Smoking Topography and Harm Exposure in Menthol Cigarettes

Cigarette Smoking Toxicity Clinical Trial

— MQAT  

Official title:

Smoking Topography and Harm Exposure in Menthol Cigarettes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01329263
• Other study ID #: 812369
• Secondary ID: R01CA120594R01CA
• Status: Completed
• Phase: N/A
• First received: April 1, 2011
• Last updated: December 15, 2014
• Start date: September 2010
• Est. completion date: September 2011

Study information

• Verified date: December 2014
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cigarette Smoking Toxicity

Intervention

Other:
• Menthol to non-menthol
Switch from smoking menthol to non-menthol cigarettes.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
University of Pennsylvania	National Cancer Institute (NCI), National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	Yes
Primary	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	No