TY - JOUR
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
N1 - Funding Information:
Disclosure: Dr. Bailey has received research support from the National Institute of Drug Abuse (NIDA), Titan Pharmaceuticals, Inc., and Alkermes, Inc. Dr. Trello-Rishel has served on the speakers' bureau for Shire. Dr. Woody is a member of the RADARS System post-marketing study external advisory group, which is administered by Denver Health, and supported by pharmaceutical companies. He has served as a consultant for Alkermes. Drs. Riggs, Winhusen, Davies, Leimberger, Mikulich-Gilbertson, Jaffee, Hodgkins, Whitmore, Tamm, Acosta, Royer-Malvestuto, Subramaniam, Fishman, Vargo, Nunes, and Liu, and Ms. Klein, Ms. Macdonald, Ms. Lohnman, Ms. Haynes, Ms. Hamilton, Ms. Holmes, and Ms. Kaye report no biomedical financial interests or potential conflicts of interest.
Funding Information:
The project described was supported by the following grants from the National Institute on Drug Abuse (NIDA): U10 DA13716 (P.D.R., R.D.D., S.M.G., C.K., M.M., M.L., E.W.); U10 DA13732 (P.D.R., T.W., R.D.D., S.M.G., C.K., M.M., M.L., E.W.); U10 DA15831 (G.L.B., W.B.J.); U10 DA13727 (L.H., B.W.H.); U10 DA13720 (N.H., C.H., M.A.V.); U10 DA20024 (K.T.R., L.T.); U10 DA13035 (E.V.N., M.C.A.); K24 DA022412 (E.V.N.); U10 DA13043 (C.R.M., G.E.W.); U10 DA13034 (G.S., M.F.); K12 DA000357 (G.S.); and U10 DA20036 (M.E.K.). Drug and matching placebo were provided by Ortho McNeil Janssen Scientific Affairs, LLC.
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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U2 - 10.1016/j.jaac.2011.06.010
DO - 10.1016/j.jaac.2011.06.010
M3 - Article
C2 - 21871372
AN - SCOPUS:84855416151
SN - 0890-8567
VL - 50
SP - 903
EP - 914
JO - Journal of the American Academy of Child and Adolescent Psychiatry
JF - Journal of the American Academy of Child and Adolescent Psychiatry
IS - 9
ER -