Millions of opioid prescriptions are written each year. In 2018, nearly 70% of the 70,237 drug overdose deathsin the U.S. involved opioids, a figure that is projected to grow to 81,700 deaths by 2025. The COVID-19 pandemicis further exacerbating this and has exposed many vulnerabilities in the treatment of patients with OUD.Provisional data from the Centers for Disease Control and Prevention (CDC) shows that drug overdose deathshave increased by more than 15% from May 2019 to May 2020. Of those patients prescribed opioids, between8-12% will later develop opioid use disorder (OUD). Given that prescription opioids remain the dominant routethrough which OUD begins, reducing their abuse and diversion can translate over time into reduced deaths.Many patients with OUD are treated by a combination of buprenorphine with counseling and behavioraltherapies, also known as Medication Assisted Treatment (MAT). Although buprenorphine is less addictive thanopioids or other treatments (e.g., methadone), it is not invulnerable to abuse or diversion. There is therefore asignificant opportunity for the development of new technologies aimed at remotely treating OUD, and preventingdrug misuse, abuse, and diversion. Although several secure dispenser technologies are under development,there remains a critical need for a comprehensive solution that prevents and/or treats addiction, tracks usage,collects data, and eliminates excess medication, while also remaining modular and cost effective enough to bewidely accessible. Addinex Technologies, Inc. is developing the only solution that, for less than $20/patient,combines: 1) a patented, secure, low-cost and modular medication-dispenser which controls medication accessand encourages convenient and safe unused medication disposal, combined with 2) companion mobile patientapp and physician/pharmacist web-based software that features interactive modules and surveys to improvepatient education and engagement, caregiver monitoring, and teletherapy to facilitate patient-providerinteractions. In this Phase I SBIR, Addinex will (Aim 1) develop their comprehensive system for at-home OUDtreatment by modifying it for use with suboxone strips and enhancing their companion software for OUDtreatment and text-compatibility. We will then (Aim 2) leverage a collaboration with Yale School of Medicine andthe In-Home Addiction Treatment Institute (IHATI)/Aware Recovery to survey treatment providers to obtainfeedback that will guide the integration of the Addinex system into OUD treatment programs and conduct ausability and acceptability study for the text-based and app-based system across patients (n = 60) undergoingOUD treatment. Successful completion of these aims will provide critical insights to further optimize the Addinexsystem and to guide the design of a larger, randomized controlled trial to demonstrate its efficacy and cost-effectiveness. Ultimately, this study will be the springboard for the development of a system that is cost-efficient,widely accessible, and user-friendly, with the aim of increasing adherence, decreasing treatment time,decreasing the misuse of medication, increasing treatment retention, and reducing relapses in OUD treatmentfor the many who are suffering.
Public Health Relevance Statement: PROJECT NARRATIVE
Estimates suggest that up to 10 million Americans misuse opioids yearly. With nearly 70% of drug overdose
deaths involving opioids, Addinex Technologies recognizes the need for better systems aimed at preventing and
treating addiction, tracking usage, collecting data, and eliminating excess medication to reduce opioid misuse,
abuse, and diversion. To this end, we are developing a widely accessible low-cost modular secure medication-
dispenser combined with a treatment-focused opioid use disorder (OUD) mobile application that is text-
compatible to increase adherence, and reduce relapses and costs for patients in OUD treatment.
Project Terms: 