Nicotine Mouth Film for Craving Relief.

Phase 3

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: Nicotine

• Registration Number: NCT01702532
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Nicotine mouth film is a new dosage form of nicotine replacement therapy. The purpose of this study is to investigate the craving relief efficacy of nicotine mouth film by comparing mint nicotine mouth film to nicotine lozenge in light smokers using the provoked craving model. The cues used to provoke a craving episode will be the sight and smell of a lit cigarette and the manipulations required to light a cigarette. The smokers will be denied access to cigarettes for 4 hours prior to the provoked craving session in order to precipitate nicotine withdrawal and an increase level of cigarette craving.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-10-04
• Study First Submitted QC: 2012-10-04
• Study First Posted: 2012-10-08
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-01
• Results First Submitted: 2013-12-12
• Results First Submitted QC: 2013-12-12
• Last Update Submitted: 2013-12-12
• Results First Posted: 2014-01-30
• Last Update Posted: 2014-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• BMI within the range of 19-35 kg/m2;
• Current cigarette smokers who have smoked regularly daily for at least a year,
• Participants who smoke their first cigarette more than 30 minutes after waking up

Exclusion Criteria

• Known or suspected intolerance or hypersensitivity to nicotine (or closely related compounds) or any of the stated ingredients in formulation.
• Any participant whose CO level rises during the sequestration period (i.e., the subject's two expired CO assessments immediately prior to the provoked craving paradigm are higher than the mean baseline CO assessment) and, in the opinion of the investigator, may have smoked during that time.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nicotine Mouth Film	Nicotine	mint nicotine mouth film, buccal administration
Nicotine Lozenge	Nicotine	nicotine lozenge, buccal administration

Primary Outcome Measures

Name	Time	Method
The Change From Pre-dose Post-provocation in Craving Score at 50 Seconds	Pre-dosing post-provocation to 50 seconds	Participants completed a cigarette craving assessment consisting of the following five items: "I have a desire for a cigarette right now; If it were possible I would smoke right now; All I want right now is a cigarette; I have an urge for a cigarette; I crave a cigarette right now. All participants indicated craving intensity on a pre-drawn 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as craving score for each time point.

Secondary Outcome Measures

Name	Time	Method
The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes	Pre-dosing post-provocation to 3, 5, 7, 10, 15, 20, 25, and 30 minutes	Participants completed a cigarette craving assessment consisting of the following five items: "I have a desire for a cigarette right now; If it were possible I would smoke right now; All I want right now is a cigarette; I have an urge for a cigarette; I crave a cigarette right now. All participants indicated craving intensity on a pre-drawn 100 mm VAS ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as the craving score for each time .

Trial Locations

Locations (2)

Central Kentucky Research Associates, Inc.; 🇺🇸 Lexington, Kentucky, United States

Los Angeles Clinical Trials; 🇺🇸 Burbank, California, United States