Funded Projects

Explore our currently funded projects. You may search with all three fields, then focus your results by applying any of the dropdown filters. After customizing your search, you may download results and even save your specific search for later.

Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
3UM1DA049412-03S2
Research Supplement to Promote Diversity in Health-Related Research under MassHEAL - Reducing overdose deaths by 40% (2019-2023) Translation of Research to Practice for the Treatment of Opioid Addiction HEALing Communities Study NIDA BOSTON MEDICAL CENTER SAMET, JEFFREY H Boston, MA 2021
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:

Understanding municipal policies that influence implementation of effective evidence-based practices (EBPs) as well as effective strategies for working with municipal groups may inform local efforts to translate EBPs. Just as important, engaging with local stakeholders may help to facilitate the long-term sustainability of EBPs. This can only occur if diverse local actors in municipal governance are thinking about health and behavioral health in the context of municipal planning and policy. Building from research related opioid use disorder and the risk environment, built environment, and zoning, this research will work to support coalition-based approach currently implemented by the HEALing Communities Study. The research aims to develop an understanding of local policies that may affect implementation of community action plans in the HEALing Communities Study Massachusetts communities.

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.

1R24DA051975-01
Innovations in Recovery through Infrastructure Support (IRIS) Translation of Research to Practice for the Treatment of Opioid Addiction Recovery Research Networks NIDA UNIVERSITY OF MARYLAND BALTIMORE UNICK, GEORGE J Baltimore, MD 2020
NOFO Title: Research Networks for the Study of Recovery Support Services for Persons Treated with Medications for Opioid Use Disorder (R24 Clinical Trial Optional)
NOFO Number: RFA-DA-20-014
Summary:

The opioid epidemic in the United States is associated with alarming rates of overdose and overdose deaths. Medication Assisted Treatment (MAT), in combination with psychosocial intervention, is the most effective treatment for OUD; however, many individuals are unable to access treatment, are not sufficiently retained in treatment, or experience barriers that prohibit their participation in treatment. A multipronged approach is needed that includes 1) development of integrated networks of care, both formal and informal, to better address the needs of individuals with OUDs and 2) measures of the efficacy of these integrated networks for addressing the needs of individuals with OUD. This project will build a learning collaborative to address gaps in knowledge about the delivery, sustainability, and assessment of recovery service for individuals on MAT. The collaborative will foster collaboration and communication between stakeholders and with the larger community of research and providers interested in improving the delivery of OUD recovery support services. This community-academic partnership will address the lack of evidence regarding effective recovery support services.

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.

3UG1DA049436-02S2
Developing an intervention to address intersecting prescription opioid and chronic pain stigma in cancer survivors 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 PITTSBURGH AT PITTSBURGH LIEBSCHUTZ, JANE M. 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:

While advances in cancer treatment have increased survival rates, these patients often suffer from chronic cancer pain. Prescription opioids are often prescribed during active cancer treatment, but their long-term use for chronic cancer pain is associated with risk for opioid use disorder and risk for stigmatization associated with emotional distress, suboptimal health behaviors and coping strategies, and difficult patient-provider communication. This study aims to conduct qualitative interviews exploring prescription opioid and chronic pain stigma in cancer survivors with moderate-to-severe pain, caregivers, and clinicians who treat patients with chronic cancer pain, including oncologists, primary care providers, pain management specialists, and palliative care physicians. An analysis of potential contributors to stigma in cancer survivors will be completed to support development of multi-level behavioral interventions to reduce stigma and explore long-term health outcomes from such interventions.

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.

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.

1R24DA051946-01
Family-based Recovery Support Service Network for Youth OUD Translation of Research to Practice for the Treatment of Opioid Addiction NIDA NATIONAL CENTER ON ADDICTION/SUB ABUSE HOGUE, AARON New York, NY 2020
NOFO Title: Research Networks for the Study of Recovery Support Services for Persons Treated with Medications for Opioid Use Disorder (R24 Clinical Trial Optional)
NOFO Number: RFA-DA-20-014
Summary:

Opioid Use Disorder (OUD) prevalence has reached unprecedented levels among adolescents and emerging adults. Recovery Support Services (RSS) for persons with SUDs typically focus on the individual client after acute care. But for youth, developmental theory underscores the primacy of family-level risk and protective factors, and family-based interventions have the strongest empirical support. Yet there is a lack of research, clinical resources, and generalizable metrics focused on family-based RSS for youth with OUD. This study will establish a sustainable research network to develop and evaluate innovative family-based RSS across the youth OUD services cascade. The overall goal is to conduct research to strategies to promote family integration in youth OUD services, increase service engagement, and build supportive family environments for youth recovery. The specific goals focus on 1) innovations in family RSS interventions and metrics to assist youth OUD providers with integrating families in OUD services and, 2) innovations in measurement of direct-to-family RSS for families of youth with OUD. If successful, this study will systematically build a research and technical assistance infrastructure designed to develop and evaluate innovative family-based RSS for youth with OUD that span all phases of the services cascade: screening and referral, treatment initiation, treatment delivery, and continuing care.

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.

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.

3UG1DA013727-20S1
CTN Workforce Development Program 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 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 opioid epidemic has increased the demand for a research workforce with the necessary expertise and skills to conceptualize and carry out studies to expand and improve treatment options for opioid use disorders (OUDs). In particular, as the NIDA-funded Clinical Trials Network (CTN) expands the number of nodes and takes on additional studies as part of the HEAL Initiative, the need for an increasing number of staff who are familiar with the CTN research environment is amplified, and opportunities to provide a platform for training new investigators interested in the OUD area are increased. The CTN Research workforce development and dissemination program will provide multi-modal training, including didactic, experiential, and mentoring, to prepare research staff (regulatory personnel, study coordinators, project managers), post-doctoral fellows and faculty from a variety of disciplines (MD, PhD, PharmD, Nurse Practitioners, etc.) to participate in HEAL Initiative studies being conducted within the CTN.

3UG1DA040314-05S3
Primary Care Opioid Use Disorders Treatment Trial (PROUD) Economic Analysis Study Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA KAISER FOUNDATION RESEARCH INSTITUTE CAMPBELL, CYNTHIA I; BRADLEY, KATHARINE ANTHONY; WEISNER, CONSTANCE M. Oakland, 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:

Effective treatment for OUD has been shown to improve patient outcomes and reduce health care costs; however, evidence of this effect in primary care settings is severely limited. The health economic findings from this study will supplement the parent PROUD trial’s results regarding clinical effectiveness and implementation outcomes and provide critical contextual information for health systems and other health care stakeholders. The study will evaluate the economic viability of the PROUD collaborative care model for OUD—that is, from the perspective of the health care sector, to what extent do the downstream cost savings associated with improved patient outcomes offset the additional costs of the PROUD intervention? The specific aims are to (1) estimate the start-up and ongoing management costs of the PROUD intervention, (2) assess costs associated with health care utilization for patients who receive primary care treatment in PROUD and usual care clinics and have been identified with recognized OUDs before clinic randomization, and (3) estimate the economic value of the PROUD intervention, measured as net monetary benefit (NMB, incremental benefit minus incremental cost), from the health care sector perspective.

3U01DA036221-05S3
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.

3R01DA043122-03S1
HEALTH AND JUSTICE: A CONTINUUM OF CARE FOR HIV AND SU FOR JUSTICE-INVOLVED YOUTH Translation of Research to Practice for the Treatment of Opioid Addiction NIDA NEW YORK STATE PSYCHIATRIC INSTITUTE ELKINGTON, KATHERINE S New York, NY 2018
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Overcoming barriers to substance use (SU) screening and enrollment in SU care is central to decreasing justice-involved youth’s (JIY) negative HIV-related outcomes. This project proposes to embed HIV testing outreach workers from a youth-focused medical and HIV treatment program into an alternative sentencing program (ASP) to deliver a new service delivery model (Link2CARE) that integrates evidenced-based protocols for JIY to promote HIV and sexually transmitted infection (STI) testing and HIV and SU risk screening, and provide on-site intervention and cross-system linkage to HIV, STI, and SU care. We propose to determine the efficacy of Link2CARE delivered by health staff embedded within the ASP on HIV, STI, and SU outcomes; to determine the influence of theoretically based intervention mechanisms of change on the proposed HIV and SU outcomes; and to describe Link2CARE implementation and elucidate the system/organizational-, staff-, and youth-level factors that influence implementation of Link2CARE in an ASP.

1UG1DA050077-01
A comparative effectiveness trial of extended release naltrexone versus extended-release buprenorphine with individuals leaving jail Translation of Research to Practice for the Treatment of Opioid Addiction Justice Community Opioid Innovation Network (JCOIN) NIDA FRIENDS RESEARCH INSTITUTE, INC. GORDON, MICHAEL SCOTT (contact); MITCHELL, SHANNON GWIN Baltimore, MD 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:

A large number of individuals under criminal justice supervision with opioid use disorders (OUDs) have limited access to pharmacotherapy treatment, an intervention found to reduce substance use, HIV-risk behavior, and criminal activity. This randomized clinical trial will assess the effectiveness of an extended-release buprenorphine (XR-B) formulation compared to extended-release naltrexone (XR-NTX) in county jail inmates prior to release. Understanding how to expand acceptance of medications for OUD, particularly long-acting medications, in jails has far-reaching implications for treatment expansion in this population.

1UG1DA050074-01
Justice Community Opioid Innovation Network (JCOIN): TCU Clinical Research Center Translation of Research to Practice for the Treatment of Opioid Addiction Justice Community Opioid Innovation Network (JCOIN) NIDA TEXAS CHRISTIAN UNIVERSITY KNIGHT, KEVIN (contact); KNIGHT, DANICA K; OLSON, DAVID ; PAINTER DAVIS, NOAH Fort Worth, TX 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:

NIH is supporting the Justice Community Opioid Innovation Network (JCOIN), a collaboration of justice and behavioral health stakeholders that will study approaches to increase high-quality care for people with opioid misuse and opioid use disorder in justice populations. This multi-site clinical research center aims to improve local community public health and safety outcomes for reentering justice- involved individuals who have a history of (or are at risk for) using opioids by comparing two implementation strategies and two interventions at the client and system levels. The study will also examine which implementation strategy is most effective for increasing service linkage and initiation, services retention, and improved opioid-related public health safety outcomes.

3UG1DA040309-05S5
Rural Expansion of Medication Treatment for Opioid Use Disorder Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA DARTMOUTH COLLEGE MARSCH, LISA A. Hanover, NH 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.

1R01DA051067-01
Hub and Spoke Opioid Treatment Networks: 2nd Generation Approaches to Improve Medication Treatment for Opioid Use Disorders Translation of Research to Practice for the Treatment of Opioid Addiction Behavioral Research to Improve Medication-Based Treatment NIDA Brandeis University REIF, SHARON Waltham, MA 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:

Washington state used federal Opioid-STR funding to develop the Washington State Hub and Spoke Model (H&S), an integrated care model to expand access to OUD medications by incorporating primary care and substance use treatment programs, referral organizations, nurse care managers, and care navigators. Based on the initial success, Washington provided more funding and developed a second-generation, low-barrier H&S model, to place medication initiation sites in nontraditional settings, such as emergency departments, syringe exchanges, jails, and homeless shelters, and to have community partners offer OUD medication maintenance. The study will determine the implementation and effectiveness of the new H&S model, maintaining a hybrid effectiveness-implementation approach, and utilizing social network analysis to understand how H&S networks develop to serve the OUD population. The findings will demonstrate what makes the H&S model effective for increasing OUD medication treatment, improving outcomes for people with OUD, and reaching individuals who may not seek treatment.

1UM1DA049412-01
HEALing Communities Study - Massachusetts Translation of Research to Practice for the Treatment of Opioid Addiction HEALing Communities Study NIDA BOSTON MEDICAL CENTER SAMET, JEFFREY H Boston, MA 2019
NOFO Title: HEALing Communities Study: Developing and Testing an Integrated Approach to Address the Opioid Crisis (Research Sites) (UM1 - Clinical Trial Required)
NOFO Number: RFA-DA-19-016
Summary:

Although there are effective prevention and treatment programs and services to address opioid misuse, opioid use disorder (OUD), and overdose, gaps remain between those needing and those receiving prevention and treatment, in part because of a need to better understand how to make these programs and services most effective at a local level. The National Institutes of Health (NIH) and the Substance Abuse and Mental Health Services Administration (SAMHSA) launched the HEALing Communities Study to generate evidence about how tools for preventing and treating opioid misuse and OUD are most effective at the local level. This multisite implementation research study will test the impact of an integrated set of evidence-based practices across health care, behavioral health, justice, and other community-based settings. The goal of the study is to reduce opioid-related overdose deaths by 40 percent over three years. Boston Medical Center is partnering with academic institutions in three other states to study the impact of these efforts in 67 highly affected communities. The study will also look at the effectiveness of coordinated systems of care designed to increase the number of individuals receiving medication to treat OUD, increase the distribution of naloxone, and reduce high-risk opioid prescribing.

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

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

75N95019D00013-0-759501900092-1
Culturally Centered MAT for OUD 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 Emmes Corporation VanVeldhuisen, Paul Rockville, MD 2019
NOFO Number:
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.

3UG1DA015831-18S8
OUD Phenotyping Feasibility for Clinical Trials (CTN-0092) 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:

Very little research has been conducted on better understanding of phenotypic characterization of individuals with OUD (beyond DSM-5 diagnoses) and how these features predict illness severity, treatment retention or outcomes. The primary objective of the deep phenotyping study is to provide a comprehensive phenotypic characterization (e.g., domains of negative affect, reward salience, cognitive control, mental health) of a heterogeneous sample of individuals (n = 1,000) who currently meet one or more DSM-5 diagnostic criteria for OUD and are in treatment for OUD. In a subset of this sample (n = 100), the investigators conduct digital phenotyping to examine the utility of ecological momentary assessment (EMA), digital sensing and social media to predict retention, medication adherence and opioid use outcomes in patients receiving buprenorphine for OUD. It is anticipated that this foundational study will inform the feasibility and utility of such assessments that can be successfully embedded into imminent and future CTN and other OUD clinical trials.

3UG1DA013732-20S2
Validation of a Community Pharmacy-based Prescription Drug Monitoring Program Risk Screening Tool (PHARMSCREEN) 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:

Community pharmacies are optimal—yet underutilized—settings for identifying individuals with opioid use disorder (OUD) and increasing their access to treatment. Approximately 93 percent of individuals in the U.S. live within 5 miles of a community pharmacy. The most common opioid-related tool available to pharmacists is the prescription drug monitoring program (PDMP), which provides highly limited information and support for clinical decision making. Appriss Health, the largest U.S. PDMP vendor, covering 42 states, has developed an opioid risk measure, the NarxScore. This study will clinically validate the NarxScore metric and identify high, moderate and low opioid risk thresholds to inform OUD care management within urban and rural community pharmacies. This is a prospective cross-sectional comprehensive OUD risk and behavioral/physical health survey administered electronically with patients (n = 1,523) filling opioid medications in urban/rural community pharmacies in Ohio (pharmacy sites: n = 12) and Indiana (pharmacy sites: n = 3), states that continue to have disproportionately high rates of overdose and opioid prescribing. Correlation, regression and kappa statistics will be calculated for validation; receiver operating curves with sensitivity/specificity values will be employed for threshold identification (with >95 percent power to detect an area of 0.7 under the curve value).

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.

3UG1DA013727-20S4
Exemplar Hospital Initiation Trial to Enhance Treatment Engagement (EXHIT ENTRE) 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:

Hospital inpatient stays due to opioid-related health problems are a reachable moment for increasing access to treatment with medications for opioid use disorder (MOUD). Hospitalized patients with opioid use disorder (OUD) are at particularly high risk for morbidity, mortality, and high medical costs in the U.S. This study will substantially inform the care management of OUD in hospitalized patients. The project includes a comparative effectiveness research trial and an implementation research trial, which will lead to models of broad dissemination for treatment approaches to this largely unaddressed population. They will examine whether (1) in hospitals with addiction medicine consultation services, hospital-initiated extended-release buprenorphine (XR-BUP), compared with other OUD medications, results in increased engagement in treatment with MOUD following hospital discharge and (2) training hospitals without such consultation services on best practices for initiating MOUD using consultation service hubs improves medication uptake in hospitals and increased MOUD treatment engagement following discharge.