SBIR/STTR Award attributes
Project Summary/Abstract: Millions of opioid prescriptions are written each year. In 2018, nearly 70% of the 70,237 drug overdose deaths in the U.S. involved opioids, a figure that is projected to grow to 81,700 deaths by 2025. The COVID-19 pandemic is 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 deaths have increased by more than 15% from May 2019 to May 2020. Of those patients prescribed opioids, between 8-12% will later develop opioid use disorder (OUD). Given that prescription opioids remain the dominant route through 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 behavioral therapies, also known as Medication Assisted Treatment (MAT). Although buprenorphine is less addictive than opioids or other treatments (e.g., methadone), it is not invulnerable to abuse or diversion. There is therefore a significant opportunity for the development of new technologies aimed at remotely treating OUD, and preventing drug 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 be widely 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 access and encourages convenient and safe unused medication disposal, combined with 2) companion mobile patient app and physician/pharmacist web-based software that features interactive modules and surveys to improve patient education and engagement, caregiver monitoring, and teletherapy to facilitate patient-provider interactions. In this Phase I SBIR, Addinex will (Aim 1) develop their comprehensive system for at-home OUD treatment by modifying it for use with suboxone strips and enhancing their companion software for OUD treatment and text-compatibility. We will then (Aim 2) leverage a collaboration with Yale School of Medicine and the In-Home Addiction Treatment Institute (IHATI)/Aware Recovery to survey treatment providers to obtain feedback that will guide the integration of the Addinex system into OUD treatment programs and conduct a usability and acceptability study for the text-based and app-based system across patients (n = 60) undergoing OUD treatment. Successful completion of these aims will provide critical insights to further optimize the Addinex system 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 treatment for the many who are suffering.
