Schnoll 2010a.
Study characteristics | ||
Methods | Study design: parallel RCT Country: USA Recruitment: community volunteers |
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Participants | 575 adult smokers of > 10 cigarettes per day for > 1 year, motivated to quit 53% men, average age 48, average cigarettes per day 21.1, average FTND 5.3 |
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Interventions | 1) 21 mg/24‐hour patch for 24 weeks 2) 21 mg/24‐hour patch for 8 weeks, followed by 16 weeks of placebo patch |
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Outcomes | 7‐day PPA at 12 months (also reported for 24 weeks) Validation: CO ≤ 10 ppm Adverse events: measured throughout treatment (24 weeks), and also at 52‐week follow‐up |
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Notes | This study was supported by a Transdisciplinary Tobacco Use Research Center Grant from the National Cancer Institute and the National Institute on Drug Abuse (P50 CA/DA84718 and P50 CA143187). Conflicts of interest: Dr. Lerman has served as a consultant to GlaxoSmithKline, one company that manufactures the nicotine patch. She has also served as a consultant or has received research funding from AstraZeneca, Pfizer, and Novartis. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "computer‐based randomization table" |
Allocation concealment (selection bias) | Unclear risk | Not specified |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "supply of patches was prepackaged and coded with participant information. The computer program linked the randomization to the patch supply, and only the database manager could link identification with treatment allocation." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropouts included as smokers in outcome data. Similar number of dropouts in both groups |