Changes in Biomarkers Associated With Use of Electronic Cigarettes

Not Applicable

Completed

• Conditions: Biomarkers
• Interventions: Device: E-Cig 24mg Nicotine; Device: E-Cig Zero Nicotine

• Registration Number: NCT03084315
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study Start: 2016-11-15
• Study First Submitted: 2017-03-13
• Study First Submitted QC: 2017-03-13
• Study First Posted: 2017-03-20
• Primary Completion: 2019-03-08
• Study Completion: 2019-03-08
• Results First Submitted: 2020-03-06
• Results First Submitted QC: 2020-03-06
• Results First Posted: 2020-03-20
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

1. self-identify as African American or Black;
2. age 18 years or older;
3. smoke at least five cigarettes daily for the past year;
4. not interested in quitting smoking in the next 6 months;
5. Willing to use e-cigarettes;
6. Good physical health (no unstable medical or mental health condition);
7. no contraindications for e-cigarette use.

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Exclusion Criteria

1. Recent unstable or untreated psychiatric diagnosis including substance abuse, as determined by the DSM-IV criteria;
2. use in the past 30 days of tobacco or nicotine products including e-cigarettes, other than regular cigarettes;
3. participation in a smoking cessation program in the past 30 days;
4. pregnant or nursing.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E-Cig 24mg Nicotine	E-Cig 24mg Nicotine	E-cigarette with 24mg of nicotine added
E-Cig Zero Nicotine	E-Cig Zero Nicotine	E-Cigarette with no nicotine added

Primary Outcome Measures

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

Trial Locations

Locations (1)

DCRU; 🇺🇸 Minneapolis, Minnesota, United States