In December 2018, the FDA announced its approval of reSET-O, a new mobile medical app marketed by Pear Therapeutics to treat opioid use disorder (OUD). Mobile medical apps (MMAs) are a rapidly expanding class of smartphone apps intended to improve patient health and wellness. The FDA defines MMAs as software programs that run on smartphones and “transform a mobile platform into a regulated medical device.” A related term used in marketing MMAs is “prescription digital therapeutics.”

Rather than being a stand-alone treatment, reSET-O is touted as a “training, monitoring, and reminder tool” for use as an adjunct to traditional outpatient OUD treatment programs. It can be downloaded directly to a patient’s mobile device, but unlike most apps it requires a prescription to unlock and use. Cost information is not available, but the app is reportedly covered by some insurance plans.

reSET-O incorporates several functions. At its most basic, it provides text- or audio-based cognitive behavioral therapy lessons based on the community reinforcement model (this is the broad behavioral approach that involves analyzing the function of drugs in the person’s life, identifying triggers, and replacing substance use with healthy lifestyle rewards). It also has the capability to transmit self-reported cravings, triggers, and medication adherence data to clinicians. The app’s most novel feature may be its use of a “compliance reward system.” For example, patients can earn “special icons on a prize wheel within the app,” presumably through self-reported adherence to outpatient treatment.

Although the reSET CONNECT website states the device is intended to increase abstinence, reSET-O has not been shown to improve abstinence or reduce overdose deaths in patients with OUD. Instead, its claim to fame—and its FDA approval—is based on a multi-site, non-blinded trial of 170 participants who received supervised buprenorphine treatment and behavioral therapy either with or without reSET-O.

At the end of the 12-week trial, patients who used reSET-O had an 82.4% retention rate compared with 68.4% in the non-reSET-O group. The difference was statistically significant. However, it’s worth noting that reSET-O was administered through desktop computers in this study. It’s a big experiential leap from a desktop computer in a research facility to a handheld device in the community, and it’s not clear whether the smartphone app will provide the same behavioral reinforcement that research participants experienced.

According to the Pear Therapeutics website, rather than taking medication, patients “are treated with software.” This isn’t quite true, since the app was designed as a complement rather than a substitute for opioid agonist treatment. Regardless, many questions remain about whether this “treatment” will help patients accomplish real-life goals. In an age of smartphone apps that collect and sell personal data for marketing purposes, some patients might have privacy concerns as well.

Since reSET-O is an app, consumer ratings will play a role in determining its value to consumers. As of this writing, there are only four ratings for reSET-O on the iPhone App Store—one 5-star rating and three 1-star ratings. Skeptics can take solace, however, that the app has no known side effects.