Assessment of V0018 2.5 mg Effect on Craving

October 7, 2015 updated by: Pierre Fabre Medicament

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

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

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 ≥ 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 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 on Day 2
Drug: V0018
Oromucosal - Single dose
Drug: Placebo
Oromucosal - Single dose

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pierre Fabre Medicament

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)

May 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

February 3, 2015

First Submitted That Met QC Criteria

February 5, 2015

First Posted (ESTIMATE)

February 6, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

October 8, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • V00018 PC 2 06
  • 2014-004387-38 (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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