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Outcomes from Engagement and Use of a Prescription Digital Therapeutic to Treat Opioid Use Disorder: A Real-World Pilot Study

Abstract Introduction The opioid epidemic in the United States is getting worse: in 2020 opioid overdose deaths hit an all-time high of 92,183. This underscored the need for more effective and readily available treatments for patients with opioid use disorder (OUD). Prescription digital therapeutics (PDTs) are FDA-authorized treatments delivered via mobile devices (eg, smartphones). A real-world pilot study was conducted in an outpatient addiction treatment program to evaluate patient engagement and use of a PDT for patients with OUD. The objective was to assess the ability of the PDT to improve engagement and care for patients receiving buprenorphine medication for opioid use disorder (MOUD). Methods Patients with OUD treated at an ambulatory addiction treatment clinic were invited to participate in the pilot. The reSET-O PDT is comprised of 31 core therapy lessons plus 36 supplementary lessons, plus contingency management rewards. Patients were asked to complete at least 4 lessons per week, for 12-weeks. Engagement and use data were collected via the PDT and rates of emergency room data were obtained from patient medical records. Data were compared to a similar group of 158 OUD patients treated at the same clinic who did not use the PDT. Abstinence data were obtained from deidentified medical records. Results Pilot participants (N = 40) completed a median of 24 lessons: 73.2% completed at least 8 lessons and 42.5% completed all 31 core lessons. Pilot participants had significantly higher rates of abstinence from opioids in the 30 days prior to discharge from the program than the comparison group: 77.5% vs 51.9% (P < .01). Clinician-reported treatment retention for pilot participants vs the comparison group was 100% vs 70.9% 30 days after treatment initiation (P < .01), 87.5% vs 55.1% at 90 days post-initiation (P < .01), and 45.0% vs 38.6% at 180 days post-initiation (P = .46). Emergency room visits within 90 days of discharge from the addiction program were significantly reduced in pilot participants compared to the comparison group (17.3% vs 31.7%, P < .01). Conclusions These results demonstrate substantial engagement with a PDT in a real-world population of patients with OUD being treated with buprenorphine. Abstinence and retention outcomes were high compared to patients not using the PDT. These results demonstrate the potential value of PDTs to improve outcomes among patients with OUD, a population for which a significant need for improved treatments exists. Funding Trinity Health Innovation and Pear Therapeutics Inc.