Randomized controlled trial of osmotic-release methylphenidate with CBT in adolescents with ADHD and substance use disorders.

This is the primary outcomes paper for CTN-0028.

National Drug Abuse Treatment Clinical Trials Network protocol CTN-0028 was designed to evaluate the efficacy and safety of osmotic-release methylphenidate (OROS-MPH) compared with placebo for attention-deficit/hyperactivity disorder (ADHD), and the impact on substance treatment outcomes in adolescents concurrently receiving cognitive-behavioral therapy (CBT) for substance use disorders (SUD). The study was a 16-week, randomized controlled multi-site trial of OROS-MPH + CBT versus placebo + CBT in 303 adolescents (aged 13 through 18) meeting DSM-IV diagnostic criteria for ADHD and SUD. Primary outcome measures included the following: for ADHD, clinician-administered ADHD Rating Scale (ADHD-RS), adolescent informant; for substance use, adolescent-reported days of use in the past 28 days. Secondary outcome measures included parent ADHD-RS and weekly urine drug screens. Analysis of the results found no group differences on reduction in ADHD-RS scores or reduction in days of substance use. Some secondary outcomes favored OROS-MPH, including lower parent ADHD-RS scores at 8 and 16 weeks, and more negative urine drug screens in OROS-MPH compared with placebo.

Conclusions: OROS-MPH did not show greater efficacy than placebo for ADHD or on reduction in substance use in adolescents concurrently receiving individual CBT for co-occurring SUD. However, OROS-MPH was relatively well tolerated and was associated with modestly greater clinical improvement on some secondary ADHD and substance outcome measures.