Changes in Biomarkers Associated With Use of Electronic Cigarettes

University of Minnesota (UMN)

Status: Completed

Conditions: Biomarkers

Treatments: Device: E-Cig Zero Nicotine; Device: E-Cig 24mg Nicotine

Study type: Interventional

Funder types: Other

Identifiers

NCT03084315

2015NTLS139

Details and patient eligibility

About

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.

Full 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.

Enrollment: 234 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

234 participants in 2 patient groups

E-Cig Zero Nicotine

Sham Comparator group

Description:

E-Cigarette with no nicotine added

Treatment:

Device: E-Cig Zero Nicotine

E-Cig 24mg Nicotine

Active Comparator group

Description:

E-cigarette with 24mg of nicotine added

Treatment:

Device: E-Cig 24mg Nicotine