A Randomized, Double-Blind, Crossover, Pilot Study to Evaluate the Safety and Efficacy of Ariva® Silver Wintergreen, a Smoking Aversive Lozenge, in Reducing Craving for a Cigarette in Daily Smokers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Effectiveness of Ariva® Silver Wintergreen lozenge on reducing craving for a cigarette in daily smokers
研究概览
简要总结
Study to determine the safety and effectiveness of Ariva® Silver Wintergreen lozenge on reducing craving for a cigarette in daily smokers.
详细描述
Each subject will be given an Ariva® Silver Wintergreen lozenge or a Silver Wintergreen lozenge, which contains only silver salt, 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
研究组 & 干预措施
Ariva® Silver Wintergreen
Subjects allow study product lozenge to dissolve in the mouth, smoke a cigarette, then answer questionnaires about the effect of the product on both their desire to smoke and on cigarette taste.
干预措施: Ariva® Silver Wintergreen (Other)
Silver Wintergreen
Subjects allow comparator product lozenge to dissolve in the mouth, smoke a cigarette, then answer questionnaires about the effect of the product on both their desire to smoke and on cigarette taste.
干预措施: Silver Wintergreen (Other)
结局指标
主要结局
Effectiveness of Ariva® Silver Wintergreen lozenge on reducing craving for a cigarette in daily 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