FDA Okays First Prescription Mobile App To Help Patients With Substance Use Disorders

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FDA Okays First Prescription Mobile App To Help Patients With Substance Use Disorders

The U.S. Food and Drug Administration has given the go-ahead to Pear Therapeutics to market their new mobile app reSET, a program that was developed to help those with substance use disorders.

The digital app focuses on therapy to prevent relapse from alcohol, cocaine,stimulants, and marijuana use. The app, however, has not yet been designed to treat opioid abuse and dependence.

The app is structured as a 90-day treatment program and will be available by prescription. reSET includes a patient application and dashboard for health care providers. It offers cognitive-behavioral therapy techniques that teach critical skills used to continue treatment, increase abstinence from drug abuse, and improve outpatient program retention.

The FDA examined data from a 3-month trial that included nearly 400 patients who participated in either standard treatment for substance use disorders, or standard treatment for SUDs in addition to a desktop version of reSET.

According to an agency press release, results showed a marked increase in sustained abstinence among patients who used the app (more than 40%) compared to those who did not use the app (17.6%.)

The FDA stressed that the app should be used in conjunction with outpatient therapy, as well as a contingency management system, a common method used to treat substance abuse that encourages compliance through a system of rewards.

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:

“This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment. More therapy tools means a greater potential to help improve outcomes, including abstinence, for patients with substance use disorder.”

Next, Pear Therapeutics is planning to begin distributing the application to patients and clinicians over the next few months.

~ G. Nathalee Serrels, M.A., Psychology

References

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm576087.htm

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