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Submitted by PatientsEngage on 25 September 2017

In a milestone, the Food and Drug Administration (FDA) approved the first-ever mobile medical app to help treat people with substance use disorders (SUDs). The Reset device is designed by Pear Therapeutics and is now cleared in the US to assist in outpatient therapy for alcohol, cocaine, marijuana, and stimulant addiction—although it is notably not permitted for treating opioid dependence.

So just how does an app assist in addiction therapy?

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.

Clinical studies underscored the digital health technology's promise. More than 40% of patients who used the Reset system in addition to standard therapy abstained from alcohol, cocaine, marijuana, and stimulant substance abuse over a three month period, compared with 17.6% abstinence for those receiving standard therapy alone, according to the FDA. 

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 indicated as a prescription-only adjunct treatment for patients with SUD who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or whose primary substance of abuse is not opioids.

Data from the clinical studies did not indicate any side effects associated with the device. The adverse events evaluated were typical of patients with SUD, including cardiovascular disease, gastrointestinal events, depression, mania, suicidal behavior, suicidal ideation and attempts.

The Reset device was reviewed through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no legally marketed predicate device to which the device can claim substantial equivalence.

For more details, see the FDA announcement here