Evaluation of the effects of oral nicotine substitutes (1.5mg lozenge) on the craving in moderate smokers placed in non-smoking situations. A randomized, double-blind, placebo-controlled parallel groups trial.

Cessation of smoking

Questionnaire of Smoking Urges (QSU)-brief Total score change from baseline at 30 minutes and any earlier times using.

QSU-brief Total score improvement from Baseline., QSU-brief Total score change from baseline at 45, 60 and 90 minutes., Area under curve of QSU-brief Total score improvement from baseline over 30 minutes., • VAS Global evaluation of the craving during the day. • Number of lozenges., Change from baseline Minnesota Nicotine Withdrawal Scale (MNWS) score at the end of Day 1., 5 points Lickert scale., Incidence, severity, causality and outcomes of treatment-emergent adverse events (TEAEs), treatment emergent serious adverse events (TESAEs). Clinically significant abnormalities in physical examinations and vitals signs measurements.

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