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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
- 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.
- 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.
|Study Start Date:||September 2010|
|Estimated Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Other: Menthol to non-menthol
Switch from smoking menthol to non-menthol cigarettes.
|No Intervention: Menthol|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01329263
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|