Project Summary/Abstract RFA-DA-24-018 Field-Deployable, Low-Cost Point-of-Need Approaches and Technologies to Lower the Barriers to Substance Use Disorders (SUD) Diagnosis and Treatment Twenty years after the FDA approval of buprenorphine for treatment of opioid use disorder (OUD), its availability remains far too restricted. This restriction is in spite of regulatory relaxations over these two decades: from increased panel size to broadening qualifying clinicians to ultimately removing any required waiver. It has also become clear that certain circumstances make patients especially vulnerable to harm from OUD. These include settings where medical attention is possible but buprenorphine is not provided (e.g, jails and prisons, emergency departments, and residential treatment for OUD), geographic areas where people are especially isolated from treatment (e.g, rural Tribal Nations), and life circumstances that confer additional risk (e.g., the perinatal period). We now have new tools to deliberately reach these settings. The regulatory suspension of an in-person visit during the COVID-19 pandemic allowed telehealth to dramatically increase its ability to care for patients, especially those with Medicaid. This increase in telehealth care has consequently allowed for research as to its effectiveness. Repeated studies find remote treatment with buprenorphine to be as good—and often better—than in-person treatment as usual. Research also calls attention to gaps that must be addressed to achieve treatment success with telehealth, including an affordable, readily-available working phone with reliable cellular and/or network coverage. These relatively low-cost technologies are the ones we propose to make available in the crucial settings described previously. Provision of a smartphone and connectivity will allow people in high-risk situations to begin treatment with Boulder Care’s proven approach and capabilities. We propose 5 partnerships that will, in Phase I, allow us to develop and test workflows with 5 participants per site and refine them for each setting, culminating with qualitative and quantitative research findings, including focus groups with participants and sites. With our workflows studied and optimized, our Phase II will then enroll 50 participants in Boulder Care from these 5 sites. Our primary endpoint, as with our prior SBIR grant, is duration of treatment with buprenorphine over a 48 week period. Secondary patient-centered outcomes will include measures of quality of life, functional outcomes, and assessments of recovery capital. Our partners include Sano Health, an experienced provider of technologies to vulnerable populations, and National Survivors Union, an organization of People Who Use Drugs who are accomplished community researchers. Together with site partners, this collaboration has proven, real-world, community-based expertise and will provide scalable life-saving treatment at the point of need.

Project Narrative RFA-DA-24-018 Field-Deployable, Low-Cost Point-of-Need Approaches and Technologies to Lower the Barriers to Substance Use Disorders (SUD) Diagnosis and Treatment Opioid Use Disorder (OUD), already a life-threatening condition, has additional risk in certain settings such as correctional reentry, Emergency Departments, Tribal Nations, residential substance use disorder treatment, and the perinatal period. We propose just-in-time provision of smartphones with needed connectivity to allow for enrollment in and continuity of telehealth that includes buprenorphine. Our efforts will be co-led and guided by partner researchers with lived experience in a Phase I that informs scaled efforts in Phase II.