Funded Projects

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

A large number of probationers/parolees with opioid use disorder have limited access to effective treatment. This study is the first random clinical trial in the United States that will assess the effectiveness of buprenorphine treatment using MedicaSafe, a system composed of secure pre-packaged buprenorphine/naloxone cartridges, designed to be dispensed by a SmartKey device that enables clinicians to track patient adherence. The study will initiate treatment at a community corrections office compared to referral to a community program. The public health impact of the proposed study would be widespread, as this model of care could be implemented throughout many areas of the United States with high rates of opioid use disorder in their probation/parolee populations that lack access to methadone treatment.

NOFO Title: Clinical Trials or Observational Studies of Behavioral Interventions for Prevention of Opioid Use Disorder or Adjunct to Medication Assisted Treatment-SAMHSA Opioid STR Grants (R21/R33)
NOFO Number: RFA-AT-18-002
Summary:

Office-based opioid treatment (OBOT) with buprenorphine/naloxone prevents overdose deaths. Nonpharmacologic approaches to anxiety, stress, and emotion dysregulation are needed during primary care OBOT, which is the primary access point for opioid use disorder (OUD) treatment in most U.S. counties. Mindfulness-based interventions (MBI) safely and reliably reduce the impact of stress, anxiety, depression, and chronic pain, which could increase OBOT retention while reducing rates of relapse and overdose deaths. Current 8-week standard MBIs do not appear to have strong, sustained impact on substance use outcomes, suggesting longer or enhanced MBIs are needed in the OUD treatment setting. This project proposes to adapt, refine, and compare the effectiveness of the 6-month Mindful Recovery OUD Care Continuum delivered within group-based opioid treatment (GBOT) versus standard GBOT alone.

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

Social big data analysis of publicly available user data on social media platforms is a promising approach for attaining organic observations of behavior that can monitor and predict real-world public health problems, such as HIV incidence. In preliminary research, our team identified and collected tweets suggesting HIV risk behaviors (e.g., drug use, high-risk sexual behaviors), modeled them alongside CDC statistics on HIV diagnoses, and found a significant positive relationship between HIV-related tweets and county-level HIV cases. We propose to create a single automated platform that collects social media data, identifies and labels tweets that suggest HIV-related behaviors, and predicts regional HIV incidence. We will interview staff and participants at local and regional HIV organizations to understand ethical issues associated with mining people’s data. The software developed from this application will be shared with HIV researchers and health care workers to combat the spread of HIV.

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

We propose to estimate the impact of expanded access to medication-assisted treatment (MAT) in prisons and jails on post-release rates of overdose. Our approach will use agent-based modeling, data collected through the parent study, existing surveillance data, and recently published data from similar settings to understand how different MAT interventions in the prison and jail setting impact overdose death post-release. We will examine the impact of standard of care/no intervention, providing access to depot-naltrexone alone, providing access to all three MATs to only those who were prescribed it prior to incarceration, and comprehensive provision of all three MATs on post-release rates of overdose. These models will incorporate advanced methodological techniques that will allow for the investigation of engaged treatment, program attrition, and other complex events on a population level. This study’s findings may be used by health agencies, policymakers, and correctional systems to inform their efforts to expand MAT access.

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

There is a significant treatment gap between patients diagnosed with OUD and those who seek treatment, and only a small proportion of those seeking treatment receive MOUD. Primary care is the most common point of health care contact in the U.S. and is an important venue to address stigma, improve access to treatment and improve quality of care. Over the past decade, electronic health record (EHR)-linked Web-based point-of-care clinical decision support (CDS) systems designed to improve quality of chronic disease care have become increasingly sophisticated and successful. A Web-based and EHR-integrated OUD CDS system to offer expert guidance to primary care providers (PCPs) on the diagnosis and management of OUD was developed and piloted. This project will implement the OUD clinical decision support system in three large diverse health care systems and randomize a minimum of 30 clinics to receive the OUD-CDS intervention or usual care (UC). The project will evaluate the impact of OUD CDS on practice process measures and patient outcomes. The study will also prepare for scalability and dissemination by evaluating facilitators and barriers to implementation, determining the costs of implementation and maintenance and assessing the short-term cost impacts of the OUD-CDS.

NOFO Title: HEAL Initiative: Behavioral Research to Improve MAT: Behavioral and Social Interventions to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-AT-19-006
Summary:

Young people are disproportionately affected by the opioid crisis due to lack of access to medications for opioid use disorder (OUD) and poor adherence to these treatments. The Youth Opioid Recovery Support (YORS) model is an innovative wraparound approach that attempts to address barriers to treatment engagement in the young adult population, especially difficulties with medication adherence. The YORS model components include home delivery of extended-release naltrexone for OUD, engagement of families in collaborative treatment planning and monitoring focusing on medication adherence, assertive outreach from the treatment team by text messaging and social media to promote engagement and adherence, and contingency management to provide incentives for medication adherence. If the refining and testing demonstrates the efficacy of the YORS intervention, future work could include an economic analysis, a larger multisite study, longer intervention duration, study of extended-release buprenorphine, and study of step-down to less intensive interventions.

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.

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

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

The opioid crisis continues its highly negative impact, with more than 49,000 opioid-related overdose deaths in 2017. In 2016, the Centers for Disease Control and Prevention (CDC) issued guidelines for opioid prescribing that included opioid dosing and risk mitigation strategies, and health systems implemented similar initiatives even earlier. This has resulted in a quickly changing and more conservative prescribing environment. National data indicate the number of prescriptions has fallen between 2013 and 2016. Registries and electronic health record (EHR) data are increasingly cited as valuable resources to address critical research questions on opioid use with high efficiency. To our knowledge, no investigators have established an EHR-based prescription opioid registry across several diverse health systems with common data algorithms with the flexibility to address multiple questions. The goal of the proposed research is to develop a prescription opioid registry across 10 diverse health systems with harmonized EHR data from years 2012-2018 and leverage it to answer several key “next-step” research questions in response to the opioid crisis. The registry will include medications prescribed for treatment of OUD, including buprenorphine products.

NOFO Title: HEAL Initiative: Behavioral Research to Improve MAT: Behavioral and Social Interventions to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-AT-19-006
Summary:

Poor medication-assisted treatment (MAT) retention disproportionately affects low-income racial/ethnic minority individuals with opioid use disorder (OUD) and increases risk for relapse; therefore, evidence-based interventions are needed to improve MAT retention. Peer recovery coaches (PRCs), trained individuals with experiences with substance use disorder, may be uniquely suited to address common MAT retention barriers among underserved populations, including stigma, challenges navigating services, housing instability, and other structural and psychosocial factors. Preliminary work by the research team suggests that behavioral activation (BA) by PRCs may be a feasible, scalable reinforcement-based approach for improving MAT retention for low-income minority OUD individuals. The study builds upon the research team’s formative work to adapt and evaluate the effectiveness and implementation of a PRC-delivered BA intervention (Peer Activate) to improve MAT retention for low-income, minority individuals with OUD.

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

This training and dissemination project will develop an office-based buprenorphine treatment module for primary care, including the algorithm for buprenorphine treatment and integration of OUD measures; assess the acceptability of the OUD module; evaluate the impact of the OUD module on screening and identification rates of problem opioid use and successful initiation and maintenance rates of buprenorphine in primary care; assess barriers to implementation of buprenorphine treatment and methods for overcoming these barriers in the network partner clinics; and develop a strategy to refine and more broadly implement opioid problem use and OUD treatment.

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

This health care data mining study analyzes existing Veterans Health Administration data sets to examine patient and organizational characteristics associated with buprenorphine termination during outpatient OUD treatment. This project will generate data useful for predictive modeling on how to implement targeted approaches to improve retention in OUD treatment. An objective is to identify patient, provider and system targets to reduce unnecessary or inappropriate discontinuation of buprenorphine care. These analyses are critical for establishing initial constructs to evaluate reasons for treatment discontinuation based upon patient, provider and system factors in different health care settings.