Smoking Topography and Harm Exposure in Menthol Cigarettes

Not Applicable

Completed

• Conditions: Cigarette Smoking Toxicity
• Interventions: Other: Menthol to non-menthol

• Registration Number: NCT01329263
• Lead Sponsor: University of Pennsylvania

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-04-01
• Study First Submitted QC: 2011-04-04
• Study First Posted: 2011-04-05
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Results First Submitted: 2013-01-24
• Status Verified: 2014-12
• Results First Submitted QC: 2014-12-04
• Results First Posted: 2014-12-15
• Last Update Submitted: 2014-12-15
• Last Update Posted: 2015-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nonmenthol	Menthol to non-menthol	Participants switch from menthol to non-menthol cigarettes.

Primary Outcome Measures

Name	Time	Method
Smoking Topography- Carbon Monoxide Boost	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	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	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	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.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States