Conditions: Smoking
Keywords: smoking cessation nicotine lozenge nicotine replacement therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 723
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 2 mg nicotine lozenge arm 2: 2 mg placebo arm 3: 4 mg nicotine lozenge arm 4: 4 mg placebo

Interventions: intervention 1: Nicotine intervention 2: Placebo
Intervention descriptions: intervention 1: 2 mg or 4 mg nicotine lozenge intervention 2: placebo lozenge

Protocol document: