Rose 1994.
Study characteristics | ||
Methods | Study design: factorial RCT Country: USA Recruitment: community volunteers |
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Participants | 48 smokers (≥ 20 cigarettes per day) 40% men, average age 34, average cigarettes per day 27 to 29 | |
Interventions | 2 x 2 factorial trial. Mecamylamine arms combined. 1) Nicotine patch (21 mg/24‐hour for 2 weeks before TQD) 2) Placebo After TQD, both groups received active patch for 6 weeks, counselling at clinic visits and self‐help materials | |
Outcomes | Sustained abstinence at 12 months
Validation: CO ≤ 8 ppm Adverse events: measured at visits until 1 week post‐treatment |
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Notes | This study was supported by grant PBR‐61 from the American Cancer Society (Atlanta, GA); by grant DA 02665 from the National Institute on Drug Abuse (Rockville, MD), and by the Medical Research Service of the Department of Veterans Affairs (Washington, DC). Conflicts of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Assessment of blinding indicated higher‐than‐chance participant awareness of treatment regimen |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropout rate reported (low) |