Methodological Advances in Evaluating Abuse Deterrent Opioid Analgesics

The Methodological Advances in Evaluating Abuse Deterrent Opioid Analgesics is a visionary research and dissemination project intended to advance the science of studies of opioid analgesics by leveraging emerging advances in data connectivity and establishing new standards for methodological rigor, with a focus on abuse deterrent formulations.

The overall project goal is to develop and disseminate new “open source” epidemiologic tools to facilitate evaluation of abuse deterrent formulations (ADFs). The methodologic products from this project will be made available to the research community, in the expectation that researchers will apply them to improve the quality of studies in the area of opioids.

The project comprises three inter-related sections: Theory, Practice, and Lived Experience.

The project is co-led by the University of North Carolina (Injury Prevention Research Center and the Department of Epidemiology at the Gillings School of Global Public Health) and the University of Kentucky (College of Public Health, College of Pharmacy, Kentucky Injury Prevention Research Center, Institute for Pharmaceutical Outcomes and Policy), with other collaborators coming on board in Fall 2019.



Led by the University of North Carolina at Chapel Hill (UNC), these studies will apply pharmacoepidemiology theory to the practice of ADF evaluation, with the goal of developing and gathering feedback on open source tools that will assist in advancing the science of this field, for both ADF and non-ADF opioids. Specific issues of focus are the choice of comparators and confounding by “indication”, use of tools for addressing misclassification and quantitative bias analysis), and identifying out-of-hospital deaths in claims data.


Led by the University of Kentucky (UKY), these studies will provide insight on practice- level decisions that impact how ADFs are prescribed and dispensed, focusing on motivators of physician choice in ADF prescribing and pharmacists experience with ADF dispensing. Additionally, the pioneering electronic linkage of Prescription Monitoring Program (PMP), mortality, toxicology, and claims data in Kentucky will be leveraged to examine issues in the validity of epidemiologic studies utilized real-time individual-level mortality data.


Understanding the lived experience of opioid patients and people who use drugs is critical to comprehending the role of ADFs in society. Led by the Research Triangle Institute (RTI) International and run in conjunction with the Urban Survivors Union (USU) in Greensboro, NC, a health advocacy organization, this study will use ethnographic methods to provide much-needed data on ADF injection and excipient harm.

Access the project’s open source data and tools.

This project is supported by the U.S. Department of Health and Human Services’ Food and Drug Administration.