Muramoto Myra L, Ranger-Moore James, Leischow Scott J
Department of Family and Community Medicine University of Arizona Tucson AZ 85719, USA.
Nicotine Tob Res. 2003 Apr;5(2):223-30. doi: 10.1080/1462220031000073270.
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.
尼古丁替代疗法可缓解戒断症状，显著提高戒烟率。口腔黏膜尼古丁（OT-NIC）是一种新型尼古丁给药系统，由含4毫克尼古丁的含片（OT-NIC单位）组成，该含片溶解于颊囊，释放尼古丁经颊黏膜吸收。OT-NIC的理论优势包括无需特殊咀嚼方法，不干扰牙科治疗，具有口腔感官效果，且可根据效果调整剂量。本研究旨在确定OT-NIC在8天戒烟期内抑制尼古丁戒断症状的初步安全性和有效性，并评估口味偏好、感官特性和可接受性。在一项开放标签的自身对照设计中，11名吸烟者根据戒断症状和烟瘾自行使用三种不同口味的OT-NIC。在第1天和第8天，对使用的前三个OT-NIC单位（以随机顺序呈现三种不同口味）给药前后的分数进行测量，以评估戒断症状。每天结束时对口味偏好、吸烟欲望、感官特性、可接受性和OT-NIC的总体表现进行评分。采用广义估计方程分析来处理重复测量设计。使用OT-NIC导致综合戒断评分显著降低，该评分汇总了所有八项症状的分数（在可能的4分范围内下降了0.57分，p<0.01）。焦虑、烟瘾、注意力不集中、不耐烦和坐立不安的戒断分数显著下降。情绪低落、食欲增加和易怒症状未改变。口味偏好顺序为薄荷味优于肉桂味优于原味。感官特性的可接受性和评分良好，OT-NIC耐受性良好，无严重不良反应。总之，OT-NIC有望成为一种潜在的戒烟新辅助手段。
