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. 2023 May 5;2023(5):CD006103. doi: 10.1002/14651858.CD006103.pub8

Hurt 2018.

Study characteristics
Methods Country: USA
Study design: phase II/III randomised quadruple‐blind placebo‐controlled trial
Study period: July 2011‐April 2013
Participants 33 adult alcohol‐dependent smokers
Interventions Varenicline 1 mg 2 x day for 12 weeks vs placebo
Outcomes PA at 12 weeks (EoT), and at 6 months
Abstinence self‐reported and biochemically validated by exhaled CO
Notes Study results posted on www.clinicaltrials.gov May 2014
Study funding: "This current study was supported by grant R21 DA30645 to Dr Richard D. Hurt and Pfizer IIR to Dr J. Taylor Hays"
Author declaration of interests: "R.T.H. reports research grants from Pfizer and the NIH. J.T.H. reports research grants from Pfizer. J.O.E. reports grants from Pfizer during the conduct of the study and grants from Takeda, the U.S. Department of Defense and the NIH outside the submitted work. R.D.H. reports a research grant from the NIH. All other others have nothing to disclose"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Stated "randomized" but method not reported
Allocation concealment (selection bias) Unclear risk Not stated
Blinding (performance bias and detection bias)
All outcomes Low risk "Pharmacy personnel dispensed study medication into containers labeled with study identification numbers. Study participants, investigators, and pharmacy staff were blinded to treatment assignment." Abstinence biochemically validated
Incomplete outcome data (attrition bias)
All outcomes High risk High attrition rates: 4/16 varenicline group (1 withdrawal, 3 lost), 12/17 placebo group (7 withdrawals, 5 lost)
Selective reporting (reporting bias) Low risk Pre‐specified outcomes from NCT record all reported in results paper