Tuesday, December 11, 2018

FDA Clears App to Help Retain Patients in Treatment for Opioid Use Disorder

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

Modeled on a similar app cleared by the FDA last year for patients with alcohol, cocaine, marijuana, and stimulant substance use disorders, reSET-O is specifically tailored for patients with opioid use disorder. 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.

According to a statement by Pear Therapeutics, developer of reSET, 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 therapy as 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.

John Torous, M.D. (pictured above), director of the Division of Digital Psychiatry at Beth Israel Deaconess Medical Center in Boston, told Psychiatric News that he is excited to see technology innovations proposed to help patients with opioid use disorder. Torous is also a member of APA’s Committee on Mental Health Information Technology and chair of the Smartphone App Evaluation Work Group.

“As with any new technology, we want to see how well it really works outside of a structured research environment, in the complicated world of real life,” he continued. “Will people actually use it? Will insurance companies pay for it? And will it be any better than what we have today?”

For related information, see the Psychiatric News article “FDA Clears First Prescription-Based ‘Digital Therapeutic’.”

(Image: John Torous, M.D., Beth Israel Deaconess Medical Center)


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