Garvey 2000.
Study characteristics | ||
Methods | Study design: parallel RCT Country: USA Recruitment: community volunteers |
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Participants | 608 smokers, aged > 20, smoking > 5 cigarettes per day 49% men, average cigarettes per day: 23 | |
Interventions | 1) 4 mg nicotine gum (recommended 9 to 15 pieces), weaning from 2 months 2) 2 mg nicotine gum, use as described for group 1 3) Placebo gum All received brief counselling (5 to 10 minutes) at each study visit (1, 7, 14, 30 days, 2, 3, 6, 9, 12 months) | |
Outcomes | Sustained abstinence at 12 months (relapse defined as 7+ consecutive days or episodes of smoking)
Validation: CO ≤ 8 ppm Adverse events: not measured |
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Notes | This study was supported by grants DA06183 and DA10073 from the National Institute on Drug Abuse, and by the Department of Veterans Affairs. Conflicts of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Stratified by dependence level (high/low) and then allocated [Quote]: "using a randomized, double‐blind procedure" |
Allocation concealment (selection bias) | Unclear risk | No further detail |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Described as double‐blind, but no further information |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Relapsers were included as failures. Dropout rates not reported |