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OpenTrials
Completed

NCT Number: NCT02357888

Assessment of V0018 2.5 mg Effect on 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.

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Key information

Conditions

Healthy Highly Dependant Smokers

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Gières, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

V0018

Drug

Oromucosal - Single dose

Placebo

Drug

Oromucosal - Single dose

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 6, 2015
Registry last updated
Oct 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.