FDA Clears App to Help Retain Patients in Treatment for OUD

The Food and Drug Administration (FDA) in December 2018 cleared for marketing a prescription smartphone application to help individuals being treated for opioid use disorder (OUD) stay in treatment and maintain their motivation to recover.

Modeled on an app cleared by the FDA in 2017 for patients with alcohol, cocaine, marijuana, and stimulant substance use disorders, reSET-O is specifically tailored for patients with OUD. The reSET-O app is intended for use in combination with outpatient psychosocial treatment that also includes treatment with buprenorphine. The app is downloaded directly to a patient’s smartphone after the patient receives a prescription to do so from his or her physician.

“Often on the road to recovery, patients find their commitment to staying in treatment may wane,” said FDA Commissioner Scott Gottlieb, M.D., in a statement. “Providing Americans suffering from opioid use disorder with more options and proper support to address treatment challenges is key to helping them succeed. We know medication-assisted treatment works and we support novel ways to keep individuals more engaged in their treatment programs and to provide clinicians with new ways to intervene to help them remain in treatment.”

According to a statement by Pear Therapeutics, developer of reSET-O, the app is modeled on the Community Reinforcement Approach (CRA)—a psychosocial intervention for individuals with alcohol and other drug use disorders. The focus of CRA is to help individuals find healthier, more adaptive ways to meet their social and emotional needs than using substances by offering rewards for certain kinds of behavior.

The reSET-O app delivers a series of interactive therapy lessons, each of which is composed of a cognitive behavioral–therapy component and skill-building exercises. The FDA said that the app can serve as a training, monitoring, and reminder tool for health care professionals and patients in maintaining treatment and includes a reward system whereby patients can earn special icons on a prize wheel within the app.

The FDA reviewed data from a multisite, unblinded, controlled 12-week clinical trial of 170 patients who received supervised buprenorphine treatment paired with a behavior therapy program, either with or without the addition of a desktop-based version of reSET-O. The data showed a statistically significant increase in retention in a treatment program for 12 weeks for the patients who used the desktop computer version of the reSET-O program compared with those who did not.

The FDA noted that the reSET-O app has not been shown to decrease illicit drug use or improve abstinence in patients with OUD, and that the app is not intended to be used as a stand-alone therapy or as a substitute for medication.

“This is exciting news,” said John Renner, M.D., co-chair of the APA Council on Addiction Psychiatry. “Similar apps have been shown to be helpful for other types of substance use disorders, but there has been relatively little uptake within the treatment community. The challenge will be to encourage providers and patients to incorporate this new technology into their treatment approaches.”

Addiction psychiatrist Stuart Gitlow, M.D., immediate past president of the American Society of Addiction Medicine, agreed. “Digital therapeutics are certainly worth exploring with any patient population facing a chronic life-threatening illness,” he said. “If we can help the patient engage and truly become participatory with respect to their illness on an hourly basis, not just a daily or weekly or monthly basis, the potential for treatment success will undoubtedly rise.”

He added, “As with anything technological, the first out of the box may find itself quickly being replaced by newer alternatives. Pear’s entry here gives all of us a chance to dip our toes in the water possibly to embrace the approach and obtain a win for our patients. What happens next will depend upon Pear’s ability to quickly adapt their software to demonstrate results in the field. Hopefully, such adaptation will be easy to accommodate within the new and developing regulatory system applying to digital therapeutics.”

John Torous, M.D., director of the Division of Digital Psychiatry at Beth Israel Deaconess Medical Center in Boston, told Psychiatric News that it will be important to evaluate how well the app works outside of a structured research environment. Torous is a member of the APA Committee on Mental Health Information Technology and chair of the Smartphone App Evaluation Work Group.

“It is exciting to see digital technology move into the opioid use disorder space,” he said. “Will people actually use it? Will insurance companies pay for it? And will it be any better than what we have today?” ■