Funded Projects

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

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

NOFO Number:
Summary:

Emergency department (ED)-initiated buprenorphine/naloxone (BUP) with referral for ongoing BUP is superior to referral alone in engaging patients with untreated opioid use disorder (OUD) in treatment at 30 days and is cost-effective. However, logistical barriers exist in translating research into practice. New BUP formulations such as the extended-release injectable BUP (CAM2038, XR-BUP) hold promise in addressing many of the barriers more effectively than sublingual buprenorphine (SL-BUP) by treating the patients’ symptoms for up to seven days. This study will recruit, train and provide resources to 30 ED sites throughout the U.S. using implementation facilitation strategies to address stigma and provide ED-initiated BUP for patients presenting with OUD who are not receiving medications for OUD. Once implementation is adequately achieved, the sites will conduct a randomized controlled trial (RCT) to compare the effectiveness of SL-BUP versus XR-BUP on ED patients’ engagement in formal addiction treatment seven days after their ED visit. In addition, in an ancillary component of the study, the use of XR-BUP will be assessed in ED patients with Clinical Opioid Withdrawal Scale (COWS) scores of 4-7.

NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Reduce Stigma in Pain Management and Opioid Use Disorder (OUD) and Treatment
NOFO Number: NOT-OD-20-101
Summary:

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

NOFO Title: HEAL Initiative Limited Competition: Behavioral Research to Improve MAT: Ancillary Studies to Enhance Behavioral or Social Interventions to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders (R01 Clinical Trial Optional)
NOFO Number: RFA-AT-19-007
Summary:

Chronic pain may be linked to poorer outcomes in those using medication-assisted treatments (MAT) to treat opioid use disorders (OUD). Psychosocial interventions for pain have been effective in patients with chronic pain and substance use disorders, but these interventions have not been thoroughly examined in the OUD population receiving MAT. The study team previously refined and adapted a psychosocial pain management intervention (PPMI) to be delivered by telephone for patients with OUD receiving MAT. The current study will understand the potential applicability of this intervention to other high-risk groups, such as veterans, study the longer-term impact of PPMI, and gather data to inform the implementation of PPMI in MAT patients. This work will provide a robust test of the PPMI intervention to help enhance MAT outcomes in a larger and more representative group of participants while also paving the way for future implementation of interventions to improve MAT retention.

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.

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.

NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

As part of an ongoing teleECHO learning collaborative (LC),this study will expand clinical research training in evidence-based quality improvementmethods that were central to delivering and sustaining science-based medication-assisted treatment for opioid use disorder (MOUD) within the Vermont Hub-and-Spoke Model (HSM) with fidelity. Participating primary care practices will be trained in the (1) use of astudy-developedtoolkit of research and evaluationquality improvementmethodsintended to expand provider knowledge and performance in the delivery of evidence-based MOUD, (2) systematic tracking of standardized outcome metrics, and (3) sharing of these standardized data with other LC membersso that practices can use this empirical information to refine their care model over time. The study will measure changes in providers’ knowledge about best practices for MOUD, their comfort in caring for OUD patients with MOUD and their performance on all the standardized outcome metrics.

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.

NOFO Title: Research Networks for the Study of Recovery Support Services for Persons Treated with Medications for Opioid Use Disorder (R24 Clinical Trial Optional)
NOFO Number: RFA-DA-20-014
Summary:

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

NOFO Title: The National Drug Abuse Treatment Clinical Trials Network (UG1 Clinical Trial Optional)
NOFO Number: RFA-DA-19-008
Summary:

There is a critical need to expand research infrastructure to develop, test, and implement new clinical interventions and evidence-based opioid use disorder (OUD) treatment into diverse clinical settings. The University of Utah’s Greater Intermountain Node (GIN) will expand the existing NIDA Clinical Trial Network’s (CTN) infrastructure by developing and testing innovative OUD interventions, expanding the settings for CTN research, and bringing new research acumen to the CTN. GIN brings expertise in three spheres of OUD research: (1) non-addiction health care settings, (2) large health systems of care, and (3) implementation science. GIN’s specific aims include (1) enhance CTN’s ability to conduct research in primary care and non-addiction care settings; (2) enhance CTN’s ability to conduct research within integrated systems of care with “big data” resources; and (3) enhance CTN’s implementation of science research to integrate and disseminate evidence-based addiction care into diverse non-addiction and health system targets.

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.

NOFO Title: HEALing Communities Study: Developing and Testing an Integrated Approach to Address the Opioid Crisis (Research Sites) (UM1 - Clinical Trial Required)
NOFO Number: RFA-DA-19-016
Summary:

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