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. 2020 Apr 22;2020(4):CD000031. doi: 10.1002/14651858.CD000031.pub5

NCT00578669.

Study characteristics
Methods Study design: RCT
Country: USA
Setting and recuirment method not specified
Participants Participants had elevated depression symptoms.
206 participants randomized; 48% female; average age 44; average cigarettes per day 21; mean FTND 5.7
Interventions
  • Fluoxetine. 20 mg once daily, 8 weeks prior to target quit date and weeks thereafter

  • Placebo. Given according to schedule detailed above


Common components: nicotine patch as well as "standard smoking cessation treatment"
Outcomes
  • Smoking cessation: 7‐day ppa at 12 months. Validated by CO and saliva cotinine

  • Adverse events: measured for a period of one year

Funding Source None specified
Author conflicts of interest None specified
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No relevant information given
Allocation concealment (selection bias) Unclear risk No relevant information given
Blinding (performance bias and detection bias)
All outcomes Unclear risk Placebo controlled, but no further information on blinding provided
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Clinical trial registry implies 100%, but not explicitly, so we concluded there was not sufficient information given