Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
3UG1DA013720-19S3
Individual Level Predictive Modeling of Opioid Use Disorder Treatment Outcome Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA UNIVERSITY OF MIAMI SCHOOL OF MEDICINE SZAPOCZNIK, JOSE; FEASTER, DANIEL J CORAL GABLES, FL 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

A persistent problem in the dissemination of medications for opioid use disorder (MOUD) is patient dropout, and matching patients to suitable medication early has the potential to minimize dropout. The overall objective of this secondary data analysis study is to develop and disseminate individual level risk prediction models using harmonized data collected from three multi-site clinical trials from the CTN, in order to predict specific clinical outcomes (e.g., dropout, relapse) for patients treated with MOUD, including methadone, buprenorphine or extended-release depot naltrexone. The relative importance of predictors in the best predictive models will be estimated, which may facilitate refinement of common data elements for future OUD studies. The comprehensive, harmonized database of treatment data created in this study can be used for future secondary data analysis studies and will provide a replicable data pipeline to process and validate OUD data in future protocols.

1R34DA050287-01
4/4 Investigation of opioid exposure and neurodevelopment (iOPEN) Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA NEW YORK UNIVERSITY SCHOOL OF MEDICINE THOMASON, MORIAH E (contact); BERGINK, VEERLE New York, NY 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:

Rates of neonatal abstinence syndrome have reached a staggering 6.5 per 1,000 births nationwide, creating an urgent need to identify how in-utero exposure to opioids and associated risk factors influence the developing brain. A multidisciplinary team will address these challenges in Oregon, a state particularly hard hit by the opioid epidemic. Through linking sites, the impact of the Phase I project is enhanced and will provide critical information to support a national-level effort for Phase II of the HEALthy Brain and Child Development Study. Aim 1 will develop, implement, and evaluate innovative recruitment and retention strategies for high-risk populations. Aim 2 will address anticipated challenges of the planned Phase II study by implementing and evaluating a multi-site, standardized research protocol including multimodal MRI of placenta, fetus, neonate, and 24-month-old brain; biospecimen collection; and assessment of substance use and other key domains. Aim 3 will evaluate data acquisition, processing, and statistical considerations to maximize data quality, usability, and integration across sites.

1R34DA050268-01
4/5 Establishing Innovative Approaches for the HEALthy Brain and Child Development Study Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA CINCINNATI CHILDRENS HOSP MED CTR MERHAR, STEPHANIE L (contact); VANNEST, JENNIFER J Cincinnati, OH 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:

A more than 5-fold increase in the incidence of neonatal abstinence syndrome has been reported since 2000. Preliminary studies show that prenatal opioid exposure is associated with increased risk of impaired neurodevelopment. Five institutions (Duke University, Arkansas Children’s Research Institute, Cincinnati Children’s Hospital, University of Illinois at Urbana–Champaign, and University of North Carolina at Chapel Hill) have formed a consortium to develop strategies for the Phase II HEALthy Brain and Child Development Study. Research teams will develop instruments and strategies (recruitment/retention protocols, assessment batteries, and novel tools); conduct pilot studies (fetal and postnatal imaging, advanced imaging harmonization and quality control, assessment administration, biosampling) to evaluate instruments; and analyze available data, including imaging, behavioral, cognitive, and maternal data from studies on early brain development, to guide the Phase II study design. Upon completion, the consortium aims to conduct the Phase II study.

75N95019D00013-0-759501900095-1
Emergency Department-INitiated bupreNOrphine and VAlidaTIOn Network Trial (ED-INNOVATION) Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA Emmes Corporation VanVeldhuisen, Paul Rockville, MD 2019
NOFO Number:
Summary:

Emergency department (ED)-initiated buprenorphine/naloxone (BUP) with referral for ongoing BUP is superior to referral alone in engaging patients with untreated opioid use disorder (OUD) in treatment at 30 days and is cost-effective. However, logistical barriers exist in translating research into practice. New BUP formulations such as the extended-release injectable BUP (CAM2038, XR-BUP) hold promise in addressing many of the barriers more effectively than sublingual buprenorphine (SL-BUP) by treating the patients’ symptoms for up to seven days. This study will recruit, train and provide resources to 30 ED sites throughout the U.S. using implementation facilitation strategies to address stigma and provide ED-initiated BUP for patients presenting with OUD who are not receiving medications for OUD. Once implementation is adequately achieved, the sites will conduct a randomized controlled trial (RCT) to compare the effectiveness of SL-BUP versus XR-BUP on ED patients’ engagement in formal addiction treatment seven days after their ED visit. In addition, in an ancillary component of the study, the use of XR-BUP will be assessed in ED patients with Clinical Opioid Withdrawal Scale (COWS) scores of

1R01HD096798-01
SAFETY, PHARMACOKINETICS AND EFFICACY OF EXTENDED-RELEASE NALTREXONE IN PREGNANT WOMEN WITH OPIOID USE DISORDER Enhanced Outcomes for Infants and Children Exposed to Opioids NICHD Boston Medical Center WACHMAN, ELISHA Boston, MA 2018
NOFO Title: Opioid Use Disorder in Pregnancy (R01)
NOFO Number: RFA-HD-18-036
Summary:

Opioid use disorders (OUDs) in pregnancy are a U.S. public health crisis; the current standard of care is treatment with an opioid agonist such as buprenorphine (BPH), which has an associated risk for neonatal abstinence syndrome (NAS) and possible long-term neurodevelopmental consequences. As a novel treatment option for OUD in pregnancy, naltrexone would not expose the developing fetus to opioids, greatly reducing the risk for NAS and potentially improving maternal and infant outcomes. This study will evaluate the safety, efficacy, pharmacokinetics, and pharmacogenomics of naltrexone for pregnant women with OUDs, evaluating comprehensive mother-infant outcomes throughout the pregnancy and first year after birth. It will enroll 50 pregnant women stabilized pre-pregnancy on extended-release naltrexone (XR-NTX) and 50 comparison women on BPH from Boston Medical Center and the University of North Carolina in this multi-center prospective comparative cohort study.

1R01DE029342-01
Identification and Validation of a Novel Central Analgesia Circuit Preclinical and Translational Research in Pain Management Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain NIDCR DUKE UNIVERSITY WANG, FAN Durham, NC 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:

This project focuses on identifying and validating a new central analgesic circuit in the brain, based on a highly innovative hypothesis that the strong analgesic effects of general anesthesia (GA) are in part carried out by GA-mediated activation of the endogenous analgesic circuits. Preliminary discovery studies found that a subset of GABAergic neurons located in the central amygdala (CeA) become strongly activated and express high levels of the immediate early gene Fos under GA (hereafter referred to as CeAGA neurons). Furthermore, activation of these neurons exert profound pain-suppressing effects in an acute pain model and a chronic orofacial neuropathic pain model in mice. Based on these exciting preliminary findings, this project will identify and validate CeAGA neurons’ analgesic functions utilizing multiple mouse pain models. Identification of these shared common pathways that need to be suppressed by specific subtypes of CeAGA analgesic neurons will be highly critical for developing precise CeAGA-targeted therapies to treat chronic pain.

3UG1DA015831-18S7
Emergency Department-INitiated bupreNOrphine and VAlidaTIOn Network Trial (ED-INNOVATION) Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA McLean Hospital Weiss, Roger Belmont, MA 2019
NOFO Title: Research Supplements to Promote Re-Entry into Biomedical and Behavioral Research Careers (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: PA-18-592
Summary:

Emergency department (ED)-initiated buprenorphine/naloxone (BUP) with referral for ongoing BUP is superior to referral alone in engaging patients with untreated opioid use disorder (OUD) in treatment at 30 days and is cost-effective. However, logistical barriers exist in translating research into practice. New BUP formulations such as the extended-release injectable BUP (CAM2038, XR-BUP) hold promise in addressing many of the barriers more effectively than sublingual buprenorphine (SL-BUP) by treating the patients’ symptoms for up to seven days. This study will recruit, train and provide resources to 30 ED sites throughout the U.S. using implementation facilitation strategies to address stigma and provide ED-initiated BUP for patients presenting with OUD who are not receiving medications for OUD. Once implementation is adequately achieved, the sites will conduct a randomized controlled trial (RCT) to compare the effectiveness of SL-BUP versus XR-BUP on ED patients’ engagement in formal addiction treatment seven days after their ED visit. In addition, in an ancillary component of the study, the use of XR-BUP will be assessed in ED patients with Clinical Opioid Withdrawal Scale (COWS) scores of

1UH2AR076741-01
Imaging Epigenetic Dysregulation in Patients with Low Back Pain Clinical Research in Pain Management Back Pain Consortium Research Program NIAMS MASSACHUSETTS GENERAL HOSPITAL WEY, HSIAO-YING Boston, MA 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:

Inhibitors of the epigenetic enzymes histone deacetylases (HDACs) produce analgesic responses and are therefore therapeutic targets for pain. The research team recently resolved a PET imaging agent, [11C]Martinostat, that selectively binds to a subset of HDAC enzymes. A series of initial proof-of-concept clinical validation studies will be conducted to evaluate whether [11C]Martinostat PET is a sensitive biomarker to detect the typical (axial) chronic low back pain (cLBP). The research team will validate [11C]Martinostat PET’s ability to differentiate subtypes of pain by comparing axial cLBP and other cLBP patients with radiculopathy and longitudinally study subacute LBP patients (sLBP) to investigate whether there is a unique imaging signature that differentiates patients who develop cLBP and those who recover from low back pain. Using [11C]Martinostat to understand HDAC expression changes in chronic pain patients will validate an epigenetic drug target, refine patient selection based on HDAC expression, and facilitate proof of mechanism in developing novel analgesics.

3UG1DA040317-05S2
Pharmacists’ knowledge of, attitudes about, and intention to provide pharmacy-based services for screening, brief intervention, and referral to treatment and medication treatment for opioid use disorders 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 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:

Given the magnitude of the opioid death epidemic, we need multiple approaches to increase use of medication treatment for opioid use disorder (MOUD) for people from diverse geographical locations. Pharmacists as dispensers of and gatekeepers to opioid medications, including those used for OUD treatment, are natural partners of health care providers. Community pharmacists are widely available even in rural areas. This 2-year study will use a mixed-method design that includes qualitative and quantitative approaches to study pharmacists’ knowledge of, attitudes about, and intention to provide patient care and services for screening, brief intervention, and referral to treatment for substance use disorders and MOUD. Study aims are to conduct stakeholder interviews, develop a survey instrument to assess such barriers and facilitators, pilot test the survey instrument, and conduct the survey among licensed pharmacists.

1R61AT010606-01
Adapting the HOPE Online Support Intervention to Increase MAT Uptake Among OUD Patients Translation of Research to Practice for the Treatment of Opioid Addiction Behavioral Research to Improve Medication-Based Treatment NCCIH UCLA YOUNG, SEAN 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:

Online peer-led support interventions may increase medication-assisted therapy (MAT) initiation and sustainment among participants with opioid use disorder (OUD) because they can leverage peers to widely and rapidly scale changes in social norms (e.g., interest in using MAT) throughout people’s natural, real-world, virtual environments. Harnessing Online Peer Education (HOPE), an online peer support community intervention designed to reduce stigma and increase health behavior change, has effectively changed health behaviors among stigmatized populations, such as for HIV. This study will determine how to adapt the HOPE online support intervention to increase MAT initiation and sustainment among participants with OUD, assess the intervention’s effectiveness at increasing MAT use among OUD participants recruited online who are not using MAT, and use an implementation science approach to determine the relationship between social network dynamics (e.g., network size), topics discussed on the online community, and behavior change.

3UH3CA261067-03S1
Optimizing the use of ketamine to reduce chronic postsurgical pain Cross-Cutting Research Training the Next Generation of Researchers in HEAL NCI NEW YORK UNIVERSITY SCHOOL OF MEDICINE WANG, JING (contact); DOAN, LISA New York, NY 2022
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-20-028
Summary:

Approximately 20% of patients who undergo surgery develop chronic Postsurgical Pain, which is linked with slow recovery, persistent opioid use and dependence. This project supports a scientist from a group underrepresented in biomedicine to expand ongoing research testing ketamine during and/or after surgery to prevent post-mastectomy pain syndrome. Ketamine is a low-risk treatment option that is easy to implement in a wide range of clinical settings.

3U2CDA050097-04S1
JCOIN Coordination and Translation Center Cross-Cutting Research Training the Next Generation of Researchers in HEAL NIDA GEORGE MASON UNIVERSITY TAXMAN, FAYE S (contact); FERGUSON, WARREN J; MOLFENTER, TODD DAVID; RUDES, DANIELLE Fairfax, VA 2022
NOFO Title: HEAL Initiative: Justice Community Opioid Innovation Network (JCOIN) Coordination and Translation Center (U2C Clinical Trial Optional)
NOFO Number: DA19-024
Summary:

Many individuals with opioid use disorder pass through the criminal justice system over the course of their life. Improved access to high-quality, evidence-based addiction treatment in justice settings is critical to addressing the opioid crisis. The Justice Community Opioid Innovation Network (JCOIN) is studying approaches to increase high-quality care for people with opioid misuse and opioid use disorder in justice populations. This research supports a scientist from a group underrepresented in biomedicine to expand capacity of the Mason Coordination and Translation Center that is managing logistics, stakeholder engagement, and dissemination of findings and products from the JCOIN network.

1RF1DA050571-01A1
Reversing opioid-induced hypoxemia with novel thiol-based drugs without compromising analgesia in goats Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA MEDICAL COLLEGE OF WISCONSIN HODGES, MATTHEW ROBERT; FORSTER, HUBERT V Milwaukee, WI 2022
NOFO Number: PA-19-056
Summary:

Opioid overdoses result from reduced oxygen in the bloodstream. Although the opioid blocker naloxone can reverse the immediate harmful effects of opioids, it also has limitations. It does not last very long, blocks pain relief, and may induce withdrawal. This project will characterize and test the effectiveness of a novel, potent, and long-lasting respiratory stimulant. The study will use a freely behaving, large animal model with physiology similar to humans.

3UG1DA049467-04S1
Great Lakes Node of the Drug Abuse Clinical Trials Network Cross-Cutting Research Training the Next Generation of Researchers in HEAL NIDA UNIVERSITY OF ILLINOIS AT CHICAGO KARNIK, NIRANJAN Chicago, IL 2022
NOFO Title: The National Drug Abuse Treatment Clinical Trials Network (UG1 Clinical Trial Optional)
NOFO Number: RFA-DA-19-008
Summary:

The Great Lakes Node of the NIDA-supported Drug Abuse Clinical Trials Network (CTN) represents all of the major academic medical centers in the Greater Chicago and Wisconsin areas and serves as a vital Midwestern hub for the CTN. This project supports a scientist from a group underrepresented in biomedicine to expand the work of this CTN node on research in several areas. These include mHealth, eHealth, artificial intelligence, natural language processing, and telehealth interventions; focus on youth/adolescent health and seniors/aging; health disparities; and professional education about opioid and substance treatment.

3U24NS112873-04S1
Clinical Coordinating Center for the Acute to Chronic Pain Signatures Program Cross-Cutting Research Training the Next Generation of Researchers in HEAL NINDS UNIVERSITY OF IOWA SLUKA, KATHLEEN A (contact); COFFEY, CHRISTOPHER S; FREY LAW, LAURA A Iowa City, IA 2022
NOFO Title: Clinical Coordination Center for Common Fund Acute to Chronic Pain Signatures (A2CPS) Program (U24 Clinical Trial Optional)
NOFO Number: RFA-RM-18-035
Summary:

The Acute to Chronic Pain Signatures Program is developing a comprehensive data set that can be used to help predict which patients will recover from acute pain associated with surgery or injury and which ones will develop long-lasting chronic pain. This project will support an early career faculty member from a group underrepresented in biomedicine. The research will enhance skills development toward conducting and coordinating clinical pain research, generating omics datasets, advancing understanding of statistical methods, and other activities required for career development. 

5UH3AT010739-04
Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults Clinical Research in Pain Management Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) NCCIH KAISER FOUNDATION RESEARCH INSTITUTE DEBAR, LYNN L (contact); COOK, ANDREA J Oakland, CA 2023
NOFO Title: HEAL Initiative: Pragmatic Randomized Controlled Trial of Acupuncture for Management of Chronic Low Back Pain in Older Adults (UG3/UH3 Clinical Trial Required)
NOFO Number: RFA-AT-19-005