Brown 2007.
Methods | BUPROPION
Randomized controlled trial, 2x2 factorial design Setting: 2 clinical sites (Butler Hospital, Miriam Hospital) Rhode Island, USA Recruitment: community volunteers |
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Participants | 524 smokers >= 10 CPD; 48% F, av. age 44, av. CPD 25, 17.6% with history of MDD single episode, 3.1% recurrent MDD | |
Interventions | 2 x 2 factorial design. Alternative psychosocial treatments were standard cessation therapy or plus CBT for depression. Both had 12 x 90 min groups twice weekly/ weekly/ monthly for 12w. TQD 5th session. Collapsed in this analysis 1. Bupropion 300 mg/day for 12 weeks 2. Placebo | |
Outcomes | Abstinence at 12m (sustained at 4 visits) Validation: CO <= 10 ppm, saliva cotinine <= 15 ng/ml | |
Notes | First included as Brown 2006, part unpublished data. Some genotyping studies combine these participants with those reported in Collins 2004 Funding: National Institutes of Health |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Participants were randomly assigned to one of two treatment sites, where they were to receive one of two manualized group treatments ... Participants were then randomly assigned to receive one of two medication conditions, bupropion or placebo, using the urn randomization technique." |
Allocation concealment (selection bias) | Unclear risk | "Whereas we were able to balance the drug and placebo conditions on an individual basis, behavioral treatments were randomized by group and thus were more susceptible to fluctuations in recruitment and to the availability at both sites of pairings of a senior and a junior therapist trained in CBTD". Knowledge of behavioural assignment was probably not concealed but seems unlikely to have lead to individual selection bias. |
Blinding (performance bias and detection bias) All outcomes | Low risk | "Double‐blind." Psychological condition unlikely to be blinded but unlikely to affect comparisons included in this review. "All participants and study staff were blind to medication condition." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 81% provided complete outcome data at all follow ups, not related to treatment condition. All participants included in ITT analyses |