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

Rose 2006.

Study characteristics
Methods Study design: factorial RCT
Country: USA
Recruitment: community volunteers
Participants 96 smokers (≥ 20 cigarettes per day), motivated to quit
47% men, average age 45, average cigarettes per day: 29
Interventions 2 x 3 x 3 factorial trial ‐ only pre‐cessation patch condition contributes to meta‐analysis, other conditions combined.
1) Nicotine patch (21 mg/24‐hour for 2 weeks before TQD)
2) Placebo
All participants received mecamylamine 2.5 mg twice a day for 4 weeks post‐TQD, and either 0 mg, 21 mg or 42 mg patch
Outcomes PPA at 6 months
Validation: CO ≤ 8 ppm
Adverse events: not measured
Notes Post‐quit conditions did not affect cessation, data not reported in paper
This study was supported by grant DA 02665 from the National Institute on Drug Abuse.
Conflicts of interest: Dr. Rose is an inventor named on several patent applications dealing with nicotine skin patch and combination nicotine/mecamylamine treatment, and receives royalties from sales of certain nicotine patches. Dr. Rose receives research funding from Phillip Morris USA, Inc.
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 Patch assignment was blinded, but not cigarette type. After quit date, all participants received mecamylamine
Incomplete outcome data (attrition bias)
All outcomes Unclear risk 8.3% of participants dropped out before TQD, and were excluded from analyses