Comparative Risk of Oral Complications Associated with Medications for Opioid Use Disorder: A Mixed-Methods Approach

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Project Summary/Abstract Combating the opioid epidemic is a federal priority. While medications for opioid use disorder (MOUD) substantially reduce mortality, treatment uptake remains low due to multiple barriers, including societal stigma as well as patient and provider safety concerns. In January 2022, the US Food and Drug Administration (FDA) released a Drug Safety Communication warning that transmucosal buprenorphine for opioid use disorder (OUD) and pain may be associated with dental problems. This Communication was based on case reports and adverse events reporting. In the absence of rigorous evidence, several addiction medicine organizations jointly wrote to the FDA recommending retraction of the Communication due to overwhelming benefit of buprenorphine and “flawed analysis regarding causation.” As a result, the FDA Communication may contribute to barriers for MOUD initiation without rigorous data that demonstrates a causal effect of MOUD on oral complications. Evaluation of the dental safety of MOUD is urgently needed to inform clinical practice and support or refute concerning findings from case series, adverse event reports, and experience of people with opioid use disorder (PWOUD). The lack of understanding of the effects of MOUD on oral complications is a critical information gap, as patients and providers need rigorous evidence to make informed treatment choices and take steps to mitigate risk of poor dental health. We will conduct an observational study using national databases, including linked dental and medical claims data for more than 120,000 Medicaid- or commercially-insured new users of MOUD to treat OUD. Next, we will use qualitative methods to examine the perspectives of PWOUD on the oral health impact of MOUD, the FDA Communication, and barriers to obtaining oral health care. Lastly, we will develop an educational aid using human-centered design activities to inform discussions of the risks and benefits associated with MOUD and oral complications. This large study will generate evidence to address critical gaps in knowledge about the impact of MOUD on adverse oral health outcomes and leverage human-centered design to create an educational aid for patients. Our results will empower PWOUD to seek effective dental treatment and foster high-quality, risk-benefit discussions around MOUD that removes barriers to receiving their life-saving treatment.