This study is focused on characterizing the toxic and carcinogenic potential of the Standardized Research E-cigarette (SREC) developed by the National Institute on Drug Abuse. In the environment of continuously changing e-cigarette market, SREC was developed as a model e-cigarette that will remain available for an extended period of time and can be used as a bridging element in various studies aimed at evaluating the value and limitations of e-cigarettes as tobacco risk reduction tools. Our overall goal is to generate initial reference data on chemical exposures and associated effects in smokers switching to SREC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
47
The device operates at a single output voltage (3.30 ± 0.05 V) and uses sealed disposable 3-mL cartridges with tobacco-flavored e-liquid (\~350 puffs/cartridge). The concentration of nicotine in e-liquid is 15 mg/mL, and the vehicle composition is 50:50 propylene glycol and glycerin. The device uses a battery that can be recharged via a micro USB port. A single charge is designed to sustain more than 400 puffs, which is more than the capacity of an e-liquid cartridge. The e-liquid and the aerosol are well-characterized in terms of chemical impurities and by-products (such as aldehydes), which are minimal. Additional information, including the results of pharmacokinetics study is available via NIDA website: https://www.drugabuse.gov/funding/supplemental-information-nida-e-cig
University of Minnesota, Masonic Cancer Center
Minneapolis, Minnesota, United States
Exposure Biomarkers: Cotinine
Cotinine (biomarker of nicotine) level after switching to SREC as percentage of baseline level
Time frame: 6 weeks
Exposure Biomarkers: NNAL
Total NNAL level after switching to SREC as percentage of baseline level
Time frame: 6 weeks
Exposure Biomarkers: CEMA
CEMA level after switching to SREC as percentage of baseline level
Time frame: 6 weeks
Exposure Biomarkers: 3-HPMA
3-HPMA level after switching to SREC as percentage of baseline level
Time frame: 6 weeks
Inflammatory Biomarkers
Urinary isoprostane level after switching to SREC as percentage of baseline level
Time frame: 6 weeks
Salivary Biomarkers
Levels of NNN in saliva after switching to SREC
Time frame: 6 weeks
Product Use
For cigarettes, cigarettes per day will be assessed based on Interactive Voice Response (IVR) system.
Time frame: 1 Year
Cigarette Avoidance
The number of cigarette avoidance days, defined as no tobacco cigarettes smoked in the past 24 hours based on IVR, and the rate of cigarette avoidance, calculated as the proportion of cigarette avoidance days out of the total number of days in the product use period (56 days for those who complete the study).
Time frame: 1 Year
Exposure Biomarkers: Total NNN
Urinary total NNN level (TSNA biomarker) after switching to SREC as percentage of baseline level
Time frame: 1 Year
Exposure Biomarkers: 1-HOP
Urinary level of 1-HOP (PAH biomarker) after switching to SREC as percentage of baseline level
Time frame: 1 Year
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