> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Mobile Medical App Cleared for Substance Use Disorder
- URL: https://www.fdaweb.com/mobile-medical-app-cleared-for-substance-use-disorder/
- Published: 2017-09-14T12:00:00.000Z
- Updated: 2026-09-14T22:50:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139631

FDA has permitted under its de novo process the marketing of the first mobile medical application to help treat substance use disorders (SUDs). Pear Therapeutics Reset application is intended to be used with outpatient therapy to treat alcohol, cocaine, marijuana and stimulant SUDs, according to an [agency notice](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm576087.htm?ref=fdaweb.com). The mobile app contains a patient application and clinician dashboard. It delivers “cognitive behavioral therapy to patients to teach the user skills that aid in the treatment of SUD and are intended to increase abstinence from substance abuse and increase retention in outpatient therapy programs,” the agency says. The system is intended to be used in conjunction with outpatient therapy and in addition to a contingency management system, a program for treating SUD that uses a series of incentives to reward patients for adherence to their treatment program.

The de novo marketing permit was granted based on 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 which could be accessed at the clinic or at home. Data showed a “statistically significant increase in adherence to abstinence for the patients with alcohol, cocaine, marijuana and stimulant SUD in those who used Reset, 40.3%, compared to the patients who did not, 17.6%,” FDA says.