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Smartphone-Based Intervention from CTN-0044 Approved by the FDA for Marketing

January 10, 2017
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  • Pear Therapeutics, producer of a number of digital therapeutic tools, announced this month that the FDA has approved their marketing of a smartphone-based tool call “reSET®” for the treatment of patients with substance use disorder (SUD).
  • This is the first time the FDA has cleared a prescription digital therapeutic with claims to improve clinical outcomes in a disease. (Prescription digital therapeutics are clinically validated, FDA-cleared software applications designed to enhance clinical outcomes.)
  • ReSET® is based on the TES intervention evaluated by NIDA Clinical Trials Network protocol CTN-0044, “Web-Delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders,” in which 399 patients with SUD across 10 treatment centers received either treatment-as-usual (standard face-to-face counseling) or a reduced amount of face-to-face counseling plus the digital therapeutic.

    Results found that the digital therapeutic more than doubled the rate of abstinence compared to standard, face-to-face counseling. In a sub-group analysis of non-abstinent patients at study start, a poor prognostic indicator, patients randomized to the digital therapeutic demonstrated an almost five-fold improvement in abstinence.

    “In 2016, an estimated 20.1 million people aged 12 or older needed substance use disorder treatment according to the Substance Abuse and Mental Health Services Administration,” 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. “The clinical outcomes demonstrated in the reSET® pivotal study are remarkable. Clinically-validated digital therapeutics may become a cornerstone of future treatment.”

    reSET® provides cognitive behavioral therapy as an adjunct to a contingency management system for patients 18 years or older who are currently enrolled in outpatient treatment.

    Learn more about the original TES tool and what CTN-0044 discovered about its efficacy here: