Safety and efficacy of a digital therapeutic for substance use disorder: secondary analysis of data from a NIDA Clinical Trials Network Study.
Traditional treatments for substance use disorders (SUDs) rely heavily on face-to-face interactions, which pose substantial limitations for patients. A clinical trial of a digital therapeutic (DT) delivering behavioral therapy demonstrated safety and efficacy in a population including patients with opioid use disorder (OUD) not treatment with buprenorphine, which is not a guideline-recommended approach. This study re-analyzed the data excluding patients with OUD to more closely approximate real-world patient populations.
The study was a secondary analysis of data from CTN-0044 (“Web-Delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders;” n=399 after patients with OUD were excluded). Patients received 12 weeks of outpatient treatment-as-usual (TAU; n=193) or TAU with reduced counseling plus a digital therapeutic (DT; n=206) providing computerized cognitive behavioral therapy and contingency management (the reSET, a commercial version of the Therapeutic Education System (TES)). Primary outcomes were abstinence in weeks 9-12 and retention in treatment.
The 399 patients in the analysis (206 in the DT group and 193 in the TAU group) reported substance use disorders related to alcohol, cannabis, cocaine, or other stimulants (e.g. methamphetamine). Demographic and baseline characteristics including age, sex, race, education, and reported primary substance use disorder were balanced between treatment groups. Abstinence was significantly higher in the DT group compared to the TAU group (40.3 vs. 17.6%), as was retention in therapy (76.2 vs. 63.2%).
Conclusions: These results demonstrate that use of a digital therapeutic safely increased abstinence (reduced substance use) and retention in treatment among patients with substance use disorders related to alcohol, cannabis, cocaine, or other stimulants (including methamphetamines).
Related protocols: CTN-0044