FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs

Dec. 12, 2018

The U.S. Food and Drug Administration cleared a mobile medical application (app) to help increase retention (the amount of time a patient participates) in an outpatient treatment program for individuals with opioid use disorder (OUD). The reSET-O app is a prescription cognitive behavioral therapy intended to be used in addition to outpatient treatment under the care of a healthcare professional, in conjunction with treatment that includes buprenorphine and contingency management. Contingency management is a behavior modification intervention that establishes a connection between new, targeted behavior and the opportunity to obtain a desired reward.

The reSET-O is an app that can be downloaded directly to a patient’s mobile device after they receive a prescription to do so from their doctor. It is intended to be used while participating in an outpatient OUD treatment program. It can serve as a training, monitoring and reminder tool for healthcare providers and patients in maintaining an outpatient treatment program. It includes a compliance reward system—such as earning special icons on a prize wheel within the app.

The FDA reviewed data from a multi-site, unblinded, controlled 12-week clinical trial of 170 patients who received supervised buprenorphine treatment paired with a behavior therapy program, either with or without the addition of a desktop-based version of reSET-O, which was accessed at the clinic. Patients received supervised administration of buprenorphine and urine screens three times per week and participated in a contingency management system to reward negative urine tests.

The use of reSET-O was not shown to decrease illicit drug use any more than patients who received buprenorphine treatment and contingency management alone. However, the data showed a statistically significant increase in retention in a treatment program for 12 weeks for the patients who used the desktop computer version of the reSET-O program compared to those who did not. In the trial, patients who used the desktop computer version of reSET-O had an overall retention rate through the end of 12 weeks of treatment of 82.4% compared with 68.4% overall retention rate for patients who did not.

FDA has the full release