The purpose of this clinical study is to evaluate changes in biomarkers of exposure (BOE) to tobacco smoke constituents after smokers switch from combustible cigarettes to use of one of the three electronic cigarettes or abstinence.
This will be a two-center, randomized, controlled, switching, open-label, parallel cohort study. The study will compare biomarkers of tobacco exposure from subjects at baseline levels of biomarkers of tobacco exposure after they have switched to one of three electronic cigarettes or abstinence for 5 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
114
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, United States
DaVita Clinical Research
Minneapolis, Minnesota, United States
Change from Baseline Biomarkers of Tobacco Exposure in Urine to Day 5
A comparison of biomarkers of tobacco exposure in urine from subjects at baseline and for 5 days after they have switched to one of the electronic cigarette products or abstinence. Biomarkers of tobacco exposure in urine include: 1. 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) (NNAL) + glucuronides 2. N'-nitrosonornicotine (NNN) + glucuronides 3. 4-aminobiphenyl 4. 1-aminonaphthalene 5. 2-aminonaphthalene 6. o-toluidine 7. S-phenyl mercapturic acid (SPMA) 8. 3-hydroxy-1-methylpropyl-mercapturic acid (HMPMA) 9. 2-cyanoethyl mercapturic acid (CEMA) 10. Monohydroxybutyl mercapturic acid (MHBMA) 11. 3-hydroxypropyl mercapturic acid (HPMA) 12. 3-hydroxy-benzo\[a\]pyrene
Time frame: 5 days
Change from Baseline Biomarkers of Tobacco Exposure in Blood to Day 5
A comparison of biomarkers of tobacco exposure in blood from subjects at baseline and for 5 days after they have switched to one of the electronic cigarette products or abstinence. Biomarkers of tobacco exposure in blood include: 1\. Carboxyhemoglobin
Time frame: 5 days
Change from Baseline Biomarkers of Tobacco Exposure in Urine to Day 5
A comparison of biomarkers of tobacco exposure in urine from subjects at baseline and for 5 days after they have switched to one of the electronic cigarette products or abstinence. Biomarkers of tobacco exposure in urine include: 1. Unconjugated nicotine 2. Unconjugated cotinine 3. Unconjugated trans-3'-hydroxycotinine 4. Nicotine-N-glucuronide 5. Cotinine-N-glucuronide 6. Trans-3'-hydroxycotinine-O-glucuronide
Time frame: 5 days
Change from Baseline Biomarkers of Tobacco Exposure in Blood to Day 5
A comparison of biomarkers of tobacco exposure in blood from subjects at baseline and for 5 days after they have switched to one of the electronic cigarette products or abstinence. Biomarkers of tobacco exposure in blood include: 1. Plasma nicotine 2. Plasma cotinine
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Time frame: 5 days