Funded Projects

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Project # Sort descending	Project Title	Research Focus Area	Research Program	Administering IC	Institution(s)	Investigator(s)	Location(s)	Year Awarded
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.
3UG1DA013714-17S5	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	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: 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.
3UG1DA013714-18S3	Rural Expansion of Medication Treatment for Opioid Use Disorder (CTN-0102)	Translation of Research to Practice for the Treatment of Opioid Addiction	Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids	NIDA	University of Washington	Donovan, Dennis	Seattle, WA	2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) NOFO Number: PA-18-591 Summary: People who use opioids in rural areas suffer worse health and less insurance coverage. The opioid problem in rural areas is of particular concern, as rural areas have higher overdose rates despite equivalent rates of OUD. This is because rural areas have a scant number of clinics and clinicians who provide medication treatment for OUD. Thus, people living in rural areas must travel long distances to access clinics that may or may not have expertise in providing treatment to patients with OUD. Telemedicine (TM) could efficiently increase capacity for delivery of buprenorphine in rural areas and may increase the number of patients receiving medication treatment and improve treatment retention and outcomes. While the development of medication treatments for opioid use disorder (MOUD) capacity in primary care settings with optimal/comprehensive services is desirable, the current opioid crisis with escalating overdose death rates in rural areas suggests a need to implement an efficient, cost-effective system of MOUD services that can be scaled up quickly. The use of a centralized and Medicare-covered TM vendor utilizing a developed methodology and established organizational infrastructure offers the great potential for a rapid rollout to increase access to MOUD and improve treatment retention in rural areas. This cluster randomized clinical trial with two phases will test expanded treatment access to improve retention on MOUD in highly affected rural areas. Phase I will include implementing telemedicine in a limited number of rural sites with varying levels of office-based opioid treatment (OBOT) to inform implementation strategies for the main trial, and Phase II will include evaluate comparative effectiveness between OBOT alone and OBOT + TM at 30 sites.
3UG1DA013714-18S4	CLINICAL TRIALS NETWORK: PACIFIC NORTHWEST NODE	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
3UG1DA013714-18S5	Derivation and Validation of New Measurement-Based Care Tools Derived from the Brief Addiction Monitor (BAM)	Translation of Research to Practice for the Treatment of Opioid Addiction	Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids	NIDA	University of Washington	Donovan, Dennis	Seattle, WA	2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) NOFO Number: PA-18-591 Summary: Given the severity of the current opioid crisis, there is a pressing need to maximize the effectiveness of our interventions and increase retention in medication for opioid use disorder (MOUD) treatment. Measurement-based care (MBC), in which patient progress is regularly and systematically assessed to aid in treatment decisions, is a promising approach. Assessment tools are needed that can be administered quickly and that yield information that can be used to suggest improvements in treatment. In this study, the Investigator will conduct a series of analyses with data from the Brief Addiction Monitor (BAM), which has been selected for a national MBC initiative within the Veterans Administration. The goal of the work will be to derive and validate two new scales from the BAM. One scale is intended for use in opioid use disorder (OUD) specialty care programs. The second version is intended for use in primary care–based MOUD.
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.
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.
3UG1DA013720-20S3	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.
3UG1DA013727-19S1	Integrating Nurse Practitioner Buprenorphine Wavier Training into Graduate Nursing Curriculum	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: This proposal would address barriers to the NP’s ability to prescribe buprenorphine by incorporating waiver education into NP final semester curriculum. The initial eight hours of training would be provided to students in a face-to-face classroom setting or via live video streaming. The remaining 16 hours would be completed by the NP students through online modules offered by the AANP. Trained NP students would be eligible for one year of peer-to-peer mentorship and inclusion in the MUSC Project ECHO tele-mentoring for new providers. Outcomes to be tracked would be the number of NPs trained who obtain their waiver and the number of individuals treated with MOUD by the NPs trained. Secondary data collected would offer insight into wavier obtainment process and determine need for mentorship for newly waivered providers.
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.
3UG1DA013727-20S3	Medication treatment for Opioid-dependent expecting Mothers (MOMs): A Pragmatic Randomized Trial Comparing Extended-Release and Daily Buprenorphine Formulations (CTN-0080)	Translation of Research to Practice for the Treatment of Opioid Addiction	Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids	NIDA	MEDICAL UNIVERSITY OF SOUTH CAROLINA	BRADY, KATHLEEN T.; CARPENTER, MATTHEW J	Charleston, SC	2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) NOFO Number: PA-18-591 Summary: The growing opioid use epidemic in the U.S. has been associated with a significant increase in the prevalence of pregnant opioid-dependent women and neonatal abstinence syndrome, which is associated with adverse health effects for the infant and with costly hospitalizations. Maintenance with sublingual (SL) buprenorphine (BUP) is efficacious for opioid use disorder but has disadvantages that may be heightened in pregnant women, including the potential for poor adherence, treatment dropout, and negative maternal/fetal effects associated with daily BUP peak-trough cycles. Extended release (XR) formulations may address some of these disadvantages. The primary objective of CTN-0080 is to evaluate the impact of treating opioid use disorder in pregnant women (n = 300) with BUP-XR, compared to BUP-SL, on maternal-infant outcomes. Other objectives include testing a conceptual model of the mechanisms by which BUP-XR may improve maternal-infant outcomes, relative to BUP-SL; determining the economic value of BUP-XR, compared with BUP-SL, to treat OUD in pregnant women; and evaluating the impact of BUP-XR, relative to BUP-SL, on neurodevelopment when the infant/child is approximately 12 and 24 months of age. Ultimately, this study will help in increasing access to treatment as well as provide quality care for pregnant/postpartum women.
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.
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.
3UG1DA013732-19S3	Medication treatment for Opioid-dependent expecting Mothers (MOMs): A Pragmatic Randomized Trial Comparing Extended-Release and Daily Buprenorphine Formulations (CTN-0080)	Translation of Research to Practice for the Treatment of Opioid Addiction	Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids	NIDA	UNIVERSITY OF CINCINNATI	WINHUSEN, THERESA M	Cincinnati, OH	2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) NOFO Number: PA-18-591 Summary: The growing opioid use epidemic in the U.S. has been associated with a significant increase in the prevalence of pregnant opioid-dependent women and neonatal abstinence syndrome, which is associated with adverse health effects for the infant and with costly hospitalizations. Maintenance with sublingual (SL) buprenorphine (BUP) is efficacious for opioid use disorder but has disadvantages that may be heightened in pregnant women, including the potential for poor adherence, treatment dropout, and negative maternal/fetal effects associated with daily BUP peak-trough cycles. Extended release (XR) formulations may address some of these disadvantages. The primary objective of CTN-0080 is to evaluate the impact of treating opioid use disorder in pregnant women (n = 300) with BUP-XR, compared to BUP-SL, on maternal-infant outcomes. Other objectives include testing a conceptual model of the mechanisms by which BUP-XR may improve maternal-infant outcomes, relative to BUP-SL; determining the economic value of BUP-XR, compared with BUP-SL, to treat OUD in pregnant women; and evaluating the impact of BUP-XR, relative to BUP-SL, on neurodevelopment when the infant/child is approximately 12 and 24 months of age. Ultimately, this study will help in increasing access to treatment as well as provide quality care for pregnant/postpartum women.
3UG1DA013732-19S4	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 M	Cincinnati, OH	2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) NOFO Number: PA-18-591 Summary: 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).
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).
3UG1DA013732-20S3	Medication treatment for Opioid-dependent expecting Mothers (MOMs): a pragmatic randomized trial comparing Extended-Release and Daily Buprenorphine formulations (CTN-0080)	Translation of Research to Practice for the Treatment of Opioid Addiction	Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids	NIDA	University of Cincinnati	Winhusen, Theresa	Cincinnati, OH	2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) NOFO Number: PA-18-591 Summary: The growing opioid use epidemic in the U.S. has been associated with a significant increase in the prevalence of pregnant opioid-dependent women and neonatal abstinence syndrome, which is associated with adverse health effects for the infant and with costly hospitalizations. Maintenance with sublingual (SL) buprenorphine (BUP) is efficacious for opioid use disorder but has disadvantages that may be heightened in pregnant women, including the potential for poor adherence, treatment dropout, and negative maternal/fetal effects associated with daily BUP peak-trough cycles. Extended release (XR) formulations may address some of these disadvantages. The primary objective of CTN-0080 is to evaluate the impact of treating opioid use disorder in pregnant women (n = 300) with BUP-XR, compared to BUP-SL, on maternal-infant outcomes. Other objectives include testing a conceptual model of the mechanisms by which BUP-XR may improve maternal-infant outcomes, relative to BUP-SL; determining the economic value of BUP-XR, compared with BUP-SL, to treat OUD in pregnant women; and evaluating the impact of BUP-XR, relative to BUP-SL, on neurodevelopment when the infant/child is approximately 12 and 24 months of age. Ultimately, this study will help in increasing access to treatment as well as provide quality care for pregnant/postpartum women.
3UG1DA015815-17S4	Selection Bias-Free Estimation of the Impact of Drug-Focused 12-step Mutual Help Groups	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 CALIFORNIA, SAN FRANCISCO	SORENSEN, JAMES L.; KORTHUIS, PHILIP TODD	San Francisco, 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: Using a meta-analytic approach, this study analyzes existing data sets of individuals with drug use disorders to determine the impact of drug-focused 12-step mutual help groups, free of selection bias, in reducing opioid consumption and opioid-related problems.These data will be used to predict how augmentation of 12-step mutual help groups, added to medications for opioid use disorder (MOUD), may be used to improve retention in OUD treatment.
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
3UG1DA015831-18S4	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	MCLEAN HOSPITAL	WEISS, ROGER D.; CARROLL, KATHLEEN M.	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: 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.
3UG1DA015831-18S5	Medication treatment for Opioid-dependent expecting Mothers (MOMs): A Pragmatic Randomized Trial Comparing Extended-Release and Daily Buprenorphine Formulations (CTN-0080)	Translation of Research to Practice for the Treatment of Opioid Addiction	Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids	NIDA	McLean Hospital	Weiss, Roger	Belmont, MA	2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) NOFO Number: PA-18-591 Summary: The growing opioid use epidemic in the U.S. has been associated with a significant increase in the prevalence of pregnant opioid-dependent women and neonatal abstinence syndrome, which is associated with adverse health effects for the infant and with costly hospitalizations. Maintenance with sublingual (SL) buprenorphine (BUP) is efficacious for opioid use disorder but has disadvantages that may be heightened in pregnant women, including the potential for poor adherence, treatment dropout, and negative maternal/fetal effects associated with daily BUP peak-trough cycles. Extended release (XR) formulations may address some of these disadvantages. The primary objective of CTN-0080 is to evaluate the impact of treating opioid use disorder in pregnant women (n = 300) with BUP-XR, compared to BUP-SL, on maternal-infant outcomes. Other objectives include testing a conceptual model of the mechanisms by which BUP-XR may improve maternal-infant outcomes, relative to BUP-SL; determining the economic value of BUP-XR, compared with BUP-SL, to treat OUD in pregnant women; and evaluating the impact of BUP-XR, relative to BUP-SL, on neurodevelopment when the infant/child is approximately 12 and 24 months of age. Ultimately, this study will help in increasing access to treatment as well as provide quality care for pregnant/postpartum women.
3UG1DA015831-18S6	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	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: 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.
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
3UG1DA015831-18S8	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.
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