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OpenTrials
Completed

NCT Number: NCT03084315

Changes in Biomarkers Associated With Use of Electronic Cigarettes

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

DCRU

Minneapolis, Minnesota, 55414, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

E-Cig Zero Nicotine

Device

E-Cig Zero Nicotine

E-Cig 24mg Nicotine

Device

E-Cig 24mg Nicotine

Primary outcomes

  1. Change in Biomarker Concentrations: Nicotine Equivalents

    Time frame: Baseline, Week 6

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

  2. Change in Biomarker Concentrations: NNAL

    Time frame: Baseline, Week 6

    Change in urinary concentration of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in units of pmol/mg creatinine.

Other outcomes

  1. Change in Average Cigarettes Per Day

    Time frame: Baseline, Week 6

    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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 20, 2017
Registry last updated
Aug 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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