Clinical trial NCT03084315: Changes in Biomarkers Associated With Use of Electronic Cigarettes
Official title: Changes in Biomarkers Associated With Use of Electronic Cigarettes Among African American Menthol and Nonmenthol Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biomarkers
Keywords: smoking
electronic cigarettes
nicotine
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-03-20
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Blocked randomization, block size unknown to staff or investigators
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Biomarker Concentrations: Nicotine Equivalents
timeFrame: Baseline, Week 6
measure: Change in Biomarker Concentrations: NNAL
timeFrame: Baseline, Week 6
Secondary outcomes:
Other outcomes:
measure: Change in Average Cigarettes Per Day
timeFrame: Baseline, Week 6
Locations:
city: Minneapolis
country: United States
facility: DCRU
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Anne Joseph, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Okuyemi KS, Ojo-Fati O, Aremu TO, Friedrichsen SC, Grude L, Oyenuga M, Shyne M, Murphy SE, Hatsukami D, Joseph AM. A Randomized Trial of Nicotine versus No-nicotine E-cigarettes Among African American Smokers: Changes in Smoking and Tobacco Biomarkers. Nicotine Tob Res. 2022 Mar 1;24(4):555-563. doi: 10.1093/ntr/ntab212.