Assessment of V0018 1.5 mg Effect on Craving

• Register: ClinicalTrials.gov
• Last refreshed on: 4 May 2015
• Main ID: NCT02359201
• Date of registration: 04/02/2015
• Prospective Registration: No
• Primary sponsor: Pierre Fabre Medicament
• Public title: Assessment of V0018 1.5 mg Effect on Craving
• Scientific title: Double-blind, Randomized, Placebo-controlled, Cross-over Study of the Effect of a 1.5 mg Nicotine Lozenge on Smoking Craving
• Date of first enrolment: February 2015
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02359201
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Françoise MD TONNER
• Affiliation: Pierre Fabre Medicament

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 64 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Smoking

Intervention(s)

Drug: Placebo

Drug: V0018

Primary Outcome(s)

Questionnaire for Smoking Urges Brief (QSU-Brief) (10 items) [Time Frame: 15 minutes]

Secondary ID(s)

2014-004424-21

V00018 PC 2 07

Source(s) of Monetary Support

Please refer to primary and secondary sponsors