reSET-O is a Prescription Digital Therapeutic (PDT) for the treatment of Opioid Use Disorder (OUD) that received Breakthrough Designation and was authorized by the FDA in December 2018. The 84-day program provides cognitive behavioral therapy (CBT) as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management for patients 18 years or older who are currently under the supervision of a clinician. An associated dashboard for clinicians and other healthcare providers can be used as part of treatment and displays information about patients’ use of reSET-O.
reSET-O is intended to increase retention of patients in outpatient treatment and is intended for patients whose primary language is English or Spanish with a reading level of 7th grade or above and who have access to an Android/iOS tablet or smartphone. The program is intended only for patients who own a smartphone and are familiar with using smartphone apps.
It is important to note that reSET-O is not intended to be used as a standalone therapy for OUD, and should not be used to communicate with patients about emergency medical issues. It is not intended to reduce the frequency or duration of in-person therapy or replace care by a licensed medical practitioner. Patients should continue to take their medications as directed by their healthcare provider. Additionally, the long-term benefit of reSET-O has not been evaluated in studies lasting beyond 12 weeks (84 days) in the OUD population, and the ability of reSET-O to prevent potential relapse after therapy discontinuation has not been studied.