De Dios 2012

Methods	Country: Rhode Island and Massachussetts, USA Setting: Butler Hospital, RI Aim: To assess the relative efficacy of varenicline and NRT on smoking cessation in Latino light smokers (< 10 CPD) Study Design: Feasibility double‐blind placebo‐controlled 3‐arm RCT Dates conducted: April 2010 ‐ July 2010 Analysis: No power calculation, as this was a pilot study with small sample size
Participants	32 Latino volunteer light smokers (≤ 10 CPD), aged 18+, willing to set a quit date. Mean age 42, 53.1% women, mean CPD 7.6, mean FTND 2.9. Allocated to varenicline (10), NRT (11), placebo (11) Exclusions: Usual pharmacological conditions, on NRT or smokeless tobacco, history of suicide attempts, chronic or acute psychiatric disorder, employed as a pilot, driver or heavy machinery operator
Interventions	1. Varenicline 12‐wk treatment course, titrated 1st wk 2. NRT 24‐hour patch: 12 wks: 4 wks @ 14 mg, 8 wks @ 7 mg 3. Varenicline‐placebo, i.e. identical tablet, same regimen All participants received a 30‐minute face‐to‐face "culturally informed" smoking cessation behavioural intervention, + a non‐tailored self‐help brochure, all available in both English and Spanish. All participants were compensated for attendance, and could receive travel vouchers if necessary
Outcomes	Primary: 7‐day PPA at 6m Secondary: 7‐day PPA at wks 1, 2, 1m, 2m, 3m, 4m; adherence Validation: CO < 5 ppm; salivary cotinine (not for the NRT group) > 10 mg/nL Adverse events not reported in detail, although study reports that "There was no pattern that suggested a higher side‐effect profile for those in the varenicline group"
Treatment type	Medication: VARENICLINE / NRT
Notes	New for 2016 update Funding: NCI grant R01CA0129226‐S1 (De Dios); NIDA grant K24‐DA000512 (Stein); NIDA grant R01‐DA1234, NCI grant K07‐CA95623 (Stanton)
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	"Study personnel and participants in the two‐pill groups (varenicline and varenicline‐placebo) were blinded to treatment condition. The research pharmacy maintained the study blind." NRT group could not be blinded to treatment; outcome assessment blinding not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	Losses to follow‐up were fully reported; per protocol and ITT analyses conducted
Selective reporting (reporting bias)	Unclear risk	None noted
Other bias	Unclear risk	None noted