Project Grant R43DA061387

ADVANCING ACCESS TO OPIATE CARE AND TREATMENT THROUGH A NOVEL LIQUID METHADONE DISPENSING DEVICE AND SMART CONTAINER - SIGNIFICANCE AND ECONOMIC IMPACT: IN 2017, THE ECONOMIC BURDEN FOR OPIOID USE DISORDER (OUD) WAS ESTIMATED AT $68.7 BILLION FOR 47,600 PERSONS SUFFERING A FATAL OPIOID OVERDOSE ($1.4 MILLION PER CAPITA), WHILE NEARLY 110,000 PEOPLE ARE ESTIMATED TO HAVE DIED FROM DRUG OVERDOSES IN 2022.1-5 MEDICATIONS TO TREAT OPIOID USE DISORDER (MOUD) ARE EFFECTIVE IN PREVENTING OVERDOSE MORTALITY AND IMPROVING OUTCOMES.2,16 UNMET NEEDS: METHADONE, THE MOST DISPENSED MOUD IN POOR AND MINORITY NEIGHBORHOODS, MAINTAINS THE MOST STRINGENT FEDERAL REGULATIONS, AS IT MUST BE OBTAINED AT AN OPIOID TREATMENT PROGRAM (OTP) FOR ONE, TWO, OR THREE YEARS OF DAILY SUPERVISED USE BEFORE A PERSON RECEIVES UP TO 6, 14, AND 30 DAYS OF UNSUPERVISED TAKE-HOME DOSES, RESPECTIVELY.7,8,9 IN ADDITION, SMARTPHONES WERE ACCESSIBILE IN 60% OF PERSONS ASSESSED WITH SERIOUS MENTAL ILLNESS (SMI) AND SUBSTANCE USE DISORDER (SUD), WHILE SMARTPHONE PRIVACY BREACHES REMAIN SIGNIFICANT BARRIERS TO SUPERVISED USE (ASYNCHRONOUS RECORDING).15-17 HEALTH INNOVATIONS: FUTURE HEALTH INNOVATIONS MUST DELIVER LOW-COST LIQUID METHADONE DISPENSING AND TELEHEALTH SOLUTIONS THROUGH A SINGLE DEVICE WHICH OVERCOMES CURRENT DIGITAL BARRIERS (E.G., REQUIRED USE OF A MOBILE PHONE/SMARTPHONE) AND TRADITIONAL SUD BARRIERS (E.G., TAKING TIME OFF WORK, LONG TRAVEL TIMES, TRANSPORTATION COSTS, PHARMACY PREPARATION COSTS). SANO'S MOUD-EID WAS SPECIFICALLY DESIGNED AS A NOVEL SINGLE DEVICE SOLUTION, AS IT IS COMPRISED OF (A) AN INNER- CONTAINER, WHICH USES ELECTROMECHANICAL VALVES TO PRECISELY DISPENSE UP TO 30-DAYS LIQUID METHADONE THROUGH A LOW-COST VOLUMETRIC-CONTROL SYSTEM; (B) A REUSABLE EXTERNAL SMART- CONTAINER WITH AUDIO, VIDEO, AND A LOW-COST GRAVIMETRIC-CONTROL SYSTEM (SUPPLEMENTAL ADHERENCE/DEVICE EFFICACY ASSESSMENT); (C) WI-FI AND BLUETOOTH CAPABILITY FOR REMOTE SUPERVISED USE [VIDEO OBSERVED THERAPY (VOT)] AND TELEHEALTH/BEHAVIORAL HEALTH ACCESS, WITHOUT USE OF A SMARTPHONE; AND (D) A UNIQUE DEVICE IDENTIFICATION SYSTEM WITH BIOMETRIC SECURITY (PHASE 2). SPECIFICALLY, WE WILL CONSTRUCT A LOW-COST CONTROL-VOLUME SYSTEM, GRAVIMETRIC CONTROL SYSTEM, AND INCORPORATE ASYNCHRONOUS RECORDING TO SUPPORT REMOTE LIQUID METHADONE DISPENSING, SUPERVISED USE, AND TELEHEALTH/BEHAVIORAL HEALTH SUPPORT, WHICH MAY PROVIDE MOUD INTERVENTION TO ALL WHO MAY BENEFIT, WITHOUT NEED FOR A SMARTPHONE. HEREIN, SANO'S MOUD-EID SUPPORTS PERSON-CENTERED CARE AND FEASIBILITY FOR OBTAINING FDA BREAKTHROUGH MEDICAL DEVICE DESIGNATION.