Abstract Methadone is an effective treatment for opioid use disorder (OUD) that is delivered in the U.S. through specialized Opioid Treatment Programs (OTPs). Since the inception of the OTP system many decades ago, federal regulations have required frequent clinic attendance to monitor patients’ response to treatment and reduce the risks of methadone diversion. Patients can only ‘earn’ take-home methadone after significant time in treatment while demonstrating rigid standards for adherence and stability. However, these classic regulations are not grounded in strong empirical evidence. The COVID-19 pandemic transformed service delivery practices at OTPs. To reduce crowding in clinics, SAMHSA regulators swiftly issued regulatory exemptions that gave OTPs unprecedented discretion to provide take-home methadone doses and deliver counseling via telehealth. OTPs were suddenly permitted to dispense up to 14 days of take-home methadone for ‘less stable’ patients, and 28 days for ‘stable’ patients. More recently, SAMHSA reaffirmed the regulatory exemptions and announced intentions to pursue permanent regulatory reform for OTPs. However, research is needed to examine the scope and impact of these major changes to care delivery. This study will (1) characterize practice changes at OTPs following the COVID-19 pandemic and the issuance of regulatory exemptions, (2) Examine the relationship of two major practice changes (expanded take-home methadone and telehealth practices) and patient outcomes, (3) develop a prediction model to inform decision- making about when patients can safely receive take-homes without increasing risk of negative outcomes, and (4) examine the relationship between expanded take-home methadone and methadone overdose deaths at a population level. The study will use clinical and administrative data from BayMark Health Services, the largest provider of outpatient OUD treatment in the U.S., with 100 OTPs in 23 states. Advanced analytical methods will be applied to answer the research questions, including multilevel generalized linear mixed modeling, predictive modeling and simulation methods, and interrupted time series. All analyses will consider behavioral health equity and examine disparities with respect to patients’ sex, race, and ethnicity. This study will provide critical data for regulators, OTP administrators, and practitioners. It will yield highly novel data to support evidence-driven regulatory reform, and could shape methadone treatment delivery over the next decade and beyond. The COVID-19 pandemic and associated federal exemptions offer an unprecedented opportunity to evaluate long-held assumptions about how methadone treatment should be structured to maximize its benefits while safeguarding patients and the public from unintended harm.

Project Narrative This study will examine major changes in methadone treatment delivery that occurred following COVID-19, and will evaluate the impact of COVID-driven regulatory exemptions that expanded take-home methadone and telehealth counseling in Opioid Treatment Programs. The study will provide novel empirical data to guide regulatory reform and patient care, and is poised to have high public health impact.