Changes in Biomarkers Associated With Use of Electronic Cigarettes Among African American Menthol and Nonmenthol Smokers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Biomarkers
- Sponsor
- University of Minnesota
- Enrollment
- 234
- Locations
- 1
- Primary Endpoint
- Change in Biomarker Concentrations: Nicotine Equivalents
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •self-identify as African American or Black;
- •age 18 years or older;
- •smoke at least five cigarettes daily for the past year;
- •not interested in quitting smoking in the next 6 months;
- •Willing to use e-cigarettes;
- •Good physical health (no unstable medical or mental health condition);
- •no contraindications for e-cigarette use.
Exclusion Criteria
- •Recent unstable or untreated psychiatric diagnosis including substance abuse, as determined by the DSM-IV criteria;
- •use in the past 30 days of tobacco or nicotine products including e-cigarettes, other than regular cigarettes;
- •participation in a smoking cessation program in the past 30 days;
- •pregnant or nursing.
Outcomes
Primary Outcomes
Change in Biomarker Concentrations: Nicotine Equivalents
Time Frame: Baseline, Week 6
Change in concentration of nicotine equivalents in units of mmol/mg creatinine.
Change in Biomarker Concentrations: NNAL
Time Frame: Baseline, Week 6
Change in urinary concentration of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in units of pmol/mg creatinine.