The U.S. Food and Drug Administration has permitted the startup Pear Therapeutics to market the first medical app aiding in the treatment of substance use disorders, the agency announced Sept. 14.
The app, called Reset, is intended to treat alcohol, cocaine, marijuana and stimulant substance use disorders alongside outpatient therapy. The prescription-only digital therapeutic delivers cognitive behavioral therapy to patients to increase their retention of skills taught in outpatient programs. In addition to the patient app, Reset also comprises a clinical dashboard for providers.
To evaluate Reset, the FDA reviewed data from a multisite 12-week clinical trial of 399 patients who received either standard treatment with or without a desktop-based version of Reset. The clinical trial found patients who used Reset reported significant increase in adherence to abstinence from alcohol, cocaine, marijuana and stimulants.
In the clinical trial, 40.3 percent of those who used Reset indicated abstinence, compared to the 17.6 percent of those who did not use Reset. The clinical trial did not indicate any side effects associated with the app. However, the FDA emphasized the clinical trial did not demonstrate the effectiveness of using Reset for patients in treatment for opioid dependence.
"This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment," said Carlos Peña, PhD, 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."