The goals of this project are to determine the effects of varying degrees of cigarette filter ventilation on biomarkers of toxicant exposure and smoking behavior and on subjective responses to the cigarette. The primary aim of this study is to examine the effects of unventilated vs ventilated filter cigarettes on urinary biomarkers of toxicant exposure and smoking behavior (e.g., cigarettes per day, intensity of smoking). The secondary objectives are 1) to examine the effects of cigarette filter ventilation on subjective measures such as cigarette dependence and responses to study cigarettes.
This randomized controlled multi-site study will assess the effect of cigarettes with unventilated vs. ventilated filters on smoking behavior and biomarkers of tobacco toxicant exposure. The study, using telehealth and brief visits, will also examine the feasibility of remote collection of multiple biological samples. Subjects (N=164; N=82 in each group) will be randomly assigned to: 1) Ventilated cigarettes; or 2) Unventilated cigarettes. Smokers will undergo an in person screening and then a 9 week experimental trial; 1 week of usual brand cigarettes; 2 weeks of ventilated study cigarettes and 6 weeks on either the ventilated or unventilated study cigarettes. Subjective measures, alveolar carbon monoxide, blood pressure and cigarettes per day will be collected remotely. Biological samples collected at home will be dropped off at the clinic where the study cigarettes will be dispensed. Biomarker samples will be assessed for total nicotine equivalents, tobacco specific nitrosamines and volatile organic compound.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
164
Ventilated Cigarette Filter
Unventilated Cigarette Filter
University of Minnesota Tobacco Research Program
Minneapolis, Minnesota, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Change in Total NNAL: 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol [ng/g Creatinine]
Absolute change from baseline level of total NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) at the week 6 visit (ng/g creatinine) measured in urine using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
Time frame: 6 weeks randomized intervention
Change in Cigarettes Per Day (CPD)
Change in cigarettes per day, daily diary reviewed data.
Time frame: 7 days prior to week 0 visit and 7 days prior to week 6 visit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.