Tonnesen 2003.
Methods | BUPROPION Randomized controlled trial Setting: 28 clinical trial centres in 8 European countries, Australia, NZ Recruitment: community volunteers |
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Participants | 710 smokers >= 10 CPD; 51% F, av. age 42, median CPD 20, no details of depression history | |
Interventions | 1. Bupropion SR 300 mg/day for 7w 2. Placebo Both arms: brief motivational support at weekly clinic visits and telephone support during follow up. 11 clinic visits and 10 phone calls scheduled. | |
Outcomes | Abstinence at 52w (prolonged from w4) Validation: CO <= 10 ppm | |
Notes | First included 2003 as Tonstad 2001.
ITT population defined as those taking at least one dose of study medication excludes 3 randomized participants Funding: GlaxoSmithKline |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "GlaxoSmithKline created a randomization schedule in a 3 : 1 bupropion: placebo ratio. Each centre received a list with treatment numbers and subjects were consecutively assigned a treatment number at the baseline visit." |
Allocation concealment (selection bias) | Low risk | As per above. "GlaxoSmithKline supplied bupropion SR 150 mg and placebo‐to‐match tablets for oral administration as white, film‐coated tablets." |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Double blind but methods not described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 9% of bupropion SR and 12% placebo were lost to follow‐up. |