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Study Title and Description

Randomized, controlled trial of atomoxetine for attention-deficit/hyperactivity disorder in adolescents with substance use disorder.



Key Questions Addressed
1 Evidence map
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Primary Publication Information
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TitleData
Title Randomized, controlled trial of atomoxetine for attention-deficit/hyperactivity disorder in adolescents with substance use disorder.
Author Thurstone C., Riggs PD., Salomonsen-Sautel S., Mikulich-Gilbertson SK.
Country Denver Health and Hospital Authority, Behavioral Health Services, and the University of Colorado Denver, 80238, USA. Christian.Thurstone@dhha.org
Year 2010
Numbers Pubmed ID: 20494267

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Evidence Map
Arms
Number Title Description Comments
1 Atomoxetine_CBT_MI
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2 Placebo_CBT_MI
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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? ... Trial registry number ... NCT00399763
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Ages eligible (in years) 13
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19
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Total sample size (in all arms) 70
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Age distribution of enrolled population (in years) 16
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Substance used SUD (not further described, except maybe excluding nicotine)
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Interventions studied? Behavioral
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Combined behavioral and pharmacologic
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Outcome? Self report of use/abstinence and/or intensity
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Mental health
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Adverse effects
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Age variation of enrolled population (in years) 1.78
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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 Upper income
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Results & Comparisons


Results Data
Outcome: Adverse event      Population: All Participants
Time Point Measure Atomoxetine_CBT_MI Placebo_CBT_MI


12 weeks

Percentage 66 46
N Analyzed 32 33
Outcome: Adverse event      Population: All Participants
Time Point Measure Atomoxetine_CBT_MI Placebo_CBT_MI


12 weeks

Percentage 60 37
N Analyzed 32 33
Outcome: Adverse event      Population: All Participants
Time Point Measure Atomoxetine_CBT_MI Placebo_CBT_MI


12 weeks

Percentage 60 71
N Analyzed 32 33
Outcome: Adverse event      Population: All Participants
Time Point Measure Atomoxetine_CBT_MI Placebo_CBT_MI


12 weeks

Percentage 60 51
N Analyzed 32 33
Outcome: Adverse event      Population: All Participants
Time Point Measure Atomoxetine_CBT_MI Placebo_CBT_MI


12 weeks

Percentage 57 46
N Analyzed 32 33
Outcome: Adverse event      Population: All Participants
Time Point Measure Atomoxetine_CBT_MI Placebo_CBT_MI


12 weeks

Percentage 51 60
N Analyzed 32 33
Outcome: Adverse event      Population: All Participants
Time Point Measure Atomoxetine_CBT_MI Placebo_CBT_MI


12 weeks

Percentage 51 43
N Analyzed 32 33
Outcome: Adverse event      Population: All Participants
Time Point Measure Atomoxetine_CBT_MI Placebo_CBT_MI


12 weeks

Percentage 51 20
N Analyzed 32 33
Outcome: nos use days      Population: All Participants
Time Point Measure Atomoxetine_CBT_MI Placebo_CBT_MI


0 weeks

Mean 18 17
N Analyzed 35 35


4 weeks

Mean 16 13
N Analyzed 35 35


8 weeks

Mean 14 12
N Analyzed 35 35


12 weeks

Mean 12 15
N Analyzed 32 33
Outcome: ADHD-RS      Population: All Participants
Time Point Measure Atomoxetine_CBT_MI Placebo_CBT_MI


0 weeks

Mean 41 36
N Analyzed 35 35


4 weeks

Mean 25 22
N Analyzed 35 35


8 weeks

Mean 24 23
N Analyzed 35 35


12 weeks

Mean 22 17
N Analyzed 35 35


Quality Dimensions
Dimension Value Notes Comments
Intention-to-treat-analysis: Bias due to incomplete reporting and analysis according to group allocation Yes Per flow diagram
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Group similarity at baseline (selection bias): Selection bias due to dissimilarity at baseline for the most important prognostic indicators No Multiple factors, not accounted for.
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Co-interventions (performance bias): Performance bias because co-interventions were different across groups Yes Same
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Compliance (performance bias): Performance bias due to inappropriate compliance with interventions across groups Yes 82%-87%, similar for both groups
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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 Same
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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
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Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data Low <10%
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Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting need to check NCT00399763: ADHD scale; TLFB (any substance); Drug side effects
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Quality Rating
No quality rating data was found.