WASHINGTON – In a first, the US Food and Drug Administration (FDA) has approved marketing of a novel mobile medical application designed to help treat people with substance use disorders such as addiction to alcohol, cocaine and marijuana.
The “Reset” app developed by Pear Therapeutics — a US-based Prescription Digital Therapeutics firm — delivers cognitive behavioural therapy to teach users the skills that aid in the treatment of substance use disorders.
The app, which is also a web interface for clinicians, is also intended to increase abstinence from substance abuse and increase retention in treatment compared to other therapies, the agency said in a statement on Thursday.
“This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment,” said Carlos Pena, Director at 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,” Pena added.
As part of the approval process, the FDA reviewed data from a multi-site, in a 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 home.
The data showed a statistically significant increase in adherence to abstinence for the patients with alcohol, cocaine, marijuana and stimulant substance use disorders in those who used Reset, 40.3 per cent, compared to the patients who did not, 17.6 per cent.
The clinical trial did not demonstrate the effectiveness of using the Reset device in patients reporting opioids as their substance of abuse. Data from the clinical studies also did not indicate any side effects associated with the device, the statement said.