Synthesizing evidence on the impacts of COVID-19 regulatory changes on methadone treatment for opioid use disorder: Implications for U.S. federal policy

As the U.S. faces a worsening overdose crisis, improving access to evidence-based treatment for opioid use disorder (OUD) remains a central policy priority. Federal regulatory changes in response to the COVID-19 pandemic significantly expanded flexibilities on take-home doses for methadone treatment for OUD. These changes have fueled critical questions about the impact of new regulations on OUD outcomes, and the potential health impact of permanently integrating these flexibilities into treatment policy going forward. To aide US policy makers as they consider implementing permanent methadone regulatory changes, we conducted a review synthesizing peer-reviewed research evidence on the impact of the COVID-19 methadone-take-home flexibilities on methadone program operations, OUD patient and provider experiences, and patient health outcomes. We interpret this evidence in the context of the federal rulemaking process and discuss avenues by which these important findings can be incorporated and implemented into U.S. substance use treatment policy going forward. ### Competing Interest Statement Dr. Krawczyk provides expert testimony in ongoing opioid litigation ### Funding Statement This work was supported by a grant from the Pew Charitable Trusts ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors