Background: Varenicline is the most effective sole pharmacotherapy for smoking cessation. If used in combination with nicotine replacement therapy (NRT) cessation rates may be further improved.   

Objective: To determine if hospitalized smokers treated with varenicline and NRT lozenges achieved higher prolonged smoking abstinence rates compared to those treated with varenicline alone.

Methods: A double-blind, placebo-controlled trial was conducted in adult inpatients with a history of smoking ≥10 cigarettes/day. 12-weeks varenicline was initiated during hospitalization at standard doses in all participants. Participants were randomized to additionally use NRT (2mg) or placebo lozenges if there was an urge to smoke. Behavioural support (Quitline) was offered to all participants. Logistic regression models examined the effect of intervention on abstinence.

Results: We randomized 320 participants (mean±SD age 52.5±12.1 years, 57.2% male). Biochemically verified and self-reported abstinence favoured combination therapy: 1) self-reported 6-months prolonged abstinence (OR=1.49 [95%CI 0.93-2.37]); 2) 7-day point prevalence abstinence at 6-months (OR=1.70 [95%CI 1.04-2.78]); 3) biochemically verified 12-months prolonged abstinence (OR=2.27 [95%CI 0.84-6.14]); 4) self-reported 12-months prolonged abstinence (OR=1.81 [95%CI 1.07-3.06]); and 5) 7-day point prevalence abstinence at 12-months (OR=1.79 [95%CI 1.06-3.01]).

Medicine-related adverse events at 6 months were similar in the two groups – intervention 102 (74.5%) vs control 86 (68.3%).

Conclusions: The combination of varenicline and NRT lozenges improved abstinence following hospitalization, without compromising safety.