Nicotine Mouth Film for Craving Relief.
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | September 2012 |
| End Date: | December 2012 |
| Contact: | US GSK Clinical Trials Call Center |
| Email: | GSKClinicalSupportHD@gsk.com |
| Phone: | 877-379-3718 |
A Study to Evaluate Relief of Provoked Acute Craving by Nicotine Mouth Film and Nicotine Lozenge
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.
Inclusion Criteria:
- BMI within the range of 19-35 kg/m2;
- Current cigarette smokers who have smoked regularly daily for at least a year,
- 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 subject 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.
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