Randomized controlled trial of osmotic-release methylphenidate with cognitive-behavioral therapy in adolescents with attention-deficit/hyperactivity disorder and substance use disorders

Paula D. Riggs, Theresa Winhusen, Robert D. Davies, Jeffrey D. Leimberger, Susan Mikulich-Gilbertson, Constance Klein, Marilyn Macdonald, Michelle Lohman, Genie L. Bailey, Louise Haynes, William B. Jaffee, Nancy Haminton, Candace Hodgkins, Elizabeth Whitmore, Kathlene Trello-Rishel, Leanne Tamm, Michelle C. Acosta, Charlotte Royer-Malvestuto, Geetha Subramaniam, Marc FishmanBeverly W. Holmes, Mary Elyse Kaye, Mark A. Vargo, George E. Woody, Edward V. Nunes, David Liu

Research output: Contribution to journalArticle

62 Scopus citations

Abstract

Objective: To evaluate the efficacy and safety of osmotic-release methylphenidate (OROSMPH) compared with placebo for attention-deficit/ hyperactivity disorder (ADHD), and the impact on substance treatment outcomes in adolescents concurrently receiving cognitivebehavioral therapy (CBT) for substance use disorders (SUD). Method: This was a 16-week, randomized, controlled, multi-site trial of OROS-MPH + CBT versus placebo + CBT in 303 adolescents (aged 13 through 18 years) 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 (UDS). Results: There were no group differences on reduction in ADHD-RS scores (OROS-MPH: -19.2, 95% confidence interval [CI], -17.1 to -21.2; placebo, -21.2, 95% CI, -19.1 to -23.2) or reduction in days of substance use (OROS-MPH: -5.7 days, 95% CI, 4.0-7.4; placebo: -5.2 days, 95% CI, 3.5-7.0). Some secondary outcomes favored OROS-MPH, including lower parent ADHD-RS scores at 8 (mean difference = 4.4, 95% CI, 0.8-7.9) and 16 weeks (mean difference =6.9; 95% CI, 2.9-10.9) and more negative UDS in OROS-MPH (mean = 3.8) compared with placebo (mean = 2.8; p =.04). 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. Clinical Trial Registration Information-Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents with Substance Use Disorders (SUD); http://www.clinicaltrials.gov; NCT00264797.

Original languageEnglish (US)
Pages (from-to)903-914
Number of pages12
JournalJournal of the American Academy of Child and Adolescent Psychiatry
Volume50
Issue number9
DOIs
StatePublished - Sep 2011

Keywords

  • ADHD
  • Osmotic-release methylphenidate
  • Randomized controlled trial
  • Substance use disorders

ASJC Scopus subject areas

  • Developmental and Educational Psychology
  • Psychiatry and Mental health

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    Riggs, P. D., Winhusen, T., Davies, R. D., Leimberger, J. D., Mikulich-Gilbertson, S., Klein, C., Macdonald, M., Lohman, M., Bailey, G. L., Haynes, L., Jaffee, W. B., Haminton, N., Hodgkins, C., Whitmore, E., Trello-Rishel, K., Tamm, L., Acosta, M. C., Royer-Malvestuto, C., Subramaniam, G., ... Liu, D. (2011). Randomized controlled trial of osmotic-release methylphenidate with cognitive-behavioral therapy in adolescents with attention-deficit/hyperactivity disorder and substance use disorders. Journal of the American Academy of Child and Adolescent Psychiatry, 50(9), 903-914. https://doi.org/10.1016/j.jaac.2011.06.010