Efficacy and Safety Study of Nicotine Mint Lozenge (2mg and 4mg) in Smoking Cessation

Summary

A multi-center, randomized, double-blind, placebo-controlled, 4-arm clinical study to evaluate efficacy and safety of nicotine lozenge (2mg and 4mg) in smoking cessation in adult cigarette smokers who are motivated to quit smoking. Successful quitters or participants who smoke occasionally will be followed up after week 24 till 12 months.

Timeline

Start

2009-05

Primary completion

2011-03

Completion

2011-03

Outcome

Missed primary endpoint

registry Nicotine Lozenge 2 mg (Low Dependence Smokers) vs Placebo Lozenge (Low Dependence Smokers); p = 0.3851; Odds Ratio (OR) 1.22 (95% CI 0.78 to 1.92) NCT00985985 ↗

registry Nicotine Lozenge 4 mg (High Dependence Smokers) vs Placebo Lozenge (High Dependence Smokers); p = 0.0565; Odds Ratio (OR) 1.82 (95% CI 0.99 to 3.32) NCT00985985 ↗

Publications

• Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nicotine	Unknown	2 mg	—
Subject	Nicotine	Unknown	4 mg	—

Indications

No indication recorded.