Smoking Topography and Harm Exposure in Menthol Cigarettes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Smoking Topography and Harm Exposure in Menthol Cigarettes

Conditions
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Cigarette Smoking Toxicity

Intervention / Treatment
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* Other: Menthol to non-menthol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nonmenthol<br>Participants switch from menthol to non-menthol cigarettes. | Other: Menthol to non-menthol<br>* Switch from smoking menthol to non-menthol cigarettes.<br>|
| No Intervention: Menthol<br>Participants smoke own brand of menthol cigarettes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Topography- Puff Volume | 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. | over 35 day study period | 
| Smoking Topography- Carbon Monoxide Boost | 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. | Measured before and after each cigarette smoked at study sessions | 
| Nicotine Levels | 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. | 35 days | 
| Subjective Rating of Cigarettes | 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. | Immediately after a cigarette smoked at the study session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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menthol cigarettes