Assessment of V0018 2.5 mg Effect on Craving

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Highly Dependant Smokers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sequence 1

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

Group Type EXPERIMENTAL

V0018

Intervention Type DRUG

Oromucosal - Single dose

Placebo

Intervention Type DRUG

Oromucosal - Single dose

Sequence 2

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

Group Type EXPERIMENTAL

V0018

Intervention Type DRUG

Oromucosal - Single dose

Placebo

Intervention Type DRUG

Oromucosal - Single dose

Interventions

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V0018

Oromucosal - Single dose

Intervention Type DRUG

Placebo

Oromucosal - Single dose

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes