NCT01347112

Methods	Phase II/III randomised quadruple‐blind placebo‐controlled trial
Participants	33 adult alcohol‐dependent smokers
Interventions	Varenicline 1 mg bid for 12 weeks vs placebo
Outcomes	Prolonged abstinence at 12 weeks (end of treatment), and at 6m Abstinence self‐reported, not biochemically confirmed
Treatment type	VARENICLINE
Notes	Study results posted on www.clinicaltrials.gov May 2014
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not stated
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Described as "double‐blind"
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Selective reporting (reporting bias)	High risk	Results unpublished; available only on www.ClinicalTrials.gov
Other bias	High risk	Trial planned to include 70 participants, but recruited only 33