Smoking Topography and Harm Exposure in Menthol Cigarettes (MQAT)

• ClinicalTrials.gov Identifier: NCT01329263
• Recruitment Status: Completed
• First Posted: April 5, 2011
• Results First Posted: December 15, 2014
• Last Update Posted: January 6, 2015
• Sponsor: University of Pennsylvania
• Collaborators: National Institutes of Health (NIH); National Cancer Institute (NCI); National Institute of Environmental Health Sciences (NIEHS)
• Information provided by (Responsible Party): Andrew Strasser, University of Pennsylvania

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cigarette Smoking Toxicity	Other: Menthol to non-menthol	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 87 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Smoking Topography and Harm Exposure in Menthol Cigarettes
• Study Start Date: September 2010
• Actual Primary Completion Date: September 2011
• Actual Study Completion Date: September 2011

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Smoking Topography- Puff Volume [ Time Frame: 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.
2. Smoking Topography- Carbon Monoxide Boost [ Time Frame: 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.
3. Nicotine Levels [ Time Frame: 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.
4. Subjective Rating of Cigarettes [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

University of Pennsylvania

National Institutes of Health (NIH)

National Cancer Institute (NCI)

National Institute of Environmental Health Sciences (NIEHS)

Investigators

• Principal Investigator: Andrew A Strasser, Ph.D.; University of Pennsylvania

More Information

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.

• Responsible Party: Andrew Strasser, Associate Professor Department of Psychiatry, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT01329263
• 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 )
• First Posted: April 5, 2011
• Results First Posted: December 15, 2014
• Last Update Posted: January 6, 2015
• Last Verified: December 2014

Keywords provided by Andrew Strasser, University of Pennsylvania:

menthol cigarettes

Additional relevant MeSH terms:

Menthol; Antipruritics; Dermatologic Agents