Changes in Biomarkers Associated With Use of Electronic Cigarettes

University of Minnesota234 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

234

Conditions

Biomarkers

Interventions

E-Cig Zero NicotineDEVICE

E-Cig Zero Nicotine

E-Cig 24mg NicotineDEVICE

E-Cig 24mg Nicotine

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

DCRU

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Change in Biomarker Concentrations: Nicotine Equivalents

Change in concentration of nicotine equivalents in units of mmol/mg creatinine.

Time frame: 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.

Time frame: Baseline, Week 6

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.