Moolchan 2005.
Study characteristics | ||
Methods | Study design: randomised, 3‐arm trial Country: USA Recruitment: community volunteers |
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Participants | 120 adolescent smokers (aged 13 to 17) (≥ 10 cigarettes per day), motivated to quit 30% male, average age 15, average cigarettes per day: 19 | |
Interventions | 1) Nicotine patch (21 mg, or 14 mg for < 20 cigarettes per day) for 6 weeks plus placebo gum 2) Nicotine gum (4 mg, or 2 mg for < 24 cigarettes per day) for 6 weeks plus placebo patch 3) Double placebo | |
Outcomes | PPA at 6 months
Validation: CO and cotinine Adverse events: measured during treatment visits (treatment length 12 weeks) |
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Notes | This study was supported by funds from the National Institute on Drug Abuse, Intramural Research Program. GlaxoSmithKline (Research Triangle Park, NC) provided study medications (21‐ and 14‐mg Nicoderm, 2‐ and 4‐mg Nicorette, and placebo patch and gum) Conflicts of interest: none |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "randomized ... according to an algorithm held by the National Institute on Drug Abuse Pharmacy, with true replacement of the non‐completers" |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Described as "double‐blind, double‐dummy", but no further information |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Losses to follow‐up were included as failures for cessation. Losses fully reported |