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Study Title and Description

A double-blind randomized controlled trial of N-acetylcysteine in cannabis-dependent adolescents.



Key Questions Addressed
1 Evidence map
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Primary Publication Information
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TitleData
Title A double-blind randomized controlled trial of N-acetylcysteine in cannabis-dependent adolescents.
Author Gray KM., Carpenter MJ., Baker NL., DeSantis SM., Kryway E., Hartwell KJ., McRae-Clark AL., Brady KT.
Country Department of Psychiatry and Behavioral Sciences, the Hollings Cancer Center, Charleston, SC, USA.graykm@musc.edu
Year 2012
Numbers Pubmed ID: 22706327

Secondary Publication Information
UI Title Author Country Year
Low Pretreatment Impulsivity and High Medication Adherence Increase the Odds of Abstinence in a Trial of N-Acetylcysteine in Adolescents with Cannabis Use Disorder. Bentzley JP., Tomko RL., Gray KM. Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 125 Doughty Street, Suite 190, MSC861, Charleston, SC 29425, USA. 2016
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Alcohol use during a trial of N-acetylcysteine for adolescent marijuana cessation. Squeglia LM., Baker NL., McClure EA., Tomko RL., Adisetiyo V., Gray KM. Medical University of South Carolina, Department of Psychiatry and Behavioral Sciences, Addiction Sciences Division, Charleston, SC, USA. 2016
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The role of depressive symptoms in treatment of adolescent cannabis use disorder with N-Acetylcysteine. Tomko RL., Gilmore AK., Gray KM. Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, United States. Electronic address: tomko@musc.edu. 2018
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Extraction Form: Evidence Map
Arms
Number Title Description Comments
1 N-acetylcysteine_CM N-acetylcysteine_CM
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2 Placebo_CM
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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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21
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Total sample size (in all arms) 116
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Age distribution of enrolled population (in years) 18.9
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Substance used Cannabis
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Interventions studied? 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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Age variation of enrolled population (in years) 1.5
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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 ... United States
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Results & Comparisons


Results Data
Odds Ratio (OR) 95% CI low 95% CI high P-Value Odds Ratio (OR) 95% CI low 95% CI high P-Value Odds Ratio (OR) 95% CI low 95% CI high P-Value
Outcome: pct abstinent for cannabis      Population: All Participants Between-Arm Comparisons
Time Point Measure N-acetylcysteine_CM Placebo_CM Comparison Measure


0 weeks

Percentage 40.9 27.2 2.35
N Analyzed 58 58 1.05
5.24
0.029


2 weeks

Percentage 36.2 20.7 2.32
N Analyzed 58 58 0.99
5.43
0.054


4 weeks

Percentage 27.6 15.5 2.14
N Analyzed 58 58 0.85
5.42
0.108
Mean Difference 95% CI low 95% CI high P-Value
Outcome: cannabis use days      Population: All Participants Between-Arm Comparisons
Time Point Measure N-acetylcysteine_CM Placebo_CM Comparison Measure N-acetylcysteine_CM vs. Placebo_CM


4 weeks

N Analyzed 58 58 -4
Mean 41.1 37 -15.8
SD 4.3 4.4 7.9
0.512


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 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 No
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Additional Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes. No Not bias, per se. But intervention (both arms) included a financial reward for abstinence.
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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 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 Low
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Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting Unclear
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Quality Rating
No quality rating data was found.