Nicotine Mouth Film for Craving Relief.

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-12-31

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.

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Detailed Description

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Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nicotine Mouth Film

mint nicotine mouth film, buccal administration

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

Comparison of different dosage forms of nicotine

Nicotine Lozenge

nicotine lozenge, buccal administration

Group Type ACTIVE_COMPARATOR

Nicotine

Intervention Type DRUG

Comparison of different dosage forms of nicotine

Interventions

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Nicotine

Comparison of different dosage forms of nicotine

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes