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

Adolescents with substance use disorders (SUDs) have a higher prevalence of ADHD (30%-50%) compared to adolescents in the general population (5%-10%), but little is known about the safety and efficacy of pharmacotherapy for ADHD in adolescents with co-occurring disorders. Clinicians are reluctant to prescribe medications for ADHD in substance-involved adolescents due to their exclusion from pharmacotherapy trials, commonly first referring them for substance treatment. A number of studies have shown that such youths have poorer treatment outcomes. The researchers could find no previous controlled trials evaluating the impact of psychostimulant treatment on both ADHD and substance treatment outcomes in comorbid adolescents concurrently enrolled in substance treatment.

This study, protocol CTN-0028, was a randomized controlled multisite trial of OROS-MPH + CBT vs placebo + CBT. It found that, overall, OROS-MPH was well-tolerated, had low abuse liability, and had a good safety profile despite non-abstinence. There was no difference between OROS-MPH and placebo on primary ADHD and substance outcome measures. However, secondary measures suggested some added benefit of OROS-methylphenidate (OROS-MPH) compared to placebo based on lower parent-rated DSM-IV ADHD-RS scores at 8 and 16 weeks. Greater than expected reduction in ADHD symptoms in both groups suggests that CBT may have contributed to ADHD response consistent with findings from adult studies. However, if ADHD does not respond to CBT early in treatment, OROS-MPH may be considered, even in youths who have not yet achieved abstinence.

Related protocols: CTN-0028