Changes in Biomarkers Associated With Use of Electronic Cigarettes

Biomarkers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03084315
• Other study ID #: 2015NTLS139
• Status: Completed
• Phase: N/A
• Start date: November 15, 2016
• Est. completion date: March 8, 2019

Study information

• Verified date: August 2021
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: March 8, 2019
• Est. primary completion date: March 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Biomarkers

Intervention

Device:
• E-Cig Zero Nicotine
E-Cig Zero Nicotine
• E-Cig 24mg Nicotine
E-Cig 24mg Nicotine

Locations

Country	Name	City	State
United States	DCRU	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Average Cigarettes Per Day	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.	Baseline, Week 6
Primary	Change in Biomarker Concentrations: Nicotine Equivalents	Change in concentration of nicotine equivalents in units of mmol/mg creatinine.	Baseline, Week 6
Primary	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