FDA approves first app for substance abuse disorders

The US Food and Drug Administration has approved a mobile app for therapeutic purposes for the first time.

Someone using mobile phone

The US Food and Drug Administration (FDA) has approved a mobile app for therapeutic purposes for the first time.

The reSET app is a cognitive behavioural therapy-based tool intended to help those with substance use disorders remain abstinent and engaged with their outpatient therapy. It is approved for use in alcohol, cocaine, marijuana and stimulant substance use disorders.

“This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment,” said Carlos Peña, from the 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.”

The app is modular and teaches patients skills for achieving and maintaining abstinence. It also allows the patient’s medical provider to access data on self-reported substance use, triggers, cravings and outcomes.

The app is not intended as a stand-alone treatment, but to be used alongside outpatient therapy and a contingency management system that incentivises and rewards patients for their adherence to their treatment plan.

reSET’s creators, a startup called Pear Therapeutics, conducted a randomised trial of a desktop-based version of their app involving 399 people with substance use disorders. They showed that 40.3% of those who used reSET alongside standard face-to-face counselling were abstinent at 12 weeks compared with 17.6% of those who received standard counselling alone.

The company said it plans to trial a version of the software for opioid addiction, and are also working on products for use in schizophrenia, combatting post-traumatic stress disorder and generalised anxiety disorder.

Last updated
The Pharmaceutical Journal, FDA approves first app for substance abuse disorders;Online:DOI:10.1211/PJ.2017.20203600

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