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Study Title and Description

A randomized controlled trial of pemoline for attention-deficit/hyperactivity disorder in substance-abusing adolescents.



Key Questions Addressed
1 Evidence map
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Primary Publication Information
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TitleData
Title A randomized controlled trial of pemoline for attention-deficit/hyperactivity disorder in substance-abusing adolescents.
Author Riggs PD., Hall SK., Mikulich-Gilbertson SK., Lohman M., Kayser A.
Country Department of Psychiatry, University of Colorado School of Medicine, Denver 80262, USA. paula.riggs@uchsc.edu
Year 2004
Numbers Pubmed ID: 15187802

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


Extraction Form: Evidence Map
Arms
Number Title Description Comments
1 Pemoline
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2 Placebo
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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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19
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Total sample size (in all arms) 69
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Age distribution of enrolled population (in years) 15.8
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Substance used SUD (not further described, except maybe excluding nicotine)
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Interventions studied? Pharmacologic
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No active treatment
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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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Mental health
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Age variation of enrolled population (in years) 1.4
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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: nos use days      Population: All Participants
Time Point Measure Pemoline Placebo


0 months

N Analyzed 35 34
Mean 13.4 14.4
SD 12.3 12.9
SE


4 months

N Analyzed 35 34
Mean 12.1 13.7
SD 11.3 11.5
SE
Within-Arm Comparisons
Comparison Measure Pemoline Placebo
0 months vs. 4 months Mean Difference -1.3 -0.7
SD 11.3 8.8
Outcome: nos use days      Population: All Participants
Time Point Measure Pemoline Placebo


0 months

N Analyzed 35 34
Mean nr nr
SD nr nr
SE


4 months

N Analyzed 35 34
Mean 2.4 3.1
SD 2.7 2.9
SE
Outcome: Psychiatric outcome      Population: All Participants
Time Point Measure Pemoline Placebo


0 months

N Analyzed 34 34
Mean 80.7 78.4
SD 15.2 13.7
SE


4 months

N Analyzed 34 34
Mean 68.5 71.2
SD 21.0 14.8
SE


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 No Cannabis use not equal, but ignored
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Co-interventions (performance bias): Performance bias because co-interventions were different across groups Yes no diff
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Compliance (performance bias): Performance bias due to inappropriate compliance with interventions across groups Unsure Measured but not reported
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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 High 435 dropout
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Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting
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Quality Rating
No quality rating data was found.