Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2011 Sep;50(9):903-14.
doi: 10.1016/j.jaac.2011.06.010. Epub 2011 Aug 4.

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  1 , 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 Fishman, Beverly W Holmes, Mary Elyse Kaye, Mark A Vargo, George E Woody, Edward V Nunes, David Liu
Affiliations
Randomized Controlled Trial

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 et al. J Am Acad Child Adolesc Psychiatry. 2011 Sep.

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).

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.

PubMed Disclaimer

Figures

Figure 1
Figure 1. Study Flow Diagram
Note: CBT = cognitive behavioral therapy; OROS = osmotic-release methylphenidate
Figure 2
Figure 2. Change in DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) Scores by Treatment Group
Note: Estimates are derived from the cubic longitudinal model with random subject and linear time effects and serially-correlated residual errors. OROS = osmotic-release methylphenidate.
Figure 3
Figure 3. Change in Past 28 Day Non-Tobacco Drug Use by Treatment Group
Note: Past 28-day drug use trajectories were modeled based on the assumption of normal distribution for the response variable (Intent-to-treat sample; here, N=302, 1 subject did not have valid data for this variable). Estimates were derived from the selected quadratic longitudinal model with random subject and linear time effects. OROS = osmotic-release methylphenidate.
See this image and copyright information in PMC

References

    1. Wilens TE, Gignac M, Swezey A, Monuteaux MC, Biederman J. Characteristics of adolescents and young adults with ADHD who divert or misuse their prescribed medications. J Am Acad Child Adolesc Psychiatry. 2006 Apr;45(4):408–414. - PubMed
    1. Kessler RC, Adler L, Ames M, et al. The prevalence and effects of adult attention deficit/hyperactivity disorder on work performance in a nationally representative sample of workers. J Occup Environ Med. 2005 Jun;47(6):565–572. - PubMed
    1. Katusic SK, Barbaresi WJ, Colligan RC, Weaver AL, Leibson CL, Jacobsen SJ. Psychostimulant treatment and risk for substance abuse among young adults with a history of attention-deficit/hyperactivity disorder: a population-based, birth cohort study. J Child Adolesc Psychopharmacol. 2005 Oct;15(5):764–776. - PubMed
    1. Whitmore EA, Riggs PD. Developmentally informed diagnostic and treatment considerations in comorbid conditions. In: Liddle HA, Rowe CL, editors. Adolescent Substance Abuse: Research and Clinical Advances. Cambridge University Press; Cambridge, U.K.: 2006. pp. 264–283.
    1. Rowe CL, Liddle HA, Greenbaum PE, Henderson CE. Impact of psychiatric comorbidity on treatment of adolescent drug abusers. J Subst Abuse Treat. 2004 Mar;26(2):129–140. - PubMed

Publication types

MeSH terms

Associated data