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) Sort ascending | Location(s) | Year Awarded |
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3UG1DA013714-17S3
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Preventing and Identifying Opioid Use Disorder (OUD) Using the Six Building Blocks (6BBs) for Improving Opioid Prescription Management | 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 Washington | DONOVAN, DENNIS; HATCH-MAILLETTE, MARY AKIKO | SEATTLE, WA | 2019 |
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591 Summary: This project seeks to develop and test a “train-the-trainer” curriculum and training experience that will facilitate the spread and use of the 6BBs by adapting the 6BBs framework and toolkit for health systems and other organizations, training personnel to facilitate its implementation and monitoring results of this implementation. |
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3UG1DA013714-18S3
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Rural Expansion of Medication Treatment for Opioid Use Disorder (CTN-0102) | 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 Washington | Donovan, Dennis | Seattle, WA | 2019 |
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591 Summary: People who use opioids in rural areas suffer worse health and less insurance coverage. The opioid problem in rural areas is of particular concern, as rural areas have higher overdose rates despite equivalent rates of OUD. This is because rural areas have a scant number of clinics and clinicians who provide medication treatment for OUD. Thus, people living in rural areas must travel long distances to access clinics that may or may not have expertise in providing treatment to patients with OUD. Telemedicine (TM) could efficiently increase capacity for delivery of buprenorphine in rural areas and may increase the number of patients receiving medication treatment and improve treatment retention and outcomes. While the development of medication treatments for opioid use disorder (MOUD) capacity in primary care settings with optimal/comprehensive services is desirable, the current opioid crisis with escalating overdose death rates in rural areas suggests a need to implement an efficient, cost-effective system of MOUD services that can be scaled up quickly. The use of a centralized and Medicare-covered TM vendor utilizing a developed methodology and established organizational infrastructure offers the great potential for a rapid rollout to increase access to MOUD and improve treatment retention in rural areas. This cluster randomized clinical trial with two phases will test expanded treatment access to improve retention on MOUD in highly affected rural areas. Phase I will include implementing telemedicine in a limited number of rural sites with varying levels of office-based opioid treatment (OBOT) to inform implementation strategies for the main trial, and Phase II will include evaluate comparative effectiveness between OBOT alone and OBOT + TM at 30 sites. |
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3UG1DA013714-18S5
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Derivation and Validation of New Measurement-Based Care Tools Derived from the Brief Addiction Monitor (BAM) | 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 Washington | Donovan, Dennis | Seattle, WA | 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 severity of the current opioid crisis, there is a pressing need to maximize the effectiveness of our interventions and increase retention in medication for opioid use disorder (MOUD) treatment. Measurement-based care (MBC), in which patient progress is regularly and systematically assessed to aid in treatment decisions, is a promising approach. Assessment tools are needed that can be administered quickly and that yield information that can be used to suggest improvements in treatment. In this study, the Investigator will conduct a series of analyses with data from the Brief Addiction Monitor (BAM), which has been selected for a national MBC initiative within the Veterans Administration. The goal of the work will be to derive and validate two new scales from the BAM. One scale is intended for use in opioid use disorder (OUD) specialty care programs. The second version is intended for use in primary care–based MOUD. |
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1RM1DA059365-01
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Improving Quality and Equity of Opioid Use Disorder Treatment Using a Multi-State Medicaid Research Network | Translation of Research to Practice for the Treatment of Opioid Addiction | Optimizing the Quality, Reach, and Impact of Addiction Services | NIDA | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | DONOHUE, JULIE MARIE (contact); BARNES, ANDREW JAMES | Pittsburgh, PA | 2023 |
NOFO Title: HEAL Initiative: Research to Foster an Opioid Use Disorder Treatment System Patients Can Count On (RM1 - Clinical Trial Optional)
NOFO Number: RFA-DA-23-046 Summary: Medicaid covers the cost of treatment for opioid use disorder (OUD) for most individuals who need it, including minoritized populations and those with risk factors related to low income, education, and employment. The Medicaid Outcomes Distributed Research Network has supported efforts to improve OUD treatment by developing novel measures of treatment quality and examining effects of treatment quality on overdoses. Using this network, this project will leverage university-state partnerships in 12 states to inform quality improvement initiatives and Medicaid policy. The research will develop provider-level quality measures for OUD using Medicaid administrative data and measure patient-reported outcomes. The research will also look for approaches to use claims-based quality measures and practice-level quality improvement strategies to improve treatment outcomes for people with OUD. |
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1R44DA049685-01
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Noninvasive Brain Stimulation for Treating Addiction | Cross-Cutting Research | Small Business Programs | NIDA | HIGHLAND INSTRUMENTS, INC | DIPIETRO, LAURA; WAGNER, TIMOTHY ANDREW | Cambridge, MA | 2019 |
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)
NOFO Number: PA-18-573 Summary: Noninvasive brain stimulation (NIBS) may be effective in treating some forms of addiction, but the most common NIBS methods, Transcranial Magnetic Stimulation (TMS) and Transcranial Direct Current Stimulation (tDCS), have not been found to be effective in treating opioid use disorder (OUD). This project seeks to test the efficacy in OUD patients of Electrosonic Stimulation (ESStim™), an improved NIBS modality that combines independently controlled electromagnetic and ultrasonic fields to focus and boost stimulation currents via tuned electromechanical coupling in neural tissue. |
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1UG3DA050322-01
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Preclinical and clinical evaluation of the NMDA modulator NYX-783 for OUD | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | Yale University | DiLeone, Ralph | New Haven, CT | 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: This study will conduct preclinical and clinical assessments of the NMDA modulator NYX-783 for treatment of opioid drug-seeking and relapse to opioid use disorder (OUD). NYX-783, a novel small molecule being developed by Aptinyx, has shown evidence of safety/tolerability in Phase 1 studies and is currently in Phase 2 trials for post-traumatic stress disorder. This project will test the safety, tolerability, and pharmacokinetics (PK) of NYX-718 in morphine-maintained patients in residential settings and then conduct a combined inpatient (safety/tolerability/PK) / outpatient (preliminary efficacy) study testing NYX-783’s effects on opioid use and relapse, stress/cue reactivity, craving, and quality of life in OUD subjects maintained on standard extended release naltrexone over a 10-week period. Successful completion of these studies will set the stage for larger scale Phase 2/3 studies of efficacy in OUD that will ultimately be required for FDA approval of NYX-783 for the treatment of drug-seeking and relapse in OUD. |
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1UG1HD107649-01
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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 |
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1UG3DA058544-01A1
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Antibody-based therapy for fentanyl-related 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 | MCLEAN HOSPITAL | DESAI, RAJEEV INDRAJIT (contact); BREMER, PAUL T | Belmont, MA | 2023 |
NOFO Title: Development of Medications to Prevent and Treat Opioid and/or Stimulant Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)
NOFO Number: PAR-22-200 |
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1R61AT010604-01
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Testing the Effects of Contingency Management and Behavioral Economics on Buprenorphine-Naloxone Treatment Adherence Using a Sequential Multiple Assignment Randomized Trial (SMART) Design | Translation of Research to Practice for the Treatment of Opioid Addiction | Behavioral Research to Improve Medication-Based Treatment | NCCIH | University of Tennessee | DEREFINKO, KAREN J | Knoxville, TN | 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: This application will develop and execute a sequential multiple assignment randomized trial (SMART) design to test two forms of behavioral economics intervention to promote medication-assisted treatment (MAT) for opioid use disorder. The two interventions, in person, brief motivational interviewing and substance-free activities intervention (BMI+SFAS), initially will be tested for satisfaction and acceptability with participants who are initiating buprenorphine-naloxone treatment and then be tested by SMART for its ability to promote MAT adherence. This innovative SMART design that tests two psychosocial interventions to increase adherence to MAT initiation is likely to have a significant impact on engagement of opioid use disorder patients in treatment and address an underserved population with opioid use disorder who is resistant to MAT adherence. |
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3R61AT010604-01S1
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Behavioral Economics based stigma reduction intervention for low income, African American individuals with OUD | Translation of Research to Practice for the Treatment of Opioid Addiction | Behavioral Research to Improve Medication-Based Treatment | NCCIH | UNIVERSITY OF TENNESSEE HEALTH SCI CTR | DEREFINKO, KAREN J | Memphis, TN | 2020 |
NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Reduce Stigma in Pain Management and Opioid Use Disorder (OUD) and Treatment
NOFO Number: NOT-OD-20-101 Summary: Buprenorphine-naloxone is known to work for the treatment of Opioid Use Disorder (OUD). However, despite its success in treating OUD, retention for these kinds of medication-assisted treatments (MATs) for OUD is notoriously low, having a dropout rate of approximately 50 percent within the first 6 months. One factor known to negatively impact a person?s adherence to treatment is stigma. This includes, not only stigma associated with having OUD, but also that of multiple stigmatized identities, including stigma associated with race. The goal of this supplement award is to decrease OUD- and race-related stigma in low income African American communities using a Behavioral Economics Stigma Reduction intervention that functions at the intrapersonal, interpersonal, and community levels. The investigators will work at the individual level to address stigma in untreated individuals who present with OUD at local community or faith organizations through stigma reduction counseling and tangible rewards for treatment uptake. To assess the interpersonal stigma, referred family members or support persons of these individuals will also be enrolled to receive stigma reduction and supportive skills counseling. Finally, a stigma reduction campaign will be developed and administered to the community via social media and billboards. Community members? substance use stigma will be compared before and after the campaign. |
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1U01DA055343-01
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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. |
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1R34DA050284-01
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1/5 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 | WOMEN AND INFANTS HOSPITAL-RHODE ISLAND | DEONI, SEAN CL (contact); AMSO, DIMA ; D'SA, VIREN ANDREW; MUELLER, HANS-GEORG | Providence, RI | 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. |
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3U01DA036221-05S3
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TRIALS COORDINATING CENTER TO REDUCE SUBSTANCE USE, HIV RISK BEHAVIORS, & CRIME | Translation of Research to Practice for the Treatment of Opioid Addiction | NIDA | CHESTNUT HEALTH SYSTEMS, INC. | DENNIS, MICHAEL L; SCOTT, CHRISTY K | Bloomington, IL | 2018 | |
NOFO Title: Translational Research on Interventions for Adolescents in the Legal System: TRIALS (U01)
NOFO Number: RFA-DA-13-009 Summary: Less than half of youth in the juvenile justice system who meet the criteria for substance use disorders (SUD) have ever received treatment, and less than one third of those received treatment while under community or correctional supervision. SUDs during adolescence can lead to significantly longer periods of substance use, more severe offending, and penetration in the justice system. The Translational Research on Interventions for Adolescents in the Legal System (TRIALS) cooperative is intended to develop and test implementation strategies and associated measures to improve the continuum of substance abuse and HIV prevention and treatment services delivered to youth under juvenile justice supervision. |
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1UG1DA050065-01
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Improving Retention across the OUD Service Cascade upon Re-entry from Jail using Recovery Management Checkups | Translation of Research to Practice for the Treatment of Opioid Addiction | Justice Community Opioid Innovation Network (JCOIN) | NIDA | CHESTNUT HEALTH SYSTEMS, INC. | DENNIS, MICHAEL L (contact); GRELLA, CHRISTINE E; SCOTT, CHRISTY K | Bloomington, IL | 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: This multi-site clinical research study will collaborate with six county jails in Illinois and medication-assisted treatment (MAT) providers to test an adapted version of an evidence-based intervention, the Recovery Management Checkups (RMC) model, which provides quarterly check-ups and assistance with treatment retention and re-linkage as indicated at the quarterly check-ups. The study will determine if tailoring the check-ups to an individual’s need for treatment leads to more efficient targeting of resources to those in need, reduces the intervention burden on those with lower need, and results in an improved overall effectiveness and cost-effectiveness of RMC. |
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3U01DA036221-05S4
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TRIALS COORDINATING CENTER TO REDUCE SUBSTANCE USE, HIV RISK BEHAVIORS, & CRIME | Translation of Research to Practice for the Treatment of Opioid Addiction | Justice Community Opioid Innovation Network (JCOIN) | NIDA | CHESTNUT HEALTH SYSTEMS, INC. | Dennis, Michael L | Bloomington, IL | 2019 |
NOFO Title: Translational Research on Interventions for Adolescents in the Legal System: TRIALS (U01)
NOFO Number: RFA-DA-13-009 Summary: Less than half of youth in the juvenile justice system who meet the criteria for substance use disorders (SUD) have ever received treatment, and less than one third of those received treatment while under community or correctional supervision. SUDs during adolescence can lead to significantly longer periods of substance use, more severe offending, and penetration in the justice system. The Translational Research on Interventions for Adolescents in the Legal System (TRIALS) cooperative is intended to develop and test implementation strategies and associated measures to improve the continuum of substance abuse and HIV prevention and treatment services delivered to youth under juvenile justice supervision. |
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1UF1MH121949-01
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Patient-centered team-based primary care to Treat Opioid Use Disorder, Depression, and Other conditions | New Strategies to Prevent and Treat Opioid Addiction | Optimizing Care for People with Opioid Use Disorder and Mental Health Conditions | NIMH | KAISER FOUNDATION RESEARCH INSTITUTE | DEBAR, LYNN L (contact); BRADLEY, KATHARINE ANTHONY | Oakland, CA | 2019 |
NOFO Title: HEAL Initiative: Effectiveness Trials to Optimize, Implement, Scale, and Sustain the Collaborative Care Model for Individuals with Opioid Use Disorders and Mental Health Conditions (U01 Clinical Trial Required)
NOFO Number: RFA-MH-19-525 Summary: Some medications for opioid use disorder (MOUD) can be provided in primary care (PC). Systems of team-based PC show promise for improving access and retention in OUD treatment. One such model, collaborative care (CC), includes a care manager, supervised by experts, who help provide evidence-based high-quality OUD care. While CC improves outcomes of depression, other mental health and substance use (MH/SU) disorders and pain, it is unknown how to optimally integrate CC for OUD with other MH/SU disorders. This pragmatic trial tests whether our model of CC for OUD and comorbid conditions increases engagement in MOUD treatment and improves depression symptoms in PC patients with OUD and depression. Innovative pragmatic elements include inclusion of all eligible patients in participating PC clinics, random recruitment and consent, and measurement of main outcomes using only secondary data. These pragmatic elements avoid studying only motivated patients and avoid activating patients randomized to usual care. |
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1U01DA055370-01
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21/24 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 WISCONSIN-MADISON | DEAN III, DOUGLAS CARL (contact); POEHLMANN-TYNAN, JULIE A | Madison, WI | 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 the University of Wisconsin, Madison, where researchers will have access to a diverse group of people, including women with criminal justice involvement. |
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1R01HL150566-01
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Arousal circuitry and opiate-associated memories | New Strategies to Prevent and Treat Opioid Addiction | Sleep Dysfunction as a Core Feature of Opioid Use Disorder and Recovery | NHLBI | Stanford University | DE LECEA, LUIS (contact); CHEN, XIAOKE | Stanford, CA | 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: Repetitive drug use forms powerful memories associating drug-evoked experiences with its proximal environmental cues. Memories are major obstacles for successfully treating addiction, since even after a prolonged period of abstinence, reexposure to such cues often triggers craving that promotes relapse. A polysynaptic pathway from the paraventricular nucleus of the thalamus (PVT) to the lateral hypothalamus (LH) has been shown to play a role in the maintenance of the opioid-associated memories. Hypocretin (Hcrt) neurons in the LH strongly innervate the PVT, required for maintaining wakefulness and involved in drug seeking. These factors may link sleep disorders in opioid addicts with their long-lasting drug-associated memories. This study will (1) determine whether Hcrt neurons in the LH are the major target; (2) examine whether manipulating the LH (Hcrt)-PVT pathway can effectively prevent relapse; and (3) test whether sleep intervention could be an effective strategy to prevent relapse. |
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1U24HD107621-01
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Data Coordinating Center (DCC) for the Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial (NOWS PhaCET) | Enhanced Outcomes for Infants and Children Exposed to Opioids | Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) | NICHD | RESEARCH TRIANGLE INSTITUTE (NC) | DAS, ABHIK | Research Triangle Park, NC | 2021 |
NOFO Title: HEAL Initiative: Data Coordinating Center for the Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial (U24 Clinical Trial Required)
NOFO Number: RFA-HD-21-032 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. This site will serve as the Data Coordinating Center for the clinical trial to provide high-quality and impartial biostatistical expertise for all the study sites. |
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5U24HD095254-02
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ACT NOW Clinical Trials: ESC and Weaning Protocols | Enhanced Outcomes for Infants and Children Exposed to Opioids | Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) | NICHD | RESEARCH TRIANGLE INSTITUTE | Das, Abhik | Research Triangle Park, NC | 2019 |
NOFO Title: Data Coordinating Center for the NICHD Neonatal Research Network (U24)
NOFO Number: RFA-HD-18-010 Summary: The ACT NOW Eat, Sleep, Console (ESC) Clinical Trial approach to the management of neonatal opioid withdrawal syndrome (NOWS) emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies. Although outcomes following implementation of the ESC care approach, inclusive of the ESC Care Tool, appear promising and initial accounts suggest that it is safe, there has yet to be a rigorous randomized clinical trial to demonstrate the safety, efficacy and generalizability of its use in the care of infants with NOWS. The ESC Clinical Trial leverages the infrastructure and collaborations of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network and the IDeA States Pediatric Clinical Trials Network to reach the populations most affected by the opioid epidemic. The trial will provide answers to numerous critical gaps in our knowledge with respect to the best practices for the identification and management of infants with NOWS, as well as our understanding of the outcomes of these infants. |
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1R43DA046998-01
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DEVELOPMENT OF A MULTIPLEX PEPTIDE ARRAY TO IDENTIFY PATIENTS WITH AN AUTOANTIBODY SIGNATURE FOR CHRONIC PAIN | Cross-Cutting Research | Small Business Programs | NIDA | Affinergy, LLC | Darby, Martyn | Durham, NC | 2019 |
NOFO Title: Development of a Device to Objectively Measure Pain (R43/R44)
NOFO Number: RFA-DA-18-012 Summary: One of the most widely used treatments for chronic pain is opioid analgesics. Importantly, there is evidence of a pathological interaction between opioids and the immune system that can contribute to both opioid tolerance and elevated levels of pain. Chronic pain conditions for which opioids are most often prescribed have been shown to involve dysregulation of the immune system, which may contribute to pathological effects of opioid use in these patients. To address this unmet need, this study aims to develop a reliable, cost-effective, and non-invasive in vitro diagnostic assay for chronic pain with an underlying inflammatory pathology, as a blood test available in primary care settings, with the hope that doctors can use the test to identify which patients might benefit less from opioids and be more likely to become addicted. |
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1R34DA050044-01
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Improving health and employment outcomes through workplace opioid policies | New Strategies to Prevent and Treat Opioid Addiction | Preventing Opioid Use Disorder | NIDA | Washington University | Dale, Anne Marie | St. Louis, MO | 2019 |
NOFO Title: Pilot Health Services and Economic Research on the Treatment of Drug, Alcohol, and Tobacco Use Disorders (R34 Clinical Trial Optional)
NOFO Number: PA-18-774 Summary: This study will develop and test the feasibility of implementing guidelines on workplace policies to reduce prescription opioid use, decrease chronic opioid use, promote recovery from opioid use disorder, and improve health-related employment outcomes. The researchers will develop and test these guidelines among construction workers. This project will provide critical information to design and conduct a randomized trial to implement and evaluate insurance and employment policy guidelines among labor-management health funds in the building trades. Aim 1 will identify current best-practice health care and employment policies to prevent health and employment consequences of opioid use. Aim 2 will characterize the opioid problem in construction and adapt best-practice healthcare and employment policies to the unique needs of the construction industry. Aim 3 will evaluate the feasibility of implementing workplace opioid guidelines in the construction trades and will define and collect measures of implementation and effectiveness. |
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3R01AA025848-03S1
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AOD Use Trajectories from Age 10 to 24: Multi-level Predictors, Health and Behavioral Functioning, and Racial/ethnic Disparitie | New Strategies to Prevent and Treat Opioid Addiction | Preventing Opioid Use Disorder | NIAAA | RAND Corporation | D'Amico, Elizabeth J. | Santa Monica, CA | 2019 |
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591 Summary: There is a great deal of research aimed at better understanding transitions in alcohol and other drug (AOD) use patterns from early to late adolescence and from late adolescence to emerging adulthood. However, no studies to date have (a) assessments of AOD use from ages 10 to 24 across all developmental periods (middle school, high school, and emerging adulthood); (b) a large sample with substantial racial and ethnic diversity, particularly among Hispanic and Asian youth; (c) in-depth coverage of 10 areas of functioning across three key domains; (d) subjective and objective neighborhood data; or (e) the capacity to examine developmental trajectories for more than one substance. The current proposal is a continuation of previous projects that assessed AOD use across nine waves of data from age 10 to age 19. The proposed study capitalizes on the longitudinal data on protective and risk factors we have collected since age 10 in an ethnically diverse cohort by continuing to annually assess these youth in order to capture important transitions to emerging adulthood (through age 24). By advancing the epidemiology of alcohol use during adolescence and emerging adulthood, our findings can affect prevention and intervention programming for young people and address critical issues of public health policy. |
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1UG3DA050235-01
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Development and Implementation of a Culturally Centered Opioid Prevention Intervention for American Indian/Alaska Native Young Adults in California | New Strategies to Prevent and Treat Opioid Addiction | Preventing Opioid Use Disorder | NIDA | RAND CORPORATION | D'AMICO, ELIZABETH J (contact); DICKERSON, DANIEL LEE | Santa Monica, CA | 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: Data from 2015 show that American Indians/Alaska Natives (AI/AN) have the highest rates of diagnosis for opioid use disorder (OUD) and death from drug overdose. Of particular concern is the prevalence in emerging adults (ages 18-25), as this is a developmental period of heightened vulnerability and critical social, neurological, and psychological development. This study will develop and implement a culturally centered intervention to address opioid misuse among urban AI/AN emerging adults in California: POMANAYA (Preventing Opioid Misuse Among Native American Young Adults). POMANAYA will developed by adapting and enhancing our existing culturally sensitive prevention intervention program that uses motivational interviewing in AI/AN youth to address social network factors in emerging adults that amplify (or reduce) opioid and other drug use risk. Results from this study could significantly advance scientific knowledge and clinical practice for AI/AN emerging adults. |
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3UH3DA050235-02S1
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Development and Implementation of a Culturally Centered Opioid Prevention Intervention for American Indian/Alaska Native Young Adults in California | New Strategies to Prevent and Treat Opioid Addiction | Preventing Opioid Use Disorder | NIDA | RAND CORPORATION | D'AMICO, ELIZABETH | Santa Monica, CA | 2020 |
NOFO Title: Notice of Special Interest(NOSI): HEAL Initiative: Social Network Analyses to Reduce American Indian and Alaska Native Opioid Use Disorder and Related Risks for Suicide and Mental Health Disorders
NOFO Number: NOT-DA-20-033 Summary: Data from 2015 show that American Indian/Alaska Natives (AI/AN) have the highest rates of diagnosis for opioid use disorders (OUD) and deaths from drug overdose; yet, there are no prevention programs addressing opioid misuse among urban AI/AN young adults that integrate culturally-appropriate strategies with evidence-based treatment. This project proposes to address that gap and help prevent OUD in Older Adolescents and Young Adults (ages 16-30) by developing and implementing a culturally-centered intervention to address opioid misuse among urban AI/AN emerging adults in California. The study will examine outcomes at 3-, 6-, and 12- months, and explore potential mechanisms of change for decreases in opioid and alcohol and other drug use outcomes through mediation analyses, including changes in social networks and cultural connectedness. Results from this study could significantly advance scientific knowledge and clinical practice for AI/AN emerging adults. |