Enhanced Treatment Management of Opioid-Dependence in an Office-Based Setting

Medicasafe, Inc., New York NY

Investigators

Abstract

PROJECT SUMMARY/ABSTRACT Opioid use disorder is the leading cause of accidental death in the US, with over 50,000 lethal drug overdoses in 2015. SAMHSA estimates that 12 million Americans misuse prescription opioids for non-medical purposes annually. Public health officials and policymakers have acknowledged the urgent need for innovative approaches to the treatment of those with opioid use disorder; in spite of this, the availability and acceptance of medication-assisted treatment has not kept pace with the rise of the opioid epidemic. Certain strides have been made, as with the Drug Addiction Treatment Act of 2000 which allows specifically waived physicians to prescribe Schedule III-V drugs. Buprenorphine/naloxone (B/N) was approved in 2002, and is intended to mitigate patients? opioid cravings, while discouraging injection by precipitating withdrawal when administered parenterally. In chronic illness, patient compliance to a prescribed regimen correlates with treatment success, and, conversely, poor patient compliance correlates with negative outcomes. Studies have demonstrated that with B/N specifically, compliance is predictive of both relapse and treatment retention. Relapse events are costly in terms of total healthcare expenditures (around $15,000 per patient), and personally?upwards of 800,000 years of potential life lost before the age of 65 in the United States alone. It is clear that not only expanding access to treatment is a priority, but that increasing patient compliance is urgent. In the proposed study, we will examine whether the MedicaSafe BNT can help bolster treatment compliance. This undertaking will be comprised of an initial pilot for study design validation, followed by a final iteration of software for the existing device and coupled platform, and, lastly, a randomized controlled trial that will aim to take patients from induction to stable maintenance in office-based buprenorphine treatment. The results from the randomized controlled trial will be analyzed and incorporated into further projects. Addiction is a chronic illness, and this project intends to demonstrate that the behavioral support technology developed in Phase I serves as a continuous compliance aid beyond induction and the early stages of treatment.