A Randomized, Double-Blinded, Active-Controlled, Crossover, Pilot Study to Evaluate the Efficacy and Safety of Ariva® Silver Wintergreen, a Smoking Aversive Lozenge, Containing Tobacco and Silver Salt - in Healthy Smokers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Effectiveness of Ariva® Silver Wintergreen lozenge on discouraging smoking in smokers
研究概览
简要总结
Study to determine the safety and effectiveness of silver salt in Ariva® Silver Wintergreen Lozenge on discouraging smoking, by its imparting an unfavorable taste to the smoker when tobacco is smoked.
详细描述
Each subject will be given an Ariva® Silver Wintergreen lozenge or an Ariva® Wintergreen lozenge on a random basis.
Once the lozenge has dissolved in the mouth, subjects will smoke one of their own cigarettes, and will answer questions about the experience and their craving for a cigarette.
After a washout period, each subject will repeat the steps with the second type of lozenge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 23 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy adult smoker
- •smoking for at least 5 years
- •smoking at least one (1) pack of cigarettes a day
- •interest in quitting smoking
排除标准
- •known allergy to silver or silver salts
- •pregnant or breast-feeding
- •current drug or alcohol abuse, and/or history of drug or alcohol dependence within 3 months of study
结局指标
主要结局
Effectiveness of Ariva® Silver Wintergreen lozenge on discouraging smoking in smokers
时间窗: 90 minutes
Effectiveness to be measured by the change in score on a craving questionnaire, from before to after product use.
次要结局
未报告次要终点