The Development and Evaluation of of Video-­Based Directly Observed Therapy for Office-­Based Treatment of Opioid Use Disorders with Buprenorphine is a project to develop a sustainable, scalable, and patient-­centered mobile health (mHealth) platform, comprised of a patient-­facing mobile application and provider-­facing web portal, for opioid use disorder treatment. Methadone clinics are based on a directly observed therapy model for treatment, where a health care worker visually confirms medication ingestion, but there are not enough methadone clinics (which require federal oversight) to support the care needs of over 2 million patients with opioid use disorders, and many persons choose not seek treatment in such settings for fear of being stigmatized. Since 2002, persons with opioid use disorders who desire medication assisted treatment can be treated with buprenorphine, which has also been shown to be efficacious. Buprenorphine treatment can occur in any medical office based setting, is prescribed by any physician who seeks to become waivered, and is taken by patients at home unsupervised. Office-­based buprenorphine programs can significantly expand access to care but face similar capacity constraints with providing the frequent, often weekly, routine care and monitoring needed for this population during initial months of treatment. Furthermore, without visual confirmation of medication ingestion, providers remain unsure if patients divert part or all of their buprenorphine medication. Medication diversion risks and care retention challenges provide significant barriers to scaling office-­based buprenorphine programs to help combat the opioid epidemic. This proposal will develop the technical and logistical workflow needs to implement a video-­based DOT application, miDOT, for office-­based buprenorphine monitoring during the initial months of care. In Phase I, we will configure miDOT to confirm medication ingestion of buprenorphine as well as provide digital support and patient engagement tools, including HIPAA-­secure in-­app chat, cravings reporting, and appointment reminders. In Phase II, we will perform a pilot randomized trial of video-­based DOT compared to treatment as usual (TAU) for office-­based buprenorphine treatment to assess differences in addiction treatment outcomes. Upon completion of Phases I and II, we will be poised to expand the research to either a larger, Phase III efficacy study, or an implementation study of effectiveness in the real-­ world setting through commercial partnerships developed over the course of this project. To the best of our knowledge, this will be the first evaluation of video-­based DOT in office-­based buprenorphine care.

The proposed study will develop and evaluate the effectiveness of video-based directly observed therapy (DOT) in office-based buprenorphine programs to improve care during initial months of treatment. Video-based DOT offers the benefit of patient and provider convenience by removing the need for frequent, in-person visits and has the potential for reduced stigma and better treatment outcomes due to improved adherence from a disease that disproportionately affects vulnerable populations. The proposal will configure a video-based DOT platform, evaluate its effectiveness in securing medication ingestion and care retention for illicit opiate users, and solidify routes of sustainable commercial viability with commercial partners.