Evaluating a Novel Approach to Dispensing Methadone in Carceral Facilities

PROJECT SUMMARY Incarcerated persons have a high prevalence of opioid use disorder (OUD) and an elevated risk of nonfatal and fatal overdose following release. Methadone is a critical medication for treating OUD but is often inaccessible in carceral facilities due to the complex federal regulations that typically restrict methadone to federally licensed opioid treatment programs (OTPs). In 2024, the Substance Abuse and Mental Health Services Administration issued a final rule clarifying that any carceral facility registered with the Drug Enforcement Administration as a “hospital/clinic” is permitted to stock and dispense methadone for the treatment of OUD, as long as the patient is primarily being treated for another medical condition. As most incarcerated people with OUD have another health condition, the hospital/clinic registration thus provides a more streamlined approach to stocking methadone that could dramatically expand access to medications for OUD (MOUD) for incarcerated persons. In partnership with our team, three state prison systems—Colorado, Delaware, and Washington—are planning widespread methadone expansion using the hospital/clinic designation. Our mixed-methods study will inform implementation efforts of this new approach to methadone treatment in the vanguard systems and nationwide. Aim 1 launches a learning collaborative with an embedded implementation study. The three vanguard state prison systems and several other jail and prison systems that are planning to implement the hospital/clinic designation will participate in a 24-month program with didactic education and applied problem-solving modules. Their baseline challenges with implementation, and ongoing progress addressing challenges, will be tracked via survey and qualitative interview data. Aim 2 will analyze electronic records on persons who have diagnosed OUD from each system spanning 2022 to 2028. Using a trial emulation study design that considers the impact of a facility starting to stock methadone under the hospital/clinic designation, we will evaluate how the rollout of new services in the three state prison systems affects pre-release initiation and retention on MOUD. Linking carceral records to Medicaid claims, Aim 3 will extend the same trial emulation framework in Washington State to study the impact on post-release outcomes such as MOUD and avoidable hospitalizations. Finally, using measures of spending, resources and staffing, and health impacts collected in Aims 1-3, Aim 4 will examine the associated costs, cost effectiveness, and budgetary impact of phasing in the hospital/clinic designation. We will calculate the incremental cost effectiveness per patient and the overall impact on the carceral budget of the hospital/clinic designation compared to the status quo. Study results will inform decisions about current and future adoption of this important new option for expanding methadone access to incarcerated populations.