ABSTRACT
Background: Approximately 1,800 opioid treatment programs (OTPs) in the US dispense methadone to upwards of 400,000 patients with opioid use disorder (OUD) annually, operating under longstanding highly restrictive guidelines. OTPs were granted novel flexibilities beginning March 15, 2020 allowing for reduced visit frequency and extended take-home doses to minimize COVID exposure with great variation across states and sites. We sought to use electronic health records to compare retention in treatment, opioid use, and adverse events among patients newly entering methadone maintenance in the post-reform period in comparison with year-ago, unexposed, controls.Methods: Retrospective observational cohort study across 9 OTPs, geographically dispersed nationally, in the National Institute of Drug Abuse Clinical Trials Network. Newly enrolled OTP methadone maintenance patients for a new care episode between April 15-October 14, 2020 (post-COVID, reform period) v. March 15-September 14, 2019 (pre-COVID, unexposed controls) were assessed. The primary outcome was 6-month retention. Secondary outcomes were opioid use and critical outcomes including emergency department (ED) visits, hospitalizations, and overdose.Findings: 821 individuals were newly admitted in the post-COVID and year-ago control periods, average age 38·3 (SD 11·1), 58·9% male. The only difference across pre- and post-reform groups was the prevalence of psychostimulant use disorder (25·7%v·32·9%,p=0·02)· Six-month retention rates were equivalent between groups (60·0% vs 60·1%) and hazards of discontinuation (HR=1·02,95%CI=0·81-1·27) and adverse events in the aggregate (X2 (1)=0·55,p=0·46) were non-inferior in the post-COVID period. However rates of opioid use throughout care was higher among post-COVID intakes compared to pre-COVID controls (64·8% v 51·1%,p<0·001). Moderator analyses accounting for stimulant use and site-level variation in take-home schedules did not change findings·Interpretation: Meaningful increases in take-home schedules were not associated with worse retention or adverse events despite slightly elevated rates of measured opioid use. Relaxed guidelines were not associated with increased harms and findings could inform permanent system redesign.Funding: SDHHS NIDA CTN UG1 DA013035-15.Declaration of Interest: Dr. Williams receives equity, consulting fees, and travel expenses from Ophelia Health Inc. a telehealth company for the treatment of opioid use disorder. Other authors have no financial conflicts to disclose.Ethical Approval: In accordance with applicable federal regulations (45 CFR 46·116(d)), the study was approved for a waiver of informed consent by the New York University Institutional Review Board.