Hughes 1990.
Study characteristics | ||
Methods | Study design: parallel RCT Country: USA Recruitment: community volunteers |
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Participants | 78 smokers, motivated to quit 46% men, average age 34 to 44, average cigarettes per day 24 to 30 | |
Interventions | 1) Placebo gum 2) 1 mg nicotine gum (unbuffered formula, available dose approximately 0.5 mg) 3) 2 mg nicotine gum 4) 4 mg nicotine gum Gum use not recommended for longer than 3 months | |
Outcomes | Sustained abstinence at 6 months
Validation: independent observer report Adverse events: measured at 1‐week follow‐up (within treatment) using a 13‐item side effects scale. Note: none of the side effects included in the scale are cardiovascular |
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Notes | This study was supported by Grants DA‐03728 and DA‐04066 and Research Scientist Development Award DA‐00109 (to JRH) from the National Institute on Drug Abuse. Merrell‐Dow Research Institute provided the drug for the study. 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 | Quote: "Subjects were randomly assigned" |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Quote: "in a double‐blind manner"; participants guessed to which group they had been assigned |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "Subjects unable to be contacted were counted as smokers". Losses not reported |