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Study Title and Description

Topiramate and motivational enhancement therapy for cannabis use among youth: a randomized placebo-controlled pilot study.



Key Questions Addressed
1 Evidence map
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Primary Publication Information
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TitleData
Title Topiramate and motivational enhancement therapy for cannabis use among youth: a randomized placebo-controlled pilot study.
Author Miranda R., Treloar H., Blanchard A., Justus A., Monti PM., Chun T., Swift R., Tidey JW., Gwaltney CJ.
Country Brown University, Providence, RI, USA.
Year 2017
Numbers Pubmed ID: 26752416

Secondary Publication Information
UI Title Author Country Year
Predictors of Topiramate Tolerability in Heavy Cannabis-Using Adolescents and Young Adults: A Secondary Analysis of a Randomized, Double-Blind, Placebo-Controlled Trial. Gray JC., Treloar Padovano H., Wemm SE., Miranda R. -- Not Found -- 2018
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Predictors of Topiramate Tolerability in Heavy Cannabis-Using Adolescents and Young Adults: A Secondary Analysis of a Randomized, Double-Blind, Placebo-Controlled Trial. Gray JC., Treloar Padovano H., Wemm SE., Miranda R. -- Not Found -- 2018
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Extraction Form: Evidence Map
Arms
Number Title Description Comments
1 Topiramate_MI
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2 Placebo_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? No
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No
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No
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Ages eligible (in years) 15
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24
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Total sample size (in all arms) 66
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Age distribution of enrolled population (in years) 18.81
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Substance used Cannabis
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Cannabis
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Cannabis
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Interventions studied? Pharmacologic
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Pharmacologic
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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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Adverse effects
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Objective measurement of use/abstinence and/or intensity
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Self report of use/abstinence and/or intensity
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Adverse effects
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Objective measurement of use/abstinence and/or intensity
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Self report of use/abstinence and/or intensity
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Adverse effects
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Age variation of enrolled population (in years) 2.08
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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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Upper income
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Results & Comparisons


Results Data
Outcome: Adverse event      Population: All Participants
Time Point Measure Topiramate_MI Placebo_MI


6 weeks

Percentage 30 50
N Analyzed 40 26
Outcome: Adverse event      Population: All Participants
Time Point Measure Topiramate_MI Placebo_MI


6 weeks

Percentage 30 15.4
N Analyzed 40 26
Outcome: Adverse event      Population: All Participants
Time Point Measure Topiramate_MI Placebo_MI


6 weeks

Percentage 27.5 15.4
N Analyzed 40 26
Outcome: Adverse event      Population: All Participants
Time Point Measure Topiramate_MI Placebo_MI


6 weeks

Percentage 27.5 7.7
N Analyzed 40 26
Outcome: Adverse event      Population: All Participants
Time Point Measure Topiramate_MI Placebo_MI


6 weeks

Percentage 25 7.7
N Analyzed 40 26
Outcome: Adverse event      Population: All Participants
Time Point Measure Topiramate_MI Placebo_MI


6 weeks

Percentage 25 3.8
N Analyzed 40 26
Outcome: Adverse event      Population: All Participants
Time Point Measure Topiramate_MI Placebo_MI


6 weeks

Percentage 25 0
N Analyzed 40 26
Outcome: Adverse event      Population: All Participants
Time Point Measure Topiramate_MI Placebo_MI


6 weeks

Percentage 22.5 34.6
N Analyzed 40 26
Outcome: Adverse event      Population: All Participants
Time Point Measure Topiramate_MI Placebo_MI


6 weeks

Percentage 20 19.2
N Analyzed 40 26
Outcome: pct abstinent for cannabis      Population: All Participants
Time Point Measure Topiramate_MI Placebo_MI


1 weeks

Percentage 15 8
N Analyzed 40 26


2 weeks

Percentage 8 3
N Analyzed 40 26


3 weeks

Percentage 5 16
N Analyzed 40 26


4 weeks

Percentage 30 16
N Analyzed 40 26


5 weeks

Percentage 16 10
N Analyzed 40 26


6 weeks

Percentage 20 16
N Analyzed 40 26
Outcome: cannabis use days      Population: All Participants
Time Point Measure Topiramate_MI Placebo_MI


1 weeks

N Analyzed 40 26
Mean 69 70
95% CI low 65 65
95% CI high 73 76


2 weeks

N Analyzed 40 26
Mean 57 66
95% CI low 52 59
95% CI high 63 73


3 weeks

N Analyzed 40 26
Mean 58 63
95% CI low 51 54
95% CI high 64 70


4 weeks

N Analyzed 40 26
Mean 53 56
95% CI low 46 48
95% CI high 59 63


5 weeks

N Analyzed 40 26
Mean 39 63
95% CI low 32 54
95% CI high 46 71


6 weeks

N Analyzed 40 26
Mean 41 56
95% CI low 34 47
95% CI high 47 63


Quality Dimensions
Dimension Value Notes Comments
Intention-to-treat-analysis: Bias due to incomplete reporting and analysis according to group allocation No What they call ITT is "all available data"
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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 No
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Compliance (performance bias): Performance bias due to inappropriate compliance with interventions across groups No
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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 Low
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Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment Unclear
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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
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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.