title: Randomized controlled trial of osmotic-release methylphenidate with cognitive-behavioral therapy in adolescents with attention-deficit/hyperactivity disorder and substance use disorders.
abstract: OBJECTIVE
  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).
  
  
  METHODS
  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.
authors.affiliation: University of Colorado-Denver, Aurora, CO 80045, USA. paula.riggs@ucdenver.edu
authors.forename: Paula D
authors.initials: PD
authors.lastname: Riggs
authors.forename: Theresa
authors.initials: T
authors.lastname: Winhusen
authors.forename: Robert D
authors.initials: RD
authors.lastname: Davies
authors.forename: Jeffrey D
authors.initials: JD
authors.lastname: Leimberger
authors.forename: Susan
authors.initials: S
authors.lastname: Mikulich-Gilbertson
authors.forename: Constance
authors.initials: C
authors.lastname: Klein
authors.forename: Marilyn
authors.initials: M
authors.lastname: Macdonald
authors.forename: Michelle
authors.initials: M
authors.lastname: Lohman
authors.forename: Genie L
authors.initials: GL
authors.lastname: Bailey
authors.forename: Louise
authors.initials: L
authors.lastname: Haynes
authors.forename: William B
authors.initials: WB
authors.lastname: Jaffee
authors.forename: Nancy
authors.initials: N
authors.lastname: Haminton
authors.forename: Candace
authors.initials: C
authors.lastname: Hodgkins
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Whitmore
authors.forename: Kathlene
authors.initials: K
authors.lastname: Trello-Rishel
authors.forename: Leanne
authors.initials: L
authors.lastname: Tamm
authors.forename: Michelle C
authors.initials: MC
authors.lastname: Acosta
authors.forename: Charlotte
authors.initials: C
authors.lastname: Royer-Malvestuto
authors.forename: Geetha
authors.initials: G
authors.lastname: Subramaniam
authors.forename: Marc
authors.initials: M
authors.lastname: Fishman
authors.forename: Beverly W
authors.initials: BW
authors.lastname: Holmes
authors.forename: Mary Elyse
authors.initials: ME
authors.lastname: Kaye
authors.forename: Mark A
authors.initials: MA
authors.lastname: Vargo
authors.forename: George E
authors.initials: GE
authors.lastname: Woody
authors.forename: Edward V
authors.initials: EV
authors.lastname: Nunes
authors.forename: David
authors.initials: D
authors.lastname: Liu
mesh_terms: D000293:Adolescent; D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015928:Cognitive Behavioral Therapy; D003131:Combined Modality Therapy; D003692:Delayed-Action Preparations / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D019966:Substance-Related Disorders / Q000175:diagnosis / Q000628:therapy*; D016896:Treatment Outcome
chemical_list: D000697:Central Nervous System Stimulants; D003692:Delayed-Action Preparations; D010919:Placebos; D008774:Methylphenidate