A patient preference trial of sublingual versus extended-release buprenorphine telemedicine and pharmacy linkage for individuals re-entering the community from jail - Abstract This proposed study is a patient preference trial (PPT) of XR-B vs. SL-B in 8 rural jails in Maryland. A total of 500 adults with moderate/severe OUD soon-to-be-released from jail will be recruited and will choose to receive XR-B or SL-B treatment in jail via telemedicine followed by 6-months of post-release XR-B/SL-B treatment via telemedicine at community pharmacies, a 7-month safety visit, and 12-month follow-up. All individuals receiving XR-B will have their injection administered by a pharmacist, allowing the telemedicine treatment to be fully remote and equivalent to that of SL-B which will also be filled at a local pharmacy. In addition, the consolidated Framework for Implementation Research (CFIR) and Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework will be utilized to understand implementation of telemedicine of XR-B and SL-B in jails and continued at community pharmacies. Aim 1. Compare the effectiveness of XR-B vs. SL-B in terms of: Primary Outcome. (a) retention in buprenorphine treatment (i. days receiving buprenorphine and ii. time to treatment dropout). Secondary Outcomes. (b) illicit opioid use (i. urine toxicology; ii. self-reported days of opioid use; and iii. time to opioid relapse); (c) other illicit substance use (i. urine toxicology; ii. self-reported days of illicit substance use; (d) overdose events (non-fatal and fatal); (e) health-related quality of life (i. physical health; ii. mental health); (f) HIV risk behaviors (i. sexual risk behavior; ii. needle use or sharing); and (g) criminal activity (i. crime days; ii. re-arrest; iii. technical violations; iv. re- incarceration). Aim 2. Document factors relevant to implementation and sustainability of the telemedicine buprenorphine intervention in jails and pharmacy settings. Guided by CFIR and RE-AIM we will gauge 1) how to optimize key intervention components (e.g., dose induction, telemedicine procedures, medication preferences, continuity of care, inner and outer context factors, stigma, pharmacy procedures, improvement of the cascade of care for OUD) and 2) the RE-AIM of key implementation factors. To achieve this aim, we will conduct interviews with stakeholders (n = 10, e.g., pharmacists, telemedicine providers, jail staff per site; total n = 80). The study will be innovative for two reasons: 1) it would be the first large scale PPT of XR-B/SL-B using telemedicine among individuals leaving jail; and 2) it would be the first study continuing XR-B injections with a re-entry population at pharmacies. The study will be highly significant because most individuals with OUD do not receive treatment while in jail, thereby substantially raising their likelihood of relapse to drug use, overdose death, and re-incarceration when they are released. A telemedicine program may improve the continuity of care between incarceration and re-entry which is the period in which individuals with an OUD are most vulnerable. Finally, understanding how to expand acceptance of MOUDs in jails using telemedicine and pharmacy administration of XR-B, has far-reaching implications for expanding treatment access.
