COPA: A clinical program to evaluate benefits of a hand-held, automated, personalized oral liquid dispensing system for take-home methadone medication management for patients with opioid use disorder.

Abstract Centers for Disease Control and Prevention (CDC) predicted 109,940 Americans died from a drug overdose in the 12-month period ending January 2023. There is consistent evidence that while in treatment with methadone, patients with opioid use disorder (OUD) have lower use of opioids, lower risk of death, significantly fewer opioid-related ER visits, are less involved in crime, feel and function better, and are more socially productive. Missing a dose of methadone results in significant consequences, such as developing opioid withdrawal syndrome and risk of opioid relapse. Daily in-clinic administration is cost prohibitive and a burden to patients and systems. It has a negative impact on the patient’s quality of life and their ability to work. The limitations or disallowance of take-home doses can be a deterrent to initiating treatment, and patients are more likely to discontinue methadone treatment when take-home doses are removed from treatment. At-home options for Medications for Opioid Use Disorder (MOUD) are currently limited due to the concerns of misuse, overdose, and/or diversion, as well as requirements for oversight. The requirement to travel to an Opioid Treatment Program (OTP) clinic daily has also been shown to reduce treatment retention and deter other patients from even starting treatment. A mixed methods study found that take-home dose flexibility among stable patients was associated with receiving more take- homes, higher rates of treatment retention, and lower rates of opioid-positive drug tests. Higher retention rates in opioid use disorder medication among patients with OUD were associated with better outcomes. There have been a considerable number of retrospective studies evaluating opioid use disorder treatment retention; however, there are very few prospective comparison studies. The Computerized Oral Prescription Administration System (COPATM) is a hand-held, automated, personalized, oral liquid dispensing system with remote monitoring and advanced data analytics, designed and intended to deliver controlled and non-controlled liquid oral medications (including methadone) to only the Authenticated Intended user (AIU™) upon confirmation of dual biometric identification (fingerprint and dentition). We propose to conduct a two-phased prospective clinical study beginning with a Single-Site, Single-Arm Observational Pilot Study of Feasibility and Acceptability (Feasibility Study), which will be executed during the Fast-Track Phase I, followed by an Open-Label Randomized Parallel Multi-Site Study (Multi-Site Study) conducted during Fast-Track Phase II. The primary objective of the Feasibility Study will be to evaluate the functionality and acceptance of COPA™ to dispense methadone take-home medication. The primary endpoint of the Multi-Site Study is to evaluate treatment retention between two-arms of patients with OUD, who are newly admitted to methadone.