Cooney 2009.
Study characteristics | ||
Methods | Study design: parallel RCT Country: USA Recruitment: community volunteers and referrals from substance abuse clinic |
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Participants | 96 alcohol‐dependent tobacco smokers (≥ 15 cigarettes per day) 75% men, average age 45, average cigarettes per day 25, motivated to quit, average FTND 6, 31% veterans |
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Interventions | 1) Nicotine patch (titrated, 21 mg/day for 8 weeks, 14 mg/day for 2 weeks, 7 mg/day for 2 weeks) plus nicotine gum (2 mg for 24 weeks, ad lib but advised 6 to 20/day) 2) Nicotine patch plus placebo gum (doses as above) |
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Outcomes | Continuous abstinence at 12 months (with 30‐day grace period immediately following quit date) Validation: CO < 10 ppm Adverse events: measured at 2 weeks, 3 months and 6 months (gum or placebo gum use continued until 6 months) |
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Notes | This study was supported by award number R01 AA011197 and P50 AA1563 from the National Institute on Alcohol Abuse and Alcoholism and by a MIRECC award from the Department of Veterans Affairs. Conflicts of interest: JC and KS have worked as promotional speakers for Pfizer |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "urn randomization computer program that balanced the two groups for history of previous substance use treatment, age, sex, baseline drinks/drinking day and baseline [cigarettes per day]." |
Allocation concealment (selection bias) | Low risk | Randomisation procedure required participant characteristics to be provided before allocation assigned |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Quote: "Double blind." "Research assistants who collected these data were blind to medication assignment and did not conduct psychosocial treatments." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 26 dropouts at 12 months included as smokers; all previously verified as having relapsed |