Brown 2013.
Methods | FLUOXETINE Randomized controlled trial Setting: clinic, USA Recruitment: community volunteers |
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Participants | 216 smokers with elevated depressive symptoms (CES‐D score ≥ 6) smoking ≥ 10 cpd. 38.4% F, av age 46, av cpd 21, mean FTND 5.6, mean CES‐D 11.4 | |
Interventions | 1. 10 weeks of 20 mg fluoxetine (beginning 2 weeks prior to TQD) 2. 16 weeks of 20 mg fluoxetine (beginning 8 weeks prior to TQD) 3. Control (no placebo) All arms: nicotine patch for 8 weeks starting on TQD (21 mg/day for 4 weeks, 14mg/day for 2 weeks, 7 mg/day for last 2 weeks), 5 sessions of brief behavioural smoking cessation treatment (in person and phone over 4 weeks, 20‐ 30 mins each) |
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Outcomes | Continuous abstinence at 12m Validation: salivary cotinine < 10 ng/ml |
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Notes | New for 2013. Significantly higher abstinence in 16 week arm than in 10 week arm, results presented separately in meta‐analysis with control divided. N abstinent not reported, extrapolated from percentages provided. Funding: American Cancer Society |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Urn randomization, no further detail provided |
Allocation concealment (selection bias) | Unclear risk | Not specified |
Blinding (performance bias and detection bias) All outcomes | High risk | Open‐label |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Over 90% followed up at 12m. Similar rates across arms. |