George 2003.
Study characteristics | ||
Methods | Study design: RCT Country: USA Setting: outpatient smoking research clinic Recruitment: community volunteers |
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Participants | 40 smokers; 63% female; average age 49; average cigarettes per day 23 | |
Interventions |
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Outcomes |
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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 |
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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 |