Rose 2006.
Study characteristics | ||
Methods | Study design: factorial RCT Country: USA Recruitment: community volunteers |
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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 |
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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. |
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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 | 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 |