A Study to Evaluate Relief of Provoked Acute Craving by Nicotine Mouth Film and Nicotine Lozenge
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- The Change From Pre-dose Post-provocation in Craving Score at 50 Seconds
研究概览
简要总结
Nicotine mouth film is a new dosage form of nicotine replacement therapy. The purpose of this study is to investigate the craving relief efficacy of nicotine mouth film by comparing mint nicotine mouth film to nicotine lozenge in light smokers using the provoked craving model. The cues used to provoke a craving episode will be the sight and smell of a lit cigarette and the manipulations required to light a cigarette. The smokers will be denied access to cigarettes for 4 hours prior to the provoked craving session in order to precipitate nicotine withdrawal and an increase level of cigarette craving.
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
- None
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
- •BMI within the range of 19-35 kg/m2;
- •Current cigarette smokers who have smoked regularly daily for at least a year,
- •Participants who smoke their first cigarette more than 30 minutes after waking up
排除标准
- •Known or suspected intolerance or hypersensitivity to nicotine (or closely related compounds) or any of the stated ingredients in formulation.
- •Any participant whose CO level rises during the sequestration period (i.e., the subject's two expired CO assessments immediately prior to the provoked craving paradigm are higher than the mean baseline CO assessment) and, in the opinion of the investigator, may have smoked during that time.
研究组 & 干预措施
Nicotine Mouth Film
mint nicotine mouth film, buccal administration
干预措施: Nicotine (Drug)
Nicotine Lozenge
nicotine lozenge, buccal administration
干预措施: Nicotine (Drug)
结局指标
主要结局
The Change From Pre-dose Post-provocation in Craving Score at 50 Seconds
时间窗: Pre-dosing post-provocation to 50 seconds
Participants completed a cigarette craving assessment consisting of the 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 craving intensity on a pre-drawn 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as craving score for each time point.
次要结局
- The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes(Pre-dosing post-provocation to 3, 5, 7, 10, 15, 20, 25, and 30 minutes)