| Methods |
Country: USA
Recruitment: primary care |
| Participants |
315 daily smokers, motivated to quit
56% female, average age 37, average cpd 29 |
| Interventions |
1. Nicotine gum (2 mg for 3 to 4 months)
2. Placebo gum
Level of support: low (29 to 35 mins at 1st visit including nurse and physician advice and materials, follow‐up appointment 1 to 2 weeks later) |
| Outcomes |
Sustained abstinence at 12 months
Validation: salivary cotinine < 15 ng/mL or thiocyanate < 1.6 mmol/L |
| Notes |
Time spent at 1st visit is marginal for inclusion in low‐intensity support category
Study was funded by National Institute on Drug Abuse; gum supplied by Merrel‐Dow Research Institute |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
A 4th random digit (1 to 9) was added to their 3‐digit subject ID number. Only exception was members of same household got the same treatment |
| Allocation concealment (selection bias) |
Low risk |
2:1 randomization scheme. Quote: "Subjects were assigned randomly in a double‐blind manner" |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Pharmacists dispensed gum from numbered bins, and were unaware of assignment |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Dropouts and lost to follow‐up were included as smokers. Full details of losses reported |
