Take-home expansion: Scope and impact study (THESIS)

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 could only ‘earn’ take-home methadone after significant time in treatment while demonstrating rigid standards for adherence and stability. However, these classic regulations were not grounded in strong empirical evidence. Recent regulatory changes transformed service delivery practices at OTPs. To reduce crowding in clinics, federal regulators swiftly issued exemptions that gave OTPs unprecedented discretion to provide take-home methadone. 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, the methadone regulations were permanently revised to allow even more flexibility and provider discretion. 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 during a period of regulatory change, (2) examine the relationship of expanded take-home methadone with patient outcomes, (3) develop a prediction model for safe receipt of take-home methadone, and (4) examine the relationship between expanded take-home methadone and methadone overdose deaths. The study will use clinical and administrative data from BayMark Health Services, one of the largest providers of methadone treatment in the U.S. This study will provide critical data for regulators, OTP administrators, and practitioners. It will yield highly novel data that could inform methadone treatment delivery over the next decade and beyond.