Efficacy of oral transmucosal nicotine lozenge for suppression of withdrawal symptoms in smoking abstinence

Abstract

Nicotine replacement therapy relieves withdrawal symptoms, significantly improving smoking cessation rates. Oral transmucosal nicotine (OT-NIC) is a novel nicotine delivery system consisting of a lozenge (OT-NIC unit) containing 4 mg of nicotine, which is dissolved in the cheek pouch, releasing nicotine for absorption through the buccal mucosa. Theoretical advantages of OT-NIC include that it does not require special chewing methods or interfere with dental work, it provides sensory oral effect, and it can be dosed to effect. This study aimed to determine the preliminary safety and efficacy of OT-NIC for suppression of nicotine withdrawal symptoms over 8 days of smoking abstinence and to assess flavor preference, sensory characteristics, and acceptability. In an open-label, within-subjects design, 11 smokers used three different flavors of OT-NIC ad lib in response to withdrawal symptoms and craving. On days 1 and 8, withdrawal symptoms were measured with pre- and postadministration scores for each of the first three OT-NIC units used (three different flavors presented in random order). Flavor preference, desire to smoke, sensory characteristics, acceptability, and overall OT-NIC performance were rated at the end of each day. A generalized estimating equation analysis was conducted to account for the repeated-measures design. Use of OT-NIC resulted in a significant decrease in a composite withdrawal score aggregating scores from all eight symptoms (decline of.57 units in a possible range of 4, p<.01). Withdrawal scores for anxiety, craving, difficulty concentrating, impatience, and restlessness significantly decreased. Depressed mood, increased appetite, and irritability did not change. Order of flavor preference was peppermint over cinnamon over plain. Acceptability and ratings for sensory characteristics were favorable, and OT-NIC was well tolerated with no serious adverse effects. In conclusion, OT-NIC showed promise as a potential new aid for smoking cessation.