| Methods |
Country: USA
Setting: Baltimore, MD, by invitation through media advertisements, schools, churches
Study design: RCT |
| Participants |
Participants: 120 Smokers (I = 80, C = 40)
Age range: 13‐17 years
Criteria for inclusion: smoking ≥ 10 cpd for ≥ 6 months and motivation to quit > 5 on 10‐point integer scale. Only those who were happy to inform parents of smoking status were included.
Follow‐up method: interim and final questionnaires and final visit for verification of smoking status
Inducements to enter study: USD 90 for baseline and USD 135 after final visit/completion
Pre‐study status assessment: mean 18.8 cpd, 'youth appropriate' FTQ mean 7.04
No significant demographic differences between arms of the trial |
| Interventions |
Intervention: nicotine patch and gum, and self‐help written materials. 2 active groups (a) active patch with placebo gum (n = 34) (b) active gum with placebo patch (n = 46). NRT for both groups was tailored to weight and smoking level. Participants received 11 visits over 12 weeks to receive NRT, and attended 45‐min group CBT session at the end of each visit, + self‐help materials. Theoretical basis of intervention: pharmacological
Control: placebo patch and gum (n = 40), same course of CBT sessions as intervention group |
| Outcomes |
Measurement: 7‐day PPA, and "prolonged abstinence", i.e. continuous abstinence after a 2‐week grace period from end of intervention; follow‐up periods: > 3 months, 6 months
Verification: CO, salivary cotinine and thiocyanate
Losses to follow‐up: 54% |
| Notes |
Timeline for trial was verified with study authors
Adverse event "profile consistent with that reported for adults" |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"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 of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Described as "double‐blind, double‐dummy", but no further information |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Biochemically validated abstinence |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Losses to follow‐up were included as failures for cessation. Losses fully reported |
