232454 Main study findings from a multi-site CTN trial of OROS-MPH + CBT in adolescents with ADHD and SUD

Tuesday, November 9, 2010

Paula Riggs, MD , University of Colorado Denver, Aurora, CO
Theresa Winhusen, PhD , University of Cincinnati/CinARC, Cincinnati, OH
Jeff Leimberger, PhD , Duke Clinical Research Institute (DCRI), Durham, NC
David Liu, MD , Center for the Clinical Trials Network, National Institute on Drug Abuse, Bethesda, MD
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.

Learning Areas:
Other professions or practice related to public health
Social and behavioral sciences

Learning Objectives:
Results of a multisite trial OROS-MPH + CBT in adolescents with ADHD and SUD showed good safety and tolerability for OROS-MPH despite non-abstinence. Results were mixed but overall suggested some added benefit of OROS-MPH vs placebo as well as the possible contribution of CBT to both ADHD and substance outcomes.

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I am qualified to give this presentation on this material because I was the Lead Investigator for the multi-site CTN trial. As LI/Principal Investigator, I was responsible for overseeing all aspects of protocol implementation, fidelity and safety monitoring; data collection and validity checks; all primary and secondary analyses and publications/abstracts submitted
Any relevant financial relationships? Yes

Name of Organization Clinical/Research Area Type of relationship
McNeil Medication research trial Provided study medication and matching placebo for the CTN 0028 trial

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.