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Study Title and Description

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



Key Questions Addressed
1 Evidence map
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Primary Publication Information
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TitleData
Title Randomized controlled trial of osmotic-release methylphenidate with cognitive-behavioral therapy in adolescents with attention-deficit/hyperactivity disorder and substance use disorders.
Author 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.
Country University of Colorado-Denver, Aurora, CO 80045, USA. paula.riggs@ucdenver.edu
Year 2011
Numbers Pubmed ID: 21871372

Secondary Publication Information
UI Title Author Country Year
Cigarette and cannabis use trajectories among adolescents in treatment for attention-deficit/hyperactivity disorder and substance use disorders. Gray KM., Riggs PD., Min SJ., Mikulich-Gilbertson SK., Bandyopadhyay D., Winhusen T. Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 67 President Street, MSC861, Charleston, SC 29425, USA. graykm@musc.edu 2011
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An application of analyzing the trajectories of two disorders: A parallel piecewise growth model of substance use and attention-deficit/hyperactivity disorder. Mamey MR., Barbosa-Leiker C., McPherson S., Burns GL., Parks C., Roll J. Department of Psychology, Washington State University. 2015
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Attention-deficit/hyperactivity disorder subtypes in adolescents with comorbid substance-use disorder. Tamm L., Adinoff B., Nakonezny PA., Winhusen T., Riggs P. Department of Pediatrics, Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, OH 45229-3039, USA. leanne.tamm@cchmc.org 2012
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Predictors of treatment response in adolescents with comorbid substance use disorder and attention-deficit/hyperactivity disorder. Tamm L., Trello-Rishel K., Riggs P., Nakonezny PA., Acosta M., Bailey G., Winhusen T. Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA. leanne.tamm@cchmc.org 2013
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Major depression and treatment response in adolescents with ADHD and substance use disorder. Warden D., Riggs PD., Min SJ., Mikulich-Gilbertson SK., Tamm L., Trello-Rishel K., Winhusen T. Department of Psychiatry, University of Texas Southwestern Medical Center at Dallas, 5323 Harry Hines Blvd., Dallas, TX 75390-9119, United States. Diane.Warden@UTSouthwestern.edu 2012
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Subjective effects, misuse, and adverse effects of osmotic-release methylphenidate treatment in adolescent substance abusers with attention-deficit/hyperactivity disorder. Winhusen TM., Lewis DF., Riggs PD., Davies RD., Adler LA., Sonne S., Somoza EC. Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio 45220, USA. winhusen@carc.uc.edu 2011
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Extraction Form: Evidence Map
Arms
Number Title Description Comments
1 Methylphenidate_CBT_MI Osmotic-release methylphenidate + CBT
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2 Placebo_CBT_MI Placebo + CBT
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Design Details
Question... Follow Up Answer Follow-up Answer
Should this citation be included? Yes
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Does this paper originate from a primary study of interest? No
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Ages eligible (in years) 13
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18
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Total sample size (in all arms) 303
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Age distribution of enrolled population (in years) 16.5
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Substance used SUD (not further described, except maybe excluding nicotine)
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Interventions studied? Combined behavioral and pharmacologic
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Outcome? Objective measurement of use/abstinence and/or intensity
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Self report of use/abstinence and/or intensity
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Other ... ADHD
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Age variation of enrolled population (in years) 1.3
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Study type RCT
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Is any arm a brief intervention (or single session)? No
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Income level of country(ies) of origin ... Country(ies) name(s) Unclear ...
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Results & Comparisons


Results Data
Outcome: ADHD-RS      Population: All Participants
Time Point Measure Methylphenidate_CBT_MI Placebo_CBT_MI


0 months

N Analyzed 151 152
Mean 36.2 37.6
95% CI low 34.6 36.1
95% CI high 37.7 39.1


1 months

N Analyzed 151 152
Mean 20.6 21.4
95% CI low 19.1 19.9
95% CI high 22.1 22.9


2 months

N Analyzed 151 152
Mean 18.2 18.2
95% CI low 16.6 16.5
95% CI high 19.9 19.8


3 months

N Analyzed 151 152
Mean 20 19.4
95% CI low 18.1 17.5
95% CI high 21.9 21.3


4 months

N Analyzed 151 152
Mean 17 16.4
95% CI low 14.7 14.1
95% CI high 19.3 18.8
Outcome: nos use days      Population: All Participants
Time Point Measure Methylphenidate_CBT_MI Placebo_CBT_MI


0 months

N Analyzed 151 152
Mean 14 15.2
95% CI low 12.5 13.8
95% CI high 15.4 16.7


1 months

N Analyzed 151 152
Mean 11 11.7
95% CI low 9.7 10.3
95% CI high 12.4 13


2 months

N Analyzed 151 152
Mean 9.1 9.6
95% CI low 7.7 8.2
95% CI high 10.5 11.1


3 months

N Analyzed 151 152
Mean 8.2 9.1
95% CI low 6.8 7.6
95% CI high 9.6 10.5


4 months

N Analyzed 151 152
Mean 8.3 10
95% CI low 6.7 8.3
95% CI high 9.9 11.7


Quality Dimensions
Dimension Value Notes Comments
Intention-to-treat-analysis: Bias due to incomplete reporting and analysis according to group allocation Yes
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Group similarity at baseline (selection bias): Selection bias due to dissimilarity at baseline for the most important prognostic indicators Yes similar
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Co-interventions (performance bias): Performance bias because co-interventions were different across groups Yes No difference
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Compliance (performance bias): Performance bias due to inappropriate compliance with interventions across groups Yes Compliance ok
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Timing of outcome assessments (detection bias): Detection bias because important outcomes were not measured at the same time across groups Yes
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Additional Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes. No
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Random sequence generation (selection bias): Selection bias (biased allocation to interventions) due to inadequate generation of a randomized sequence Unclear
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Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment Low
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Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study Low
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Blinding of personnel/ care providers (performance bias): Performance bias due to knowledge of the allocated interventions by personnel/care providers during the study. Low
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Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. Low per NCT00264797 protocol
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Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data High >20% noncompleters
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Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting need to check NCT00264797: Substance use (TLFB), Urine drug screen
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Quality Rating
No quality rating data was found.