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.
