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The app, known as Reset, uses cognitive-behavioral therapy and is intended to be used in combination with outpatient therapy to treat alcohol, cocaine, marijuana, and stimulant SUDs. The goal is to increase retention in outpatient therapy programs and promote abstinence from substance abuse. The app is not intended to be used for the treatment of opioid dependence, the FDA noted.
“This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment,” Carlos Peña, Ph.D., M.S., director of the Division of Neurological and Physical Medicine Devices in FDA’s Center for Devices and Radiological Health, said in a press release.
The Reset app is indicated as a 12-week prescription-only adjunct treatment for patients with SUD who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not have an opioid use disorder. The product combines patient-facing interventions and assessments via a mobile app with clinician-facing dashboards and data analytics.
The FDA reviewed data from a multisite, 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. The 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 with the patients who did not (17.6%). The clinical trial did not demonstrate effectiveness of using Reset in patients reporting opioid use.
There were no reports of side effects associated with the device, according to data from the clinical studies.
With the FDA’s clearance of Reset, Pear Therapeutics (based in Boston and San Francisco), the developer of the technology, can now begin to market the app.
For related information, see the Psychiatric News article “APA to Provide Framework to Evaluate Mobile Health Apps.”
(Image: iStock/Cecilie_Arcurs)