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FDA Clears First Mobile App for Substance Abuse

White smartphone

(kote baeza, Pexels.com)

15 September 2017. A smartphone app designed to help treat substance abuse disorders received approval from the U.S. Food and Drug Administration. FDA approved the reSet app, created by Pear Therapeutics, for use in outpatient therapy prescribed for individuals abusing alcohol, cocaine, marijuana, and stimulants. The agency says it’s the first app cleared for substance abuse disorders.

These conditions, as defined by the Substance Abuse and Mental Health Services Administration, occur when individuals face significant clinical or functional impairment from recurrent use of alcohol or drugs, such as health problems or disability, as well as failure to meet home, work, or school responsibilities. Substance abuse disorders can range from mild to severe, based on evidence of impairment.

Pear Therapeutics, in Boston and San Francisco, designed the reSet mobile app to encourage adherence to medications and support outpatient therapy for substance abuse. The app adapts cognitive behavioral therapy, a form of psychotherapy that seeks to change attitudes and behavior by concentrating on a person’s cognitive processes — thoughts, images, and beliefs — related to that individual’s behavior. Users of the app receive incentives and rewards for sticking with their therapy, while clinicians can track clients’ progress with a dashboard in a desktop software program.

FDA based its approval in part on results from a clinical trial with some 400 individuals with substance use disorder enrolled in a 12-week therapy program. Participants were randomly assigned to receive the standard counseling therapy alone or with an earlier version of the software, known then as Therapeutic Education System. Individuals receiving the electronic assistance had two hours less counseling time than those receiving the standard counseling. The results show participants using the software in their therapy reporting a higher rate of abstinence from drugs and alcohol (40%) than those receiving the standard therapy (18%).

This and other clinical trials did not reveal any adverse side effects from the software. While participants in the trial experienced adverse events associated with substance abuse disorders, such as depression and suicidal thoughts or behavior, they were not associated with the tested software.

FDA, however, did not approve reSet for opioid addiction therapy. Results of the clinical trial show participants abusing opioid drugs were no more likely to be helped by the software than those receiving counseling alone. As reported in Science & Enterprise in July 2017, Pear Therapeutics is developing a separate version of reSet, called reSet-O, designed specifically to help in opioid addiction therapy. The company received a $180,000 Small Business Innovation Research grant from National Institute of Drug Abuse, an agency of NIH, to accelerate its development.

FDA used the agency’s de novo premarket review procedure to clear the reSet app. This process is reserved for new types of low- to moderate-risk medical devices where there are few, if any, earlier equivalent devices.

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