Assessment of V0018 2.5 mg Effect on Craving

Double-blind, Randomized, Placebo-controlled, Cross-over Study of the Effect of a 2.5 mg Nicotine Lozenge on Smoking Craving

The purpose of this study is to evaluate the reduction of craving and its time course after administration of V0018 2.5 mg compared to placebo in healthy highly dependant smokers.

Inclusion Criteria:

• Male and female aged 18 to 64 years
• Smoking ≥ 20 cigarettes/day continuously for the last two years
• With a first cigarette smoked within 30 min after waking
• Not currently in the process of quitting smoking

Exclusion Criteria:

Related to pathologies

• Current or recurrent buccal lesions which, in the opinion of the investigator, would interfere with the assessment of the different parameters
• Hyposalivation or asialia
• Intolerance to lactose, or any pathology that could cause endogenous production of carbon monoxide (CO)

Related to treatments

• Use of antidepressants within the last three months
• Use of sedatives, hypnotics, tranquilizers or any other addictive agents within the last 3 months
• Routine use of tobacco other than cigarettes
• Regular use for more than one week of any treatment for smoking cessation (gum, patch, inhaler, lozenge, tablet, bupropion, varenicline) and other smokeless tobacco products (including e-cigarettes) within three months
• History of hypersensitivity to nicotine, peanut, soya or to any of the excipients of study treatment
• Intolerance to fructose
• History of phenylketonuria (aspartame)

For women of childbearing potential:

• Is pregnant or in post-partum period or a nursing mother