Assessment of V0018 1.5 mg Effect on Craving

Phase 2

Completed

• Conditions: Smoking
• Interventions: Drug: V0018; Drug: Placebo

• Registration Number: NCT02359201
• Lead Sponsor: Pierre Fabre Medicament

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-04
• Study First Submitted QC: 2015-02-06
• Study First Posted: 2015-02-09
• Status Verified: 2015-04
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-20
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 2	Placebo	Treatment group sequence: Placebo on Day 1 and Test Product (V0018) on Day 2
Sequence 1	V0018	Treatment group sequence: Test Product (V0018) on Day 1 and Placebo on Day 2
Sequence 1	Placebo	Treatment group sequence: Test Product (V0018) on Day 1 and Placebo on Day 2
Sequence 2	V0018	Treatment group sequence: Placebo on Day 1 and Test Product (V0018) on Day 2

Primary Outcome Measures

Name	Time	Method
Questionnaire for Smoking Urges Brief (QSU-Brief) (10 items)	15 minutes	Change from study baseline to 15 minutes after treatment intake for the QSU-brief total score and demonstrate any earlier effect.