Funded Projects

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.

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.

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.

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.

Rates of opioid use (OU), opioid use disorder (OUD), and overdose (OD) disproportionately affect those in the justice system. Yet, despite such high rates of misuse and associated negative outcomes of untreated OUD, screening and the availability or use of evidence-based treatments for OU and OUD—including medication to treat OUD—are substantially underused in justice populations. This project will leverage the unique, real-time scale-up of a new opioid court model (OCM) to address a critical public and correctional health problem by developing and evaluating an implementation intervention (OCM RISE), designed to build cross-system partnerships to permit the development of generalizable yet tailored strategies that allow the OCM to be scaled up across a variety of contexts.

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

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.

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.

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.

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.

Despite substantial increases in overdose deaths among people who use methamphetamine, little is known about how to effectively provide harm reduction services to these individuals. This project will combine and test two harm reduction interventions for people who use methamphetamine. First, peer recovery support specialists will help identify personal harm reduction goals. The project will also test the value of incentives toward achieving these goals (a strategy known as contingency management).

Justice-involved veterans have lower access to opioid use disorder (OUD) pharmacotherapy and need an effective transition from the justice system to the Department of Veterans Affairs (VA) and community health care systems to improve drug addiction treatment and outcomes. We will quantitatively evaluate patient and facility characteristics associated with differences in receipt of OUD pharmacotherapy among justice-involved veterans compared with non-justice-involved veterans and within-facility changes over time; qualitatively identify drivers of higher or lower access to OUD pharmacotherapy among justice-involved veterans compared with other veterans with OUD at the same facility; evaluate stakeholders’ perceptions of factors that explain within-facility changes in access to OUD pharmacotherapy over time; and develop and conduct a formative evaluation of implementation strategies to improve access to OUD pharmacotherapy. Results will be used to design and select implementation strategies that address identified barriers to improve access to OUD pharmacotherapy for justice-involved veterans.