Skip to main content
. 2021 Oct 6;2021(10):CD006219. doi: 10.1002/14651858.CD006219.pub4

2 Simon 2009.

Study characteristics
Methods Setting: San Francisco Veterans Affairs Medical Center, USA
Recruitment: hospitalized volunteers
Study start date: January 2004; Study end date: August 2006
Participants 85 inpatient smokers, 3.5% female, av age 56 yrs, av BMI 27.5, av cpd 16
Interventions
  • Bupropion 300 mg for 7 wks

  • Placebo


All ppts received Individual cognitive behavioural 30 ‐ 60 mins during hospital stay + 5 phone calls at wk 1, wk 3, wk 5, wk 8, wk 12; recycling encouraged
Outcomes Mean (SD) weight change (kg) in continuous abstainers at 6m (data from email communication) validation: saliva cotinine < 15 ng/ml
Study funding "California Tobacco‐Related Disease Research Program (12RT‐0148)"
Author declarations "None declared"
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk used a computer algorithm to generate a random list of treatment assignments
Allocation concealment (selection bias) Low risk All study personnel engaged in providing interventions to participants were blinded to treatment assignment
Blinding of participants and personnel (performance bias)
All outcomes High risk Double‐blind + placebo controlled.
Quote: “All study personnel engaged in providing interventions to participants were blinded to treatment assignment.“ “A significant percentage of participants were able to guess whether they were taking either active bupropion or placebo“
Blinding of outcome assessment (detection bias)
Smoking Low risk Quote: "Because many of the participants live great distances from the SFVAMC, we used salivary cotinine levels ( ≥ 15 ng/ml) as an indicator of current tobacco use, rather than measuring carbon monoxide in person (Jarvis, Tunstall‐Pedoe, Feyerabend, Vesey, & Saloojee, 1987 ). We permitted the mailing of saliva samples in special envelopes when necessary. For self‐reported quitters who had salivary cotinine levels of 15 ng/ml or higher, we ascertained by telephone interview whether they were using NRT at the time the sample was provided. We considered three participants (two in the bupropion arm and one in the placebo arm) to be nicotine dependent and, thus, smokers"
Blinding of outcome assessment (detection bias)
Weight High risk Quote: "Body mass index and change in weight over time were determined using self‐reported or medical record data“. Comment: Participants were blinded to treatment condition, but a significant percentage correctly guessed allocation
Incomplete outcome data (attrition bias)
All outcomes Low risk 24‐week completion bupropion + counselling group: 38/42 (90.47%) (2 withdrew, 1 died, 1 lost to follow‐up); 24‐week completion placebo + counselling group: 36/43 (83.72%) (5 withdrew, 1 died, 1 lost to follow‐up)