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. 2023 Jun 19;2023(6):CD013308. doi: 10.1002/14651858.CD013308.pub2

Rose 1994.

Study characteristics
Methods Study design: factorial RCT
Country: USA
Recruitment: community volunteers
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
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
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)