Smoking Topography and Harm Exposure in Menthol Cigarettes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Smoking Topography- Carbon Monoxide Boost
研究概览
简要总结
This study will examine how menthol affects smoking when menthol smokers switch to non-menthol cigarettes. Participants will smoke their preferred brand (control) or Camel Crush cigarettes, which have the ability to be menthol or non-menthol. Participants given Camel Crush cigarettes will smoke them as menthol, then non-menthol cigarettes for 15 days each. Participants will provide breath and urine samples, track cigarette usage and complete smoking topography assessments of smoking behavior.
详细描述
This study will examine how menthol affects smoking behaviors and biomarker level when menthol smokers switch to non-menthol cigarettes. Participants will initially smoke their preferred brand (control) cigarettes, followed by smoking Camel Crush cigarettes, which have the ability to be menthol or non-menthol. Participants given Camel Crush cigarettes will smoke them as menthol, then non-menthol cigarettes for 15 days each. Participants will provide breath and urine samples to measure smoke exposures, track cigarette usage to establish changes in daily cigarette consumption and complete smoking topography assessments of smoking behavior, such as puff volume.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Self-report smoking daily cigarettes
- •Self-report smoking menthol flavored cigarettes
- •Not currently trying to quit or planning to quit in the next 2 months.
- •Interested in trying a novel cigarette product and willing to smoke a non-menthol cigarette
- •Self-report smoking only filtered commercially made cigarettes
排除标准
- •Self-report drinking equal to or greater than a certain number of alcohol-containing drinks per week
- •Self report using any nicotine replacement products or nicotine-containing products other than cigarettes
- •Self-report substance use disorders in the last 5 years
- •Self-report current Axis I psychiatric disorders
- •Self-report past history of Axis I psychiatric disorders other than depression
- •Self-report myocardial infarction, angina or abnormal rhythms requiring medication
- •Self-report use of select medications and illicit drugs within past six months
- •Females must not be currently pregnant, planning a pregnancy during the study, or currently breastfeeding/lactating
- •Provide a baseline carbon monoxide (CO) reading < 10 ppm at initial session
- •Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator
研究组 & 干预措施
Nonmenthol
Participants switch from menthol to non-menthol cigarettes.
干预措施: Menthol to non-menthol (Other)
Menthol
Participants smoke own brand of menthol cigarettes.
结局指标
主要结局
Smoking Topography- Carbon Monoxide Boost
时间窗: Measured before and after each cigarette smoked at study sessions
Carbon monoxide content in exhaled breath samples is measured before and after each cigarette smoked during study sessions. CO boost is the amount in parts per million that the subject's CO increases.
Nicotine Levels
时间窗: 35 days
Urine nicotine levels will be measured to examine the effect of cigarette menthol on harm exposure measures. Participants provided samples on the final day of each period. NNK and 1-hop were not analyzed, total nicotine metabolites were assayed.
Subjective Rating of Cigarettes
时间窗: Immediately after a cigarette smoked at the study session
Subjects completed a visual analog scale rating each cigarette smoked at each session. Subjects rated characteristics of the cigarette on a scale represented as a continuous horizontal line 10 cm long. Subjects drew an intersecting line to represent their rating. The rating reported is for the taste of the cigarette at the end of the period averaged across subjects in the group. A rating of 0 corresponds to Very Bad and a rating of 100 to Very Good for taste. There is no better or worse outcome for higher or lower ratings for taste.
Smoking Topography- Puff Volume
时间窗: over 35 day study period
The total puff volume for a single subject is the sum of puff volumes for a subject's cigarette smoked during the study session. The mean puff volume for the subjects will be used to examine the effect of cigarette menthol on smoking topography. The values provided are the average of subjects at study Day 5 (completion of baseline smoking own cigarettes), Day 20 and Day 35.
次要结局
未报告次要终点
研究者
Andrew Strasser
Associate Professor Department of Psychiatry
University of Pennsylvania