Simon 2009.
Methods | BUPROPION Randomized controlled trial Setting: VAMC hospital, USA Recruitment: hospitalised volunteers |
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Participants | 83 inpatients smoking at least 5 CPD in previous year, smoking in week before admission, in contemplation or preparation stage of change; | |
Interventions | 1. Bupropion 300 mg for 7w 2. Placebo Both arms: Individual cognitive behavioural 30‐60 min during hospital stay + 5 phone calls at w1, w3, w5, w8, w12, recycling encouraged. | |
Outcomes | Abstinence at 6m, continuous at each assessment Validation: saliva cotinine <15 ng/ml | |
Notes | 1 death in bupropion, 1 in placebo excluded from analyses Funding: California Tobacco‐Related Disease Research Program |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "computer algorithm to generate a random list of treatment assignments." |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding (performance bias and detection bias) All outcomes | Low risk | "All study personnel engaged in providing interventions to participants were blinded to treatment assignment." "A significant percentage of participants were able to guess correctly whether they were taking active bupropion or placebo" but as results did not favour intervention group, authors suggest this unblinding did not bias the results. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 5 withdrawals, 1 lost to follow‐up, 1 death in placebo, 2 withdrawals, 1 lost, 1 death in bupropion. All except deaths included in MA |