Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
1RM1DA055301-01
Integrative Treatment for Achieving Holistic Recovery from Comorbid Chronic Pain and Opioid Use Disorder Clinical Research in Pain Management Reducing Opioid-Related Harms to Treat Chronic Pain (IMPOWR and MIRHIQL) NIDA UNIVERSITY OF NEW MEXICO WITKIEWITZ, KATIE A (contact); PEARSON, MATTHEW RYAN Albuquerque, NM 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:

There are a dearth of integrated treatments that simultaneously address the fundamental causes of chronic pain and opioid misuse/opioid use disorder and that focus on well-being among individuals with chronic pain and opioid misuse/disorder. This research will study how to improve the lives of patients with chronic pain and opioid misuse/disorder via tailored interventions that explicitly target increasing quality of life and engagement in valued activities, the cultural centering of interventions to meet the needs of diverse patient populations and reducing stigma of chronic pain and opioid misuse/disorder. Specific research projects will i) test the effectiveness, mechanisms, and implementation of an integrated psychosocial treatment for chronic pain and opioid use disorder among individuals receiving buprenorphine from outpatient treatment clinics, and ii) will use community-based participatory research methods to develop a culturally centered strategy for screening and brief intervention of chronic pain and opioid use disorder among American Indian/Alaska Native patients in primary care settings. This research will shed light on a difficult problem and improve health and wellbeing with a focus on diverse and underserved populations.
3RM1DA055301-01S1
Integrative Treatment for Achieving Holistic Recovery from Comorbid Chronic Pain and Opioid Use Disorder Cross-Cutting Research Training the Next Generation of Researchers in HEAL NIDA UNIVERSITY OF NEW MEXICO WITKIEWITZ, KATIE A; PEARSON, MATTHEW RYAN Albuquerque, NM 2022
NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for PA-20-222: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: NOT-NS-20-107; PA-21-071
Summary:

Few integrated treatments are available that simultaneously address the fundamental causes of chronic pain and opioid misuse/opioid use disorder and focus on well-being among individuals with chronic pain and opioid misuse/opioid use disorder. This research will inform development of patient-centered interventions that increase quality of life and engagement in valued activities, are culturally appropriate for use by diverse patient populations, and reduce stigma related to chronic pain and opioid misuse/opioid use disorder. The results of this project will be used to inform future research focused on developing mobile health treatments for individuals with chronic pain and opioid use disorder, and for developing culturally appropriate treatments for chronic pain and opioid use disorder in Hispanic/Latino individuals.
1R61CA280979-01
Cancer Pain Management: A Technology-Based Intervention for Asian American Breast Cancer Survivors Clinical Research in Pain Management Advancing Health Equity in Pain Management NCI EMORY UNIVERSITY IM, EUN-OK (contact); CHEE, WONSHIK Atlanta, GA 2022
NOFO Title: HEAL Initiative: Advancing Health Equity in Pain and Comorbidities (R61/R33 Clinical Trial Required)
NOFO Number: RFA-NS-22-037
Summary:

Asian American women who have survived breast cancer and who also have depression are less likely to receive adequate pain treatment due to cultural stigma attached to breast cancer, cultural attitudes about living with pain and symptoms, and language barriers. This project will use a personalizable, technology-based approach to treat cancer pain and depression in Japanese American, Chinese American, and Korean American women who have survived breast cancer. The intervention will accommodate flexibility, accessibility, and anonymity: three factors that have historically hindered effective pain management for this population of breast cancer survivors.
3UG1DA015831-18S7
Emergency Department-INitiated bupreNOrphine and VAlidaTIOn Network Trial (ED-INNOVATION) Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA McLean Hospital Weiss, Roger Belmont, MA 2019
NOFO Title: Research Supplements to Promote Re-Entry into Biomedical and Behavioral Research Careers (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: PA-18-592
Summary:

Emergency department (ED)-initiated buprenorphine/naloxone (BUP) with referral for ongoing BUP is superior to referral alone in engaging patients with untreated opioid use disorder (OUD) in treatment at 30 days and is cost-effective. However, logistical barriers exist in translating research into practice. New BUP formulations such as the extended-release injectable BUP (CAM2038, XR-BUP) hold promise in addressing many of the barriers more effectively than sublingual buprenorphine (SL-BUP) by treating the patients’ symptoms for up to seven days. This study will recruit, train and provide resources to 30 ED sites throughout the U.S. using implementation facilitation strategies to address stigma and provide ED-initiated BUP for patients presenting with OUD who are not receiving medications for OUD. Once implementation is adequately achieved, the sites will conduct a randomized controlled trial (RCT) to compare the effectiveness of SL-BUP versus XR-BUP on ED patients’ engagement in formal addiction treatment seven days after their ED visit. In addition, in an ancillary component of the study, the use of XR-BUP will be assessed in ED patients with Clinical Opioid Withdrawal Scale (COWS) scores of
3UG1DA015831-18S9    
Emergency Department-INitiated bupreNOrphine and VAlidaTIOn Network Trial (ED-INNOVATION) Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA McLean Hospital Weiss, Roger Belmont, MA 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
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
3UG1DA015831-17S8
Emergency Department-INitiated bupreNOrphine and VAlidaTIOn Network Trial (ED-INNOVATION) Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA MCLEAN HOSPITAL WEISS, ROGER D.; CARROLL, KATHLEEN M. Belmont, MA 2019
NOFO Title: The National Drug Abuse Treatment Clinical Trials Network (UG1)
NOFO Number: RFA-DA-15-008
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
1UG3DA050310-01
A once-weekly oral methadone for maintenance therapy for 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 Lyndra Therapeutics, Inc. Bellinger, Andrew; Zale, Steve Boston, MA 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:

Methadone maintenance therapy has been shown to facilitate recovery and prevent deaths from opioid use disorder (OUD). This proposal is for development of a once-weekly oral methadone for maintenance therapy for OUD. Lyndra has developed an oral gastric residence dosage form that has been demonstrated to provide at least seven days of continuous delivery. A once-weekly oral methadone product could lower a major barrier to treatment for many patients, reduce the stigma and socioeconomic impact of medication-assisted therapy, and increase the capacity of methadone treatment centers by reducing the number of patient visits. This study will perform pharmaceutical development and pharmacological characterization of a once-weekly oral methadone dosage form, leading to the selection of a clinical candidate for a first-in-human trial and submission of an IND. Clinical trials will then be performed to evaluate the safety and pharmacokinetics of the once-weekly oral methadone dosage form in subjects with OUD.
3R61AT010806-01S1
Enhancing Exercise and Psychotherapy to Treat Comorbid Addiction Translation of Research to Practice for the Treatment of Opioid Addiction Behavioral Research to Improve Medication-Based Treatment NCCIH CASE WESTERN RESERVE UNIVERSITY NOCK, NORA L. Cleveland, OH 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:

Among the more than half-million adults entering addiction treatment for prescription opioid abuse every year, 50%-60% report co-morbid chronic pain, and 80% report that pain triggers relapse. Individualized/self-stigma among adults with substance abuse has been shown to lead to delayed recovery, increased relapse and reduced treatment-related attendance. Stigma may induce significant burden on patients with OUD and chronic pain and there may be unique characteristics of stigma for this population due to the overlap between medical treatment and substance abuse. Multiple sources of stigma may be imposed including internalized/self-stigma as well as intragroup/peer-to-peer (?horizontal?) stigma whereby peers impose stigma upon each other based on the type and severity of past drug use. Furthermore, stigma could be ?vertical? in that stigma may be enacted by health care providers or by treatment center staff. However, there is notably a lack of research and related assessment tools to measure these multidimensional facets of stigma, particularly in patients with OUD and chronic pain. The investigators will utilize a mixed-methods approach to evaluate internalized/self-stigma, anticipated/expected stigma and enacted stigma using existing standardized surveys, and to describe horizontal and vertical stigma in individuals with OUD and pain at multiple sites. In addition, the investigators will integrate the quantitative and qualitative information to help inform modifications to the psychotherapy component (I-STOP) of the parent award intervention, which would then also target multidimensional stigma in patients with OUD and chronic pain.
1R61AT010799-01
Peer-Delivered Behavioral Activation Intervention to Improve Adherence to MAT Among Low-Income, Minority Individuals With OUD Translation of Research to Practice for the Treatment of Opioid Addiction Behavioral Research to Improve Medication-Based Treatment NCCIH University of Maryland MAGIDSON, JESSICA F College Park, MD 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:

Poor medication-assisted treatment (MAT) retention disproportionately affects low-income racial/ethnic minority individuals with opioid use disorder (OUD) and increases risk for relapse; therefore, evidence-based interventions are needed to improve MAT retention. Peer recovery coaches (PRCs), trained individuals with experiences with substance use disorder, may be uniquely suited to address common MAT retention barriers among underserved populations, including stigma, challenges navigating services, housing instability, and other structural and psychosocial factors. Preliminary work by the research team suggests that behavioral activation (BA) by PRCs may be a feasible, scalable reinforcement-based approach for improving MAT retention for low-income minority OUD individuals. The study builds upon the research team’s formative work to adapt and evaluate the effectiveness and implementation of a PRC-delivered BA intervention (Peer Activate) to improve MAT retention for low-income, minority individuals with OUD.
3R61AT010799-01S2
Understanding How Peers Can Shift Stigma to Retain Low-Income, Minority Individuals in Opioid Treatment Translation of Research to Practice for the Treatment of Opioid Addiction Behavioral Research to Improve Medication-Based Treatment NCCIH UNIV OF MARYLAND, COLLEGE PARK MAGIDSON, JESSICA F College Park, MD 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:

Stigma is a key barrier to retention in medication-based treatment for opioid use disorder, particularly among low-income, minority individuals. Stigma that exists at multiple levels contributes to poor retention in care, including internalized and anticipated stigma at the individual level, as well as enacted stigma at the health care provider- and community levels. There is an urgent need to develop and evaluate innovative strategies to reduce stigma at these multiple levels among low-income, racial/ethnic minority individuals to improve engagement in care. One of the most promising strategies to reduce multiple intersecting stigmas simultaneously and improve engagement in care for low-income, minority individuals is through the use of peer recovery coaches (PRCs). PRCs, individuals who have gone through the recovery process themselves and are typically state-certified, have been shown to be more acceptable for engaging and retaining low-income, racial/ethnic minority patients in treatment compared to other health workers. However, scarce research has formally evaluated the effects of PRCs on stigma. This study will test how a PRC model can reduce multiple intersecting stigmas among low-income, racial/ethnic minority individuals to improve retention in methadone treatment.
1R61DA059948-01
Workforce and System Change to Treat Adolescent Opioid Use Disorder Within Integrated Pediatric Primary Care Translation of Research to Practice for the Treatment of Opioid Addiction Optimizing the Quality, Reach, and Impact of Addiction Services NIDA INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS HULVERSHORN, LESLIE A (contact); AALSMA, MATTHEW; ADAMS, ZACHARY WILLIAM Indianapolis, IN 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:

The overdose crisis has expanded rapidly among adolescent populations in recent years, largely due to illicit substances containing lethal amounts of the highly potent synthetic opioid fentanyl. However, a provider shortage limits access to effective treatment for adolescents with opioid use disorder and other substance use disorders (SUD). Although primary care is a promising setting for expanding delivery of SUD treatment to adolescents, many primary care providers lack the training, resources, and support systems to deliver these services confidently and effectively. This project will leverage a large-scale rollout of integrated behavioral health care in a statewide health system. The research will test whether embedding behavioral health specialists into primary care visits, introducing case management and electronic clinical decision support tools, and reducing stigma will increase delivery of SUD treatment to adolescents.
3R33AT010606-03S1
Adapting the HOPE Online Support Intervention to Increase MAT Uptake Among OUD Patients Translation of Research to Practice for the Treatment of Opioid Addiction Behavioral Research to Improve Medication-Based Treatment NCCIH UNIVERSITY OF CALIFORNIA-IRVINE YOUNG, SEAN Irvine, CA 2021
NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
NOFO Number: NOT-NS-21-025
Summary:

Effective medications for opioid use disorder (MOUD) are approved by the Food and Drug Administration for the treatment of people with opioid use disorder; however, only a small fraction of patients who would benefit from these medications actually use them. Several reasons contribute to low MOUD use, including lack of insurance; lack of knowledge about the medications, both among patients and providers; stigma associated with MOUD; and social norms. Innovative methods are needed to help increase MOUD use. One such option is peer-led interventions that might increase patients’ interest in MOUD. One existing peer-led intervention is the Harnessing Online Peer Education (HOPE) online community intervention that has been designed to reduce stigma and increase health behavior change among stigmatized populations, such as people living with HIV. This project will investigate whether and how HOPE can be adapted for people with opioid use disorder. It will assess whether HOPE can effectively increase MOUD requests, MOUD uptake, and sustained adherence to MOUD as well as reduce overdose rates.  
1R61AT010606-01
Adapting the HOPE Online Support Intervention to Increase MAT Uptake Among OUD Patients Translation of Research to Practice for the Treatment of Opioid Addiction Behavioral Research to Improve Medication-Based Treatment NCCIH UCLA YOUNG, SEAN Los Angeles, CA 2019
NOFO Title: HEAL Initiative: Behavioral Research to Improve MAT: Behavioral and Social Interventions to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-AT-19-006
Summary:

Online peer-led support interventions may increase medication-assisted therapy (MAT) initiation and sustainment among participants with opioid use disorder (OUD) because they can leverage peers to widely and rapidly scale changes in social norms (e.g., interest in using MAT) throughout people’s natural, real-world, virtual environments. Harnessing Online Peer Education (HOPE), an online peer support community intervention designed to reduce stigma and increase health behavior change, has effectively changed health behaviors among stigmatized populations, such as for HIV. This study will determine how to adapt the HOPE online support intervention to increase MAT initiation and sustainment among participants with OUD, assess the intervention’s effectiveness at increasing MAT use among OUD participants recruited online who are not using MAT, and use an implementation science approach to determine the relationship between social network dynamics (e.g., network size), topics discussed on the online community, and behavior change.
3R61AT010800-02S1
OUD Stigma Mechanisms in the Context of Buprenorphine Treatment Translation of Research to Practice for the Treatment of Opioid Addiction Behavioral Research to Improve Medication-Based Treatment NCCIH UNIVERSITY OF CALIFORNIA LOS ANGELES GLASNER-EDWARDS, SUZETTE V Los Angeles, CA 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 has been shown to be is an effective method for treating Opioid Use Disorder (OUD). However, despite its success, treatment retention rates are notoriously low ? about half of those seeking treatment will have dropped out within the first 6 months. One factor known to negatively impact treatment adherence is stigma. This stigma derives from not only being viewed as individuals with OUD, but even as individuals seeking medications for OUD as these medications often include other forms of opioids. Additionally, individuals with OUD often suffer from other conditions, including psychiatric illness, leading them to live with multiple stigmatized identities. This study will develop tools to assess stigma associated with OUD, seeking medical treatment for OUD, and mental health. This knowledge will then be used to adapt the parent award?s mobile Health intervention intended to overcome stigma barriers and increase adherence to buprenorphine treatment for OUD.
3R61AT010604-01S1
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.
3UG1DA040316-06S4
NorthStar Node of the Clinical Trials Network-Bring two lines of research together to help primary care clinicians (PCCs) recognize and address increased risk of suicide for people at elevated risk of opioid use disorder (OUD) Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA HENNEPIN HEALTHCARE RESEARCH INSTITUTE BART, GAVIN Minneapolis, MN 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:

Increasing primary care clinician intention and behavior to obtain waivers to prescribe buprenorphine for treatment of opioid use disorder and increase use of the Opioid Wizard, a clinical decision support tool, has potential for patient benefit. This supplement will provide support to evaluate a training tool as an intervention to reduce stigma in primary care clinics by integrating a stigma reduction training component into the Opioid Wizard training at multiple sites of the NIDA Clinical Trial Network. Primary care providers will be randomized to novel stigma reduction training, grounded in stigma science, or an attention-control training to determine whether stigma reduction training reduces provider stigma, increases intention to apply for a waiver to prescribe buprenorphine, and ultimately increase the likelihood that providers use Opioid Wizard. The proposed supplement will utilize the randomized controlled trial design embedded in the larger multisite trial to evaluate the Opioid Wizard tool to help primary care clinicians identify, diagnose, and treat patients with opioid use disorder while evaluating the effect of the stigma reduction training.
3UG1DA040316-04S4
Clinic-Randomized Trial of Clinical Decision Support for Opioid Use Disorders in Medical Settings Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA HENNEPIN HEALTHCARE RESEARCH INSTITUTE BART, GAVIN; JOSEPH, ANNE Minneapolis, MN 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 significant treatment gap between patients diagnosed with OUD and those who seek treatment, and only a small proportion of those seeking treatment receive MOUD. Primary care is the most common point of health care contact in the U.S. and is an important venue to address stigma, improve access to treatment and improve quality of care. Over the past decade, electronic health record (EHR)-linked Web-based point-of-care clinical decision support (CDS) systems designed to improve quality of chronic disease care have become increasingly sophisticated and successful. A Web-based and EHR-integrated OUD CDS system to offer expert guidance to primary care providers (PCPs) on the diagnosis and management of OUD was developed and piloted. This project will implement the OUD clinical decision support system in three large diverse health care systems and randomize a minimum of 30 clinics to receive the OUD-CDS intervention or usual care (UC). The project will evaluate the impact of OUD CDS on practice process measures and patient outcomes. The study will also prepare for scalability and dissemination by evaluating facilitators and barriers to implementation, determining the costs of implementation and maintenance and assessing the short-term cost impacts of the OUD-CDS.
3UG1DA040316-05S2
Clinic-Randomized Trial of Clinical Decision Support for Opioid Use Disorders in Medical Settings Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA HENNEPIN HEALTHCARE RESEARCH INSTITUTE BART, GAVIN; JOSEPH, ANNE Minneapolis, MN 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 significant treatment gap between patients diagnosed with OUD and those who seek treatment, and only a small proportion of those seeking treatment receive MOUD. Primary care is the most common point of health care contact in the U.S. and is an important venue to address stigma, improve access to treatment and improve quality of care. Over the past decade, electronic health record (EHR)-linked Web-based point-of-care clinical decision support (CDS) systems designed to improve quality of chronic disease care have become increasingly sophisticated and successful. A Web-based and EHR-integrated OUD CDS system to offer expert guidance to primary care providers (PCPs) on the diagnosis and management of OUD was developed and piloted. This project will implement the OUD clinical decision support system in three large diverse health care systems and randomize a minimum of 30 clinics to receive the OUD-CDS intervention or usual care (UC). The project will evaluate the impact of OUD CDS on practice process measures and patient outcomes. The study will also prepare for scalability and dissemination by evaluating facilitators and barriers to implementation, determining the costs of implementation and maintenance and assessing the short-term cost impacts of the OUD-CDS.
3UG1DA040316-05S3
Clinic-Randomized Trial of Clinical Decision Support for Opioid Use Disorders in Medical Settings Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA HENNEPIN HEALTHCARE RESEARCH INSTITUTE BART, GAVIN; JOSEPH, ANNE Minneapolis, MN 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 significant treatment gap between patients diagnosed with OUD and those who seek treatment, and only a small proportion of those seeking treatment receive MOUD. Primary care is the most common point of health care contact in the U.S. and is an important venue to address stigma, improve access to treatment and improve quality of care. Over the past decade, electronic health record (EHR)-linked Web-based point-of-care clinical decision support (CDS) systems designed to improve quality of chronic disease care have become increasingly sophisticated and successful. A Web-based and EHR-integrated OUD CDS system to offer expert guidance to primary care providers (PCPs) on the diagnosis and management of OUD was developed and piloted. This project will implement the OUD clinical decision support system in three large diverse health care systems and randomize a minimum of 30 clinics to receive the OUD-CDS intervention or usual care (UC). The project will evaluate the impact of OUD CDS on practice process measures and patient outcomes. The study will also prepare for scalability and dissemination by evaluating facilitators and barriers to implementation, determining the costs of implementation and maintenance and assessing the short-term cost impacts of the OUD-CDS.
3UG1 DA013035
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.
3UG1DA015831-21S3
National Institute on Drug Abuse Clinical Trial Network: New England Consortium Node Cross-Cutting Research Training the Next Generation of Researchers in HEAL NIDA Yale University D’ONOFRIO, GAIL New Haven, CT 2022
NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for PA-20-222: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: NOT-NS-20-107
Summary:

The goal of this project is to discover potential targets for emergency department-based interventions that could enhance access to addiction treatment among Black and Latino individuals, who face significant disparities in access to ongoing addiction treatment. Through qualitative interviews with Black, Latino, and non-Latino White patients receiving emergency department-initiated buprenorphine, the research will identify patterns of barriers and facilitators for continuation of opioid use disorder treatment outside of the emergency department through a referral. The study will also evaluate differences in factors previously identified as predictors of worse treatment outcomes in these patient groups, including opioid overdose, polysubstance use, major depressive disorder, and stigma.
3UG1DA013035-17S8
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 NEW YORK UNIVERSITY SCHOOL OF MEDICINE ROTROSEN, JOHN P; NUNES, EDWARD V. New York, NY 2019
NOFO Title: The National Drug Abuse Treatment Clinical Trials Network (UG1)
NOFO Number: RFA-DA-15-008
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
3UG1DA013035-18S6
Culturally Centered Medication for OUD (MOUD) Implementation Facilitation for Primary Care and Addiction Treatment Programs Serving American Indian/Alaska Natives Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA NEW YORK UNIVERSITY SCHOOL OF MEDICINE ROTROSEN, JOHN P; NUNES, EDWARD V. New York, NY 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 U.S. is in the midst of a devastating opioid epidemic. Since 1999, the number of overdose (OD) deaths involving opioids has quadrupled. These trends are magnified among American Indians/Alaska Natives (AI/ANs) compared to other racial/ethnic groups. AI/ANs are second only to Whites in the rate of OD mortality (8/100,000 versus 12/100,000 deaths, respectively). Medications for opioid use disorder (OUD; i.e., methadone, buprenorphine and naltrexone) are considered the most effective treatment, reducing mortality and increasing abstinence and retention. However, numerous barriers limit the uptake of medications for OUD in tribal communities and within urban treatment settings serving AI/AN individuals. This is a two-phase formative research study to develop and test an implementation intervention for programs to provide medications to treat OUD specifically with AI/AN consumers. The objective of Phase I (12 months) is to develop a culturally centered implementation intervention to integrate medications for opioid use disorder (MOUD) into health care/addiction specialty settings. The objective of Phase II (24 months) is to conduct a preliminary test of the implementation intervention at four sites serving AI/AN communities. Community-based participatory research (CBPR) methods will be used throughout both phases. This study will help with decreasing stigma and increase the utilization of MOUD in health care settings that serve AI/AN populations.
3UG1DA013035-18S3
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 NEW YORK UNIVERSITY SCHOOL OF MEDICINE ROTROSEN, JOHN P; NUNES, EDWARD V. New York, NY 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
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
3U01DK123812-01S1
Creating a multi-level intervention to reduce stigma for buprenorphine use for individuals with End Stage Kidney Disease and Chronic Pain Clinical Research in Pain Management Integrated Approach to Pain and Opioid Use in Hemodialysis Patients NIDDK UNIVERSITY OF PITTSBURGH AT PITTSBURGH JHAMB, MANISHA Pittsburgh, PA 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:

Medications have proven to be effective for treating opioid use disorder (OUD). Increasing accessibility to buprenorphine provides an opportunity for many with OUD to benefit from its proven effectiveness. Adherence to medication-based treatments however is low, in part because of the stigma associated with use of this and other effective drugs and as such, leads to inadequate treatment and poor outcomes. This study aims to understand the effects of stigma on patient engagement, retention, and outcomes of buprenorphine treatment. Knowledge drawn from the HIV Stigma Theory and tools developed to reduce HIV associated stigma will be used to assess OUD stigma and to develop interventions to reduce it in the context of buprenorphine treatment. The study findings may provide resources to address stigma and thus maximize treatment adherence among those affected by OUD.