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

Phase 3 Completed 723 enrolled GlaxoSmithKline

RandomizedParallel-groupDouble-blindTreatment

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

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.