Randomized Controlled Trial of Osmotic-Release Methylphenidate With Cognitive-Behavioral Therapy in Adolescents With Attention-Deficit/Hyperactivity Disorder and Substance Use Disorders - 24/08/11
, Theresa Winhusen, Ph.D. b, Robert D. Davies, M.D. a, Jeffrey D. Leimberger, Ph.D. c, Susan Mikulich-Gilbertson, Ph.D. a, Constance Klein, L.C.S.W. a, Marilyn Macdonald, B.A. a, Michelle Lohman, R.N. a, Genie L. Bailey, M.D. d, Louise Haynes, M.S.W. e, William B. Jaffee, Ph.D. f, Nancy Haminton, MPA p, Candace Hodgkins, Ph.D. g, Elizabeth Whitmore, Ph.D. a, Kathlene Trello-Rishel, M.D. h, Leanne Tamm, Ph.D. h, Michelle C. Acosta, Ph.D. i, Charlotte Royer-Malvestuto, M.Ed. j, Geetha Subramaniam, M.D. k, l, Marc Fishman, M.D. k, m, Beverly W. Holmes, M.S.W. n, Mary Elyse Kaye, B.S.N. o, Mark A. Vargo, Ph.D. p, George E. Woody, M.D. j, Edward V. Nunes, M.D. q, David Liu, M.D. r
Correspondence to Dr. Paula D. Riggs, University of Colorado–Denver, Mail Stop F478, 12469 E. 17th Place, Room 235, Aurora, CO 80045Résumé |
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); www.clinicaltrials.gov; NCT00264797.
Le texte complet de cet article est disponible en PDF.Key Words : osmotic-release methylphenidate, randomized controlled trial, ADHD, substance use disorders
Plan
| 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. |
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| Timothy Wilens, M.D. (Harvard University) provided technical assistance for K-SADS-E training, and with Len Adler, M.D. (New York University) and James Swanson, Ph.D. (University of California–Los Angeles) served as external consultants to the National Intitute of Drug Abuse (NIDA) and the primary investigator (PI)/lead team on the selection of study outcome measures. Jeffery Leimberger, Ph.D. (Duke Clinical Research Institute) and Susan Mikulich-Gilbertson, Ph.D. (University of Colorado–Denver) provided biostatistical expertise. Ashley Kayser, M.A.S. (University of Colorado–Denver) provided expert editorial assistance in preparing the manuscript. Suzell Klein, M.A. (University of Colorado–Denver) and Frankie Kropp, M.S. (University of Cincinnati) provided administrative and training support for implementation. The following persons provided site medical support: Georgia Welnick, R.N, (Lexington/Richland Alcohol and Drug Abuse Council); Himanshu Upadhyaya, M.D. (Medical University of South Carolina); Jill Ridley, R.N. (Synergy Outpatient Services, University of Colorado–Denver); Eileen Duggan, M.D. (Crittenton Children's Center); Steven Cuffe, M.D. (Lexington/Richland Alcohol and Drug Abuse Council); Charles Maddix, R.N. (Gateway Community Services); Roberto Dominguez, M.D. (University of Miami); Betsy Macaraig, R.N. (Stanley Street Treatment and Resources, Inc.); John Thomas, M.D. (Rehab After Work); Michael Sheehan, M.D. (Operation PAR, Inc.). The following individuals collected data at participating sites: Ashley Myracle, M.A. (Synergy Outpatient Services, University of Colorado–Denver); Michelle Rapoza (Stanley Street Treatment and Resources, Inc.); Kim Pressley, M.A. (Lexington/Richland Alcohol and Drug Abuse Council); John Bensinger, M.A. (Addiction Medicine Services, Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center); Christine Neuenfeldt, Ph.D. (Gateway Community Services); Randi Adelman, N.P. (St. Luke's-Roosevelt Hospital Center); and Julia Hemphill, B.A. (Operation PAR, Inc.). |
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| The contents of this manuscript are solely the responsibility of the authors and do not necessarily represent the official views of the National Institute on Drug Abuse. |
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| 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. |
Vol 50 - N° 9
P. 903-914 - septembre 2011 Retour au numéro
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