FDA Clears Mobile App to Support Buprenorphine Treatment

Developers of a mobile app using a cognitive-behavioral approach to support outpatients receiving buprenorphine for opioid addiction received clearance for their product this month from the Food and Drug Administration (FDA).

The reSET-O app, marketed by Pear Therapeutics, also reinforces a contingency management approach to treatment by including a reward system that allows users to earn icons on a prize wheel within the app.

“We know medication-assisted treatment works and we support novel ways to keep individuals more engaged in their treatment programs and to provide clinicians with new ways to intervene to help them remain in treatment,” FDA Commissioner Scott Gottlieb, MD, said in a news release.

A 12-week multi-site trial involving 170 patients receiving buprenorphine and behavioral therapy found that while use of a desktop version of reSET-O did not decrease individuals' drug use more than the same treatments without reSET-O, use of the program did generate a significant increase in treatment retention at 12 weeks. The app is not designed to be used as a replacement for medication or as a stand-alone therapy.