Funded Projects
Explore our currently funded projects. You may search with all three fields, then focus your results by applying any of the dropdown filters. After customizing your search, you may download results and even save your specific search for later.
Project # | Project Title | Research Focus Area | Research Program | Administering IC | Institution(s) | Investigator(s) | Location(s) | Year Awarded |
---|---|---|---|---|---|---|---|---|
1RM1DA055310-01
Show Summary |
HEAL Initiative: Integrative Management of Chronic Pain and OUD for Whole Recovery (IMPOWR): Research Centers | Clinical Research in Pain Management | Reducing Opioid-Related Harms to Treat Chronic Pain (IMPOWR and MIRHIQL) | NIDA | YALE UNIVERSITY | BECKER, WILLIAM C (contact); BARRY, DECLAN T; FIELLIN, DAVID | New Haven, CT | 2021 |
NOFO Title: HEAL Initiative: Integrative Management of Chronic Pain and OUD for Whole Recovery (IMPOWR): Research Centers (RM1 Clinical Trial Required)
NOFO Number: RFA-DA-21-030 Summary: Health care services for patients with both chronic pain and opioid use disorder are fragmented in the United States. To develop effective and feasible interventions for chronic pain and opioid misuse/disorder that can be implemented in both general medical and addiction treatment settings, this research examines two different care-delivery strategies. The first project will compare the effectiveness of a pharmacist-led, collaborative care approach for patients prescribed long-term opioids who have chronic pain and opioid misuse/disorder compared to a pharmacist program with a cognitive behavior therapy-based pain self-management program. The second project will examine the effectiveness of a multimodal, interdisciplinary chronic pain management program that includes cognitive behavioral therapy, exercise, and stress management. With input from stakeholders and individuals with lived experience, this research has the potential to generate novel, reproducible, and scalable findings that addresses fragmented care delivery for co-occurring chronic pain and opioid misuse/disorder. |
||||||||
3UG1 DA013035
Show Summary |
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 | YALE UNIVERSITY; NEW YORK UNIVERSITY | Gail D'Onofrio/Roger Weiss; John Rotrosen/Edward Nunes | New Haven, CT | 2021 |
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 4-7. |
||||||||
1U01DA055352-01
Show Summary |
1/6 HBCD Prenatal Experiences and Longitudinal Development (PRELUDE) Consortium | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | ARKANSAS CHILDREN'S HOSPITAL RES INST | OU, XIAWEI (contact); ACHESON, ASHLEY ; MCKELVEY, LORRAINE M | Little Rock, AR | 2021 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020 Summary: The objective of the HEALthy Brain and Child Development (HBCD) Prenatal Experiences and Longitudinal Development (PRELUDE) multi-site consortium is to characterize typical brain development from birth through childhood. All sites in this consortium will measure the influence of key biological and environmental factors on child social, cognitive, and emotional development. Researchers will assess how prenatal exposure to opioids and other substances, as well as other adverse environmental factors, affect brain development and other child health outcomes. The Arkansas Children’s Research Institute site is in a predominantly rural state with the second highest rate of opioid prescriptions in the U.S. |
||||||||
1U01DA055369-01
Show Summary |
14/24 The Healthy Brain & Child Development National Consortium | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | UNIVERSITY OF CALIFORNIA, SAN DIEGO | BANDOLI, GRETCHEN E (contact); GAHAGAN, SHEILA | San Diego, CA | 2021 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020 Summary: The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first 10 years of life. The University of San Diego study site will recruit a diverse cohort of mother-infant pairs, including Hispanic and American Indian individuals. |
||||||||
1U01DA055347-01
Show Summary |
6/6 HBCD Prenatal Experiences and Longitudinal Development (PRELUDE) Consortium Vanderbilt | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | VANDERBILT UNIVERSITY | CUTTING, LAURIE E (contact); OSMUNDSON, SARAH SCHEIDERICH | Vanderbilt, TN | 2021 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020 Summary: The objective of the HBCD PRELUDE (Prenatal Experiences and Longitudinal Development) multi-site consortium is to characterize typical brain development from birth through childhood. All sites in this consortium will measure the influence of key biological and environmental factors on child social, cognitive, and emotional development. Researchers will assess how prenatal exposure to opioids and other substances, as well as other adverse environmental factors, affect brain development and other child health outcomes. The Vanderbilt University site will enroll a diverse sample of mother-infant dyads reflective of the racial, ethnic, and economic composition of the demographics of Tennessee, including rural areas dramatically affected by the opioid crisis. |
||||||||
1U01DA055343-01
Show Summary |
1/2 Assessing the Cumulative Impact of Early Life Substance and Environment Exposure on Child Neurodevelopment and Health | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | RHODE ISLAND HOSPITAL | DEONI, SEAN CL (contact); D'SA, VIREN ANDREW | Providence, RI | 2021 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020 Summary: This study aims to determine how exposure to opioids and other substances affects the developing fetal brain and shapes later child cognitive outcomes. Researchers will collect neuroimaging and behavioral data, as well as measures of environmental exposures related to social equity, COVID-19, and socioeconomic factors. The project will reduce traditional barriers to participation by using innovative data collection methods and mobile labs to bring the research to underrepresented and marginalized communities. This approach aims to clarify the impact of substance exposure on child development through an equitable approach to research, with generalizable findings. The study will take place at Rhode Island Hospital, where participants will be drawn from a largely rural population. |
||||||||
1UG1HD107580-01
Show Summary |
UAB Clinical Site HEAL Neonatal Opioid Withdrawal Pharmacological Treatments | Enhanced Outcomes for Infants and Children Exposed to Opioids | Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) | NICHD | UNIVERSITY OF ALABAMA AT BIRMINGHAM (AL) | AMBALAVANAN, NAMASIVAYAM | Birmingham, AL | 2021 |
NOFO Title: HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial - Clinical Sites (UG1 Clinical Trial Required)
NOFO Number: RFA-HD-21-031 Summary: Neonatal Opioid Withdrawal Syndrome (NOWS) is a condition that occurs when newborns are exposed to opioids during pregnancy. Symptoms often include tremors, excessive crying, sleep deprivation, and swallowing difficulties. Cases are rising, with a newborn affected by NOWS approximately every 15 minutes. Currently, healthcare providers in the United States lack standard, evidence-based treatments for NOWS. This project is part of a multi-center, randomized controlled clinical trial that directly compares NOWS treatments—morphine, methadone, and buprenorphine—and takes into account other types of non-drug therapies, such as behavioral interventions. The goal is to generate results that can inform clinical practice guidelines and give newborns with NOWS the best start possible. The University of Alabama at Birmingham routinely treats newborns with NOWS and has been part of NICHD’s Neonatal Research Network (NRN) for more than 25 years. The center has an excellent track record of enrollment in clinical studies, with successful follow-up to 2 years of age and beyond. |
||||||||
1R24DA055306-01
Show Summary |
Wake Forest IMPOWR Dissemination Education and Coordination Center (IDEA-CC) | Clinical Research in Pain Management | Reducing Opioid-Related Harms to Treat Chronic Pain (IMPOWR and MIRHIQL) | NIDA | WAKE FOREST UNIVERSITY HEALTH SCIENCES | ADAMS, MEREDITH C B | Winston-Salem, NC | 2021 |
NOFO Title: HEAL Initiative: Integrative Management of Chronic Pain and OUD for Whole Recovery (IMPOWR): Coordination and Dissemination Center (R24 Clinical Trial Optional)
NOFO Number: RFA-DA-21-029 Summary: The IMPOWR (Integrative Management of Chronic Pain and OUD for Whole Recovery) Dissemination, Education, and Coordination Center (IDEA-CC) will develop infrastructure to amplify and create momentum for the findings of the IMPOWR initiative and other linked research networks. This center will i) rapidly deploy a communication framework to link IMPOWR clinical sites with each other and the larger HEAL research frameworks; ii) develop an educational infrastructure addressing stigma and health disparities in patients with co-morbid chronic pain and opioid misuse/disorder; iii) disseminate research findings effectively to targeted audiences; iv) develop a novel composite screening tool for chronic pain and opioid misuse/disorder; and v) harmonize processes for data collection and common data elements of chronic pain and opioid misuse/disorder measures across the IMPOWR research centers, providing a coordinated platform for gathering data from these studies. This center will rapidly disseminate key findings to stakeholders, clinicians, and patients to improve the health and wellbeing of individuals with co-occurring chronic pain and opioid misuse/disorder. |
||||||||
1R01MH128904-01
Show Summary |
Supporting Treatment Access and Recovery for Co-Occurring Opioid Use and Mental Health Disorders (STAR-COD) | New Strategies to Prevent and Treat Opioid Addiction | Optimizing Care for People with Opioid Use Disorder and Mental Health Conditions | NIMH | University of Massachusetts Medical School | SMELSON, DAVID A (contact); GONZALEZ, GERARDO ; LI, WENJUN ; OLMSTEAD, TODD ALDEN | Worcester, MA | 2021 |
NOFO Title: HEAL Initiative: Optimizing Multi-Component Service Delivery Interventions for People with Opioid Use Disorder, Co-Occurring Conditions, and/or Suicide Risk (R01 Clinical Trials Optional)
NOFO Number: RFA-MH-21-145 Summary: Opioid use disproportionally affects people with co-occurring mental health disorders. Although medication for opioid use disorder (MOUD) is the gold standard of care, engagement rates are low. Also, it is unclear whether addition of one or more behavioral interventions improves outcomes of MOUD treatment, particularly in patients with co-occurring mental health disorders. This project evaluates the effectiveness of the “Maintaining Independence and Sobriety through Systems Integration, Outreach and Networking (MISSION)” intervention—a multi-component, cross-disciplinary, team-based treatment approach that combines three evidence-based practices with MOUD—in people with co-occurring mental health disorders. The 4-year, five-arm, randomized controlled clinical trial will determine the therapeutic benefit of adding MISSION to MOUD and identify the MISSION components that yield the largest clinical improvement and offer the greatest return on investment. |
||||||||
1U01DA055344-01
Show Summary |
5/6 HBCD Prenatal Experiences and Longitudinal Development (PRELUDE) Consortium | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | UNIV OF NORTH CAROLINA CHAPEL HILL | LIN, WEILI (contact); GREWEN, KAREN M | Chapel Hill, NC | 2021 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020 Summary: The objective of the HBCD PRELUDE (Prenatal Experiences and Longitudinal Development) multi-site consortium is to characterize typical brain development from birth through childhood. All sites in this consortium will measure the influence of key biological and environmental factors on child social, cognitive, and emotional development. Researchers will assess how prenatal exposure to opioids and other substances, as well as other adverse environmental factors, affect brain development and other child health outcomes. The study site at the University of North Carolina, Chapel Hill will work with Wake Forest University to help recruit pregnant women with substance use disorders and enroll mother-infant dyads. This collaboration serves to expand participant diversity and extend recruitment to cover a larger region of North Carolina, a state hit hard by the opioid crisis. |
||||||||
1U01DA055316-01
Show Summary |
16/24 Healthy Brain and Child Development National Consortium | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | UNIV OF MARYLAND, COLLEGE PARK | FOX, NATHAN A (contact); HARDEN, BRENDA J; RIGGINS, TRACY L | College Park, MD | 2021 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020 Summary: The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first 10 years of life. The University of Maryland College Park study site is midway between Washington, DC, and Baltimore, Maryland, and will recruit a diverse sample of mother-infant pairs from across the region. |
||||||||
1U01DA055360-01
Show Summary |
4/24 Healthy Brain and Child Development National Consortium | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | EMORY UNIVERSITY | KABLE, JULIE A (contact); COLES, CLAIRE D | Atlanta, GA | 2021 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020 Summary: The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first 10 years of life. This study will be conducted at Emory University School of Medicine in Atlanta, Georgia, allowing access to a diverse population with a high representation of Black/African American women. |
||||||||
1U01DA055363-01
Show Summary |
12/24 Healthy Brain and Child Development National Consortium | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | OREGON HEALTH & SCIENCE UNIVERSITY | SULLIVAN, ELINOR L (contact); GRAHAM, ALICE M; NAGEL, BONNIE J | Portland, OR | 2021 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020 Summary: The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first 10 years of life. This study will take place at Oregon Health and Science University, giving researchers access to people in a region with very high rates of opioid misuse. |
||||||||
1UG1HD107627-01
Show Summary |
HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial New Mexico Site | Enhanced Outcomes for Infants and Children Exposed to Opioids | Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) | NICHD | UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR (NM) | LEEMAN, LAWRENCE M | Albuquerque, NM | 2021 |
NOFO Title: HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial - Clinical Sites (UG1 Clinical Trial Required)
NOFO Number: RFA-HD-21-031 Summary: Neonatal Opioid Withdrawal Syndrome (NOWS) is a condition that occurs when newborns are exposed to opioids during pregnancy. Symptoms often include tremors, excessive crying, sleep deprivation, and swallowing difficulties. Cases are rising, with a newborn affected by NOWS approximately every 15 minutes. Currently, healthcare providers in the United States lack standard, evidence-based treatments for NOWS. This project is part of a multi-center, randomized controlled clinical trial that directly compares NOWS treatments—morphine, methadone, and buprenorphine—and takes into account other types of non-drug therapies, such as behavioral interventions. The goal is to generate results that can inform clinical practice guidelines and give newborns with NOWS the best start possible. New Mexico is an epicenter of the opioid epidemic with high rates of maternal opioid use disorder and NOWS. This site has expertise in multi-center clinical trials for newborns, a history of high rates of study recruitment and follow-up, and a diverse population that includes Latinx and Native American women. The hospital currently cares for infants with NOWS in a variety of settings, including rooming in, a nursery, and a neonatal intensive care unit. |
||||||||
1OT2NS122680-01
Show Summary |
A Randomized, Double-blind, Placebo-controlled, Parallel, 20-week, Phase 2b Study of Topical Pirenzepine (WST-057) or Placebo in Type 2 Diabetes Mellitus Patients with Painful Diabetic Peripheral Neuropathy | Clinical Research in Pain Management | Early Phase Pain Investigation Clinical Network (EPPIC-Net) | NINDS | ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI | ROBINSON-PAPP, JESSICA | New York, NY | 2021 |
NOFO Title: HEAL Initiative: EPPIC-Net Pain Research - Application for Clinical Trial and Related Activities (OT2)
NOFO Number: OTA-20-008 Summary: People with diabetes are at risk for painful diabetic peripheral neuropathy. This pain may be experienced as burning, aching, hypersensitivity to touch, or simply as pain, and there are no currently FDA-approved medications that reduce its symptoms. This phase 2 clinical trial, through the EPPIC-NET program, will test a potential new treatment for painful diabetic peripheral neuropathy. The treatment, WST-057 (topical pirenzepine 4%), is a molecule that was developed in the 1980s and marketed throughout Europe and Asia in an oral form to treat gastric ulcers. Studies show that this type of molecule can increase the density of certain nerve fibers, which has been linked with improve patient-reported outcome measures for painful diabetic peripheral neuropathy. |
||||||||
3-UH3-DA050173-02
Show Summary |
Optimized Interventions to Prevent Opioid Use Disorder among Adolescents and Young Adults in the Emergency Department | New Strategies to Prevent and Treat Opioid Addiction | Preventing Opioid Use Disorder | NIDA | UNIVERSITY OF MICHIGAN AT ANN ARBOR | WALTON, MAUREEN A | 2021 | |
NOFO Number:
Summary: The emergency department (ED) is an ideal venue to reach and intervene with adolescents and young adults at risk for opioid misuse, particularly as young adults may disconnect from primary care when transitioning out of pediatric medicine. This study will evaluate the efficacy of interventions of varying type/intensity to prevent/reduce opioid misuse or opioid use disorder (OUD). The research leverages technology that is appealing to youth to facilitate intervention delivery by health coaches. In this study, adolescents and young adults in the ED screening positive for opioid use or misuse will be randomly assigned to one of four intervention conditions with outcomes measured at 4, 8, and 12 months. Technology-driven, scalable interventions delivered via health coach allow for real-time tailoring to the rapidly changing opioid epidemic, with the potential for a sustainable impact on preventing escalation of opioid misuse among adolescents and young adults. While we know that Black/African American youth are at increased risk for opioid and other substance use, they often do not participate in research studies. As a result, we do not know how well prevention interventions work with Black/African American individuals. This supplement will focus on increasing participant diversity and inclusion by recruiting additional Black/African American participants for this ongoing randomized controlled trial to study technology-driven prevention interventions. |
||||||||
1U01DA055359-01
Show Summary |
18/24 Healthy Brain and Child Development National Consortium | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR | BAKHIREVA, LUDMILA NICOLE (contact); LEEMAN, LAWRENCE M | Albuquerque, NM | 2021 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020 Summary: The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative template of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive and well curated research dataset to the scientific community at large. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first 10 years of life. The University of New Mexico Health Science Center study site is in a largely rural/mixed state with one of the highest rates of overdose in the nation. This site will enroll diverse mother-infant pairs and partners or caregivers, including Hispanic/Latinx and American Indian individuals. |
||||||||
1UG3DA050942-01A1
Show Summary |
An Intranasal GDNF Gene Therapy for Opioid Relapse Reduction | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | NORTHEASTERN UNIVERSITY | WASZCZAK, BARBARA LEE | Boston, MA | 2021 |
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: There are currently no effective non-opioid-based pharmacotherapies for treatment of opioid use disorder (OUD). Glial cell line-derived neurotrophic factor (GDNF) is a beneficial protein normally present in low levels in the adult brain, and there is strong evidence that it has clinical potential as a therapy for OUD and relapse reduction. Researchers have developed a non-invasive approach that bypasses the blood-brain barrier to increase levels of GDNF using intranasal administration of gene nanoparticles that make GDNF protein within the brain. This project will test whether this intranasal GDNF gene therapy can suppress drug craving and reduce the tendency to start using a drug again after a period of abstinence in experimental models, thus providing a long-term therapeutic strategy for reducing opioid craving and preventing relapse. |
||||||||
1U01DA055354-01
Show Summary |
20/24 The Healthy Brain and Child Development National Consortium | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | UNIVERSITY OF VERMONT & ST AGRIC COLLEGE | POTTER, ALEXANDRA S (contact); GARAVAN, HUGH P | Burlington, VT | 2021 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020 Summary: The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative template of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive and well curated research dataset to the scientific community at large. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. The majority of participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first decade of life. The University of Vermont study site will recruit mother-infant dyads from a rural area in Vermont, a state in which nearly one-third of neonatal hospitalizations are for neonatal abstinence syndrome (NAS). |
||||||||
1U01DA055338-01
Show Summary |
8/24 The Healthy Brain and Child Development National Consortium | 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); BERRY, OBIANUJU ; SHUFFREY, LAUREN CHRISTINE | New York, NY | 2021 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020 Summary: The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first decade of life. This study will take place at New York University School of Medicine, allowing researchers to recruit participants from two of the largest private and public health systems in the country and include racial and ethnic minorities of varying economic levels. |
||||||||
1U24DA055330-01
Show Summary |
Healthy Brain and Child Development National Consortium Data Coordinating Center | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | WASHINGTON UNIVERSITY | SMYSER, CHRISTOPHER DANIEL (contact); DALE, ANDERS M; FAIR, DAMIEN A | St Louis, MO | 2021 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Data Coordinating Center (U24)
NOFO Number: RFA-DA-21-023 Summary: The HEALthy Brain and Child Development National Consortium (HBCD-NC) Data Coordinating Center (HDCC) will provide data management and oversight to all HBCD-NC sites to ensure the consortium’s primary objective of establishing a normative template of developmental trajectories over the first 10 years of life is met. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. The HDCC will coordinate data collection, data quality, data harmonization, data sharing, and data analysis efforts that are central to the consortium’s ability to implement a common research protocol. The HDCC will assemble all data across the consortium sites and distribute a comprehensive and well curated research dataset to the scientific community at large. The HDCC is tightly integrated with the HEALthy Brain and Child Development Administrative Core (HCAC) and includes a multi-institution investigative team at the University of Minnesota, University of California, San Diego, and Washington University at St Louis. |
||||||||
1UG1HD107649-01
Show Summary |
Neonatal Opioid Withdrawal Syndrome (NOWS) in Kentucky: Improving Outcomes for Infants | Enhanced Outcomes for Infants and Children Exposed to Opioids | Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) | NICHD | UNIVERSITY OF LOUISVILLE (KY) | DEVLIN-PHINNEY, LORI ANN (contact); TELANG, SUCHETA | Louisville, KY | 2021 |
NOFO Title: HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial - Clinical Sites (UG1 Clinical Trial Required)
NOFO Number: RFA-HD-21-031 Summary: Neonatal Opioid Withdrawal Syndrome (NOWS) is a condition that occurs when newborns are exposed to opioids during pregnancy. Symptoms often include tremors, excessive crying, sleep deprivation, and swallowing difficulties. Cases are rising, with a newborn affected by NOWS approximately every 15 minutes. Currently, healthcare providers in the United States lack standard, evidence-based treatments for NOWS. This project is part of a multi-center, randomized controlled clinical trial that directly compares NOWS treatments—morphine, methadone, and buprenorphine—and takes into account other types of non-drug therapies, such as behavioral interventions. The goal is to generate results that can inform clinical practice guidelines and give newborns with NOWS the best start possible. The University of Louisville serves a large, diverse population that is disproportionately affected by the opioid crisis. Mothers and infants treated by the university’s healthcare team live in rural |
||||||||
1RM1DA055437-01
Show Summary |
Integrated Care for Chronic Pain and Opioid Use Disorder: The IMPOWR Research Center at Montefiore/Einstein (IMPOWR-ME) | Clinical Research in Pain Management | Reducing Opioid-Related Harms to Treat Chronic Pain (IMPOWR and MIRHIQL) | NIDA | ALBERT EINSTEIN COLLEGE OF MEDICINE | STARRELS, JOANNA L (contact); ARNSTEN, JULIA H; GABBAY, VILMA | Bronx, NY | 2021 |
NOFO Title: HEAL Initiative: Integrative Management of Chronic Pain and OUD for Whole Recovery (IMPOWR): Research Centers (RM1 Clinical Trial Required)
NOFO Number: RFA-DA-21-030 Summary: Chronic pain and opioid use disorder often occur together, but there are a striking lack of integrated treatments accessible to people in need, particularly Black and Hispanic individuals living and seeking care in under resourced settings. This research will examine multi-modal, evidence-based practices in diverse health care settings and among diverse populations with both chronic pain and opioid misuse/disorder. The first project will examine the effects of yoga and physical therapy onsite at methadone opioid treatment clinics. The second project will test Acceptance and Commitment Therapy and a care-management smartphone app for individuals in primary-care based buprenorphine treatment. The third project will compare microdosing versus standard doses/timing of buprenorphine for hospitalized patients. All three projects will improve access to care for Black and Hispanic individuals in under resourced settings by bringing integrated treatments to them. The interventions have high potential to be used broadly. |
||||||||
1K24AR081143-01
Show Summary |
Mentorship of Junior Investigators on HEAL-SKOAP | Clinical Research in Pain Management | NIAMS | JOHNS HOPKINS UNIVERSITY | Campbell, Claudia Michelle | Baltimore, MD | 2021 | |
NOFO Title: Midcareer Investigator Award in Patient-Oriented Research (Parent K24 Independent Clinical Trial Required)
NOFO Number: PA-20-193 Summary: The HEAL-funded Sequenced-strategy for Improving Outcomes in People with Knee Osteoarthritis Pain (SKOAP) clinical trial evaluates behavioral, pharmacologic, and procedural interventions for patients with knee osteoarthritis pain. It is designed to mimic clinical care for these patients by first testing the effectiveness of conservative and nonsurgical interventions before considering surgical interventions. It is a large-scale clinical trial with a novel design that evaluates multidisciplinary treatments. Therefore, it offers a unique training opportunity for junior investigators from various disciplines who are interested in pain research and management. This mentoring award will allow a selected investigator to train junior investigators by providing protected, mentorship-focused time. |
||||||||
1U01DA055353-01
Show Summary |
5/24 Healthy Brain and Child Development National Consortium | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | BOSTON CHILDREN'S HOSPITAL | GRANT, PATRICIA ELLEN (contact); BOSQUET ENLOW, MICHELLE A | Boston, MA | 2021 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020 Summary: The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first 10 years of life. The Boston Children’s Hospital study site is in Massachusetts, which has the fifth highest rate of opioid use in the U.S., and twice the U.S. average incidence of opioid use disorder in delivering mothers. |