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

Today, 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 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.

"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. That's why, for example, we launched an innovation challenge earlier this year to promote the development of medical devices that could help treat addiction," said FDA Commissioner Scott Gottlieb, M.D. "Often on the road to recovery, patients find their commitment to staying in treatment may wane. Providing Americans suffering from opioid use disorder with more options and proper support to address treatment challenges is key to helping them succeed. 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."