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Assessment of V0018 1.5 mg Effect on Craving

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02359201
Recruitment Status : Completed
First Posted : February 9, 2015
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Smoking Drug: V0018 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Placebo-controlled, Cross-over Study of the Effect of a 1.5 mg Nicotine Lozenge on Smoking Craving
Study Start Date : February 2015
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: Sequence 1
Treatment group sequence: Test Product (V0018) on Day 1 and Placebo on Day 2
Drug: V0018
Oromucosal - Single dose

Drug: Placebo
Oromucosal - Single dose

Experimental: Sequence 2
Treatment group sequence: Placebo on Day 1 and Test Product (V0018) on Day 2
Drug: V0018
Oromucosal - Single dose

Drug: Placebo
Oromucosal - Single dose




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02359201


Locations
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France
Gieres, France
Sponsors and Collaborators
Pierre Fabre Medicament
Investigators
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Study Director: Françoise MD TONNER Pierre Fabre Medicament
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Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT02359201    
Other Study ID Numbers: V00018 PC 2 07
2014-004424-21 ( EudraCT Number )
First Posted: February 9, 2015    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: April 2015
Keywords provided by Pierre Fabre Medicament:
Nicotine replacement therapy
craving
Healthy moderately dependant smokers