Remotely Observed Methadone Evaluation (ROME)

1. Executive Summary of Sonara Health SBIR Phase I and Team Methadone is an effective treatment for patients with opioid use disorder (OUD), however its use is highly regulated at the federal and state level due to concerns of overdose and diversion. As a result, methadone can only be administered in OTPs, and it can take patients months of care before an OTP will authorize take-home methadone. These barriers can reduce patient engagement and retention, which severely impacts health outcomes. They can also prevent OTPs from fully being able to serve their communities. Sonara is an innovative solution that reduces friction for OTPs providing life-saving methadone treatment for opioid use disorder. It works by combining a secure web platform with low-cost, tamper-evident, single-use packaging to track per-patient, per-dose adherence to take home methadone. Clinicians have the ability to view each dosing session on-demand (i.e. asynchronously) to ensure patient adherence to treatment regimens and intervene in the case of concerning patient behavior. Through Sonara's remote observation platform, clinicians are able to increase access to take-home methadone, while preventing opportunities for diversion or misuse. It will also improve accountability and transparency for patients and providers alike by actively reporting key indicators of recovery success. These goals serve to advance patient engagement and retention, which in turn improves clinician engagement, and ultimately the health outcomes of patients. The objective of Sonara Health's SBIR Phase I grant awarded and initiated in October 2022 was to conduct feasibility testing of the minimum viable product (MVP of Sonara's web application and evaluate its performance for opioid treatment programs (OTPs) in dispensing take-home methadone in a safe and responsible way. The specific aims of the proposed study are: 1) Conduct feasibility testing of Sonara's minimum viable product with patient- andclinician-facing web application and evaluate tracking performance 2) Research, develop, and integrate a measurement-based care framework that measuresfrequent, personalized improvement to a patient's OUD outcomes and delivers them totheir care team 3) Assess the demand and acceptability of Sonara among providers and target patients The proposed I-Corps team will include the following three members. Member Name Role Justin Geller Industry Expert Michael Giles, M.D. C-Level Corporate Officer (CEO) Kim Hoffman, PhD PD/PI All three members are committed to the time required by the I-Corps program.