FDA approves marketing of mobile app for substance abuse

The U.S. Food and Drug Administration (FDA) has approved the marketing of a mobile medical application for patients with substance use disorders (SUD). Used in conjunction with outpatient therapy, the app can help treat those with alcohol, cocaine and other SUDs. It is not intended for opioid dependence.

The Reset mobile app includes functions for both the patient and clinician, offering cognitive behavioral therapy to teach skills in substance abstinence and retention in outpatient therapy programs. In 12-week long FDA-conducted study of 399 patients who received Reset or conventional treatment, researchers found patients using Reset were likely to maintain substance abstinence at a much higher rate (40.3 percent) than those receiving standard treatment (17.6 percent).

"This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment," said Carlos Peña, PhD, MS, director of the Division of Neurological and Physical Medicine Devices in FDA's Center for Devices and Radiological Health. "More therapy tools means a greater potential to help improve outcomes, including abstinence, for patients with substance use disorder."