Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
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.
75N95019D00013-0-759501900094-1
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 Emmes Corporation VanVeldhuisen, Paul Rockville, MD 2019
NOFO Number:
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.
1R24DA057611-01
RTI HEAL Harm Reduction Network Coordination Center Translation of Research to Practice for the Treatment of Opioid Addiction Harm Reduction Approaches to Reduce Overdose Deaths NIDA RESEARCH TRIANGLE INSTITUTE OGA, EMMANUEL AJA (contact); CANCE, JESSICA DUNCAN Research Triangle Park, NC 2022
NOFO Title: HEAL Initiative: Harm Reduction Policies, Practices, and Modes of Delivery for Persons with Substance Use Disorders: Coordination Center (R24 Clinical Trial Optional)
NOFO Number: RFA-DA-22-042
Summary:

This project creates the HEAL Harm Reduction Network Coordination Center, which will provide support to the nine research studies in the HEAL Harm Research Reduction Network. The center will provide administrative and logistical help; support data harmonization and data sharing; involve stakeholders in all network activities; and share research findings and other products with researchers, practitioners, stakeholders, and the general public. 
1UG1DA049435-01
Greater Southern California Node of the 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 UNIVERSITY OF CALIFORNIA LOS ANGELES HSER, YIH-ING; MOONEY, LARISSA JEANETTE Los Angeles, CA 2019
NOFO Title: The National Drug Abuse Treatment Clinical Trials Network (UG1 Clinical Trial Optional)
NOFO Number: RFA-DA-19-008
Summary:

The overarching goal of the Greater Southern California Node (GSCN) of the National Drug Abuse Treatment Clinical Trials Network (CTN) is to expand access to and improve outcomes of treatments for substance use disorders (SUDs)—with a special emphasis on opioid use disorder (OUD). The specific aims of GSCN include the development of new research protocols, support of multi-site CTN projects, and dissemination of research findings. The GSCN research agenda includes four priority areas: (1) developing and testing effective interventions for OUD and related comorbidities, (2) applying implementation science to deliver and expand OUD treatment, (3) leveraging electronic health record systems and data science generation of innovative approaches to improve treatment for OUD, and (4) expanding OUD treatment access and utilization through mHealth and other technologies. The GSCN research agenda reflects its capacity to collaboratively expand CTN efforts to develop and implement innovative approaches to improve treatment for OUD.
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).
1R61DA059895-01
Promoting Retention in Opioid Treatment among Women Experiencing Intimate Partner Violence: A Novel Stepped Care Model Targeting PTSD Translation of Research to Practice for the Treatment of Opioid Addiction Optimizing the Quality, Reach, and Impact of Addiction Services NIDA YALE UNIVERSITY SULLIVAN, TAMI P (contact); EDELMAN, E JENNIFER; JOHNSON, DAWN M New Haven, CT 2023
NOFO Title: HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-DA-23-053
Summary:

Women with opioid use disorder (OUD) are disproportionately impacted by physical, sexual, and psychological intimate partner violence and posttraumatic stress disorder (PTSD). Yet, treatment approaches that address all these conditions together in OUD treatment settings are lacking. To address this gap, this project will evaluate delivery of two evidence-based interventions to address PTSD (Present-Centered Therapy+ and Helping to Overcome PTSD through Empowerment) for women seeking OUD treatment who have experienced intimate partner violence. It will also determine if integrated treatment can help retain the women in medication treatment for OUD.
3UG1DA049467-03S2
HEAL Diversity Supplement: Great Lakes Nodes 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 Chicago, IL 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:

Negative Affect (NA) and stress are key features of Opioid Use Disorder (OUD) and often lead to drug use and relapse. The Autonomic Nervous System (ANS) dominates physiological responses to emotions and stress, yet its function and how it unfolds over time and in real-world settings remains understudied in the context of OUD. With new wearable technologies, ANS function can be measured through heart rate variability (HRV) and can be recorded continuously via wearable sensors, providing a non-invasive method to examine physiological mechanisms underlying stress and NA in real-world settings and in real-time. The present research will serve as a pilot study to assess 1. The role of autonomic function (indexed by HRV) as a marker of NA and stress in people with OUD 2. Participants’ adherence to wearing sensor devices and response rates to daily questionnaires. To achieve these objectives, we will monitor participants for 14 days and quantify self-reports measures of stress, overall daytime HRV patterns, and the magnitude, frequency, and duration of reduced HRV instances. Our findings can help advance technologies to address the opioid epidemic, and our understanding of physiological markers as objective measures and predictors of NA and stress in OUD.
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.
1R24DA057659-01
Peer Recovery Innovation Network (PRIN) Translation of Research to Practice for the Treatment of Opioid Addiction Recovery Research Networks NIDA University of Texas Health Science Center at San Antonio POTTER, JENNIFER SHARPE (contact); ASHFORD, ROBERT San Antonio, TX 2022
NOFO Title: HEAL Initiative: 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-22-043
Summary:

About 23 million Americans identify as being in recovery from opioid and other substance use disorders. While recovery support services are an established best practice to support people in recovery, there is little scientific evidence to support the efficacy and implementation of peer recovery support services, training approaches, and delivery models. Recovery support services are particularly lacking in the U.S. Southwest and for individuals who choose to take medications for opioid use disorder as part of their recovery pathway. This project will establish the Peer Recovery Innovation Network to address research gaps. This research will incorporate input from people with lived experience in all stages of the recovery process – toward helping to set the research agenda and conducting the research, as well as enhancing infrastructure for peer recovery support services research.
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.
75N95019D00013-0-759501900095-1
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 Emmes Corporation VanVeldhuisen, Paul Rockville, MD 2019
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
1R61DA059027-01
A Multi-Team System Implementation Strategy to Improve Buprenorphine Adherence for Patients who Initiate Treatment in the Emergency Department Translation of Research to Practice for the Treatment of Opioid Addiction Optimizing the Quality, Reach, and Impact of Addiction Services NIDA UNIVERSITY OF CALIFORNIA AT DAVIS HENRY, STEPHEN G (contact); MOULIN, AIMEE; TU, SHIN-PING Davis, CA 2023
NOFO Title: HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-DA-23-053
Summary:

There is an urgent need to identify and rapidly apply strategies to expand treatment for opioid use disorder, particularly among low-income patients. This project will develop and test a novel implementation strategy that uses ongoing community partnerships designed to improve care coordination for patients who start buprenorphine treatment for opioid use disorder in the emergency department and are then referred to primary care for ongoing treatment.
3UG1DA040317-05S2
Pharmacists’ knowledge of, attitudes about, and intention to provide pharmacy-based services for screening, brief intervention, and referral to treatment and medication treatment for opioid use disorders Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA Duke University Wu, Li-Tzy Durham, NC 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Given the magnitude of the opioid death epidemic, we need multiple approaches to increase use of medication treatment for opioid use disorder (MOUD) for people from diverse geographical locations. Pharmacists as dispensers of and gatekeepers to opioid medications, including those used for OUD treatment, are natural partners of health care providers. Community pharmacists are widely available even in rural areas. This 2-year study will use a mixed-method design that includes qualitative and quantitative approaches to study pharmacists’ knowledge of, attitudes about, and intention to provide patient care and services for screening, brief intervention, and referral to treatment for substance use disorders and MOUD. Study aims are to conduct stakeholder interviews, develop a survey instrument to assess such barriers and facilitators, pilot test the survey instrument, and conduct the survey among licensed pharmacists.
3UG1DA049467-03S3
Quantifying How Cocaine Users Respond to Fentanyl Contamination in Cocaine 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 Chicago, IL 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:

The increased presence of fentanyl in cocaine has drastically increased cocaine-related overdoses, yet there is no research quantifying how cocaine users respond to fentanyl adulteration. In this online study, a modification of a behavioral economics measure, the Cocaine Purchase Task, will quantify for the first time how cocaine users respond to fentanyl contamination in cocaine. This study aims to 1) Determine how possible fentanyl adulteration affects cocaine demand, and 2) Determine which individual characteristics moderate the relationship between fentanyl adulteration and cocaine demand. Determining how possible fentanyl adulteration affects cocaine demand can help inform the development of effective harm reduction interventions for people who use cocaine to address the worsening crisis of opioid related deaths.
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.
1UG1DA050065-01
Improving Retention across the OUD Service Cascade upon Re-entry from Jail using Recovery Management Checkups Translation of Research to Practice for the Treatment of Opioid Addiction Justice Community Opioid Innovation Network (JCOIN) NIDA CHESTNUT HEALTH SYSTEMS, INC. DENNIS, MICHAEL L (contact); GRELLA, CHRISTINE E; SCOTT, CHRISTY K Bloomington, 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:

This multi-site clinical research study will collaborate with six county jails in Illinois and medication-assisted treatment (MAT) providers to test an adapted version of an evidence-based intervention, the Recovery Management Checkups (RMC) model, which provides quarterly check-ups and assistance with treatment retention and re-linkage as indicated at the quarterly check-ups. The study will determine if tailoring the check-ups to an individual’s need for treatment leads to more efficient targeting of resources to those in need, reduces the intervention burden on those with lower need, and results in an improved overall effectiveness and cost-effectiveness of RMC.
1R24DA051974-01A1
Enhancing Effectiveness Research on Recovery Housing for Persons Prescribed Medication for Opioid Use Disorder Translation of Research to Practice for the Treatment of Opioid Addiction Recovery Research Networks NIDA PUBLIC HEALTH INSTITUTE MERICLE, AMY ADALE (contact); MASSON, CARMEN L Oakland, CA 2022
NOFO Title: HEAL Initiative: 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-22-043
Summary:

Safe and stable housing is widely considered to be critical to recovery from alcohol and drug use disorders. Therefore, providing dedicated safe and substance-free housing options for individuals in recovery (recovery housing) may be an essential component of a comprehensive response to the current opioid crisis. However, there is limited evidence about effective recovery housing practices for individuals choosing treatment with medications for opioid use disorders as part of their path to recovery. This project will enhance the infrastructure necessary to study the effectiveness of recovery housing for these individuals. It will develop a national multi-stakeholder network, host webinars for researchers and recovery housing providers, and support mentored pilot studies for new researchers seeking to study recovery housing.
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.
75N95019D00013-0-759501900098-1
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 Emmes Corporation VanVeldhuisen, Paul Rockville, MD 2019
NOFO Number:
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.
1RM1DA059377-01
Person-Centered Quality Measurement and Management in a System for Addictions Treatment in New York State Translation of Research to Practice for the Treatment of Opioid Addiction Optimizing the Quality, Reach, and Impact of Addiction Services NIDA NEW YORK UNIVERSITY SCHOOL OF MEDICINE NEIGHBORS, CHARLES J (contact); BURKE, CONSTANCE; LINCOURT, PATRICIA New York, NY 2023
NOFO Title: HEAL Initiative: Research to Foster an Opioid Use Disorder Treatment System Patients Can Count On (RM1 - Clinical Trial Optional)
NOFO Number: RFA-DA-23-046
Summary:

The number of drug overdoses in New York continues to rise. In response, the New York State Office of Addiction Services and Supports (OASAS) is promoting approaches that embrace person-centered care, evidence-based practices, equitable treatment, and harm-reduction principles. In this project, researchers will partner with OASAS to build a quality measurement and management research center that provides performance feedback to support and encourage leadership and staff of treatment clinics to improve practice. The center will also publicize quality measures to ensure public accountability.
3UG1DA040317-05S2
Medication treatment for Opioid-dependent expecting Mothers (MOMs): A Pragmatic Randomized Trial Comparing Extended-Release and Daily Buprenorphine Formulations (CTN-0080) Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA DUKE UNIVERSITY WU, LI-TZY T Durham, NC 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

The growing opioid use epidemic in the U.S. has been associated with a significant increase in the prevalence of pregnant opioid-dependent women and neonatal abstinence syndrome, which is associated with adverse health effects for the infant and with costly hospitalizations. Maintenance with sublingual (SL) buprenorphine (BUP) is efficacious for opioid use disorder but has disadvantages that may be heightened in pregnant women, including the potential for poor adherence, treatment dropout, and negative maternal/fetal effects associated with daily BUP peak-trough cycles. Extended release (XR) formulations may address some of these disadvantages. The primary objective of CTN-0080 is to evaluate the impact of treating opioid use disorder in pregnant women (n = 300) with BUP-XR, compared to BUP-SL, on maternal-infant outcomes. Other objectives include testing a conceptual model of the mechanisms by which BUP-XR may improve maternal-infant outcomes, relative to BUP-SL; determining the economic value of BUP-XR, compared with BUP-SL, to treat OUD in pregnant women; and evaluating the impact of BUP-XR, relative to BUP-SL, on neurodevelopment when the infant/child is approximately 12 and 24 months of age. Ultimately, this study will help in increasing access to treatment as well as provide quality care for pregnant/postpartum women.
1UG1DA049468-01
New Mexico Clinical Trials Node: Clinical research and practice to address substance use in diverse, rural and underserved populations 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 NEW MEXICO HEALTH SCIS CTR PAGE, KIMBERLY; KOMAROMY, MIRIAM Albuquerque, NM 2019
NOFO Title: The National Drug Abuse Treatment Clinical Trials Network (UG1 Clinical Trial Optional)
NOFO Number: RFA-DA-19-008
Summary:

New Mexico (NM) is an epicenter of the opioid crisis in the United States. Many challenging social determinants, including poverty and unemployment, contribute to high rates of opioid use disorder (OUD) in NM. The aims of the NM node are to (1) develop and maintain a highly efficient platform to conduct clinical trials that will inform evidence-based prevention and treatment of OUD; (2) collaborate on and lead research that addresses and improves outcomes across the OUD Cascade of Care (CoC); and (3) promote uptake of best practices in OUD prevention and care in NM and nationwide through effective dissemination of evidence-based innovations. NM node research will ensure the development of robust and generalizable methods for prevention, identification, and treatment of OUD, including evaluation and modification of the CoC to expand the local and national knowledge base.
3UG1DA049468-03S3
Exploring Health Beliefs for Community Engagement and Diversity in 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 UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR PAGE, KIMBERLY Albuquerque, NM 2021
NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
NOFO Number: NOT-NS-21-025
Summary:

Including all population subgroups in clinical research is important to ensure that research results apply to the entire population and can be implemented effectively. However, many communities are underrepresented in health research due to individual, cultural, or structural reasons. This project aims to develop a Health Beliefs Toolkit that will be a readily accessible resource for researchers, providers, and community groups to help them engage diverse and minority populations in clinical research, particularly regarding substance use disorders. The project will examine, adapt, and test existing materials and resources targeting individual and structural barriers to research engagement. The toolkit will also assess individuals’ knowledge of health as well as health-related personal values and beliefs to enhance health and research “literacy.” The toolkit will be targeted to primary care providers, community health workers, peer counselors, agency representatives, and patient and non-patient groups to enhance practice-based research in underserved communities.
3UG1DA040314-04S5
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 Kaiser Foundation Research Institute Campbell, Cynthia 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:

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.
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.