Assessment of V0018 1.5 mg Effect on Craving

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02359201
• Other study ID #: V00018 PC 2 07
• Secondary ID: 2014-004424-21
• Status: Completed
• Phase: Phase 2
• First received: February 4, 2015
• Last updated: April 20, 2015
• Start date: February 2015
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Pierre Fabre Medicament
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking

Intervention

Drug:
• V0018
Oromucosal - Single dose
• Placebo
Oromucosal - Single dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Medicament

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No