Rigotti 2006.
Methods | BUPROPION Randomized controlled trial Setting: hospitals, USA Recruitment: volunteers |
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Participants | 248 smokers hospitalised with cardiovascular disease (excludes 3/3 dropped prior to treatment & 2 placebo deaths during follow up) 31% F, av age 56, av CPD 23/21. 30%/20% had prior use of bupropion, 54%/56% prior use of NRT | |
Interventions | 1. Bupropion 300 mg for 12w 2. Placebo Both arms: Multicomponent CBT cessation & relapse prevention programme, motivational interviewing approach, Begun in hospital, 30‐45 mins, 5 X10 min post‐discharge contacts (2 days,1,3,8, 12w), S‐H, chart prompt for physician. Total time 80‐95 mins | |
Outcomes | Abstinence at 12m (sustained at multiple follow ups) Validation: saliva cotinine at 12 & 52w, CO at 2 & 4w | |
Notes | Funding: National Heart, Lung and Blood Institute, National Institutes of Health General Clinical Research Centers Program, GlaxoSmithKline | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Using a computer program, the study statistician generated a sequence of randomly‐permuted blocks of 4 within strata formed by study site and daily cigarette consumption (10 vs 10)." |
Allocation concealment (selection bias) | Low risk | "The study pharmacist used this sequence, concealed from enrolment staff, to assign participants to study arm. Subjects and study personnel, except the statistician and pharmacist, were blind to treatment assignment." |
Blinding (performance bias and detection bias) All outcomes | Low risk | "Subjects and study personnel, except the statistician and pharmacist, were blind to treatment assignment." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "Subjects were considered smokers if they were lost to follow‐up..."; 23% lost to follow up in the bupropion group and 23% in the placebo group. |