Technology-Assisted Buprenorphine Treatment in Rural and Nonrural Settings: Two Randomized Clinical Trials.

Importance: Expansion of opioid use disorder treatment is needed, particularly in rural communities. Objective: To evaluate technology-assisted buprenorphine (TAB) efficacy (1) over a longer period than previously examined, (2) with the addition of overdose education, and (3) among individuals residing in rural communities. Design, Setting, and Participants: Two parallel, 24-week randomized clinical trials were conducted at the University of Vermont between February 1, 2018, and June 30, 2022. Participants were adults with untreated opioid use disorder from nonrural (trial 1) or rural (trial 2) communities. These trials are part of a programmatic effort to develop TAB protocols to improve treatment availability in underserved areas. Interventions: Within each trial, 50 participants were randomized to TAB or control conditions. Participants in the TAB group completed bimonthly visits to ingest medication and receive take-home doses via a computerized device. They received nightly calls via an interactive voice response (IVR) system, IVR-generated random call-backs, and iPad-delivered HIV, hepatitis C virus (HCV), and overdose education. Control participants received community resource guides and assistance with contacting resources. All participants received harm reduction supplies and completed monthly assessments. Main Outcomes and Measures: The primary outcome was biochemically verified illicit opioid abstinence across monthly assessments. Secondary outcomes included self-reported opioid use in both groups and abstinence at bimonthly and random call-back visits, treatment adherence, satisfaction, and changes in HIV, HCV, and overdose knowledge among TAB participants. Results: Fifty individuals (mean [SD] age, 40.6 [13.1] years; 28 [56.0%] male) participated in trial 1, and 50 (mean [SD] age, 40.3 [10.8] years; 30 [60.0%] male) participated in trial 2. Participants in the TAB group achieved significantly greater illicit opioid abstinence vs controls at all time points in both trial 1 (85.3% [128 of 150]; 95% CI, 70.7%-93.3%; vs 24.0% [36 of 150]; 95% CI, 13.6%-38.8%) and trial 2 (88.0% [132 of 150]; 95% CI, 72.1%-95.4%; vs 21.3% [32 of 150]; 95% CI, 11.4%-36.5%). High abstinence rates were also observed at TAB participants' bimonthly dosing visits (83.0% [95% CI, 67.0%-92.0%] for trial 1 and 88.0% [95% CI, 71.0%-95.0%] for trial 2). Treatment adherence was favorable and similar between trials (with rates of approximately 99% for buprenorphine administration, 93% for daily IVR calls, and 92% for random call-backs), and 183 of 187 urine samples (97.9%) tested negative for illicit opioids at random call-backs. iPad-delivered education was associated with significant and sustained increases in HIV, HCV, and overdose knowledge. Conclusions and Relevance: In these randomized clinical trials of TAB treatment, demonstration of efficacy was extended to a longer duration than previously examined and to patients residing in rural communities. Trial Registration: ClinicalTrials.gov Identifier: NCT03420313.