DCRU
Minneapolis, Minnesota, 55414, United States
NCT Number: NCT03084315
The objective of this clinical trial was to compare the effects of e-cigarettes with and without nicotine on patterns of combustible cigarette use and biomarkers of exposure to tobacco toxicants among African American smokers.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Minneapolis, Minnesota, 55414, United States
This study compares patterns of e-cigarette use and the exposure to the tobacco-specific carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in African American smokers, randomized to ad lib e-cigarettes containing nicotine vs. no nicotine. We hypothesized that nicotine e-cigarettes would be used more than no-nicotine e-cigarettes, and that this would be associated with reduced use of combustible cigarettes. We hypothesized that nicotine e-cigarettes would result in more substitution for combusted cigarettes than no-nicotine e-cigarettes and result in lower levels of exposure to the tobacco-specific carcinogen NNAL. These results would be relevant for developing exposure reduction strategies for adult African American smokers.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
E-Cig Zero Nicotine
E-Cig 24mg Nicotine
Time frame: Baseline, Week 6
Change in concentration of nicotine equivalents in units of mmol/mg creatinine.
Time frame: Baseline, Week 6
Change in urinary concentration of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in units of pmol/mg creatinine.
Time frame: Baseline, Week 6
Participants will record the average number of cigarettes smoked per day in the 7 days leading up to each study visit. Outcome is reported as the change in average cigarettes per day from baseline to 6 weeks of treatment.
University of Minnesota
Other
Changes in Biomarkers Associated With Use of Electronic Cigarettes Among African American Menthol and Nonmenthol Smokers
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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