FDA Clears Mobile App for Opioid Use Disorder

Megan Brooks

December 10, 2018

The US Food and Drug Administration (FDA) has cleared a mobile medical application to help increase retention in outpatient treatment programs for individuals with opioid use disorder (OUD).

The reSET-O™ app, from Pear Therapeutics, is a prescription cognitive behavioral therapy intended for use in addition to an outpatient OUD treatment program. Once prescribed by a physician, the reSET-O app can be downloaded directly to a patient's mobile device.

The reSET-O app serves 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 multicenter, 12-week clinical trial of 170 patients who received supervised buprenorphine (Buprenex, Reckitt Benckiser) treatment paired with a behavior therapy program, either with or without the addition of a desktop-based version of the reSET-O. 

Patients received supervised administration of buprenorphine and urine screens 3 times per week and participated in a contingency management system to reward negative urine tests.

Use of the reSET-O app did not decrease illicit drug use any more than patients who received buprenorphine treatment and contingency management alone. However, there was a statistically significant increase in retention in the treatment program for 12 weeks in patients who used the reSET-O program compared with those who did not.

Patients who used the reSET-O program had an overall retention rate of 82.4% through the end of 12 weeks of treatment compared with 68.4% for patients who did not use it.

"As part of our efforts to address the misuse and abuse of opioids, we're especially focused on new tools and therapies that can help more people with opioid use disorder successfully treat their addiction. Medical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in contributing to these treatment efforts," FDA Commissioner Scott Gottlieb, MD, said in a news release

"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," said Gottlieb.

The reSET-O mobile medical app for OUD was reviewed through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no legally marketed predicate device to which this new device can claim substantial equivalence.

The FDA previously approved the reSET app, also from Pear Therapeutics, to help treat substance use disorders involving alcohol, cocaine, marijuana, and stimulants, but not opioid dependence, as reported by Medscape Medical News.

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