Assessment of V0018 1.5 mg Effect on Craving

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the reduction of craving after administration of V0018 1.5 mg compared to placebo in healthy moderately dependent smokers.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pierre Fabre Medicament
• Treatments: Nicotine

Criteria

Inclusion Criteria:

• Male and female aged 18 to 64 years

• Smoking ≥ 10 cigarettes/day and < 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