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临床试验/NCT01428310
NCT01428310已完成1 期

A Single Center, Single-Blind, Randomized, Crossover Pilot Study to Evaluate the Safety and Effects of Anatabloc™, a Dietary Supplement, in Reducing the Urge to Smoke in Daily Smokers Followed by an Open-Label Extension

Rock Creek Pharmaceuticals, Inc.2 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2011年9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
109
试验地点
2
主要终点
effect on subject's craving to smoke

研究概览

简要总结

This study will consist of 2 phases. Phase 1 will be a one day crossover study to see the effects of study product on a smoker's desire to smoke, measured by changes in scores on questionnaires given over time. Phase 2 will be a two-week extension, in which subjects will self-administer the study product and visit the study site for assessment of desire to smoke and collection of samples for the evaluation of smoking-related biomarkers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Single (Participant)

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 smokers
  • using at least 1 pack of cigarettes per day, for at least 5 years

排除标准

  • allergy to study product components

结局指标

主要结局

effect on subject's craving to smoke

时间窗: 5 hours

craving is assessed by changes in questionnaire answers over time

次要结局

  • adverse events related to study product(5 hours)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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