Home > ASME Articles > Smartphone-Based Intervention from CTN-0044 Approved by the FDA for Marketing
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: http://ctndisseminationlibrary.org/protocols/ctn0044.htm