Assessment of V0018 1.5 mg Effect on Craving

NCT02359201 | Completed Phase 2

• 2 other identifiers: V00018 PC 2 072014-004424-21
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking

Keywords

Nicotine replacement therapy; craving; Healthy moderately dependant smokers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Sequence 1

EXPERIMENTAL

Treatment group sequence: Test Product (V0018) on Day 1 and Placebo on Day 2

Drug: V0018; Drug: Placebo

Sequence 2

EXPERIMENTAL

Treatment group sequence: Placebo on Day 1 and Test Product (V0018) on Day 2

Drug: V0018; Drug: Placebo

Interventions

V0018 DRUG

Oromucosal - Single dose

Sequence 1; Sequence 2

Placebo DRUG

Oromucosal - Single dose

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pierre Fabre Medicament: lead

Study Sites (1)

Unknown Facility

Gières, France

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Françoise MD TONNER

  Pierre Fabre Medicament

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: February 9, 2015
• Study Start: February 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 21, 2015

Record last verified: 2015-04

Locations

FR (1)