CHA News Article

FDA Permits Marketing of Mobile App for Treating Substance Use Disorders

The Food and Drug Administration (FDA) has announced that it will permit marketing of the first mobile medical application, called “reSET,” to help treat substance use disorders. The app, which is meant to be used in conjunction with outpatient therapy, is intended to treat disorders related to alcohol, cocaine, marijuana and stimulants; it is not intended to address opioid dependence. The device delivers cognitive behavioral therapy to patients to teach skills that aid in treatment and are intended to increase abstinence from substance use and retention in outpatient therapy programs. The FDA reviewed data from a multi-site, unblinded 12-week clinical trial of 399 patients who received either standard treatment or standard treatment with the addition of a desktop-based version of reSET that could be accessed at the clinic or at home. The data showed a statistically significant increase in adherence to abstinence for the patients who used the app compared to the patients who did not – 40.3 percent and 17.6 percent, respectively.