Nicotine Mouth Film for Craving Relief.

Study Overview
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Brief Summary
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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.

Official Title
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A Study to Evaluate Relief of Provoked Acute Craving by Nicotine Mouth Film and Nicotine Lozenge

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: Nicotine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicotine Mouth Film<br>mint nicotine mouth film, buccal administration | Drug: Nicotine<br>* Comparison of different dosage forms of nicotine<br>|
| Active Comparator: Nicotine Lozenge<br>nicotine lozenge, buccal administration | Drug: Nicotine<br>* Comparison of different dosage forms of nicotine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change From Pre-dose Post-provocation in Craving Score at 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. | Pre-dosing post-provocation to 50 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change From Pre-dose Post-provocation in Craving Score at 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 . | Pre-dosing post-provocation to 3, 5, 7, 10, 15, 20, 25, and 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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provoked craving