Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Product and NiQuitin™ Lozenge: A Study in Healthy Smokers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- McNeil AB
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Areas under the linearly interpolated urges to smoke vs. time curve evaluated in a hierarchical order starting with the 5 minutes' evaluation (AUC5min, AUC3min, AUC1min)
研究概览
简要总结
A comparison of two products for oral nicotine replacement with respect to relief of urges to smoke after single doses of nicotine.
详细描述
This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 2 mg and 4 mg, respectively, after 5 hours of witnessed nicotine abstinence with respect to urges to smoke during the first 5 minutes after start of treatment. Single doses of each treatment are given during separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 200 healthy smokers between 19-55 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion, and who smoke within 30 minutes of waking up. Subjects, study personnel and monitor will be aware of what type of product is administered at a given visit, but not of the administered dose of the lozenge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy smokers, smoking at least 10 cigarettes daily during at least one year preceding inclusion, and smoking within 30 minutes of waking up.
- •Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
- •A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.
排除标准
- •Pregnancy, lactation or intended pregnancy.
- •Use of NRT, bupropion, or varenicline, or history of a quit attempt later than 3 months before screening visit.
- •Treatment with an investigational product, other than those described in the protocol, between 1 month preceding the first treatment visit and the last treatment visit of the study.
- •Prior regular use of any of the investigational products.
研究组 & 干预措施
LHN1548
Two single doses of an experimental Nicotine Replacement Therapy (NRT) 2 mg, with five hours between treatments. Seven hours duration of total follow-up period.
干预措施: Nicotine (Drug)
2019706
Two single doses of Nicotine Lozenge 2 mg, with five hours between treatments. Seven hours duration of total follow-up period.
干预措施: Nicotine (Drug)
2020005
Two single doses of Nicotine Lozenge 4 mg, with five hours between treatments. Seven hours duration of total follow-up period.
干预措施: Nicotine (Drug)
结局指标
主要结局
Areas under the linearly interpolated urges to smoke vs. time curve evaluated in a hierarchical order starting with the 5 minutes' evaluation (AUC5min, AUC3min, AUC1min)
时间窗: from time zero following 5 hours of smoking abstinence (baseline), until 5 minutes, until 3 minutes, and until 1 minute, respectively
次要结局
- Areas under the linearly interpolated urges to smoke vs. time curve (AUC10min)(from time zero following 5 hours of smoking abstinence (baseline), until 10 minutes thereafter)
- Time to a 25%, 50%, 75%, and 90% reduction from baseline intensity of urges to smoke score(from time zero following 5 hours of smoking abstinence (baseline), until 2 hours thereafter)
- Proportion of subjects reaching 25%, 50%, 75% and 90% reduction of urges to smoke(from time zero following 5 hours of smoking abstinence (baseline), until 2 hours thereafter)
- Study treatment acceptability, evaluated using pair-wise treatment comparisons of ordered categorical-scale assessments(At the end of three separate visits, at least 36 hours apart)