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Cited by 124Attention Deficit Hyperactivity DisorderSubstance Abuse Treatment and OutcomesSchizophrenia research and treatment

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

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Riggs, Paula D., Winhusen, Theresa, Davies, Robert D., Leimberger, Jeffrey D., Mikulich-Gilbertson, Susan, Klein, Constance, Macdonald, Marilyn, Lohman, Michelle +18 more·2011·Journal of the American Academy of Child & Adolescent Psychiatry
DOI 10.1016/j.jaac.2011.06.010PMC PMC3164797
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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.

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  • The results of the reviewed randomized trials in adolescents with concurrent ADHD and SUD were equivocal, with contradictory findings between primary and secondary outcome measures for ADHD and SUD, overall negative findings for both ADHD and SUD, and a small sample size.

    “Concerning pharmacotherapy, the results of the reviewed randomized trials in adolescents with concurrent ADHD and SUD were equivocal, with contradictory findings between the primary and secondary outcome measures pertaining to ADHD [37,38] and SUD [37], overall negative findings for both ADHD and SUD [39], and a small sample size [36].”

    From Treatment of Adolescents with Concurrent Substance Use Disorder and Attention-Deficit/Hyperactivity Disorder: A Systematic Review (2021) · cites this paper as [37]

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  • Adverse pharmacological interactions between study medication and same-day substance use were reported only in Riggs et al. (2011), by four (2.8%) OROS-MPH and three (2.1%) placebo patients.

    “Adverse pharmacological interactions between the study medication and the adolescent’s substance use at the same day were only reported in the trial of Riggs et al. (2011) [37], and only by four (2.8%) and three (2.1%) of the patients taking OROS-MPH and placebo, respectively.”

    From Treatment of Adolescents with Concurrent Substance Use Disorder and Attention-Deficit/Hyperactivity Disorder: A Systematic Review (2021) · cites this paper as [37]

    The Results section (Medication Tolerability, Safety, Adverse Events) gives the stated counts and percentages for OROS-MPH and placebo, but describes the interactions as *possible* adverse interactions reported by participants, not established pharmacological interactions. This paper also cannot establish the citing document’s cross-trial assertion that such interactions were reported only in Riggs et al. (LLM, conf=0.85)

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  • In Riggs et al. (2011), parent-reported ADHD symptoms at week 8 (p = 0.02) and week 16 (p < 0.001) and the number of negative urine drug screens (p = 0.05) favored OROS-MPH.

    “However, some secondary outcomes, including parent-reported ADHD symptoms at week 8 (p = 0.02) and week 16 (p < 0.001) and the number of negative urine drug screens (p = 0.05) favored OROS-MPH”

    From Treatment of Adolescents with Concurrent Substance Use Disorder and Attention-Deficit/Hyperactivity Disorder: A Systematic Review (2021) · cites this paper as [37]

  • Riggs et al. (2011) found significant baseline-to-endpoint reductions in self-reported ADHD symptoms and self-reported number of substance use days in both OROS-MPH and placebo groups, but no between-group difference on either measure.

    “On the primary outcome measures, they found significant baseline to endpoint reductions in self-reported ADHD symptoms and self-reported number of substance use days in both treatment groups, but no between-group difference on either measure.”

    From Treatment of Adolescents with Concurrent Substance Use Disorder and Attention-Deficit/Hyperactivity Disorder: A Systematic Review (2021) · cites this paper as [37]

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Authors
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., Fishman, M., Holmes, B. W., Kaye, M. E., Vargo, M. A., Woody, G. E., Nunes, E. V., & Liu, D.
Affiliations
  • University of Colorado Denver (US)
  • University of Cincinnati (US)
  • Duke Clinical Research Institute (US)
  • Brown University (US)
  • Medical University of South Carolina (US)
  • Harvard University (US)
  • Operation PAR (US)
  • Gateway Community Services (United States) (US)
  • National Development and Research Institutes (US)
  • University of Pennsylvania (US)
  • National Institutes of Health (US)
  • Johns Hopkins University (US)
  • Lexington Richland Alcohol And Drug Abuse Council (US)
  • University of Pittsburgh (US)
  • New York State Psychiatric Institute (US)
  • National Institute on Drug Abuse (US)
Corresponding author
Riggs, Paula D.
ORCID
Venue
Journal of the American Academy of Child & Adolescent Psychiatry
Publisher
Elsevier BV
Published
2011-09
Volume
50
Issue
9
Pages
903-914
ISSN
0890-8567 (ISSN-L)
DOI
10.1016/j.jaac.2011.06.010
PMC
PMC3164797
OpenAlex
W1968499680
Cited by
124
References
45
Citations by year
2026: 3 · 2025: 5 · 2024: 11 · 2023: 6 · 2022: 7 · 2021: 9 · 2020: 15 · 2019: 6 · 2018: 9 · 2017: 9 · 2016: 5 · 2015: 11 · 2014: 13 · 2013: 3 · 2012: 9
FWCI
6.13
Type
journal article
Language
en
Open access
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Journal of the American Academy of Child & Adolescent Psychiatry (publishedVersion)
  • PubMed (publishedVersion)
  • Europe PMC (PubMed Central) (acceptedVersion)
  • PubMed Central (acceptedVersion)
Funders
  • National Institutes of Health (5u10da020036-10, 5u10da013034-15, 5u10da013043-15)
  • National Institute on Drug Abuse (U10-DA13716, U10DA013720, U10-DA-013043, U10DA013035, U10-DA-13727, U10DA13043, K24DA022412, U10 DA20024, U10 DA13035, U10-DA013034, U10DA013732, U10DA013716, U10DA020024, U10-DA020036, U10 DA13034, R01DA022284, U10DA 13720, U10-DA13732, U10DA013727, U10DA015831, U10DA20036, U10-DA15831, K12DA000357)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
  • Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
  • Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
Keywords
cognitive behavioral therapy, substance use disorders, attention deficit hyperactivity disorder, adolescents, co-occurring disorders, ADHD symptom severity, urine drug testing, stimulant medication, placebo comparison, medication adherence
MeSH terms
Adolescent, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Combined Modality Therapy, Delayed-Action Preparations, Female, Humans, Male, Methylphenidate, Placebos, Cognitive Behavioral Therapy, Treatment Outcome, Substance-Related Disorders

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