A randomized controlled trial of OROS-MPH + CBT in adolescents with ADHD and substance use disorders: Implications for clinical practice and study design.

This presentation provides an overview of protocol CTN-0028, which had three study aims: 1) to evaluate the efficacy of osmotic-release methylphenidate (OROS-MPH) vs. placebo in adolescents with ADHD, 2) to evaluate the impact of OROS-MPH plus cognitive behavioral therapy (CBT) vs. placebo plus CBT on substance abuse outcomes in this population, and 3) to evaluate the overall safety, tolerability, and abuse potential of OROS-MPH. The main study findings are presented, in terms of both ADHD outcomes and substance abuse outcomes, which found the OROS-MPH was safe and well-tolerated, ADHD outcomes were as good or better for the study group than they were for adolescents without substance use disorder, and that the contribution of CBT to both SUD and ADHD outcomes was beneficial for adolescents.

The presentation ends with a discussion of the implications of both the design and outcomes of this study on future research. For example, the results suggest that ADHD clinical response may be important to substance abuse outcomes, and that in the context of CBT (for substance use disorders), significant reduction in ADHD symptoms may occur with or without pharmacotherapy. The study also demonstrated the feasibility of recruitment and enrollment, as well as high compliance, with the difficult-to-recruit population of adolescents with co-occurring disorders.

Related protocols: CTN-0028