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临床试验/NCT01568905
NCT01568905已完成不适用

Palatability of Experimental Cigarettes

University of Minnesota2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2011年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
Change in UrineTotal Nicotine Equivalent (TNE) Between Baseline and Week 1

研究概览

简要总结

Smoking remains a leading cause of preventable disease and premature death worldwide. Approximately 1 out of every 5 deaths is associated with cigarette smoking, and roughly half of all daily smokers will die prematurely from tobacco-related illness. Reducing the nicotine in cigarettes to the point that they are rendered non-addictive can potentially be an effective public policy measure that can significantly reduce tobacco-related mortality and morbidity by decreasing the initiation of smoking and promoting cessation. The Family Smoking Prevention and Tobacco Control Act (FSPTCA) enables the FDA to establish tobacco product standards including placing limits on the allowable nicotine content of cigarettes. Currently, no reduced nicotine cigarettes are available that will allow studying the feasibility of this policy measure. The National Institute on Drug Abuse has contracted with Research Triangle Institute to assist in the development of cigarettes with varying nicotine content that can be made available to researchers. They have established a contract that will result in the manufacture of 9 million cigarettes to be distributed to the research community. Prior to full production, the palatability and nicotine intake of these cigarettes in smokers must be determined.

详细描述

Phase 3: This descriptive study will use a between subjects, double blind design. This study will test 3 nicotine levels of nicotine, tar and ventilation. Subjects and research assistants will be blind to the cigarette type.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-64 years old
  • Regular smokers (10+ cigarettes per day and has done so for the last year)
  • Inhaling when smoking
  • Carbon monoxide (CO) > 8 ppm

排除标准

  • In the past year, suffered from any cardiovascular disease such as: heart disease, heart attack, stroke or angina, any respiratory diseases such as chronic bronchitis or chronic obstructive pulmonary disease (COPD), any type of cancer
  • Currently suffering from Bipolar Disorder, General Anxiety Disorder, Schizophrenia, or a major depressive episode
  • Taken any of the following drugs more than twice per week during the past month: antidepressants, anti-anxiety medications.
  • Consumed more than 15 alcoholic drinks per week for the past month
  • Pregnant, trying to become pregnant, or lactating (assessed by self-report)
  • In the past 3 months, used nicotine replacement products (like the patch, gum, or inhaler), or the medications bupropion varenicline
  • Currently trying or planning to reduce or quit tobacco use in the next 30 days
  • Used other forms of tobacco 10 or more days in the past 30 days

研究组 & 干预措施

Arm 1 Low Level Nicotine Cigarette

Experimental

(0.4 mg/g)

干预措施: Low level nicotine cigarette (Other)

Arm 2 Intermediate Nicotine Level Cigarette

Experimental

(5.7-5.8 mg/g)

干预措施: Intermediate nicotine level cigarette (Other)

Arm 3 High Level Nicotine Cigarette

Experimental

(11.4-12.8 mg/g)

干预措施: High level nicotine cigarette (Other)

结局指标

主要结局

Change in UrineTotal Nicotine Equivalent (TNE) Between Baseline and Week 1

时间窗: Second Visit (Week 1) minus Baseline (Day 1)

Two urine TNE levels are taken, one at baseline and one at week 1, to assess TNE levels for nicotine exposure. TNE is the sum of nicotine, cotinine, trans 3'-hydroxycotinine and their respective glucuronide conjugates. Values reported in nmols/ml.

次要结局

  • Change From Baseline of Perceived Health Risk Scale Response to Test Cigarettes(Baseline (Day 1) Compared to Second Visit (Week 1))
  • Responses on Modified Cigarette Evaluation Scale(Baseline usual brand cigarettes (Day 1) compared to when using study cigarettes (Week 1))
  • Comparison of Number of Cigarettes Smoked(1 week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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