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Study Title and Description

An open randomized trial comparing disulfiram and naltrexone in adolescents with alcohol dependence



Key Questions Addressed
1 Evidence map
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Primary Publication Information
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TitleData
Title An open randomized trial comparing disulfiram and naltrexone in adolescents with alcohol dependence
Author De Sousa, A; De Sousa, A
Country Get Well Clinic and Nursing Home, Mumbai, India
Year 2008
Numbers Pubmed ID: CN-00753784

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


Extraction Form: Evidence Map
Arms
Number Title Description Comments
1 Disulfiram_Educ
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2 Naltrexone_Educ
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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) 15
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18
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Total sample size (in all arms) 58
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Age distribution of enrolled population (in years) 17.3
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Substance used Alcohol
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Interventions studied? Combined behavioral and pharmacologic
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Outcome? Self report of use/abstinence and/or intensity
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Family functioning
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Adverse effects
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Age variation of enrolled population (in years) nd
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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 Lower and lower middle income
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Results & Comparisons


Results Data
Outcome: pct abstinent for alcohol      Population: All Participants
Time Point Measure Disulfiram_Educ Naltrexone_Educ


9 months

Counts 23 15
Percentage 79.31 51.72
N Analyzed 29 29


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
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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 <10% stopped
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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 Low By statistician
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Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment High "List"
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Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study High
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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. High
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Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. High "Open"
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Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data Low 7%
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Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting
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Quality Rating
Guideline Used Overall Rating