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临床试验/NCT01202942
NCT01202942已完成不适用

Smoking Topography and Harm Exposure in a New Potentially Reduced Exposure Product

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2007年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
246
试验地点
2
主要终点
Smoking topography measures increase as nicotine levels decrease

研究概览

简要总结

The proposed research extends previous research on Quest® cigarette smoking behavior by testing whether compensatory smoking occurs as cigarette nicotine level decreases, and whether, as a result, biomarkers of harm exposure increase. This hypothesis will be tested in 210 smokers who report smoking at least 15 cigarettes per day and have been smoking for at least five years and are not currently interested in quitting, but interested in trying a new cigarette product. Participants will be randomized to one of three conditions: 1) smoke their own preferred brand (control group); 2) smoke Quest® cigarettes in progressively decreasing cigarette nicotine level (step-down); or 3) Quest® cigarette non-step-down condition, where they will smoke Quest® cigarettes in a random order. The study will consist of 4 stages beginning with a 5-day preferred own brand cigarette smoking phase for all participants, followed by one of the three cigarette conditions. For those smoking Quest® cigarettes, cigarette nicotine level will change every 10 days, either in a step-down or random fashion. The primary behavioral outcome is smoking topography, a quantitative measurement of smoke exposure. Alveolar carbon monoxide (CO), a validated assessment of smoke exposure, and urine samples to assess carcinogen exposure, specifically NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) and 1-HOP (1-hydroxypyrere), and exhaled breath condensate will also be collected at the laboratory visits. At the initiation of the study, participants will view the Quest® print advertisement and complete a survey related to product expectations in order to determine the impact marketing and advertisement has on beliefs, attitudes and behaviors related to Quest® cigarettes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Self-report smoking > 15 daily cigarettes.
  • Self-report smoking only non-menthol cigarettes.
  • Not currently trying to quit smoking, or planning to quit in the next 2 months.
  • Interested in trying a new cigarette-like product.

排除标准

  • Not meeting any of the inclusion criteria.
  • Self-report drinking > 25 alcohol-containing drinks per week.
  • Self-report currently using any nicotine replacement products.
  • Self-report substance use disorders (abuse or dependence involving alcohol, cocaine, or stimulants, benzodiazepines, not nicotine) in the last 5 years.
  • Self-report past history of Axis I psychiatric disorders other than depression
  • Self-report myocardial infarct within the past year.
  • Females must not be currently pregnant, planning a pregnancy during the study, or currently breastfeeding/lactating.
  • Provide a baseline CO reading < 10 ppm

结局指标

主要结局

Smoking topography measures increase as nicotine levels decrease

时间窗: Every five days over 35 day study participation

次要结局

  • Nicotine levels effects on smoking topography(Every 5 days over 35 day study participation.)
  • Whether smokers' inferences from advertising affect smoking behavior(Every 5 days over 35 day study participation.)
  • Whether carbon monoxide boost and biomarkers of harm increase as cigarette nicotine levels decrease(Every 5 days over 35 day study participation.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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