Dr. Jan Gryczynski Receives R01 Award

FRI is pleased to announce that Dr. Jan Gryczynski (PI) has been awarded an R01 grant from the National Institute on Drug Abuse. The “Take-Home Expansion: Scope and Impact Study”, or THESIS, will examine the impact of recent changes in the delivery of methadone treatment. FRI Co-investigators include Drs. Robert Schwartz, Mishka Terplan, and Karli Hochstatter. Key collaborators on the project include RTI International (Drs. Tami Mark and Gary Zarkin) and BayMark Health Services (Dr. Nicholas Van Dyke). 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. The COVID-19 pandemic transformed service delivery practices at OTPs. To reduce crowding in clinics, SAMHSA regulators swiftly issued regulatory exemptions that gave most 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. In late 2021, SAMHSA reaffirmed the regulatory exemptions and announced intentions to pursue permanent regulatory reform for OTPs. The THESIS project will examine the scope and impact of these major changes to care delivery, both in the immediate aftermath of the regulatory exemptions and prospectively. The study will use clinical and administrative data from BayMark Health Services, the largest provider of outpatient OUD treatment in the U.S. It could provide critical data to guide regulators, OTP administrators, and practitioners, yielding novel data that could inform methadone treatment delivery over the next decade and beyond.