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US regulators have approved the first mobile medical application for substance use disorders involving alcohol, cocaine, marijuana and stimulants.
Pear Therapeutics’ Reset app offers cognitive behavioural therapy and is designed to be used alongside outpatient therapy and a widely-used SUD contingency management programme.
Reset works by teaching users skills to increase their abstinence from substance abuse and keep them in outpatient therapy programmes.
The FDA’s approval came on the back of a 12-week clinical trial involving 399 patients on either standard treatment or standard treatment plus a desktop version of Reset.
It showed a statistically significant increase (40.3% vs 17.6%) in adherence to abstinence for patients with alcohol, cocaine, marijuana and stimulant SUD who used Reset.
The trial did not demonstrate the effectiveness of using Reset for opioid abuse and the application is not licensed to treat opioid dependence.
Via Pharma Guy
When I first saw this story, I thought this app also helped patients who are addicted to opioids. I wonder if anything could solve that problem!
The FDA’s approval came on the back of a 12-week clinical trial involving 399 patients on either standard treatment or standard treatment plus a desktop version of Reset. It showed a statistically significant increase (40.3% vs 17.6%) in adherence to abstinence for patients with alcohol, cocaine, marijuana and stimulant SUD who used Reset. The trial did not demonstrate the effectiveness of using Reset for opioid abuse and the application is not licensed to treat opioid dependence. Carlos Peña, director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said: “This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment. “More therapy tools means a greater potential to help improve outcomes, including abstinence, for patients with substance use disorder.” Reset contains a patient application and clinician dashboard and is indicated as a prescription-only adjunct treatment for patients with SUD who are not currently on opioid replacement therapy, do not abuse alcohol solely or whose primary substance of abuse is not opioids. However, Pear’s development pipeline does include a version of the app specifically for opioid use disorder, alongside devices for use in areas such as schizophrenia, pain and major depressive disorder.