SESSION TITLE: Smoking and Health
SESSION TYPE: Original Investigation Slide
PRESENTED ON: Saturday, April 16, 2016 at 05:15 PM - 06:15 PM
PURPOSE: To evaluate the efficacy in smoking cessation and safety of 2mg and 4mg Nicotine Mint Lozenges in Chinese adult smokers.
METHODS: This was a multi-centre, randomized, stratified, double-blind, placebo-controlled, parallel-group study. The low-dependence stratum had 483 smokers randomized (241 to active 2mg nicotine lozenge and 242 to placebo lozenge). The high-dependent stratum had 240 smokers randomized (120 to active 4mg nicotine lozenge and 120 to placebo lozenge). The primary endpoint was successful smoking cessation at 6 weeks post-quit; this was defined as continuous abstinence from smoking for the 28-day period up to and including the 6-week visit (verified by carbon monoxide (CO) measurement). Cochran-Mantel-Haenszel (CMH) tests were performed to compare quit rates between active nicotine and placebo separately for the high and low dependence strata.