| Methods |
Country: USA
Recruitment: outpatient settings and physician referrals (primary care subgroup) |
| Participants |
77 low‐dependence (FTND ≤ 6) and 96 high‐dependence smokers
50% female, average age 42, average cpd 29, FTND 4.7 for low dependence, 8.0 for high dependence |
| Interventions |
1. Nicotine gum 2 mg, ad lib for up to 4 months (participants given prescription for gum, not free)
2. No gum
Level of support: high (4 individual counselling sessions and ALA self‐help treatment manuals) |
| Outcomes |
Continuous abstinence at 12 months
Validation: saliva cotinine, or CO for gum users |
| Notes |
No placebo used. Data collapsed across dependence levels. As predicted by the study, smokers with lower dependence had lower quit rates with than without gum. The point estimate would be higher if inclusion restricted to the high‐dependence group
Study was supported by National Cancer Institute and National Heart, Lung, and Blood Institute |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Participants stratified on level of nicotine dependence. "Within each of the high‐ and low‐dependence groups, subjects were randomly assigned" |
| Allocation concealment (selection bias) |
Unclear risk |
Not stated |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
No placebo ‐ not relevant. But therapist and participant were blinded to FTQ score (level of dependency), and to match or mismatch status for gum use |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Dropout rates fully reported |
