Funded Projects

The project will address gaps in both risk identification and clinical management by utilizing comprehensive clinical data from a mature health information exchange containing more than 2.3 million patients across the spectrum of clinical care (hospitals, primary care, specialty care, community health centers, urgent care) to develop a statistically robust method to measure suicide risk associated with prescription opioid use. First, the team will couple data fusion techniques with machine learning-based approaches in identifying the clinical and demographic characteristics associated with elevated risk of suicidal behavior among prescription opioid users. Second, the team will develop clinical profiles of patients with higher risk of suicidal behavior associated with prescription opioids, and to incorporate these profiles in a clinical decision support platform that can be used for identification and intervention at the point of care. The clinical decision support tool developed under this proposal will provide a generalizable platform that could be extended to other more conventional opioid related outcomes such as OUD and overdose.

Neonatal Opioid Withdrawal Syndrome (NOWS) is a condition that occurs when newborns are exposed to opioids during pregnancy. Symptoms often include tremors, excessive crying, sleep deprivation, and swallowing difficulties. Cases are rising, with a newborn affected by NOWS approximately every 15 minutes. Currently, healthcare providers in the United States lack standard, evidence-based treatments for NOWS.

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.

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.

The opioid epidemic in the United States is associated with alarming rates of overdose and overdose deaths. Medication Assisted Treatment (MAT), in combination with psychosocial intervention, is the most effective treatment for OUD; however, many individuals are unable to access treatment, are not sufficiently retained in treatment, or experience barriers that prohibit their participation in treatment. A multipronged approach is needed that includes 1) development of integrated networks of care, both formal and informal, to better address the needs of individuals with OUDs and 2) measures of the efficacy of these integrated networks for addressing the needs of individuals with OUD. This project will build a learning collaborative to address gaps in knowledge about the delivery, sustainability, and assessment of recovery service for individuals on MAT. The collaborative will foster collaboration and communication between stakeholders and with the larger community of research and providers interested in improving the delivery of OUD recovery support services. This community-academic partnership will address the lack of evidence regarding effective recovery support services.

Chronic pain and opioid use disorder often occur together, but there are a striking lack of integrated treatments accessible to people in need, particularly Black and Hispanic individuals living and seeking care in under resourced settings. This research will examine multi-modal, evidence-based practices in diverse health care settings and among diverse populations with both chronic pain and opioid misuse/disorder. The first project will examine the effects of yoga and physical therapy onsite at methadone opioid treatment clinics. The second project will test Acceptance and Commitment Therapy and a care-management smartphone app for individuals in primary-care based buprenorphine treatment. The third project will compare microdosing versus standard doses/timing of buprenorphine for hospitalized patients. All three projects will improve access to care for Black and Hispanic individuals in under resourced settings by bringing integrated treatments to them. The interventions have high potential to be used broadly.

Decreasing opioid dosing faster than advised by clinical recommendations often leaves chronic pain unaddressed and may increase the risk of overdose and suicide compared to continuing long-term opioid treatment. Continued, long-term use of opioids after surgery by individuals who use opioids increases the risk of postoperative complications, opioid use disorder, and death. Surgery is a critical point-of-care moment for health care providers to interact with patients who use opioids about continued opioid use when harms outweigh benefits. This project will test of the Motivational Interviewing and guided Opioid Tapering support (MI-Opioid Taper) strategy, with or without a medication that reduces anxiety and relieves pain, at four geographically diverse hospitals across the nation.

Expanding access to naloxone in the community through the pharmacy can be a critical mechanism for extending this lifesaving medication’s reach. This study will partner with two large retail pharmacy chains and integrate two interventions that provide knowledge and training for pharmacists to identify and effectively engage with patients who may be at high risk for an opioid overdose. The interventions will be combined into a cohesive educational program, implemented in 160 community pharmacies and tested for effectiveness. Study findings will create a generalizable, evidence-based training and toolkit for pharmacists caring for patients who use prescribed or illicit opioids, in more than 40 states adopting or expanding pharmacy naloxone.

Many individuals with opioid use disorder pass through the criminal justice system over the course of their life. Improved access to high-quality, evidence-based addiction treatment in justice settings is critical to addressing the opioid crisis. The Justice Community Opioid Innovation Network (JCOIN) is studying approaches to increase high-quality care for people with opioid misuse and opioid use disorder in justice populations. This research supports a scientist from a group underrepresented in biomedicine to expand capacity of the Mason Coordination and Translation Center that is managing logistics, stakeholder engagement, and dissemination of findings and products from the JCOIN network.

Many individuals with opioid use disorder (OUD) pass through the criminal justice system over the course of their life. Improved access to high-quality, evidence-based addiction treatment in justice settings will be critical to addressing the opioid crisis. Through the Justice Community Opioid Innovation Network (JCOIN), the National Institutes of Health will study approaches to increase high-quality care for people with opioid misuse and OUD in justice populations. The Mason Coordination and Translation Center (MCTC) will manage logistics, stakeholder engagement, and dissemination of findings and products from the JCOIN network. This will include establishing infrastructure to support research education and rapid response and pilot research.

NIH is supporting the Justice Community Opioid Innovation Network (JCOIN), a collaboration of justice and behavioral health stakeholders that will study approaches to increase high-quality care for people with opioid misuse and opioid use disorder in justice populations. This multi-site clinical research center aims to improve local community public health and safety outcomes for reentering justice- involved individuals who have a history of (or are at risk for) using opioids by comparing two implementation strategies and two interventions at the client and system levels. The study will also examine which implementation strategy is most effective for increasing service linkage and initiation, services retention, and improved opioid-related public health safety outcomes.

Women are disproportionately affected by the opioid crisis due to increased pain sensitivity, physician prescribing practices, and self-medication, as well as a faster trajectory from opioid exposure to the development of opioid use disorder (OUD). The University of Kentucky proposes to establish the Women’s Clinical Research Center as part of the NIDA Justice Community Opioid Innovation Network (W-JCOIN), with the overall goal of increasing initiation and maintenance of medications for OUD among high-risk justice-involved women in the transition from jail to the community to reduce opioid relapse and overdose. The KY W-JCOIN has the potential for significant impact on the OUD treatment field by contributing empirical evidence on the effectiveness and implementation of innovative technologies to increase initiation and maintenance of life-saving medications during a critical, high-risk time of community re-entry among vulnerable, justice-involved women in both urban and rural communities.

This project provides protected time for training and research activities that are required for an independent scientific career in the development, testing, and implementation of cutting-edge digital therapies and tools (such as smartphone apps and other web-based resources) that can promote health equity in treatment of opioid use disorder (OUD). The research will adapt and test digital overdose prevention and recovery support interventions for Black Americans with co-occurring OUD and mental illness.