The Reset mobile medical application system is indicated for alcohol, cocaine, marijuana and stimulant SUDs, but not for treatment of opioid dependence.
Designed to be used in conjunction with outpatient therapy and a contingency management system commonly used to treat SUDs, the Reset features a patient application and clinician dashboard.
The device provides cognitive behavioural therapy to patients by teaching skills that help to enhance abstinence from substance abuse and elevate retention of outpatient therapy programmes.
FDA Centre for Devices and Radiological Health Neurological and Physical Medicine Devices division director Carlos Peña said: “This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment.
“More therapy tools mean a greater potential to help improve outcomes, including abstinence, for patients with substance use disorder.”
The FDA permit is based on the data obtained during a multi-centre, unblinded 12-week clinical trial performed in 399 subjects who received standard treatment in combination with the desktop-based version of Reset or standard treatment alone.
Results indicated a statistically significant increase of 40.3% in adherence to abstinence for the patients who used Reset, compared to 17.6% in the standard treatment group.
The Reset device is indicated as a prescription-only adjunct treatment for SUD patients who are not currently on opioid replacement therapy, and for people who do not solely abuse alcohol or opioids.