Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
3UG1DA040314-04S5
OUD Phenotyping Feasibility for Clinical Trials 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 Oakland, CA 2019
NOFO Title: The National Drug Abuse Treatment Clinical Trials Network (UG1)
NOFO Number: RFA-DA-15-008
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.
4R33AT010109-02
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
3UG1DA013714-17S3
Preventing and Identifying Opioid Use Disorder (OUD) Using the Six Building Blocks (6BBs) for Improving Opioid Prescription Management Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA University of Washington DONOVAN, DENNIS; HATCH-MAILLETTE, MARY AKIKO SEATTLE, WA 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

This project seeks to develop and test a “train-the-trainer” curriculum and training experience that will facilitate the spread and use of the 6BBs by adapting the 6BBs framework and toolkit for health systems and other organizations, training personnel to facilitate its implementation and monitoring results of this implementation.
3R01DA043476-02S1
BUPRENORPHINE FOR PROBATIONERS AND PAROLEES: BRIDGING THE GAP INTO TREATMENT 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 Baltimore, MD 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 large number of probationers/parolees with opioid use disorder have limited access to effective treatment. This study is the first random clinical trial in the United States that will assess the effectiveness of buprenorphine treatment using MedicaSafe, a system composed of secure pre-packaged buprenorphine/naloxone cartridges, designed to be dispensed by a SmartKey device that enables clinicians to track patient adherence. The study will initiate treatment at a community corrections office compared to referral to a community program. The public health impact of the proposed study would be widespread, as this model of care could be implemented throughout many areas of the United States with high rates of opioid use disorder in their probation/parolee populations that lack access to methadone treatment.
1UG1DA049467-01
Great Lakes Node of the Drug Abuse Clinical Trials Network Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA RUSH UNIVERSITY MEDICAL CENTER KARNIK, NIRANJAN; POLLACK, MARK H Chicago, IL 2019
NOFO Title: The National Drug Abuse Treatment Clinical Trials Network (UG1 Clinical Trial Optional)
NOFO Number: RFA-DA-19-008
Summary:

The Great Lakes Node (GLN) of the NIDA-supported Drug Abuse Clinical Trials Network (CTN) will serve as a vital Midwestern hub for the CTN and expand on the success of the CTN approach. The GLN aims include (1) identify substance misuse research and intervention protocols focused on systems-based practice; (2) establish a digital and computation health core for studies in mHealth, eHealth, artificial intelligence, natural language processing, and telehealth interventions; (3) bring substantial expertise with youth/adolescent health and seniors/aging to examine prevention strategies to mitigate these life-course pathways; (4) support work on opioid misuse that focuses on health disparities, including socioeconomic, geographic, sexual orientation, and gender identity; (5) leverage experience in professional education and practice-based learning to test the impact of professional education on opioid and substance use treatment; and (6) expand the pipeline of early investigators interested in substance misuse research.
3UG1DA040309-05S3
Ancillary Study of the Adoption and Sustainability of ED-Initiated Buprenorphine 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:

For many reasons, the emergency department (ED) is a critical venue to initiate opioid use disorder (OUD) interventions. ED patients have a disproportionately high prevalence of substance use disorders and are at an elevated risk of overdose, and many do not access health care elsewhere. Despite this, OUD interventions are rarely initiated in EDs. The Emergency Department Connection to Care with Buprenorphine for Opioid Use Disorder study (CTN-0079) will assess the feasibility, acceptability and impact of introducing clinical protocols for screening for OUD, buprenorphine treatment initiation, and referral for ongoing treatment in ED settings with high need, limited resources and different staffing structures. This extension study will use the existing infrastructure to evaluate the adoption and sustainability of the clinical protocols introduced at each of the study sites and to identify factors influencing their diffusion and effectiveness.
1UG1DA050066-01
Reducing Opioid Mortality in Illinois (ROMI) Translation of Research to Practice for the Treatment of Opioid Addiction Justice Community Opioid Innovation Network (JCOIN) NIDA UNIVERSITY OF CHICAGO POLLACK, HAROLD ALEXANDER (contact); PHO, MAI TUYET; SCHNEIDER, JOHN Chicago, IL 2019
NOFO Title: HEAL Initiative: Justice Community Opioid Innovation Network (JCOIN) Clinical Research Centers (UG1 Clinical Trial Optional)
NOFO Number: RFA-DA-19-025
Summary:

Many opioid harm reduction services are designed and implemented to serve urban populations in traditional centers of opioid use and leave rural patients underserved. The proposed project seeks to demonstrate improved MAT participation, naloxone distribution, and syringe support services (SSPs) among justice-involved persons with opioid use disorders, and thus improve health and criminal justice outcomes across diverse urban and rural settings in Illinois. Reducing Opioid Mortality in Illinois (ROMI) is a multi-site trial that will be carried out using a hub-and-spoke model, with centralized long-standing social services infrastructure at the Community Outreach Intervention Projects (COIP) hosted at the University of Illinois at Chicago. COIP provides case management/transition of care services to justice-involved opioid users, extending resources and technical assistance to less-populated rural areas hardest hit by the opioid epidemic.
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
1UG1DA050069-01
Kentucky Womens Justice Community Opioid Innovation Network (WJCOIN) Translation of Research to Practice for the Treatment of Opioid Addiction Justice Community Opioid Innovation Network (JCOIN) NIDA UNIVERSITY OF KENTUCKY STATON, MICHELE STATON Lexington, KY 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:

Women are disproportionately affected by the opioid crisis due to increased pain sensitivity, physician prescribing practices, and self-medication, as well as a faster trajectory from opioid exposure to the development of opioid use disorder (OUD). The University of Kentucky proposes to establish the Women’s Clinical Research Center as part of the NIDA Justice Community Opioid Innovation Network (W-JCOIN), with the overall goal of increasing initiation and maintenance of medications for OUD among high-risk justice-involved women in the transition from jail to the community to reduce opioid relapse and overdose. The KY W-JCOIN has the potential for significant impact on the OUD treatment field by contributing empirical evidence on the effectiveness and implementation of innovative technologies to increase initiation and maintenance of life-saving medications during a critical, high-risk time of community re-entry among vulnerable, justice-involved women in both urban and rural communities.

OUD Phenotyping Feasibility for Clinical Trials 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:

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.
1UG1DA050072-01
Transitions Clinic Network: Post Incarceration Addiction Treatment, Healthcare, and Social Support (TCN PATHS) study Translation of Research to Practice for the Treatment of Opioid Addiction Justice Community Opioid Innovation Network (JCOIN) NIDA YALE UNIVERSITY WANG, EMILY AI-HUA New Haven, CT 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:

Correctional settings have the potential to serve as key players in linking individuals with opioid use disorder (OUD) to treatment and health services upon release. Many individuals with OUD are being treated with medications, but these efforts will be ineffective if they fail to connect people to OUD treatment upon release. The Transitions Clinic Network (TCN) program provides enhanced primary care and OUD treatment for people recently released from incarceration. In TCN, formerly incarcerated community health workers are embedded within primary care teams and address social determinants of OUD, provide social support, help patients build trust in the health system, and advocate in interactions with the criminal justice system. This study will assess the effectiveness of the TCN: Post Incarceration Addiction Treatment, Healthcare, and Social Support (TCN PATHS) intervention versus referral to standard primary care on opioid treatment cascade outcomes and whether housing, food access, criminal justice contact, and social support mediate this association.
1UM1DA049394-01
HEALing Communities Study Data Coordinating Center Translation of Research to Practice for the Treatment of Opioid Addiction HEALing Communities Study NIDA RTI International WILLIAMS, RICK L Research Triangle, NC 2019
NOFO Title: HEALing Communities Study: Developing and Testing an Integrated Approach to Address the Opioid Crisis (Data Coordinating Center) (UM1- Clinical Trials Not Allowed)
NOFO Number: RFA-DA-19-017
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. As the Data Coordinating Center, RTI will provide coordination and facilitate communications to unite the HEALing Communities Study research centers into a cohesive research cooperative.
5R01AI132030-02
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.
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.
3UG1DA013727-20S4
Peer Recovery Support: A Bridge to Treatment for Overdose 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 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:

Innovative interventions being conducted in emergency departments (EDs) for the treatment of opioid use disorders (OUD) have engaged more OUD individuals in treatment and saved lives. However, individuals who present to the ED following an opioid overdose, particularly those who have received naloxone reversal, are often resistant to accepting treatment. An innovative state-funded project called FAVOR Overdose Recovery Coaching Evaluation (FORCE) was initiated to try to address this problem wherein trained peer recovery coaches are called to the ED as soon as an opioid overdose victim is admitted. The proposed project will assess the feasibility and replicability of this model, assess whether the FORCE approach leads to more opioid overdose survivors entering formal substance use disorder treatment at one month compared to treatment as usual, and assess whether the FORCE approach leads to better retention in SUD treatment for OUD overdose survivors over time.
3UG1DA040314-05S4
Developing a Prescription Opioid Registry Across Diverse Health Systems 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:

The opioid crisis continues its highly negative impact, with more than 49,000 opioid-related overdose deaths in 2017. In 2016, the Centers for Disease Control and Prevention (CDC) issued guidelines for opioid prescribing that included opioid dosing and risk mitigation strategies, and health systems implemented similar initiatives even earlier. This has resulted in a quickly changing and more conservative prescribing environment. National data indicate the number of prescriptions has fallen between 2013 and 2016. Registries and electronic health record (EHR) data are increasingly cited as valuable resources to address critical research questions on opioid use with high efficiency. To our knowledge, no investigators have established an EHR-based prescription opioid registry across several diverse health systems with common data algorithms with the flexibility to address multiple questions. The goal of the proposed research is to develop a prescription opioid registry across 10 diverse health systems with harmonized EHR data from years 2012-2018 and leverage it to answer several key “next-step” research questions in response to the opioid crisis. The registry will include medications prescribed for treatment of OUD, including buprenorphine products.
1R61AT010604-01
Testing the Effects of Contingency Management and Behavioral Economics on Buprenorphine-Naloxone Treatment Adherence Using a Sequential Multiple Assignment Randomized Trial (SMART) Design Translation of Research to Practice for the Treatment of Opioid Addiction Behavioral Research to Improve Medication-Based Treatment NCCIH University of Tennessee DEREFINKO, KAREN J Knoxville, TN 2019
NOFO Title: HEAL Initiative: Behavioral Research to Improve MAT: Behavioral and Social Interventions to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-AT-19-006
Summary:

This application will develop and execute a sequential multiple assignment randomized trial (SMART) design to test two forms of behavioral economics intervention to promote medication-assisted treatment (MAT) for opioid use disorder. The two interventions, in person, brief motivational interviewing and substance-free activities intervention (BMI+SFAS), initially will be tested for satisfaction and acceptability with participants who are initiating buprenorphine-naloxone treatment and then be tested by SMART for its ability to promote MAT adherence. This innovative SMART design that tests two psychosocial interventions to increase adherence to MAT initiation is likely to have a significant impact on engagement of opioid use disorder patients in treatment and address an underserved population with opioid use disorder who is resistant to MAT adherence.
1UG1DA050071-01
Facilitating Opioid Care Connections: System level strategies to improve use of MAT and movement through the opioid care cascade for defendants in a new Opioid Court system Translation of Research to Practice for the Treatment of Opioid Addiction Justice Community Opioid Innovation Network (JCOIN) NIDA NEW YORK STATE PSYCHIATRIC INSTITUTE ELKINGTON, KATHERINE S (contact); NUNES, EDWARD V; WAINBERG, MILTON L New York, NY 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:

Rates of opioid use (OU), opioid use disorder (OUD), and overdose (OD) disproportionately affect those in the justice system. Yet, despite such high rates of misuse and associated negative outcomes of untreated OUD, screening and the availability or use of evidence-based treatments for OU and OUD—including medication to treat OUD—are substantially underused in justice populations. This project will leverage the unique, real-time scale-up of a new opioid court model (OCM) to address a critical public and correctional health problem by developing and evaluating an implementation intervention (OCM RISE), designed to build cross-system partnerships to permit the development of generalizable yet tailored strategies that allow the OCM to be scaled up across a variety of contexts.
3R01DA045745-02S1
Intervention to Increase Naloxone Engagement and Distribution in Community Pharmacies: A Four-State Randomized Trial Translation of Research to Practice for the Treatment of Opioid Addiction Justice Community Opioid Innovation Network (JCOIN) NIDA BOSTON MEDICAL CENTER Green, Traci C Boston, 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:

Expanding access to naloxone in the community through the pharmacy can be a critical mechanism for extending this lifesaving medication’s reach. This study will partner with two large retail pharmacy chains and integrate two interventions that provide knowledge and training for pharmacists to identify and effectively engage with patients who may be at high risk for an opioid overdose. The interventions will be combined into a cohesive educational program, implemented in 160 community pharmacies and tested for effectiveness. Study findings will create a generalizable, evidence-based training and toolkit for pharmacists caring for patients who use prescribed or illicit opioids, in more than 40 states adopting or expanding pharmacy naloxone.
1U01DA047982-01
Long-acting buprenorphine vs. naltrexone opioid treatments in CJS-involved adults Translation of Research to Practice for the Treatment of Opioid Addiction Justice Community Opioid Innovation Network (JCOIN) NIDA NEW YORK UNIVERSITY SCHOOL OF MEDICINE LEE, JOSHUA D; FARABEE, DAVID J; MARSCH, LISA A; SCHWARTZ, ROBERT P; SPRINGER, SANDRA ANN; WADDELL, ELIZABETH NEEDHAM New York, NY 2019
NOFO Title: HEAL Initiative: Justice Community Opioid Innovation Network (JCOIN) Clinical Research Centers (UG1 Clinical Trial Optional)
NOFO Number: RFA-DA-19-025
Summary:

This study will assess the implementation of an evidence-based treatment in correctional settings by comparing the effectiveness of two medications used to treat opioid use disorder—extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX)—among adults currently incarcerated in U.S. jails and prisons at five distinct trial sites. This study will allow providers, correctional and public health authorities, payers, and policymakers’ timely and relevant data to assess the effectiveness of these medications as potentially useful re-entry treatment options. Findings from this study have implications for expanding public safety and limiting the societal costs of heroin, fentanyl, and prescription opioid addictions.
3UG1DA040309-04S4
OUD Phenotyping Feasibility for Clinical Trials 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:

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.
3R21DA044443-02S1
DAT-OPTIMIZING THE IMPACT OF MEDICATION ASSISTED TREATMENT INTERVENTIONS IN PRISON AND JAIL SETTINGS Translation of Research to Practice for the Treatment of Opioid Addiction NIDA MIRIAM HOSPITAL RICH, JOSIAH D Providence, RI 2018
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

We propose to estimate the impact of expanded access to medication-assisted treatment (MAT) in prisons and jails on post-release rates of overdose. Our approach will use agent-based modeling, data collected through the parent study, existing surveillance data, and recently published data from similar settings to understand how different MAT interventions in the prison and jail setting impact overdose death post-release. We will examine the impact of standard of care/no intervention, providing access to depot-naltrexone alone, providing access to all three MATs to only those who were prescribed it prior to incarceration, and comprehensive provision of all three MATs on post-release rates of overdose. These models will incorporate advanced methodological techniques that will allow for the investigation of engaged treatment, program attrition, and other complex events on a population level. This study’s findings may be used by health agencies, policymakers, and correctional systems to inform their efforts to expand MAT access.
1U2CDA050098-01
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.
3UG1DA013720-20S2
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.
75N95019D00013-0-759501900093-1
Surmounting Withdrawal to Initiate Fast Treatment with Naltrexone (SWIFT): Improving the Real-World Effectiveness of Injection Naltrexone 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 Emmes Corporation VanVeldhuisen, Paul Rockville, MD 2019
NOFO Number:
Summary:

Inpatient programs are important portals for increasing access to treatment. However, most individuals with opioid use disorder are detoxified but not offered medications to prevent relapse. This randomized-controlled trial will examine whether a rapid-transition protocol to inducting extended release naltrexone (XR-NTX) following detoxification yields a higher proportion of patients successfully receiving the first injection of XR-NTX compared with standard detoxification and naltrexone initiation. This study will also assess facilitators and barriers to implementing rapid XR-NTX initiation. The overall goal is to foster widespread adoption of a five- to seven-day protocol for initiation of treatment with XR-NTX at inpatient/residential programs.