Assessment of V0018 1.5 mg Effect on Craving

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.

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Key information

Conditions

Smoking Behavior

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Gières, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

V0018

Drug

Oromucosal - Single dose

Placebo

Drug

Oromucosal - Single dose

Primary outcomes

Questionnaire for Smoking Urges Brief (QSU-Brief) (10 items)

Time frame: 15 minutes

Change from study baseline to 15 minutes after treatment intake for the QSU-brief total score and demonstrate any earlier effect.

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Registry information

Official study title

Double-blind, Randomized, Placebo-controlled, Cross-over Study of the Effect of a 1.5 mg Nicotine Lozenge on Smoking Craving

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Feb 9, 2015
Registry last updated: Apr 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed