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# Pear App OK’d to Aid Opioid Outpatient Compliance
- URL: https://www.fdaweb.com/pear-app-okd-to-aid-opioid-outpatient-compliance/
- Published: 2018-12-10T12:00:00.000Z
- Updated: 2026-09-15T00:49:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143001

FDA has cleared a Pear Therapeutics 510(k) for its mobile medical application called reSET-O to help increase retention in an outpatient treatment program for individuals with opioid use disorder (OUD). The app is a prescription cognitive behavioral therapy intended to be used in addition to outpatient treatment under the care of a health care 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,” an [FDA release ](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628091.htm?ref=fdaweb.com)says.

The app can be downloaded directly to a patient’s mobile device after they receive a prescription 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 health care providers and patients in maintaining an outpatient treatment program. It also includes a compliance reward system– such as earning special icons on a prize wheel within the app.

To clear the device, 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,” FDA says. “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.”