Kalman 2006.
Study characteristics | ||
Methods | Study design: parallel RCT Country: USA Recruitment: Veterans Admin Medical Centre and community‐based substance abuse treatment facility |
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Participants | 130 smokers (≥ 20 cigarettes per day with history of alcohol dependence and ≥ 2 month abstinence from alcohol and illicit drugs) 84% men, average age 47, average cigarettes per day: 32 | |
Interventions | Dose response trial 1) Nicotine patch (42 mg (2 x 21 mg)) 4 weeks, then tapered for 8 weeks 2) Nicotine patch (21 mg and placebo) for 4 weeks then same tapering as group 1 | |
Outcomes | Abstinence at 36 weeks (26 weeks post‐EOT) (7‐day PPA)
Validation: CO < 10 ppm Adverse events: measured during treatment (up to 12 weeks post‐quit date) |
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Notes | This study was supported by National Institute on Drug Abuse Research Grant R29‐DA11713‐01. GlaxoSmithKline Beecham provided the nicotine patches for this project. Conflicts of interest: not reported |
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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 | Quote: "[participants] were randomly assigned". |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Double‐blind for 4 weeks, then open‐label dose tapering phase |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 10 dropped out before treatment, and 4 excluded for protocol violation. Analyses were ITT, with dropouts reported and counted as failures |