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

Cooney 2009.

Study characteristics
Methods Study design: parallel RCT
Country: USA
Recruitment: community volunteers and referrals from substance abuse clinic
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
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)
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)
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
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