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Tobacco Cessation and Prevention: Smoking and Health |

A Multicenter Randomized, Double-Blind, Parallel, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Nicotine Mint Lozenge (2 mg and 4 mg) in Smoking Cessation

Dan Xiao, PhD; Jian Kang, PhD; Mitchell Kotler; Chen Wang, PhD
Author and Funding Information

Tobacco Medicine and Tobacco Cessation Center, China-Japan Friendship Hospital, Beijing, China


Copyright 2016, American College of Chest Physicians. All Rights Reserved.


Chest. 2016;149(4_S):A589. doi:10.1016/j.chest.2016.02.615
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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.

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