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

Abstract

OBJECTIVE:

To evaluate the efficacy in smoking cessation and safety of 2 and 4 mg nicotine mint lozenges in Chinese adult smokers.

METHODS:

This was a multicenter, randomized, stratified, double-blind, placebo-controlled, parallel-group study. The low-dependence stratum included 483 smokers (241 randomized to active 2 mg nicotine lozenge and 242 to placebo lozenge). The high-dependence stratum included 240 smokers (120 randomized to active 4 mg nicotine lozenge and 120 to placebo lozenge). The primary endpoint was successful smoking cessation at 6 weeks postquit, defined as continuous abstinence from smoking for the 28-day period up to and including the 6-week visit (verified by CO measurement). Cochran-Mantel-Haenszel tests were performed to compare quit rates between active nicotine and placebo separately for the high-dependence and low-dependence strata.

RESULTS:

The primary analysis showed that in the low-dependence (2 mg) stratum, 59 subjects (24.5%) of 241 in the active nicotine group and 52 subjects (21.5%) of 242 in the placebo group were successful quitters (P = .3851). In the high-dependence (4 mg) stratum, 37 subjects (30.8%) of 120 in the active nicotine group and 24 subjects (20.2%) of 119 in the placebo group were successful quitters (P = .0565).

CONCLUSIONS:

The 4 mg nicotine lozenge provided a directionally significant improvement in smoking cessation rates compared with placebo in Chinese adult smokers with high nicotine dependence for the primary endpoint. The 2 mg nicotine lozenge provided higher, but nonsignificant, smoking cessation rates than placebo. Both nicotine lozenges were generally well tolerated in Chinese adult smokers.

• Authors: Dan Xiao, Mitchell Kotler, Jian Kang, Chen Wang
• Journal: Journal of addiction medicine (J Addict Med) 2020 Jan/Feb Vol. 14 Issue 1 Pg. 69-77 ISSN: 1935-3227 [Electronic] United States
• PMID: 31658113 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Nicotinic Agonists
• Nicotine

Topics

• Adult
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Humans
• Logistic Models
• Male
• Mentha
• Middle Aged
• Nicotine (administration & dosage, therapeutic use)
• Nicotinic Agonists (administration & dosage, therapeutic use)
• Smoking Cessation (methods)
• Tobacco Use Cessation Devices
• Tobacco Use Disorder (drug therapy)