Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2020 Jan/Feb;14(1):69-77.
doi: 10.1097/ADM.0000000000000547.

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

Affiliations
Randomized Controlled Trial

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

Dan Xiao et al. J Addict Med. 2020 Jan/Feb.

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.

PubMed Disclaimer

Conflict of interest statement

The authors report no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Continuous abstinence rate at week 6 in per-protocol set (secondary efficacy parameter). CAR, continuous abstinence rate.
FIGURE 2
FIGURE 2
Continuous abstinence rate in full analysis set over time. P < 0.05 versus corresponding placebo based on Cochran–Mantel–Haenszel test (adjusted by center). CAR, continuous abstinence rate.

References

    1. Ashare RL, Wileyto EP, Perkins KA, et al. The first 7 days of a quit attempt predicts relapse: validation of a measure for screening medications for nicotine dependence. J Addict Med 2013; 7:249–254. - PMC - PubMed
    1. Asma S, Mackay J, Song SY, et al. The Global Adult Tobacco Survey Atlas. Atlanta, GA: CDC Foundation; 2015.
    1. Baker TB, Piper ME, et al. Transdisciplinary Tobacco Use Research Center (TTURC) Tobacco Dependence. Time to first cigarette in the morning as an index of ability to quit smoking: implications for nicotine dependence. Nicotine Tobacco Res 2007; 9: Suppl 4: S555–S570. - PMC - PubMed
    1. Benowitz NL. Pharmacology of nicotine: addiction and therapeutics. Annu Rev Pharmacol Toxicol 1996; 36:597–613. - PubMed
    1. Cheung KL, de Ruijter D, Hiligsmann M, et al. Exploring consensus on how to measure smoking cessation. A Delphi study. BMC Public Health 2017; 17:890. - PMC - PubMed

Publication types