Main study findings from a multi-site CTN trial of OROS-MPH + CBT in adolescents with ADHD and SUD

Aims. Main findings will be presented from the first controlled trial of psychostimulant for ADHD in adolescents with co-occurring substance use disorders (SUD) in outpatient substance treatment. Methods. 303 adolescents (ages 13-18) with ADHD and SUD were randomized to OROS-MPH (72mg) or matching placebo. Participants in both groups received weekly, individual CBT as outpatient substance treatment during the 16-week trial. ADHD measures: 1) Adolescent and 2) Parent DSM-IV ADHD symptom checklist ratings 3) Clinician Global Impression-Improvement (CGI-I); SUD measures: 1) Days of self-reported non-tobacco substance use in the past 28 days; and 2) weekly urine drug screens (UDS). Results. There was a significant reduction in ADHD symptoms in both groups (p<0.0001), but no difference between groups based on adolescent ADHD symptom ratings. Parent-rated ADHD symptoms were lower in adolescents treated with OROS-MPH at 8 (p<0.015) and 16 weeks (p<0.002) compared to placebo. Subjects treated with OROS-MPH also had significantly more negative UDS (p < 0.05) and greater improvement in problem-solving ability (p<0.0023) and focused coping skills (p< 0.023) compared to those treated with placebo who did not improve on either measure from baseline. Conclusions. OROS-MPH demonstrated good safety, tolerability and low abuse liability despite non-abstinence in most participants. Results were mixed but overall suggested some added benefit of OROS-MPH + CBT compared to placebo + CBT for ADHD and substance outcomes as well as the possible contribution of CBT to ADHD treatment response.