Rose 1998.
Study characteristics | ||
Methods | Study design: factorial RCT Country: USA Recruitment: community volunteers |
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Participants | 80 smokers (≥ 20 cigarettes per day) 51% men, average age 41, average cigarettes per day: 30 | |
Interventions | 2 x 2 factorial trial. Mecamylamine pretreatment arms combined 1) Nicotine patch (21 mg/24‐hour for 4 weeks before TQD) 2) Placebo After TQD, both groups received active patch and mecamylamine for 6 weeks, counselling at clinic visits and self‐help materials | |
Outcomes | Sustained abstinence at 6 months
Validation: CO ≤ 8 ppm Adverse events: measured at visits during treatment |
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Notes | This study was supported by Grant PBR‐61 from the American Cancer Society and conducted with the assistance of the Medical Research Service of the Department of Veterans Affairs. Conflicts of interest: Jed E. Rose is a patent holder of the nicotine—mecamylamine combination treatment tested in this study |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "participants were randomly assigned" |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding (performance bias and detection bias) All outcomes | High risk | Placebo patches not used, but participants were blinded to mecamylamine |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Early dropouts (up to 4 weeks pre‐cessation) reported, but not long‐term |