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临床试验/NCT01336816
NCT01336816已完成1 期

A Randomized, Double-Blinded, Placebo-Controlled, Crossover, Pilot Study to Evaluate the Efficacy of Ariva® Silver Wintergreen, a Smoking Aversive Lozenge, Containing Tobacco and Silver Salt - in Healthy Smokers

Star Scientific, Inc2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
43
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

This is a 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 a Placebo 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

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 measured by change in scores over time across several questionnaires.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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