Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Nicotine Cravings VAS Scores in Heavy Smokers
研究概览
简要总结
This study is designed to evaluate the ability of a nicotine lozenge to relieve craving for a cigarette compared to a matched placebo (a placebo is like sugar pill and contains no active).
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
- 否
入选标准
- •Generally healthy smokers who smoke more than 5 cigarettes per day
- •Body mass index (BMI) within the range 19-35 kilogram (kg)/meter (m)^2
- •Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception.
排除标准
- •Women who are pregnant or who have a positive urine pregnancy test.
- •Participants with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- •Clinical Study/Experimental Medication: Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- •Prior Concomitant Medication: Treatment with enzyme altering agents (e.g. carbamazepine, phenytoin, cimetidine, sodium valporate) within 30 days of the craving provocation visit; Use of any prescription psychoactive medication (such as but not limited to antidepressants, antipsychotics, anxiolytics) within 14 days of the craving provocation visit; Participant has used an over-the-counter (OTC) medication such as antihistamines, sedating agents, or any compound that would have a sedating effect within 24 hours of the craving provocation visit; Current use of any nicotine replacement therapy.
- •Substance abuse: Recent history or current history (within the last 1 year) of alcohol or other substance abuse.
研究组 & 干预措施
Lower dose Nicotine
lower dose nicotine lozenge
干预措施: Nicotine lower dose (Drug)
Higher dose Nicotine
higher dose Nicotine lozenge
干预措施: Nicotine higher dose (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline in Nicotine Cravings VAS Scores in Heavy Smokers
时间窗: Baseline, 3 minutes and 15 minutes post-treatment
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 (in mm) was measured.
Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers
时间窗: Baseline, 1, 3, 5, 10 and 15 minutes post-treatment
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 (in mm) was measured.
次要结局
- Percentage of Responders With Improved Craving Scores in Heavy and Light Smokers Group(Baseline prior to provoked craving paradigm, baseline post provoked craving paradigm)
- Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)(Baseline, 0 minute, 60 minutes and 5 days post treatment)