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
|Condition or disease||Intervention/treatment||Phase|
|Cigarette Smoking Toxicity||Other: Menthol to non-menthol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||87 participants|
|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|
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.
- 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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01329263
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Andrew A Strasser, Ph.D.||University of Pennsylvania|