Cinciripini 2013.
Methods | BUPROPION Randomized controlled trial Setting: clinic, USA Recruitment: community volunteers |
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Participants | 294 smokers of ≥ 5 cpd 61% M, av age 44, av cpd 20, mean FTND 4.5 |
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Interventions | 1. 12 weeks bupropion started 12‐19 days before TQD (150mg/d days 1‐3, 300mg/d thereafter) 2. 12 weeks varenicline on same schedule (0.5mg/day days 1‐3, 1.0mg/day days 4‐7, 2.0mg/day thereafter) 3. Placebo on same schedule All arms: 10 individual counselling sessions (6 in person, 4 via phone, 240 mins total) |
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Outcomes | Continuous abstinence after 2 week grace period at 6m (Other prolonged abstinence outcomes also reported) Validation: CO < 10 ppm or salivary cotinine < 15 ng/mL |
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Notes | New for 2013 In less than 1% of the total cases, participants who did not attend a follow‐up were coded as abstinent because they were abstinent at the following data point. All other losses to follow‐up counted as smokers. Author provided further detail on AE measurements via e‐mail. Funding: National Institute on Drug Abuse, National Cancer Institute |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | “Adaptive randomization,” no further detail provided |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | “Blinded” but no further information provided |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 73% followed up at 6m, similar rates across arms, all lost to follow‐up known to be smokers |