This study is designed to assess the ability of the mint nicotine mouth strip to relieve provoked cigarette craving in light smokers compared to nicotine lozenge and nicotine gum.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
nicotine in the form of a mouth strip, lozenge and gum
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States
Mean Change From Baseline in Nicotine Craving Score on a VAS
Participants completed a nicotine craving assessment consisting of 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 their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.
Time frame: Baseline, 50 seconds, 3, 5, 7, 10, 15, 20, 25 and 30 minutes post treatment administration
Log Transformed Area Under the Curve of Nicotine Craving Score (AUC)
AUC between the baseline (pre-dose) and the time of measurement of craving on-treatment was determined.
Time frame: Baseline, 50 seconds, 3, 5, 7, 10, 15, 20, 25, and 30 minutes post treatment administration
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