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 Sort ascending | Research Focus Area | Research Program | Administering IC | Institution(s) | Investigator(s) | Location(s) | Year Awarded |
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1UG3DA047717-01
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MOR/DOR Heterodimer Antagonists: A Novel Treatment for Opioid Dependence | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | WASHINGTON STATE UNIVERSITY | MORGAN, MICHAEL M | Pullman, WA | 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: Tens of thousands of people die each year from opioid overdose. Many of these people began taking opioids for pain. A critical treatment goal is to reduce the development of opioid dependence either by enhancing opioid analgesia so lower doses can be used or by blocking withdrawal symptoms. Current pharmacological treatments in these two categories, although effective, present serious limitations. The recent finding that reducing the signaling through mu-delta opioid heterodimers appears to enhance opioid antinociception and reduce dependence suggests that a blocker of mixed mu-delta receptors (MDOR antagonist) could be effective in reducing dependence by limiting opioid tolerance and preventing opioid withdrawal. This research group has developed a compound with that characteristic, called D24M, which preliminary studies have shown could reduce opioid dependence by enhancing opioid antinociception, reducing opioid tolerance, or directly inhibiting opioid withdrawal. They propose to extend this research by investigating whether it can reduce chronic pain in an animal model that mimics the clinical situation of pain patients who transition to dependence. If these studies are successful, they could lead to the development of an optimized drug ready for Investigational New Drug (IND) application and enable translational and clinical testing. |
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3R01DA001411-45S2
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Monitoring the Future: Drug Use and Lifestyles of American Youth | New Strategies to Prevent and Treat Opioid Addiction | Preventing Opioid Use Disorder | NIDA | University of Michigan at Ann Arbor | Miech, Richard A. | Ann Arbor, MI | 2019 |
NOFO Title: Research Project Grant (Parent R01)
NOFO Number: PA-13-302 |
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1R01DA057645-01
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Mobile Health Strategies to Support Longitudinal Engagement in Harm Reduction Services | Translation of Research to Practice for the Treatment of Opioid Addiction | Harm Reduction Approaches to Reduce Overdose Deaths | NIDA | UNIVERSITY OF WISCONSIN-MADISON | WESTERGAARD, RYAN PATRICK (contact); SEAL, DAVID W | Madison, WI | 2022 |
NOFO Title: HEAL Initiative: Harm Reduction Policies, Practices, and Modes of Delivery for Persons with Substance Use Disorders (R01 Clinical Trial Optional)
NOFO Number: RFA-DA-22-046 Summary: Research is needed to better understand how to make life-saving harm reduction services more accessible to populations that are hard to reach. This project will identify the physical and psychological factors that make harm reduction services most effective. The findings will then be used to inform the development, implementation, and testing of an innovative strategy consisting of several internet- and smartphone-based tools designed to improve access to harm reduction services for people who are hard to reach. |
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3R42HD088325-02A1S1
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Mobile Augmented Screening Tool to Increase Adolescent HIV Testing and Linkage to Care | Cross-Cutting Research | Small Business Programs | NIDA | DIGITAL HEALTH EMPOWERMENT, INC. | ARONSON, IAN DAVID | BROOKLYN, NY | 2019 |
NOFO Title: PHS 2016-02 Omnibus Solicitation of the NIH, CDC, FDA, and ACF for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])
NOFO Number: PA-16-302 Summary: Adolescents face increased HIV risk, infrequent testing, inconsistent linkage to care, and a lack of prevention-related knowledge. We propose to complete and evaluate the Mobile Augmented Screening (MAS) tool to privately and discretely offer routine HIV testing and counseling, including prevention education, to high-need, diverse adolescent and young adult populations at a low cost. The MAS will consist of a tablet-based intervention including a brief video designed to increase adolescent HIV testing, automated text messages to facilitate linkage to care for those who test positive, and text-based education for those who test negative or decline testing. Phase I was conducted with young emergency department (ED) patients. Preliminary evaluations indicate the video led to significant knowledge increases and encouraged testing. In phase II, we seek to complete intervention development and evaluate through a randomized controlled trial with ED patients, with qualitative interviews for a subset of young patients and ED staff. |
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1U24DA058606-01
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MIRHIQL Resource Center (MRC) for Improving Quality of Life with Chronic Pain | 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 (contact); HURLEY, ROBERT WILLSON | Winston-Salem, NC | 2023 |
NOFO Title: HEAL Initiative: Multilevel Interventions to Reduce Harm and Improve Quality of Life for Patients on Long Term Opioid Therapy (MIRHIQL): Resource Center (U24- Clinical Trial Optional)
NOFO Number: RFA-DA-23-042 Summary: Decreasing opioid dosing faster than advised by clinical recommendations often leaves chronic pain unaddressed and may increase the risk of overdose and suicide compared to continuing long-term opioid treatment. Clinical and research communities are uncertain about how to assess and manage long-term opioid therapy, despite having diagnostic and treatment frameworks for chronic pain and opioid use disorder. Because of this undefined space, health policy, institutions, and practitioners lack clear advice on long-term opioid prescribing in chronic pain. The goal of the MRC is to provide infrastructure support for the network; create a risk-benefit decision tool to assist providers in determining when opioids should be continued as prescribed, tapered, or tapered/discontinued; and develop and validate a clinical definition for this population (name, identifying associated symptoms/behaviors, and generating a screening tool). This project will leverage big data analytics in administrative datasets, natural language processing approaches in electronic health records, and cohort modeling techniques to accomplish these key responsibilities. These efforts will complement the qualitative data collection approaches in the Becker Resource Center. |
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5R01AI132030-02
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MINING REAL-TIME SOCIAL MEDIA BIG DATA TO MONITOR HIV: DEVELOPMENT AND ETHICAL ISSUES | Translation of Research to Practice for the Treatment of Opioid Addiction | NIAID | UNIVERSITY OF CALIFORNIA LOS ANGELES | YOUNG, SEAN | Los Angeles, CA | 2018 | |
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591 Summary: Social big data analysis of publicly available user data on social media platforms is a promising approach for attaining organic observations of behavior that can monitor and predict real-world public health problems, such as HIV incidence. In preliminary research, our team identified and collected tweets suggesting HIV risk behaviors (e.g., drug use, high-risk sexual behaviors), modeled them alongside CDC statistics on HIV diagnoses, and found a significant positive relationship between HIV-related tweets and county-level HIV cases. We propose to create a single automated platform that collects social media data, identifies and labels tweets that suggest HIV-related behaviors, and predicts regional HIV incidence. We will interview staff and participants at local and regional HIV organizations to understand ethical issues associated with mining people’s data. The software developed from this application will be shared with HIV researchers and health care workers to combat the spread of HIV. |
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4R33AT010109-02
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Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment for Opioid Use and Chronic Pain Management | Translation of Research to Practice for the Treatment of Opioid Addiction | Behavioral Research to Improve Medication-Based Treatment | NCCIH | RBHS-ROBERT WOOD JOHNSON MEDICAL SCHOOL | COOPERMAN, NINA | Piscataway, NJ | 2019 |
NOFO Title: Clinical Trials or Observational Studies of Behavioral Interventions for Prevention of Opioid Use Disorder or Adjunct to Medication Assisted Treatment-SAMHSA Opioid STR Grants (R21/R33)
NOFO Number: RFA-AT-18-002 |
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1R21AT010109-01
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MINDFULNESS ORIENTED RECOVERY ENHANCEMENT AS AN ADJUNCT TO METHADONE TREATMENT FOR OPIOID USE AND CHRONIC PAIN MANAGEMENT | New Strategies to Prevent and Treat Opioid Addiction | NCCIH | Robert Wood Johnson Medical School | COOPERMAN, NINA; KLINE, ANNA | PISCATAWAY, NJ | 2018 | |
NOFO Title: Clinical Trials or Observational Studies of Behavioral Interventions for Prevention of Opioid Use Disorder or Adjunct to Medication Assisted Treatment-SAMHSA Opioid STR Grants (R21/R33)
NOFO Number: RFA-AT-18-002 Summary: MAT is the most effective intervention for opioid use disorder (OUD), and methadone maintenance treatment (MMT) is the most commonly prescribed MAT; however, approximately half of people who begin MMT discontinue within a year, and half of people retained in MMT have an opioid relapse within six months. Chronic pain, affecting most people on MMT, could be contributing to relapse in this group. Novel behavioral interventions that address both chronic pain and opioid relapse among people on MAT are needed. Mindfulness Oriented Recovery Enhancement (MORE) was recently developed to treat both pain and opioid misuse. MORE is a group intervention that combines training in mindfulness, cognitive reappraisal, and positive emotion regulation skills to target the dysfunctional cognitive, affective, and behavioral pathways that lead to opioid use relapse. The objective of this proposal is to examine the impact of MORE on opioid relapse and chronic pain among individuals receiving MMT. |
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2R44DA043288-02
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MINDFULNESS MOBILE APP TO REDUCE ADOLESCENT SUBSTANCE USE | Cross-Cutting Research | Small Business Programs | NIDA | Oregon Research Behavioral Intervention Strategies | Smith, Dana K | Eugene, OR | 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: Adolescents in the juvenile justice system demonstrate very high rates of tobacco, alcohol, and other drug use (ATOD), with rates that are estimated to be three times higher than non-justice-involved youth. Substance-abusing youth are at higher risk than nonusers for mental health problems, including depression, conduct problems, personality disorders, suicidal thoughts, attempted suicide, and completed suicide, as well as detrimental effects on neural development related to substance use. This project aims to adapt and test the feasibility and efficacy of a smartphone application (app) intervention prototype that would help adolescent substance users reduce or quit their substance use. The program, entitled Rewire, is based on the primary substance use cessation components tested in previous work with juvenile justice-involved adolescents and on intervention components shown to be central to smoking cessation, and applies a mindfulness approach as the guiding framework for the intervention. |
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4R33AT010117-02
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Mindful Moms in Recovery: Yoga-based mindfulness relapse prevention for pregnant women with opioid disorder | Translation of Research to Practice for the Treatment of Opioid Addiction | Behavioral Research to Improve Medication-Based Treatment | NCCIH | DARTMOUTH COLLEGE | LORD, SARAH E | Hanover, NH | 2019 |
NOFO Title: Clinical Trials or Observational Studies of Behavioral Interventions for Prevention of Opioid Use Disorder or Adjunct to Medication Assisted Treatment-SAMHSA Opioid STR Grants (R21/R33)
NOFO Number: RFA-AT-18-002 |
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1R21AT010117-01
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MINDFUL MOMS IN RECOVERY: YOGA-BASED MINDFULNESS RELAPSE PREVENTION FOR PREGNANT WOMEN WITH OPIOID DISORDER | New Strategies to Prevent and Treat Opioid Addiction | Behavioral Research to Improve Medication-Based Treatment | NCCIH | Dartmouth College | LORD, SARAH E; GOODMAN, DAISY J | Hanover, NH | 2018 |
NOFO Title: Clinical Trials or Observational Studies of Behavioral Interventions for Prevention of Opioid Use Disorder or Adjunct to Medication Assisted Treatment-SAMHSA Opioid STR Grants (R21/R33)
NOFO Number: RFA-AT-18-002 Summary: New Hampshire can anticipate as many as 1,000 infants born with prenatal opioid exposure each year. Pain management is complicated for pregnant women with opioid use disorder (OUD), and undermanagement of pain is a strong risk factor for relapse. Contemplative interventions, such as yoga and mindfulness, may reduce risks for relapse for pregnant and parenting women with OUD. This project represents a partnership with New Hampshire stakeholders to develop and pilot evaluation of a trauma-informed yoga and mindfulness relapse prevention intervention (Mindful Moms in Recovery: MMORE). It aims to: 1) identify needs and areas of adaptation of trauma-informed yoga and mindfulness-based relapse prevention protocols through formative work with pregnant and parenting woman; 2) develop an integrated 10-session intervention protocol with iterative feedback from client stakeholders; and 3) evaluate feasibility, acceptability, and efficacy trends of MMORE in a pre-post pilot with pregnant women. |
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1R01AT010742-01
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Mindful Body Awareness Training as an Adjunct to Medication Assisted Treatment for Opioid Use Disorder: An ancillary study | Translation of Research to Practice for the Treatment of Opioid Addiction | Behavioral Research to Improve Medication-Based Treatment | NCCIH | University of Washington | PRICE, CYNTHIA J (contact); MERRILL, JOSEPH O | Seattle, WA | 2019 |
NOFO Title: HEAL Initiative Limited Competition: Behavioral Research to Improve MAT: Ancillary Studies to Enhance Behavioral or Social Interventions to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders (R01 Clinical Trial Optional)
NOFO Number: RFA-AT-19-007 Summary: Opioid use disorder interventions need to address the complex needs of patients, which include substantial mental health comorbidity and high rates of chronic pain. This study takes advantage of recent federal and state opioid use disorder treatment initiatives as a platform for testing a promising mind-body intervention, Mindful Awareness in Body-oriented Therapy (MABT) as an adjunct to Medication Assisted Treatment (MAT) with buprenorphine in clinical settings funded through the Washington Opioid State Targeted Response (STR) program. Using a randomized, repeated measures design, the study team will compare those who receive MABT+ MAT to MAT only. The overarching goal of this application is to test MABT to improve MAT outcomes among patients receiving buprenorphine to treat OUD. Results of this study will inform the evidence base for behavioral treatment adjuncts to MAT with buprenorphine and directly impact the future direction of opioid use disorder treatment in Washington state. |
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1R21AT009932-01
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MINDFUL BODY AWARENESS TRAINING AS AN ADJUNCT TO MEDICATION ASSISTED TREATMENT FOR OPIOID USE DISORDER | New Strategies to Prevent and Treat Opioid Addiction | NCCIH | University of Washington | PRICE, CYNTHIA J; MERRILL, JOSEPH O | SEATTLE, WA | 2018 | |
NOFO Title: Behavioral Interventions for Prevention of Opioid Use Disorder or Adjunct to Medication Assisted Treatment-SAMHSA Opioid STR Grants (R21/R33)
NOFO Number: RFA-AT-18-001 Summary: This study leverages recent federal and state opioid use disorder treatment initiatives as a platform for testing a promising mind-body intervention, Mindful Awareness in Body-oriented Therapy (MABT) as an adjunct to MAT in two clinical settings funded through the Washington Opioid State Targeted Response (STR) program. MABT, a novel mindfulness-based intervention, uniquely addresses aspects of awareness, interoception, and regulation that may be associated with pain, mental health distress, and behavioral control that increase risk of relapse and poor treatment outcomes. Each setting employs a variation of the nationally recognized Massachusetts Nurse Care Manager model. Using a randomized, two-group, repeated measures design, we will compare those who receive MABT+MAT to MAT only. The overarching goal of this application is to test MABT to improve MAT health outcomes among patients receiving buprenorphine to treat OUD. |
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5U2COD023375-04
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MFMU Network Administrative Supplement | Enhanced Outcomes for Infants and Children Exposed to Opioids | Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) | OD | Duke University | Smith, Brian | Durham, NC | 2019 |
NOFO Title: Environmental Influences on Child Health Outcomes (ECHO) Coordinating Center (U2C)
NOFO Number: RFA-OD-16-006 |
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1U2CDA050098-01
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Methodology and Advanced Analytics Resource Center | Translation of Research to Practice for the Treatment of Opioid Addiction | Justice Community Opioid Innovation Network (JCOIN) | NIDA | UNIVERSITY OF CHICAGO | SCHNEIDER, JOHN (contact); POLLACK, HAROLD ALEXANDER | Chicago, IL | 2019 |
NOFO Title: HEAL Initiative: Justice Community Opioid Innovation Network (JCOIN) Methodology and Advanced Analytics Resource Center (U2C Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-023 Summary: Many individuals with opioid use disorder (OUD) pass through the criminal justice system over the course of their life. Improved access to high-quality, evidence-based addiction treatment in justice settings will be critical to addressing the opioid crisis. Through the Justice Community Opioid Innovation Network (JCOIN), the National Institutes of Health will study approaches to increase high-quality care for people with opioid misuse and OUD in justice populations. The Methodology and Advanced Analytics Resource Center (MAARC) will provide data infrastructure support across the network using advanced methods that provide best-in-class data storage, management and security with added value to clinical trials through products of forecasting, rapid real-time assessments, explication and exploration of trial findings, and cost-effectiveness analysis. |
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1UG3DA048387-01A1
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Methocinnamox (MCAM): A novel ?-opioid receptor antagonist for opioid use disorders | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | University of Texas Health Science Center San Antonio | Woods, James | San Antonio, TX | 2019 |
NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
NOFO Number: RFA-DA-19-002 Summary: MCAM is a novel opioid antagonist that can be used for opioid overdose reversal and has advantages over naloxone, including a pseudo-irreversible interaction with the ?-opioid receptor and a longer duration of action. Studies in animal models demonstrate MCAM’s long duration of action against the reinforcing and respiratory-depressant effects of remifentanil and heroin, indicating that could be a better treatment option for opioid use disorder. This project studies the pharmacodynamics of MCAM through animal toxicity and safety studies to establish the necessary and sufficient conditions from which to establish MCAM’s safety and antagonist activity in animals and humans. MCAM may be able to prevent all actions of any ?-receptor opioid drug in humans for a longer period of time than any other antagonist given acutely. |
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1R61DA059889-01
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Methadone Patient Access to Collaborative Treatment (MPACT) | Translation of Research to Practice for the Treatment of Opioid Addiction | Optimizing the Quality, Reach, and Impact of Addiction Services | NIDA | UNIVERSITY OF ARIZONA | MEYERSON, BETH | Tucson, AZ | 2023 |
NOFO Title: HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-DA-23-053 Summary: Current practices and culture in treatment programs for opioid use disorder, including treatment with methadone, may contribute to treatment interruption and relapse risk. This project will develop and test a staff-level intervention for opioid treatment programs to increase methadone treatment retention and decrease in-treatment overdose and patient- and staff-reported posttraumatic stress symptoms. The intervention includes components to address trauma in patients and staff as well as separate supervisory structures for counselors/case managers and medical providers. |
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3UG1DA013720-20S2
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Medication treatment for Opioid-dependent expecting Mothers (MOMs): A Pragmatic Randomized Trial Comparing Extended-Release and Daily Buprenorphine Formulations (CTN-0080) | Translation of Research to Practice for the Treatment of Opioid Addiction | Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids | NIDA | 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: The growing opioid use epidemic in the U.S. has been associated with a significant increase in the prevalence of pregnant opioid-dependent women and neonatal abstinence syndrome, which is associated with adverse health effects for the infant and with costly hospitalizations. Maintenance with sublingual (SL) buprenorphine (BUP) is efficacious for opioid use disorder but has disadvantages that may be heightened in pregnant women, including the potential for poor adherence, treatment dropout, and negative maternal/fetal effects associated with daily BUP peak-trough cycles. Extended release (XR) formulations may address some of these disadvantages. The primary objective of CTN-0080 is to evaluate the impact of treating opioid use disorder in pregnant women (n = 300) with BUP-XR, compared to BUP-SL, on maternal-infant outcomes. Other objectives include testing a conceptual model of the mechanisms by which BUP-XR may improve maternal-infant outcomes, relative to BUP-SL; determining the economic value of BUP-XR, compared with BUP-SL, to treat OUD in pregnant women; and evaluating the impact of BUP-XR, relative to BUP-SL, on neurodevelopment when the infant/child is approximately 12 and 24 months of age. Ultimately, this study will help in increasing access to treatment as well as provide quality care for pregnant/postpartum women. |
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3UG1DA040317-05S2
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Medication treatment for Opioid-dependent expecting Mothers (MOMs): A Pragmatic Randomized Trial Comparing Extended-Release and Daily Buprenorphine Formulations (CTN-0080) | Translation of Research to Practice for the Treatment of Opioid Addiction | Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids | NIDA | DUKE UNIVERSITY | WU, LI-TZY T | Durham, NC | 2019 |
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591 Summary: The growing opioid use epidemic in the U.S. has been associated with a significant increase in the prevalence of pregnant opioid-dependent women and neonatal abstinence syndrome, which is associated with adverse health effects for the infant and with costly hospitalizations. Maintenance with sublingual (SL) buprenorphine (BUP) is efficacious for opioid use disorder but has disadvantages that may be heightened in pregnant women, including the potential for poor adherence, treatment dropout, and negative maternal/fetal effects associated with daily BUP peak-trough cycles. Extended release (XR) formulations may address some of these disadvantages. The primary objective of CTN-0080 is to evaluate the impact of treating opioid use disorder in pregnant women (n = 300) with BUP-XR, compared to BUP-SL, on maternal-infant outcomes. Other objectives include testing a conceptual model of the mechanisms by which BUP-XR may improve maternal-infant outcomes, relative to BUP-SL; determining the economic value of BUP-XR, compared with BUP-SL, to treat OUD in pregnant women; and evaluating the impact of BUP-XR, relative to BUP-SL, on neurodevelopment when the infant/child is approximately 12 and 24 months of age. Ultimately, this study will help in increasing access to treatment as well as provide quality care for pregnant/postpartum women. |
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3UG1DA013727-20S3
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Medication treatment for Opioid-dependent expecting Mothers (MOMs): A Pragmatic Randomized Trial Comparing Extended-Release and Daily Buprenorphine Formulations (CTN-0080) | Translation of Research to Practice for the Treatment of Opioid Addiction | Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids | NIDA | MEDICAL UNIVERSITY OF SOUTH CAROLINA | BRADY, KATHLEEN T.; CARPENTER, MATTHEW J | Charleston, SC | 2019 |
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591 Summary: The growing opioid use epidemic in the U.S. has been associated with a significant increase in the prevalence of pregnant opioid-dependent women and neonatal abstinence syndrome, which is associated with adverse health effects for the infant and with costly hospitalizations. Maintenance with sublingual (SL) buprenorphine (BUP) is efficacious for opioid use disorder but has disadvantages that may be heightened in pregnant women, including the potential for poor adherence, treatment dropout, and negative maternal/fetal effects associated with daily BUP peak-trough cycles. Extended release (XR) formulations may address some of these disadvantages. The primary objective of CTN-0080 is to evaluate the impact of treating opioid use disorder in pregnant women (n = 300) with BUP-XR, compared to BUP-SL, on maternal-infant outcomes. Other objectives include testing a conceptual model of the mechanisms by which BUP-XR may improve maternal-infant outcomes, relative to BUP-SL; determining the economic value of BUP-XR, compared with BUP-SL, to treat OUD in pregnant women; and evaluating the impact of BUP-XR, relative to BUP-SL, on neurodevelopment when the infant/child is approximately 12 and 24 months of age. Ultimately, this study will help in increasing access to treatment as well as provide quality care for pregnant/postpartum women. |
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3UG1DA013732-20S3
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Medication treatment for Opioid-dependent expecting Mothers (MOMs): a pragmatic randomized trial comparing Extended-Release and Daily Buprenorphine formulations (CTN-0080) | Translation of Research to Practice for the Treatment of Opioid Addiction | Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids | NIDA | University of Cincinnati | Winhusen, Theresa | Cincinnati, OH | 2019 |
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591 Summary: The growing opioid use epidemic in the U.S. has been associated with a significant increase in the prevalence of pregnant opioid-dependent women and neonatal abstinence syndrome, which is associated with adverse health effects for the infant and with costly hospitalizations. Maintenance with sublingual (SL) buprenorphine (BUP) is efficacious for opioid use disorder but has disadvantages that may be heightened in pregnant women, including the potential for poor adherence, treatment dropout, and negative maternal/fetal effects associated with daily BUP peak-trough cycles. Extended release (XR) formulations may address some of these disadvantages. The primary objective of CTN-0080 is to evaluate the impact of treating opioid use disorder in pregnant women (n = 300) with BUP-XR, compared to BUP-SL, on maternal-infant outcomes. Other objectives include testing a conceptual model of the mechanisms by which BUP-XR may improve maternal-infant outcomes, relative to BUP-SL; determining the economic value of BUP-XR, compared with BUP-SL, to treat OUD in pregnant women; and evaluating the impact of BUP-XR, relative to BUP-SL, on neurodevelopment when the infant/child is approximately 12 and 24 months of age. Ultimately, this study will help in increasing access to treatment as well as provide quality care for pregnant/postpartum women. |
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3UG1DA013732-19S3
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Medication treatment for Opioid-dependent expecting Mothers (MOMs): A Pragmatic Randomized Trial Comparing Extended-Release and Daily Buprenorphine Formulations (CTN-0080) | Translation of Research to Practice for the Treatment of Opioid Addiction | Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids | NIDA | UNIVERSITY OF CINCINNATI | WINHUSEN, THERESA M | Cincinnati, OH | 2019 |
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591 Summary: The growing opioid use epidemic in the U.S. has been associated with a significant increase in the prevalence of pregnant opioid-dependent women and neonatal abstinence syndrome, which is associated with adverse health effects for the infant and with costly hospitalizations. Maintenance with sublingual (SL) buprenorphine (BUP) is efficacious for opioid use disorder but has disadvantages that may be heightened in pregnant women, including the potential for poor adherence, treatment dropout, and negative maternal/fetal effects associated with daily BUP peak-trough cycles. Extended release (XR) formulations may address some of these disadvantages. The primary objective of CTN-0080 is to evaluate the impact of treating opioid use disorder in pregnant women (n = 300) with BUP-XR, compared to BUP-SL, on maternal-infant outcomes. Other objectives include testing a conceptual model of the mechanisms by which BUP-XR may improve maternal-infant outcomes, relative to BUP-SL; determining the economic value of BUP-XR, compared with BUP-SL, to treat OUD in pregnant women; and evaluating the impact of BUP-XR, relative to BUP-SL, on neurodevelopment when the infant/child is approximately 12 and 24 months of age. Ultimately, this study will help in increasing access to treatment as well as provide quality care for pregnant/postpartum women. |
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3UG1DA015831-18S5
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Medication treatment for Opioid-dependent expecting Mothers (MOMs): A Pragmatic Randomized Trial Comparing Extended-Release and Daily Buprenorphine Formulations (CTN-0080) | Translation of Research to Practice for the Treatment of Opioid Addiction | Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids | NIDA | McLean Hospital | Weiss, Roger | Belmont, MA | 2019 |
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591 Summary: The growing opioid use epidemic in the U.S. has been associated with a significant increase in the prevalence of pregnant opioid-dependent women and neonatal abstinence syndrome, which is associated with adverse health effects for the infant and with costly hospitalizations. Maintenance with sublingual (SL) buprenorphine (BUP) is efficacious for opioid use disorder but has disadvantages that may be heightened in pregnant women, including the potential for poor adherence, treatment dropout, and negative maternal/fetal effects associated with daily BUP peak-trough cycles. Extended release (XR) formulations may address some of these disadvantages. The primary objective of CTN-0080 is to evaluate the impact of treating opioid use disorder in pregnant women (n = 300) with BUP-XR, compared to BUP-SL, on maternal-infant outcomes. Other objectives include testing a conceptual model of the mechanisms by which BUP-XR may improve maternal-infant outcomes, relative to BUP-SL; determining the economic value of BUP-XR, compared with BUP-SL, to treat OUD in pregnant women; and evaluating the impact of BUP-XR, relative to BUP-SL, on neurodevelopment when the infant/child is approximately 12 and 24 months of age. Ultimately, this study will help in increasing access to treatment as well as provide quality care for pregnant/postpartum women. |
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3U54DA038999-05S1
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MEDICATION DEVELOPMENT CENTER FOR COCAINE USE DISORDER | Novel Therapeutic Options for Opioid Use Disorder and Overdose | NIDA | VIRGINIA COMMONWEALTH UNIVERSITY | MOELLER, FREDERICK GERARD | Richmond, VA | 2018 | |
NOFO Title: Medications Development Centers of Excellence Cooperative Program (U54)
NOFO Number: RFA-DA-15-003 Summary: This U54 Center will use translational research from brain to bedside as a tool for medication development in cocaine use disorder. Preclinical and early phase I clinical PK/PD data will provide information for go/no-go decisions on phase II–III clinical trials with medications that show promise for cocaine use disorder. The overall goal of this research is to create a center that can provide important preclinical and early phase I clinical data to NIDA and pharmaceutical industry partners on novel compounds for cocaine use disorder. The aims related to the theme of the center will be achieved through two cores and three projects: The Administrative Core serves as a general resource for the other projects and the Educational Core, including oversight of fiscal and compliance matters, and will oversee interactions with outside entities, including NIDA and the pharmaceutical industry. The Educational Core will focus on training translational researchers for medication development for addictions across the two institutions. |
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3R01AT008559-02S1
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MECHANISMS OF PSYCHOSOCIAL TREATMENTS FOR CHRONIC LOW BACK PAIN | New Strategies to Prevent and Treat Opioid Addiction | NCCIH | University of Washington | JENSEN, MARK P; DAY, MELISSA ANNE | SEATTLE, WA | 2018 | |
NOFO Title: NIH Research Project Grant (Parent R01)
NOFO Number: PA-16-160 Summary: Chronic low back pain (CLBP) is a problem affecting millions of Americans. Psychosocial approaches are efficacious for addressing the multidimensional nature of CLBP. Three of the most widely implemented nonpharmacological techniques for CLBP management are cognitive therapy (CT), mindfulness meditation (MM), and behavioral activation (BA). However, there is a critical lack of research examining if these techniques work via the mechanisms specified by theory. Ecological momentary assessment (EMA) and ActiGraph technology embedded within a randomized controlled trial, consisting of daily measures of process and outcome, is ideal for testing mechanism models both during treatment and during the critical period following treatment. The current proposal seeks to utilize EMA and ActiGraph to examine if changes in cognitive content, cognitive process, and activity level are mechanisms specific to CT, MM, and BA, respectively, for reducing pain interference. Elucidating the mechanisms of pain coping skills will lead to streamlined CLBP interventions. |