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Smoking Topography and Harm Exposure in Menthol Cigarettes (MQAT)

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Andrew Strasser, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01329263
First received: April 1, 2011
Last updated: December 15, 2014
Last verified: December 2014

April 1, 2011
December 15, 2014
September 2010
September 2011   (final data collection date for primary outcome measure)
  • Smoking Topography- Puff Volume [ Time Frame: over 35 day study period ] [ Designated as safety issue: No ]
    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.
  • Smoking Topography- Carbon Monoxide Boost [ Time Frame: Measured before and after each cigarette smoked at study sessions ] [ Designated as safety issue: No ]
    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 [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Immediately after a cigarette smoked at the study session ] [ Designated as safety issue: No ]
    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 [ Time Frame: during study (up to 15 days) ] [ Designated as safety issue: Yes ]
    The total puff volume, mean puff volume will be used to examine the effect of cigarette menthol on smoking topography.
  • biomarkers of harm exposure [ Time Frame: during study (up to 15 days) ] [ Designated as safety issue: Yes ]
    CO boost, NNK, and 1-HOP levels will be measured to examine the effect of cigarette menthol on harm exposure measures.
Complete list of historical versions of study NCT01329263 on ClinicalTrials.gov Archive Site
Not Provided
  • exhaled breath condensate [ Time Frame: during study (up to 15 days) ] [ Designated as safety issue: No ]
    Exhaled breath condensate samples will be measured for biomarkers indicating changes from smoking menthol cigarettes.
  • beliefs, attitudes and knowledge [ Time Frame: during study (baseline, 15 days) ] [ Designated as safety issue: No ]
    Beliefs, attitudes and knowledge about menthol and nicotine levels of this product will be assessed at baseline as well as at followup phone call.
Not Provided
Not Provided
 
Smoking Topography and Harm Exposure in Menthol Cigarettes
Smoking Topography and Harm Exposure in Menthol Cigarettes

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Cigarette Smoking Toxicity
Other: Menthol to non-menthol
Switch from smoking menthol to non-menthol cigarettes.
  • Experimental: Nonmenthol
    Participants switch from menthol to non-menthol cigarettes.
    Intervention: Other: Menthol to non-menthol
  • No Intervention: Menthol
    Participants smoke own brand of menthol cigarettes.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
87
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
21 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01329263
812369, R01CA120594, R01CA130961, P30ES013508, P50CA143187
Yes
Andrew Strasser, University of Pennsylvania
University of Pennsylvania
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)
  • National Institute of Environmental Health Sciences (NIEHS)
Principal Investigator: Andrew A Strasser, Ph.D. University of Pennsylvania
University of Pennsylvania
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP