Evaluation of the Nicotine Mini Lozenge in Relief of Provoked Acute Craving
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 323
- 试验地点
- 1
- 主要终点
- Change From Post-cue Baseline in Nicotine Craving Score at 5 Minutes
研究概览
简要总结
Evaluation of the ability of a nicotine mini lozenge to provide early relief of craving for a cigarette in smokers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current cigarette smokers who have smoked regularly, and smoke more than 20 cigarettes per day on a regular basis for at least a year;
- •Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history.
排除标准
- •Any disease that may interfere with the absorption, metabolism or excretion of the study product.
- •A medical condition that might jeopardise the safety of the subject or the validity of the study results. For example, recent myocardial infarction or cerebrovascular incident (within 12 weeks of the screening visit), phenylketonuria, unstable or worsening angina pectoris, Prinzmetals angina or severe cardiac arrhythmia
研究组 & 干预措施
Nicotine Polacrilex mint mini lozenge
干预措施: oral nicotine (Drug)
placebo
mint mini lozenge with no active
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Post-cue Baseline in Nicotine Craving Score at 5 Minutes
时间窗: Post-cue baseline,5 minutes
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.
次要结局
- Change From Post-cue Baseline in Nicotine Craving Score at 1 Minute(Post-cue baseline, 1 minute post treatment administration)
- Change From Post-cue Baseline in Nicotine Craving Score at 3 Minutes(Post-cue Baseline, 3 minutes post treatment administration)
- Change From Post-cue Baseline in Nicotine Craving Score at 10 Minutes(Post-Cue Baseline, 10 minutes post treatment administration)
- Number of Participants With Adverse Events (AEs), Treatment Related AEs, and Serious AEs (SAEs)(Baseline to Day 5 post treatment administration)
- Change From Post-cue Baseline in Nicotine Craving Score at 7 Minutes(Post-Cue Baseline, 7 minutes post treatment administration)