Evins 2007.
Methods | BUPROPION Randomized controlled trial Setting: community mental health centre, USA Recruitment: outpatients |
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Participants | 51 smokers (>=10 CPD) with schizophrenia; av. age 44, av. CPD 28/25 | |
Interventions | 1. Bupropion 300 mg/day for 3m, nicotine patch, 21 mg for 8w incl tapering, 2 mg nicotine gum 2. Placebo + NRT as 1. Both arms: 12 session group CBT, TQD week 4 | |
Outcomes | Abstinence at 12m (from TQD) Validation: CO <= 8 ppm | |
Notes | First included as Evins 2006 based on unpublished data
Used in bupropion+NRT vs NRT comparison. Funding: Massachusetts Department of Mental Health. Medication provided by GlaxoSmithKline. |
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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 | Allocation concealment not described. |
Blinding (performance bias and detection bias) All outcomes | Low risk | "Participants and investigators remained blind to the treatment condition (bupropion or placebo) throughout the follow‐up period." "Assessment of treatment assignment was at the level of chance for both participants and staff at Weeks 4 and 12 for both treatment assignments." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 20% of the bupropion group and 18% of the placebo group were lost to follow‐up at week 12; included as smokers. All other participants followed up at 12m. |