NCT01262170已完成1 期
A Randomized, Double-Blind, Active-Controlled, Crossover, Pilot Study to Evaluate the Safety and Efficacy of CigRx™ Lozenge, a Non-Nicotine Non-Tobacco Dietary Supplement, in Daily Smokers in Temporarily Reducing the Desire to Smoke
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Effect on subject's craving to smoke
研究概览
简要总结
A randomized, double-blind, active-controlled, crossover, pilot study to evaluate the safety and efficacy of CigRx™ Lozenge, a dietary supplement, in daily smokers in temporarily reducing the desire to smoke
详细描述
Subjects will orally self-administer 2 study products, each in the form of a dissolvable lozenge, and will complete questionnaires on demographics, urges to smoke, and product rating.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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 smokers
- •Smoking for at least 5 years
- •Smoking at least one (1) pack of cigarettes a day
排除标准
- •Allergy to lozenge components
研究组 & 干预措施
CigRx Lozenge
Experimental
CigRx Lozenge
干预措施: CigRx Lozenge (Dietary Supplement)
Tobacco Lozenge
Active Comparator
Tobacco Lozenge
干预措施: Tobacco Lozenge (Other)
结局指标
主要结局
Effect on subject's craving to smoke
时间窗: 4 hours
craving is assessed by changes in questionnaire answers over time
次要结局
- Collection of information on adverse events related to study products(5 hours)
研究者
研究点 (1)
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