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

Kalman 2006.

Study characteristics
Methods Study design: parallel RCT
Country: USA
Recruitment: Veterans Admin Medical Centre and community‐based substance abuse treatment facility
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)
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
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