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CTN-0028
Primary
Outcomes

 

Randomized Controlled Trial of Osmotic-Release Methylphenidate with CBT in Adolescents with ADHD and Substance Use Disorders.

Journal of the American Academy of Child and Adolescent Psychiatry 2011;50(9):903-914. [doi: 10.1016/j.jaac.2011.06.010]

Paula D. Riggs, MD (University of Colorado, FNA Node), Theresa M. Winhusen, PhD (University of Cincinnati/CinARC, OV Node), Robert D. Davies, MD (University of Colorado, FNA Node), Jeffrey D. Leimberger, PhD (Duke Clinical Research Institute, Data and Statistics Center (DSC)), Susan K. Mikulich-Gilbertson, PhD (University of Colorado, FNA Node), Constance Klein, MPA, RN (Nathan Klein Institute for Psychiatric Research, GNY Node), Marilyn Macdonald (University of Colorado, FNA Node), Michelle Lohman, RN (University of Colorado, FNA Node), Genie L. Bailey, MD (Stanley Street Treatment and Resources, Inc., NEC Node), Louise F. Haynes, MSW (Lexington/Richland Alcohol and Drug Abuse Council, SC Node), William B. Jaffee, PhD (McLean Hospital, NEC Node), Nancy Hamilton, MPA, CAP, CCJAP (Operation PAR, Inc., FNA Node), Candace C. Hodgkins, PhD, LMHC (Gateway Community Services, Inc., FNA Node), Elizabeth Whitmore, PhD (Synergy Treatment Center, FNA Node), Kathlene Trello-Rishel, PhD (Mental Health and Mental Retardation of Tarrant County, TX Node), Leanne Tamm, PhD (University of Texas Southwestern Medical Center, TX Node), Michelle C. Acosta, PhD (National Development and Research Institutes, Inc., GNY Node), Charlotte Royer-Malvestuto, MEd, MBE (University of Pennsylvania School of Medicine, DV Node), Geetha A. Subramaniam, MD (Center for the Clinical Trials Network, NIDA), Marc J. Fishman, MD (Mountain Manor Treatment Program, MA Node), Beverly W. Holmes, MSW (Lexington/Richland Alcohol and Drug Abuse Council, SC Node), Mary Elyse Kaye, BSN, RN (Western Psychiatric Institute and Clinic, AT Node), Mark A. Vargo, PhD (Operation PAR, Inc., FNA Node), George E. Woody, MD (University of Pennsylvania School of Medicine, DV Node), Edward V. Nunes, MD (New York State Psychiatric Institute, GNY Node), David S. Liu, MD (Center for the Clinical Trials Network, NIDA).

This is the Primary Outcomes Paper for CTN-0028. National Drug Abuse Treatment Clinical Trials Network protocol CTN-0028 was designed 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). The study was a 16-week, randomized controlled multi-site trial of OROS-MPH + CBT versus placebo + CBT in 303 adolescents (aged 13 through 18) 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. Analysis of the results found no group differences on reduction in ADHD-RS scores or reduction in days of substance use. Some secondary outcomes favored OROS-MPH, including lower parent ADHD-RS scores at 8 and 16 weeks, and more negative urine drug screens in OROS-MPH compared with placebo.

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. (Article (Peer-Reviewed), PDF, English, 2010)

Keywords: ADHD Rating Scale (ADHD-RS) | Adolescents | Attention Deficit Hyperactivity Disorder (ADHD) | Community health services | Concerta | Co-occurring disorders | CTN primary outcomes | Osmotic-Release Methylphenidate (OROS-MPH) | Journal of the American Academy of Child & Adolescent Psychiatry (journal)

Document No: 710, PMID: 21871372, PMCID: PMC3164797.

Submitted by the CTN Dissemination Librarians, 8/11/2011.

AUTHORS SEARCH LINK
Acosta, Michelle C. search
Bailey, Genie L. search mail
Davies, Robert D. search mail
Fishman, Marc J. search mail
Hamilton, Nancy search mail
Haynes, Louise F. search mail
Hodgkins, Candace C. search mail
Holmes, Beverly W. search mail
Jaffee, William B. search mail
Kaye, Mary Elyse search mail
Klein, Constance search mail
Leimberger, Jeffrey D. search mail
Liu, David S. search mail
Lohman, Michelle search
MacDonald, Marilyn search
Mikulich-Gilbertson, Susan K. search
Nunes, Edward V. search mail
Riggs, Paula D. search mail
Royer-Malvestuto, Charlotte search mail
Subramaniam, Geetha A. search mail
Tamm, Leanne search mail
Trello-Rishel, Kathlene search mail
Vargo, Mark A. search mail
Whitmore, Elizabeth search mail
Winhusen, Theresa M. search mail
Woody, George E. search mail
PROTOCOLS
NIDA-CTN-0028 search www
PARTICIPATING NODES
Ohio Valley (Lead) search www
Appalachian Tri-State search www
Delaware Valley search www
Florida Node Alliance search www
Greater New York search www
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