December 9, 2018

FDA Approves First Prescription App for Opioid Use Disorder

The FDA has approved a mobile medical application to help increase retention in outpatient treatment programs for individuals with opioid use disorder (OUD).

The reSET-O app is a prescription cognitive behavioral therapy intended to be used in addition to outpatient treatment under the care of a health care professional, in conjunction with treatment that includes buprenorphine. The app must also be part of contingency management, a behavior modification intervention that establishes a connection between new, targeted behavior and the opportunity to obtain a desired reward.

The reSET-O app can be downloaded to a patient’s mobile device after they receive a prescription from their doctor, serving as a training, monitoring, and reminder tool for providers and patients to maintain treatment. It includes a compliance reward system, such as earning special icons on a prize wheel within the app.

The FDA reviewed a multi-site, unblinded, controlled 12-week clinical trial of 170 patients who received buprenorphine treatment and behavior therapy; patients were divided into groups that either did or did not use a desktop version of the reSET-O available at a clinic. Urine drug screenings were conducted three times weekly, and the reSET-O did not demonstrate reduced illicit drug use, but the reSET-O group did show a higher level of retention in the program at 82.4% compared to the group that did not use reSET-O, which had a 68.4% retention rate.

The reSET-O app is not intended to be used as a stand-alone therapy, as a substitute for medication, or for patients whose primary language is not English.

For more information, read the FDA News Release.

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