FDA permits marketing of mobile medical application for substance use disorder

US Food and Drug Administration – Today, the U.S. Food and Drug Administration permitted marketing of the first mobile medical application to help treat substance use disorders (SUD). The Reset application is intended to be used with outpatient therapy to treat alcohol, cocaine, marijuana and stimulant SUDs. The application is not intended to be used to treat opioid dependence.

“This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment,” said Carlos Peña, Ph.D., M.S., director of the Division of Neurological and Physical Medicine Devices in FDA’s Center for Devices and Radiological Health. “More therapy tools means a greater potential to help improve outcomes, including abstinence, for patients with substance use disorder.”

According to the Substance Abuse and Mental Health Services Administration, SUD occurs when an individual’s recurrent use of alcohol and/or drugs causes clinically and functionally significant impairment, such as health problems, disability, and failure to meet major responsibilities at work, school or home. According to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, a diagnosis of substance use disorder is based on evidence of impaired control, social impairment, risky use and pharmacological criteria.

The Reset device is a mobile medical application system containing a patient application and clinician dashboard. The device delivers cognitive behavioral therapy to patients to teach the user skills that aid in the treatment of SUD and are intended to increase abstinence from substance abuse and increase retention in outpatient therapy programs. The system is intended to be used in conjunction with outpatient therapy and in addition to a contingency management system, a widely-used program for treating SUD that uses a series of incentives to reward patients for adherence to their treatment program.

Read more at US Food and Drug Administration.

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