Smoking Topography and Harm Exposure in Menthol Cigarettes (MQAT)

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.

Study Overview

• Status: Completed
• Conditions: Cigarette Smoking Toxicity
• Intervention / Treatment: Other: Menthol to non-menthol

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.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH); National Institute of Environmental Health Sciences (NIEHS)
• Investigators: Principal Investigator: Andrew A Strasser, Ph.D., University of Pennsylvania

Publications and helpful links

General Publications

• Strasser AA, Ashare RL, Kaufman M, Tang KZ, Mesaros AC, Blair IA. The effect of menthol on cigarette smoking behaviors, biomarkers and subjective responses. Cancer Epidemiol Biomarkers Prev. 2013 Mar;22(3):382-9. doi: 10.1158/1055-9965.EPI-12-1097. Epub 2013 Jan 18.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: April 1, 2011
• First Submitted That Met QC Criteria: April 4, 2011
• First Posted (Estimate): April 5, 2011

Study Record Updates

• Last Update Posted (Estimate): January 6, 2015
• Last Update Submitted That Met QC Criteria: December 15, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: menthol cigarettes
• Additional Relevant MeSH Terms: Dermatologic Agents; Antipruritics; Menthol
• Other Study ID Numbers: 812369; R01CA120594 (U.S. NIH Grant/Contract); R01CA130961 (U.S. NIH Grant/Contract); P30ES013508 (U.S. NIH Grant/Contract); P50CA143187 (U.S. NIH Grant/Contract)