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. 2023 Jun 19;2023(6):CD013308. doi: 10.1002/14651858.CD013308.pub2

Garvey 2000.

Study characteristics
Methods Study design: parallel RCT
Country: USA
Recruitment: community volunteers
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
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
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