Assessment of V0018 2.5 mg Effect on Craving

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02357888

Enrollment

Registered

2015-02-06

Start date

2015-02-28

Completion date

2015-05-31

Last updated

2015-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Highly Dependant Smokers

Keywords

Nicotine replacement therapy, craving

Brief summary

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.

Interventions

DRUGV0018

Oromucosal - Single dose

DRUGPlacebo

Oromucosal - Single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Questionnaire for Smoking Urges Brief (QSU-Brief) (10 items)	15 minutes	Change from study baseline to 15 minutes after treatment intake for the QSU-brief total score and demonstrate any earlier effect.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026