Problem/Objective: Smokers' nicotine dependence levels may influence quitting outcomes. Quitting rates for varenicline, a pharmacotherapy designed for smoking cessation, were evaluated to determine whether baseline nicotine dependence influences quitting. Methods: Pooled data were analyzed from 3 randomized, double-blind, multicenter trials. Subjects received varenicline 1mg BID (n=945) or placebo (n=805) for 12 weeks, followed by 40 weeks non-drug follow-up. The primary endpoint was carbon monoxide-confirmed, 4-week continuous abstinence rate (CAR) for Weeks 9-12, which was 45.9% for varenicline and 16.9% for placebo (odds ratio [OR] 4.13; 95% confidence interval [CI] 3.29, 5.18). Outcomes were analyzed by Fagerström Test for Nicotine Dependence (FTND) score representing mild (0-3), moderate (4-6), and severe (7-10) dependence, and by cigarettes per day (CPD) representing, low (<20), medium (20-<30), and high (≥30) smoking levels. Results: For all FTND scores, Week 9-12 CAR was greater for varenicline than placebo: mild 55.1% vs 18.9% (OR 5.49; CI 3.38, 8.93); moderate 48.4% vs 20.7% (OR 3.42; CI 2.50, 4.67); and severe 35.9% vs 9.6% (OR 5.28; CI 3.25, 8.59). Similarly, Week 9-12 CAR by CPD was higher for varenicline than placebo: low 52.2% vs 22.8% (OR 3.64; CI 2.49, 5.32); medium 44.9% vs 14.4% (OR 4.76; CI 3.37, 6.62); and high 39.5% vs 14.3% (OR 3.85; CI 2.32, 6.38). Effects persisted on CAR to Week 52 by FTND score and CPD. Conclusions: As the treatment effect was similar for each FTND and CPD subgroup, these data suggest that varenicline is efficacious for smoking cessation regardless of nicotine dependence at baseline.