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

George 2003.

Study characteristics
Methods Study design: RCT
Country: USA
Setting: outpatient smoking research clinic
Recruitment: community volunteers
Participants 40 smokers; 63% female; average age 49; average cigarettes per day 23
Interventions
  • Selegiline. 10 mg/day for 9 weeks (5 mg/day in week 1 and week 9)

  • Placebo

Outcomes
  • Smoking cessation: 7 day ppa at 6 months. Validated by CO < 10 ppm

  • Adverse events: measured for unspecified period

Funding Source None specified
Author conflicts of interest None specified
Notes "The main side effects of SEL were anorexia, gastrointestinal symptoms, and insomnia. None of the differences in adverse event ratings were significant in the SEL compared with the PLA group, and the drug was well tolerated compared with the placebo group. Reports of anxiety/agitation in both the SEL and PLA groups during the trial were high."
Funding: National Institute on Drug Abuse, US Department of Veteran Affairs, National Alliance for Research on Schizophrenia and Depression
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomization method not described
Allocation concealment (selection bias) Unclear risk Method not described
Blinding (performance bias and detection bias)
All outcomes Low risk Double‐blind, adequacy of blinding tested in research staff; results suggested blinding was adequate
Incomplete outcome data (attrition bias)
All outcomes High risk 29/40 not assessed at 6 months. Greater loss to follow‐up in placebo, exact data not reported