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

56 Citations (Scopus)

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

Fingerprint

Methylphenidate
Cognitive Therapy
Attention Deficit Disorder with Hyperactivity
Substance-Related Disorders
Randomized Controlled Trials
Placebos
Confidence Intervals
Outcome Assessment (Health Care)
Urine
Therapeutics
5,10-dihydro-5-methylphenazine
Diagnostic and Statistical Manual of Mental Disorders
Pharmaceutical Preparations
Clinical Trials
Safety

Keywords

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

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Developmental and Educational Psychology

Cite this

Randomized controlled trial of osmotic-release methylphenidate with cognitive-behavioral therapy in adolescents with attention-deficit/hyperactivity disorder and substance use disorders. / Riggs, Paula D.; Winhusen, Theresa; Davies, Robert D.; Leimberger, Jeffrey D.; Mikulich-Gilbertson, Susan; Klein, Constance; Macdonald, Marilyn; Lohman, Michelle; Bailey, Genie L.; Haynes, Louise; Jaffee, William B.; Haminton, Nancy; Hodgkins, Candace; Whitmore, Elizabeth; Trello-Rishel, Kathlene; Tamm, Leanne; Acosta, Michelle C.; Royer-Malvestuto, Charlotte; Subramaniam, Geetha; Fishman, Marc; Holmes, Beverly W.; Kaye, Mary Elyse; Vargo, Mark A.; Woody, George E.; Nunes, Edward V.; Liu, David.

In: Journal of the American Academy of Child and Adolescent Psychiatry, Vol. 50, No. 9, 09.2011, p. 903-914.

Research output: Contribution to journalArticle

Riggs, PD, Winhusen, T, Davies, RD, Leimberger, JD, Mikulich-Gilbertson, S, Klein, C, Macdonald, M, Lohman, M, Bailey, GL, Haynes, L, Jaffee, WB, Haminton, N, Hodgkins, C, Whitmore, E, Trello-Rishel, K, Tamm, L, Acosta, MC, Royer-Malvestuto, C, Subramaniam, G, Fishman, M, Holmes, BW, Kaye, ME, Vargo, MA, Woody, GE, Nunes, EV & 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, vol. 50, no. 9, pp. 903-914. https://doi.org/10.1016/j.jaac.2011.06.010
Riggs, Paula D. ; Winhusen, Theresa ; Davies, Robert D. ; Leimberger, Jeffrey D. ; Mikulich-Gilbertson, Susan ; Klein, Constance ; Macdonald, Marilyn ; Lohman, Michelle ; Bailey, Genie L. ; Haynes, Louise ; Jaffee, William B. ; Haminton, Nancy ; Hodgkins, Candace ; Whitmore, Elizabeth ; Trello-Rishel, Kathlene ; Tamm, Leanne ; Acosta, Michelle C. ; Royer-Malvestuto, Charlotte ; Subramaniam, Geetha ; Fishman, Marc ; Holmes, Beverly W. ; Kaye, Mary Elyse ; Vargo, Mark A. ; Woody, George E. ; Nunes, Edward V. ; Liu, David. / Randomized controlled trial of osmotic-release methylphenidate with cognitive-behavioral therapy in adolescents with attention-deficit/hyperactivity disorder and substance use disorders. In: Journal of the American Academy of Child and Adolescent Psychiatry. 2011 ; Vol. 50, No. 9. pp. 903-914.
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T1 - Randomized controlled trial of osmotic-release methylphenidate with cognitive-behavioral therapy in adolescents with attention-deficit/hyperactivity disorder and substance use disorders

AU - Riggs, Paula D.

AU - Winhusen, Theresa

AU - Davies, Robert D.

AU - Leimberger, Jeffrey D.

AU - Mikulich-Gilbertson, Susan

AU - Klein, Constance

AU - Macdonald, Marilyn

AU - Lohman, Michelle

AU - Bailey, Genie L.

AU - Haynes, Louise

AU - Jaffee, William B.

AU - Haminton, Nancy

AU - Hodgkins, Candace

AU - Whitmore, Elizabeth

AU - Trello-Rishel, Kathlene

AU - Tamm, Leanne

AU - Acosta, Michelle C.

AU - Royer-Malvestuto, Charlotte

AU - Subramaniam, Geetha

AU - Fishman, Marc

AU - Holmes, Beverly W.

AU - Kaye, Mary Elyse

AU - Vargo, Mark A.

AU - Woody, George E.

AU - Nunes, Edward V.

AU - Liu, David

PY - 2011/9

Y1 - 2011/9

N2 - 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.

AB - 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.

KW - ADHD

KW - Osmotic-release methylphenidate

KW - Randomized controlled trial

KW - Substance use disorders

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