The U.S. Food and Drug Administration (FDA) has just approved the first-ever mobile medical app for drug treatment for those with substance use disorders (SUDs). The reSET sobriety app has the green light to assist in outpatient therapy for alcohol, cocaine, marijuana, and stimulant addiction.
Though there are other addiction recovery apps available, this marks the first time the FDA has permitted the use of a prescription digital therapeutic device to treat the disorder. “This is a defining moment for digital therapeutics and for patients with substance use disorder,” Corey McCann, president and CEO of Pear Therapeutics, said in a press release.
The reSET Sobriety App
The FDA gave the reSET app the go-ahead after reviewing the results from a 12-week clinical trial, where approximately 400 SUD patients were placed in a 12-week therapy program and randomly assigned to receive standard counseling therapy.
Those who received reSET along with their therapy reported a 40 percent higher rate of abstinence, compared to 18 percent for those participants who only used standard therapy. The results also found the app’s users had a “statistically significant increase” in refraining from cocaine, alcohol, marijuana and stimulants, according to the FDA.
“The clinical outcomes demonstrated in the reSET pivotal study are remarkable. Clinically-validated digital therapeutics may become a cornerstone of future treatment,” said Edward V. Nunes, MD, Professor of Psychiatry at Columbia University Medical Center and independent Lead Investigator on the clinical study submitted to the FDA.
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