Assessment of V0018 2.5 mg Effect on Craving

Pierre Fabre

Status and phase: Completed; Phase 2

Conditions: Healthy Highly Dependant Smokers

Treatments: Drug: V0018; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02357888

2014-004387-38 (EudraCT Number)

V00018 PC 2 06

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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45 participants in 2 patient groups

Sequence 1

Experimental group

Description:

Treatment group sequence: Test Product on Day 1 and Placebo on Day 2

Treatment:

Drug: Placebo

Drug: V0018

Sequence 2

Experimental group

Description:

Treatment group sequence: Placebo on Day 1 and Test Product on Day 2

Treatment:

Drug: Placebo

Drug: V0018