Assessment of V0018 2.5 mg Effect on Craving

Study Overview
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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.

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

Conditions
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Healthy Highly Dependant Smokers

Intervention / Treatment
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* Drug: V0018
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>Treatment group sequence: Test Product on Day 1 and Placebo on Day 2 | Drug: V0018<br>* Oromucosal - Single dose<br>Drug: Placebo<br>* Oromucosal - Single dose<br>|
| Experimental: Sequence 2<br>Treatment group sequence: Placebo on Day 1 and Test Product on Day 2 | Drug: V0018<br>* Oromucosal - Single dose<br>Drug: Placebo<br>* Oromucosal - Single dose<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nicotine replacement therapy, craving