Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
1R43DA049650-01
Patient-level Risk Identifier Models for a Multifactor Opioid Abuse Risk Assessment Strategy Cross-Cutting Research Small Business Programs NIDA PRINCIPLED STRATEGIES, INC. DuBose, Paul ENCINITAS, 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:

This project, a partnership with Principled Strategies, will develop innovative, patient-level models for opioid risk identification and integrate them into the SafeUseNow managed care system—an actionable solution for combating prescription drug abuse that currently operates at the prescriber level only. Incorporating patient-level risk identifier models will strengthen an already powerful and demonstrably effective program and constitutes a critical step in generating a first-in-class, multifactor risk assessment strategy that is truly holistic. Using a variety of data sources, advanced analytics, and multiple empirically validated risk identification models, the groundbreaking advancement in SafeUseNow technology will enable health care stakeholders to identify combinations of prescribers, patients, and pharmacies whose behaviors may contribute to prescription drug abuse. This project will work to obtain new datasets for analysis, assess them, and use them to build national patient-level risk models for relevant outcomes, which will enable the development and evaluation of a next-generation prototype for a patient-level version of SafeUseNow.
3UG1DA015831-21S3
National Institute on Drug Abuse Clinical Trial Network: New England Consortium Node Cross-Cutting Research Training the Next Generation of Researchers in HEAL NIDA Yale University D’ONOFRIO, GAIL New Haven, CT 2022
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:

The goal of this project is to discover potential targets for emergency department-based interventions that could enhance access to addiction treatment among Black and Latino individuals, who face significant disparities in access to ongoing addiction treatment. Through qualitative interviews with Black, Latino, and non-Latino White patients receiving emergency department-initiated buprenorphine, the research will identify patterns of barriers and facilitators for continuation of opioid use disorder treatment outside of the emergency department through a referral. The study will also evaluate differences in factors previously identified as predictors of worse treatment outcomes in these patient groups, including opioid overdose, polysubstance use, major depressive disorder, and stigma.
1R01HD113188-01
Impact of Maternal Substance Use on Offspring Neurobehavioral Development Enhanced Outcomes for Infants and Children Exposed to Opioids The Biology of Opioid Exposure During Pregnancy and Effects on Early Neuro-Behavioral Development NICHD MASSACHUSETTS GENERAL HOSPITAL EDLOW, ANDREA GOLDBERG (contact); BOGDAN, RYAN H; LO, JAMIE ; SULLIVAN, ELINOR L Boston, MA 2023
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-23-031
Summary:

Opioid use disorder with simultaneous misuse of cannabis and alcohol during pregnancy is associated with increased risk for several infant neurodevelopmental problems. This project will evaluate the effects of opioids and other substances of misuse on the mother’s immune system by studying maternal immune cells and measuring molecules in her blood. The research will also study the role of the nerve communication molecule serotonin produced by the placenta. This research will take advantage of data from the HEALthy Brain and Child Development Study that is focused on child development measures. Together, these studies will provide important new insights into the ways misused substances affect infant brain development and neurodevelopmental outcomes.
1K24NS126570-01
Mentorship in Precision Pain Medicine via the Early Phase Pain Investigation Clinical Network Clinical Research in Pain Management NINDS Brigham and Women's Hospital Edwards, Robert R Boston, MA 2021
NOFO Title: Midcareer Investigator Award in Patient-Oriented Research (Parent K24 Independent Clinical Trial Required)
NOFO Number: PA-20-193
Summary:

Throughout clinical pain research, there is a need to increase the workforce of researchers familiar with individualized treatment strategies known as precision pain medicine. This mentoring award will leverage EPPIC-Net’s Clinical Coordinating Center resources to encourage interest in clinical pain management, in particular through multidisciplinary pain research projects. A selected clinician-researcher  will mentor early career investigators and provide them with hands-on training activities and other skill-building experiences in clinical pain research, with a focus on precision pain medicine, biomarker development, and pain assessment. Mentoring activities will include formal educational coursework, inclusion in EPPIC-Net working groups, and collaborative writing experiences.
1K01DA044279-01A1
PREVENTING SUBSTANCE USE AMONG YOUTH: BEHAVIORAL AND ECONOMIC IMPACT OF ENHANCED IMPLEMENTATION STRATEGIES FOR COMMUNITIES New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA University of Michigan Ann Arbor EISMAN, ANDRIA B Ann Arbor, MI 2019
NOFO Title: Mentored Research Scientist Development Award (Parent K01)
NOFO Number: PA-16-190
Summary:

Quality implementation of evidence-based programs (EBPs) in community settings for youth is critical for reducing the burden of alcohol, tobacco and other drug (ATOD) use and its consequences. EBPs delivered in schools are an efficient way to reach large populations of young people, including those underserved by other settings, and reduce and prevent ATOD use. Yet youth rarely receive EBPs as intended in community settings, including schools. This training and research plan will prepare the investigator to become an independent scholar in the implementation of theories and frameworks to better understand factors related to program delivery—approaches to enhancing ATOD programs for youth in community settings. More specifically, the training will allow him to expand the application of Consolidated Framework for Implementation Research (CFIR) to inform approaches to enhancing effective EBP delivery. The proposed training and research plan extends current implementation research to focus applying implementation theories, frameworks and strategies in other community settings (schools) and on economic evaluation of implementation strategies. The results are expected to improve current efforts to deliver EBPs in diverse community settings and aid in applying evidence-based implementation strategies in the school context to ultimately reduce and prevent ATOD use among youth.
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.
1UH3NS115118-01
Transcranial focused ultrasound for head and neck cancer pain. A pilot study Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NINDS UNIVERSITY OF VIRGINIA ELIAS, WILLIAM JEFFREY Charlottesville, VA 2019
NOFO Title: HEAL Initiative: Clinical Devices to Treat Pain (UH3 Clinical Trial Optional)
NOFO Number: RFA-NS-19-018
Summary:

Head and neck cancer is particularly susceptible to nociceptive and neuropathic pains because it is dense with sensitive anatomic structures and richly innervated. Transcranial magnetic resonance imaging–guided focused ultrasound (FUS) is a new stereotactic modality capable of delivering high-intensity energy through the intact human skull with submillimeter precision. This clinical trial will target the spinothalamic and spinoreticular pain circuits by unilateral FUS mesencephalotomy, an effective procedure for cancer pain but limited by the accuracy of its era. The primary aim is to assess the safety and preliminary effectiveness in six head and neck cancer patients with opioid-resistant pain. Researchers will investigate the potential mechanism of pain relief as the mesencephalotomy target involves the confluence of the ascending and descending pain systems. Aims 2 and 3 will investigate these systems with electrophysiology specific for the spinothalamic tract and carfentenil positron emission tomography imaging that measures the brain’s endogenous opioids.
1UG3DA048388-01
Cannabidiol Effects on Craving and Relapse Prevention in Opioid Use Disorder Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA INSYS DEVELOPMENT COMPANY ELKASHEF, AHMED Chandler, AZ 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 tackle the national public health emergency posed by opioid misuse, addiction, and overdose deaths, the development of effective new medications and the FDA drug approval process must be accelerated. In response to this call, INSYS Development Company, Inc. (INSYS) has developed a cannabidiol (CBD) oral solution that shows promise as a novel medication for prevention of relapse that addresses one of the five opportunities specified in the HEAL Initiative to improve treatment options. The first phase of this project involves clinical trials of CBD on cue-induced cravings, modulation of withdrawal, alterations of negative affect states, relapse to opioid use, and treatment retention in patients with OUD receiving buprenorphine treatment in a residential drug treatment facility. The findings from this phase will inform further studies in an outpatient setting. If successful, this project could advance to the development of a new monotherapy for the treatment of OUD.
3R01DA043122-03S1
HEALTH AND JUSTICE: A CONTINUUM OF CARE FOR HIV AND SU FOR JUSTICE-INVOLVED YOUTH Translation of Research to Practice for the Treatment of Opioid Addiction NIDA NEW YORK STATE PSYCHIATRIC INSTITUTE ELKINGTON, KATHERINE S New York, NY 2018
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Overcoming barriers to substance use (SU) screening and enrollment in SU care is central to decreasing justice-involved youth’s (JIY) negative HIV-related outcomes. This project proposes to embed HIV testing outreach workers from a youth-focused medical and HIV treatment program into an alternative sentencing program (ASP) to deliver a new service delivery model (Link2CARE) that integrates evidenced-based protocols for JIY to promote HIV and sexually transmitted infection (STI) testing and HIV and SU risk screening, and provide on-site intervention and cross-system linkage to HIV, STI, and SU care. We propose to determine the efficacy of Link2CARE delivered by health staff embedded within the ASP on HIV, STI, and SU outcomes; to determine the influence of theoretically based intervention mechanisms of change on the proposed HIV and SU outcomes; and to describe Link2CARE implementation and elucidate the system/organizational-, staff-, and youth-level factors that influence implementation of Link2CARE in an ASP.
1UG1DA050071-01
Facilitating Opioid Care Connections: System level strategies to improve use of MAT and movement through the opioid care cascade for defendants in a new Opioid Court system Translation of Research to Practice for the Treatment of Opioid Addiction Justice Community Opioid Innovation Network (JCOIN) NIDA NEW YORK STATE PSYCHIATRIC INSTITUTE ELKINGTON, KATHERINE S (contact); NUNES, EDWARD V; WAINBERG, MILTON L 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:

Rates of opioid use (OU), opioid use disorder (OUD), and overdose (OD) disproportionately affect those in the justice system. Yet, despite such high rates of misuse and associated negative outcomes of untreated OUD, screening and the availability or use of evidence-based treatments for OU and OUD—including medication to treat OUD—are substantially underused in justice populations. This project will leverage the unique, real-time scale-up of a new opioid court model (OCM) to address a critical public and correctional health problem by developing and evaluating an implementation intervention (OCM RISE), designed to build cross-system partnerships to permit the development of generalizable yet tailored strategies that allow the OCM to be scaled up across a variety of contexts.
1R34DA050288-01
2/5 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 Study (HBCD) NIDA AVERA MCKENNAN ELLIOTT, AMY J Sioux Falls, SD 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.
1R61AT012309-01
Partners for Pain & Wellbeing Equity: A Randomized Trial of Community Supported Complementary and Integrative Health Self-Management for Back Pain Clinical Research in Pain Management Advancing Health Equity in Pain Management NCCIH UNIVERSITY OF MINNESOTA EVANS, RONI L; LENINGER, BRENT Minneapolis, MN 2022
NOFO Title: HEAL Initiative: Advancing Health Equity in Pain and Comorbidities (R61/R33 Clinical Trial Required)
NOFO Number: RFA-NS-22-002
Summary:

Back pain, including low back and neck pain, is one of the most prevalent and disabling pain disorders. Treatment requires ongoing self-management, but most healthcare systems do not support self-care and instead focus on costly, provider-dependent therapies that remain inaccessible to many Black and Hispanic Americans and individuals with less education and income. This project will address these health disparities by developing a personalized self-management treatment program that includes pain education, mindfulness, cognitive behavioral therapy, and exercise – and make it available in community settings.
1R01HL150523-01
Deconstructing sleep disruption as a major risk factor for relapse in opioid use New Strategies to Prevent and Treat Opioid Addiction Sleep Dysfunction as a Core Feature of Opioid Use Disorder and Recovery NHLBI Medical College of Wisconsin EVERSON, CAROL A (contact); OLSEN, CHRISTOPHER M; RAFF, HERSHEL Milwaukee, WI 2019
NOFO Title: HEAL Initiative: Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder (OUD) and Response to Medication Assisted Treatment (MAT) (R01 - Clinical Trial Not Allowed)
NOFO Number: RFA-HL-19-028
Summary:

Profound sleep disturbances during abstinence have long been suspected of perpetuating vulnerability to relapse of people who misuse or are addicted to opioids. An animal model has shown that long-term sleep deficiency results in a persistent state of physiological dysregulation that is expected to modify the biology of abstinence and increase relapse potential. This study seeks to discover how persistent sleep restriction during withdrawal from opioid use increases vulnerability to relapse in the animal model by testing whether persistent sleep restriction during abstinence from opioid use is sufficient to increase opioid drug seeking. The functional outcome measure will be the degree of mitigation of opioid seeking. These studies will provide a basis for novel translational approaches to target mechanisms that are demonstrated to cause increased vulnerability to relapse.
1R61NS131307-01
Preclinical Assessment of a Novel Systemic Drug Candidate for Osteoarthritic Pain Preclinical and Translational Research in Pain Management Development and Optimization of Non-Addictive Therapies to Treat Pain NINDS UNIVERSITY OF SOUTHERN CALIFORNIA EVSEENKO, DENIS Los Angeles, CA 2023
NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
NOFO Number: PAR-20-092
Summary:

Osteoarthritis is a degenerative joint disease marked by progressively worsening chronic joint pain that affects function and quality of life. Non-opioid, alternative medications are needed for people with this condition. Joint inflammation, damage, and pain involve signaling through the interleukin-6/glycoprotein 130 pathway. This project will test blocking this pathway in rodents with a new molecule with improved drug-like properties, toward developing an oral medication for osteoarthritis. 
1R34DA050292-01
HEALthy ORCHARD: Developing plans for a Baltimore site of the HEALthy BCD study Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA JOHNS HOPKINS UNIVERSITY FALLIN, M DANIELE Baltimore, MD 2019
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-036
Summary:

Researchers will expand a recently initiated pregnancy cohort at Johns Hopkins University (JHU) called ORCHARD (ORigins of Child Health And Resilience in Development) to create a Baltimore HEALthy BCD site, named HEALthy ORCHARD. The research team will convene investigators at JHU and the Kennedy Krieger Institute (KKI), and community partners across nine work groups to: (1) develop protocols for recruitment and retention of pregnant mothers and children with enriched sampling of pregnant women who are using substances; (2) establish community, medical, and government partnerships necessary to implement recruitment, retention, data collection and community benefits; (3) characterize the critical ethical and legal challenges raised during study design, in pilot studies, and by prospective participants, and propose solutions where possible and additional research where necessary; (4) develop protocols for longitudinal data collection across pregnancy and childhood; and (5) contribute to multi-site protocol development and nationally relevant principles regarding ethical and legal issues.
3U24NS115691-01S1
UPENN HEAL - Pain Clinical Trial Network Specialized Clinical Center Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS UNIVERSITY OF PENNSYLVANIA FARRAR, JOHN T Philadelphia, PA 2021
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:

A significant gap exists in understanding of the barriers blocking access to specialized care for children of color who experience headaches, as well as to understand and appreciate the impact of undertreatment on a child’s functional ability and quality of life. Long-term, this research aims to understand these barriers to care and test interventions to remedy disparities. As the first step, this project's primary objective is to identify socioeconomic and clinical factors that lead children experiencing headache to seek care in an emergency department in lieu of outpatient neurology care. The results of this research will help to inform efforts to reduce the negative effects of emergency department overuse in this population and guide them to potentially more appropriate outpatient care.
1U24NS115691-01
UPENN HEAL - Pain Clinical Trial Network Specialized Clinical Center Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS UNIVERSITY OF PENNSYLVANIA FARRAR, JOHN T (contact); ASHBURN, MICHAEL ALAN Philadelphia, PA 2019
NOFO Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-19-036
Summary:

EPPIC-Net will provide a robust and readily accessible infrastructure for the rapid implementation and performance of high-quality comprehensive studies of patients with well-defined pain conditions, and the rapid design and performance of high-quality Phase 2 clinical trials to test promising novel therapeutics for pain. Using the Hospital of the University of Pennsylvania as a hub and five additional centers that are part of the UPenn Health System and the Children’s Hospital of Philadelphia (CHOP) as spokes, studies will be conducted as designed by the expertise of the EPPIC Network, which intends to bring intense focus to relatively small numbers of patients with clinically well-defined pain conditions and high unmet therapeutic needs. The UPenn Specialized Clinical Center (SCC) will test novel, efficient study designs including adaptive and platform designs, validation studies of biomarkers, and biomarker-informed proof of principle or target engagement studies in Phase 2 trials of interventions from academic and industry partners.
1OT2NS122680-01
A 24-week Week Study to Evaluate the Safety and Efficacy of CNTX-6970 in Subjects with Moderate to Severe Knee Osteoarthritis Pain. Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS Massachussetts General Hospital FAVA, MAURIZIO Boston, MA 2021
NOFO Title: HEAL Initiative: EPPIC-Net Pain Research Asset Application (OT2)
NOFO Number: OTA-20-008
Summary:

This award funds EPPIC-NET’s first phase 2 clinical trial, testing the novel oral drug CNTX-6970 in patients with moderate to severe knee osteoarthritis pain. It will include 150 participants at EPPIC-Net sites across the United States. Preclinical studies of CNTX-6970, which binds effectively and dose-proportionally to C-C chemokine type 2 (CCR2) receptors, have demonstrated potent analgesia in multiple pain models, with no emergent safety issues. CNTX-6970 has effects both at an affected joint, as well as on neural signaling. Participants will be randomized to receive CNTX-6970, placebo, or a third pain medication and will be followed for 24 weeks.
3U24NS113850-03S1
Clinical Coordinating Center for the Health Initiative in Early Phase Pain Investigation Clinical Network - Murray Supplement Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS MASSACHUSETTS GENERAL HOSPITAL FAVA, MAURIZIO (contact); EDWARDS, ROBERT R; RATHMELL, JAMES P Boston, MA 2021
NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for Administrative Supplements to Support Career Enhancement Related to Clinical Research on Pain (Admin Supp – Clinical Trial Not Allowed)
NOFO Number: NOT-NS-21-048
Summary:

Key goals of the NIH HEAL Initiative are improving non-opioid pain management and expanding the workforce of clinical researchers working on individualized pain treatments know as pain precision medicine. This award enables an exceptional early career clinician with the opportunity to obtain expertise with high-quality pain-related biomarker assessment methods and biomarker-informed clinical trial design. This research centers on eating-related gastrointestinal functional/motility pain disorders – an understudied area of clinical pain science – and will prepare the clinician to be a future leader in the clinical pain research community.
1U24NS113850-01
Clinical Coordinating Center for the Health Initiative in Early Phase Pain Investigation Clinical Network Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS MASSACHUSETTS GENERAL HOSPITAL FAVA, MAURIZIO (contact); EDWARDS, ROBERT R; RATHMELL, JAMES P Boston, MA 2019
NOFO Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Clinical Coordinating Center (U24 Clinical Trials Not Allowed)
NOFO Number: RFA-NS-19-023
Summary:

The objective of the Early Phase Pain Investigation Clinical Network (EPPIC-Net) and EPPIC- Net initiatives is to rapidly and efficiently translate advances in the neurobiology of pain into treatments for people with chronic and acute pain, conditions associated with a significant burden to both patients and society. The Clinical Coordinating Center (CCC) for EPPIC-Net will promote and facilitate, from initial conception through final analysis, clinical trials in adult and pediatric populations with acute or chronic pain by providing efficient methodological, organizational, and logistical support. The EPPIC-Net-CCC will adopt and establish processes aimed at dramatically increasing the efficiency of multicenter clinical trials, improving the overall quality of clinical trials, promoting patient recruitment and retention as well as increasing the number of clinical investigators and research staff well trained and passionate about leading and conducting multicenter clinical trials.
1R21DA056740-01
Recruiting Active Expiration to Overcome Opioid-Induced Persistent Apnea Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA University of California, Los Angeles FELDMAN, JACK L Los Angeles, CA 2022
NOFO Title: HEAL Initiative: Novel Targets for Opioid Use Disorders and Opioid Overdose (R21 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-22-032
Summary:

Prescription opioids provide pain relief, but overdose can be fatal because opioids also depress breathing through opioid-induced persistent apnea, when breathing stops. This research will determine whether targeted activation of a specific, opioid-insensitive brain region that triggers exhalation can increase tolerance to fentanyl-induced apnea. The research also seeks to identify the receptors responsible for this exhalation, which could be targets for new medications that prevent the negative impact of opioids on breathing. This research lays the groundwork for more preclinical and translational studies to prevent opioid-induced persistent apnea. 
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.
1R01DA057668-01
Opioid and SUD Data Enclave (O-SUDDEn): Bringing Real-Time Data to the Opioid Crisis Cross-Cutting Research Leveraging Existing and Real-Time Opioid and Pain Management Data NIDA OHIO STATE UNIVERSITY FERNANDEZ, SOLEDAD A (contact); HUERTA, TIMOTHY R Columbus, OH 2022
NOFO Title: HEAL Initiative: Data and Methods to Address Urgent Needs to Stem the Opioid Epidemic (R01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-22-044
Summary:

The lack of timely data about drug use and overdose deaths has hindered the ability of communities and state agencies to allocate resources to regions where they are most needed. This project will develop a secure data pool that combines individual and community-level real-time data from multiple sources, including urine drug testing. These data will then be used to model the contribution of opioid, cocaine, and stimulant use to overdoses, overdose deaths, and cases of substance use disorder. This research will also use urine drug testing results and demographic/contextual data to identify populations and subpopulations at highest risk of drug use and overdose. This information will be displayed through a data platform tailored to the needs of end users (e.g., communities or agencies) and with user-friendly tools that help users make informed decisions on where resources are most urgently needed.
1UH2AR076719-01
Novel imaging of endplate biomarkers in chronic low back pain Clinical Research in Pain Management Back Pain Consortium Research Program NIAMS UNIVERSITY OF CALIFORNIA, SAN FRANCISCO FIELDS, AARON J (contact); KRUG, ROLAND San Francisco, CA 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:

This project will examine the association between end plate pathology and chronic low back pain (cLBP) and improve patient selection by developing and translating new imaging tools, technologies, and/or methods (iTTM) that provide accurate, noninvasive measures of end plate pathologies. A search for clinically relevant biomarkers of end plate pathology will focus on novel imaging measures of end plate bone marrow lesion (BML) severity with IDEAL MRI and cartilage endplate (CEP) fibrosis/damage with UTE MRI, assess interactions with paraspinal muscles, and identify metrics that associate with pain, disability, and degeneration. The research will refine imaging and post-processing methodologies by leveraging and expanding existing cross-sectional cohorts and then deploy and validate the new end plate iTTM to other BACPAC sites to test the most promising metrics’ clinical utility. These studies will provide validated iTTM that are useful for addressing the end plates pathology’s role in cLBP, identifying sub-phenotypes, discovering pain mechanisms, uncovering treatment targets, and selecting patients.
1UG3DA050251-01
A digital intervention to prevent the initiation of opioid misuse in adolescents in school-based health centers New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA Yale University Fiellin, Lynn E. New Haven, CT 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:

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 (RCT) 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.