| Methods |
Country: USA
Recruitment: community volunteers |
| Participants |
120 adolescent (age 13 to 17) smokers (≥ 10 cpd), motivated to quit
70% female, average age 15, average cpd 19 |
| Interventions |
1. Nicotine patch (21 mg, or 14 mg for < 20 cpd) for 6 weeks + placebo gum
2. Nicotine gum (4 mg, or 2 mg for < 24 cpd) for 6 weeks + placebo patch
3. Double placebo
Level of support: high (11 x 45‐min individual counselling over 12 weeks) |
| Outcomes |
PP abstinence at 6 months
Validation: CO and cotinine |
| Notes |
Placebo group contributes twice to MA ‐ too small to affect total
Sustained abstinence at 3 and 6 months could be derived from text, relative effect greater since no quitters on placebo
Study was funded by National Institute on Drug Abuse, and supported by GlaxoSmithKline |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "randomized ... according to an algorithm held by the National Institute on Drug Abuse Pharmacy, with true replacement of the non‐completers". |
| Allocation concealment (selection bias) |
Unclear risk |
Not stated |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Described as "double‐blind, double‐dummy", but no further information |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Losses to follow‐up were included as failures for cessation. Losses fully reported |
