Development of a Medication Adherence and Monitoring System Supporting Decentralized Clinical Trials for Substance Use Disorder

SUMMARY The primary goal of this project is to adapt Addinex’s existing medication management system to provide researchers running clinical trials for substance use disorder (SUD) to now have a tool that will allow at-home dispensing that controls access, monitors usage, educates patients, and collects real-time feedback. The Addinex system involves packaging medication in low-cost mechanical dispensers where each medication dose requires a unique password provided by a smartphone app. The dispenser restricts medication access by limiting each individual dose only as prescribed through unique one-time passcodes. Before each passcode is released, the patient is provided with education or questions provided by the clinician to monitor their progress. Proper passcode entry via dial-turning and the pull of a lever dispenses the next dose to the patient. To add a added level of control, patients may be required to use the app to video themselves taking the medication to assure compliance. Future dose codes are not released until the prescribed interval has passed, at which point they can request the next passcode. To refine Addinex’s system for decentralized clinical trials (DCTs), Addinex is partnering with the Chair of Psychiatry and Behavioral Health at Greenwich Hospital experienced in addiction medication research, Total Care Rx who fills prescriptions for Addinex’s current phase II study with Columbia University Medical Center, Myonex, a leading clinical trial supply company, and an addiction researcher at Yale School of Medicine who has previously worked with Addinex. These four partners will assist Addinex in developing a seamless version of its app and clinician data portal to improve at-home patient monitoring and Addinex intends to (Aim 1) determine weaknesses in current SUD treatment patient onboarding, adherence, and data collection, (Aim 2) expand the existing Addinex medication dispensing and monitoring system for DCT of SUD patients to improve patient retention and medication adherence, and (Aim 3) evaluate the usability and acceptability of the Addinex DCT system for SUD clinical trials. The project’s main goal is to develop a system to improve recruitment and retention of patients in clinical trials for SUDs.