There are lots of apps out there that claim to help consumers lose weight, improve their fitness levels and monitor their vital signs but few have won approval from the U.S. Food and Drug Administration, which today approved reSET, an app that is intended to be used with outpatient therapy to treat alcohol, cocaine, marijuana and stimulant substance abuse disorders (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.”
reSET, from Pear Therapeutics, is an app that contains both a patient application and a clinician dashboard. The device delivers cognitive behavioral therapy that is supposed to help patients learn the skills they need to abstain from substance abuse and remain active in outpatient therapy programs.
The FDA reviewed data from a multi-site, unblinded 12-week clinical trial of 399 patients who received either standard treatment or standard treatment with the addition of a desktop-based version of reSET which could be accessed at the clinic or at home. The data showed a statistically significant increase in adherence to abstinence for the patients with alcohol, cocaine, marijuana and stimulant SUD in those who used the app, 40.3 percent, compared to the patients who did not, 17.6 percent. The clinical trial did not demonstrate the effectiveness of using the app in patients reporting opioids as their substance of abuse.
reSET 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, the FDA said.
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.