Changes in Biomarkers Associated With Use of Electronic Cigarettes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Changes in Biomarkers Associated With Use of Electronic Cigarettes Among African American Menthol and Nonmenthol Smokers

Conditions
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Biomarkers

Intervention / Treatment
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* Device: E-Cig Zero Nicotine
* Device: E-Cig 24mg Nicotine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Blocked randomization, block size unknown to staff or investigators
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: E-Cig Zero Nicotine<br>E-Cigarette with no nicotine added | Device: E-Cig Zero Nicotine<br>* E-Cig Zero Nicotine<br>|
| Active Comparator: E-Cig 24mg Nicotine<br>E-cigarette with 24mg of nicotine added | Device: E-Cig 24mg Nicotine<br>* E-Cig 24mg Nicotine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Biomarker Concentrations: Nicotine Equivalents | Change in concentration of nicotine equivalents in units of mmol/mg creatinine. | Baseline, Week 6 | 
| Change in Biomarker Concentrations: NNAL | Change in urinary concentration of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in units of pmol/mg creatinine. | Baseline, Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking, electronic cigarettes, nicotine