Nicotine Mouth Film for Craving Relief.
Completed · Phase 3
Conditions studied: Smoking Cessation
In brief
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.
Key facts
- Study ID
- NCT01702532
- Run by
- GlaxoSmithKline
- People needed
- 320
- Starts
- 2012-09-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2014-01-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Los Angeles Clinical Trials — Burbank, California, United States
- Central Kentucky Research Associates, Inc. — Lexington, Kentucky, United States
Full record on ClinicalTrials.gov
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