- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02359201
Assessment of V0018 1.5 mg Effect on Craving
April 20, 2015 updated by: Pierre Fabre Medicament
Double-blind, Randomized, Placebo-controlled, Cross-over Study of the Effect of a 1.5 mg Nicotine Lozenge on Smoking 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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gieres, France
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Sequence 1
Treatment group sequence: Test Product (V0018) on Day 1 and Placebo on Day 2
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Oromucosal - Single dose
Oromucosal - Single dose
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EXPERIMENTAL: Sequence 2
Treatment group sequence: Placebo on Day 1 and Test Product (V0018) on Day 2
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Oromucosal - Single dose
Oromucosal - Single dose
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Questionnaire for Smoking Urges Brief (QSU-Brief) (10 items)
Time Frame: 15 minutes
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Change from study baseline to 15 minutes after treatment intake for the QSU-brief total score and demonstrate any earlier effect.
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15 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Françoise MD TONNER, Pierre Fabre Medicament
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (ACTUAL)
April 1, 2015
Study Completion (ACTUAL)
April 1, 2015
Study Registration Dates
First Submitted
February 4, 2015
First Submitted That Met QC Criteria
February 6, 2015
First Posted (ESTIMATE)
February 9, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
April 21, 2015
Last Update Submitted That Met QC Criteria
April 20, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- V00018 PC 2 07
- 2014-004424-21 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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