid abuse and inform the development of preventive interventions to modify risk in medical settings, which are a unique point of entry into opioid use, and a key setting in which to examine AYA outcomes. We will use a developmental model of the impact of opioid exposure by legitimate prescription during late adolescence, with consideration for pain and psychological characteristics of the individual within the psychosocial (family, peer, educational and work context). Determining mechanisms and moderators of risk during this developmental transition will provide critical information for the design of interventions aimed at reducing opioid use disorders in at-risk AYA.
1R34DA050285-01
3/5 The Cumulative Risk of Substance Exposure and Early Life Adversity on Child Health Development and Outcomes Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development (HBCD) Study NIDA UNIV OF MARYLAND, COLLEGE PARK FOX, NATHAN A College Park, MD 2019
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.
1R61AT010800-01
Effectiveness of a CBT-based mHealth Intervention Targeting MOUD Retention, Adherence, and Opioid Use Cross-Cutting Research Small Business Programs NCCIH UCLA GLASNER-EDWARDS, SUZETTE V Los Angeles, CA 2019
NOFO Title: HEAL Initiative: Behavioral Research to Improve MAT: Behavioral and Social Interventions to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-AT-19-006
Summary:

Medications for the treatment of opioid use disorders (MOUD) are effective at reducing opioid use, opioid overdose risk, and opioid-related deaths; however, retention and adherence to MOUD treatment, particularly buprenorphine (BUP), are discouragingly low. The objective of the current research is to adapt and extend a cognitive behavioral therapy-based short message system (SMS) intervention (TXT-CBT) to address MOUD treatment retention and adherence using the imFREE (Interactive Messaging for Freedom from Opioid Addiction) platform. imFREE builds upon the efficacious SMS-based TXT-CBT intervention, with content addressing retention and adherence to BUP, including mitigating risk factors for dropout, and features to notify social and provider support contacts in the face of treatment discontinuation and/or other indicators of relapse and overdose risk. By providing support to maximize BUP treatment adherence, coupled with skills to prevent relapse, imFREE may provide a cost-effective, easily deployable strategy for OUD treatment and prevention of overdose deaths.
1RF1NS113840-01
Nrf2 Activation for Addiction-Free Treatment of Neuropathic Pain Preclinical and Translational Research in Pain Management Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain NINDS UNIVERSITY OF TX MD ANDERSON CAN CTR GRACE, PETER MICHAEL Houston, TX 2019
NOFO Title: Discovery and Validation of Novel Targets for Safe and Effective Pain Treatment (R01 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-18-043
Summary:

Effective treatments are elusive for the majority of patients with neuropathic pain. Reactive oxygen and nitrogen species (ROS/RNS) are involved in neuropathic pain, because they drive mitochondrial dysfunction, cytokine production, and neuronal hyperexcitability; therefore, stimulation of endogenous antioxidants is predicted to simultaneously resolve multiple neuropathic pain mechanisms. Nuclear factor erythroid 2-related factor 2 (Nrf2) is a transcription factor that is a potential therapeutic target because it regulates the expression of a large number of endogenous antioxidant-related genes and can be activated with a single drug. This project will test the hypothesis that Nrf2 activation increases multiple endogenous antioxidants, therefore reversing neuropathic pain behaviors and counteracting neuropathic pain mechanisms that are driven by ROS/RNS and could provide an effective pain therapy, with minimal abuse/addictive potential.
1R03DA046011-01A1
Opioid sparing potential of light-induced analgesia: a pilot trial of a novel, non-pharmacological treatment for pain Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA DUKE UNIVERSITY Gulur, Padma Durham, NC 2019
NOFO Title: NIDA Small Research Grant Program (R03 Clinical Trial Required)
NOFO Number: PA-18-634
Summary:

Exposure to opioid analgesics during medical care is a key driver of the opioid epidemic. Such exposures are widespread. Yet opioids remain essential first-line agents in treating pain, and it remains vital that pain be appropriately managed. Non-opioid pain treatments help to resolve the opioid/pain conflict. This project will examine the opioid-sparing and pain-relieving potential of a novel, non-pharmacological treatment for pain, using the effects of green light exposure to reduce pain and thereby reduce the quantity of opioids needed for pain relief.
3U19TW007401-14S1
EXPLORATION, CONSERVATION, & DEVELOPMENT OF MARINE BIODIVERSITY IN FIJI AND THE SOLOMON ISLANDS Preclinical and Translational Research in Pain Management FIC GEORGIA INSTITUTE OF TECHNOLOGY HAY, MARK E ATLANTA, GA 2018
NOFO Title: Limited Competition: International Cooperative Biodiversity Groups (U19)
NOFO Number: RFA-TW-13-001
Summary:

This International Cooperative Biodiversity Group application aims to discover and develop small molecule drug leads from cultured marine microbes and diverse coral reef organisms collected from Fiji and the Solomon Islands. Drug discovery efforts will focus on four major disease areas of relevance to the United States and low- and middle-income countries: infectious disease, including tuberculosis and drug-resistant pathogens; neglected tropical diseases, including hookworms and roundworms; cancer; and neurodegenerative and central nervous system disorders. Screening in these therapeutic areas will be performed in collaboration with two major pharmaceutical companies, two highly respected academic groups, and various testing centers and government resources that are available to facilitate drug discovery and development. The acquisition of source material for this program will be linked to biotic surveys, informed by ecological investigations addressing the chemical mediation of biotic interactions, and enriched using ecology-based strategies designed to maximize secondary metabolite production and detection.
1UG3TR003081-01
Multi-organ human-on-a-chip system to address overdose and acute and chronic efficacy and off-target toxicity 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 CENTRAL FLORIDA HICKMAN, JAMES J (contact); SHULER, MICHAEL L Orlando, FL 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:

This project will build overdose models for fentanyl, methadone, codeine, and morphine in a multi-organ system and evaluate the acute and repeat dose, or chronic effects, of overdose treatments as well as off-target toxicity. Researchers developed a system using human cells in a pumpless multi-organ platform that allows continuous recirculation of a blood surrogate for up to 28 days. They will develop two overdose models for male and female phenotypes based on pre-B?tzinger Complex neurons and will integrate functional immune components that enable organ-specific or systemic monocyte actuation. Models for cardiomyopathy and infection will be utilized. Researchers will establish a pharmacokinetic/pharmacodynamic model of overdose and treatment to enable prediction for a range of variables. We will use a serum-free medium with microelectrode arrays and cantilever systems integrated on chip that allow noninvasive electronic and mechanical readouts of organ function.