Methods |
Setting: clinic, USA Recruitment: community volunteers |
Participants |
362 smokers ≥ 10 cigs/day, no current major depression 46% female, average age 45, average cigs/day 20, 25% previous bupropion use |
Interventions |
All participants received open‐label combination pharmacotherapy of bupropion 300 mg for 11 weeks, nicotine patch for 10 weeks. TQD day 7, 30‐min individual relapse prevention skills training at 6 clinic visits 1. Bupropion 150 mg for 14 weeks 2. 2 weeks tapering bupropion, then placebo Both arms had 4 further clinic visits during extended therapy |
Outcomes |
Abstinence at 12 months (6 months post‐EOT) (continuous). PP and 7‐day relapse‐free outcomes also reported Validation: CO (10 people not required to provide samples) |
Notes |
New for 2009 update PP outcomes favoured placebo, but no outcomes showed significant effects Approximately 52% were quit at the end of baseline therapy |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Preassigned random sequence stratified by gender, before open‐label phase |
Allocation concealment (selection bias) |
Low risk |
Not explicitly concealed but judged probable that it was |
Blinding of participants and personnel (performance bias) All outcomes |
Low risk |
Blinded drugs provided to investigator; " ... [the pharmaceutical company]... packaged the treatment and then shipped the blinded drug to the investigator" |
Blinding of outcome assessment (detection bias) All outcomes |
Low risk |
Treatment condition blinded, biochemical validation used |
Incomplete outcome data (attrition bias) All outcomes |
Low risk |
10% lost to follow‐up, included in ITT analysis |