A randomized controlled trial of OROS-MPH + CBT in adolescents with ADHD and substance use disorders.

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. Results of CTN-0028 were inconsistent with most controlled trials of psychostimulants vs. placebo (alone) for ADHD, but consistent with three controlled psychostimulant trials in adults concurrently receiving weekly individual CBT for substance use disorders. This suggests that in the context of individual CBT (for substance use disorder), significant reductions in ADHD symptoms may occur with or without pharmacotherapy, and that reductions in co-occurring ADHD symptoms may be important in helping adolescents achieve greater abstinence during substance treatment.

Related protocols: CTN-0028