Changes in Biomarkers Associated With Use of Electronic Cigarettes

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

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.

Study Overview

• Status: Completed
• Conditions: Biomarkers
• Intervention / Treatment: Device: E-Cig Zero Nicotine; Device: E-Cig 24mg Nicotine

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.

• Study Type: Interventional
• Enrollment (Actual): 234
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • DCRU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: E-Cig Zero Nicotine; E-Cigarette with no nicotine added	Device: E-Cig Zero Nicotine; E-Cig Zero Nicotine
Active Comparator: E-Cig 24mg Nicotine; E-cigarette with 24mg of nicotine added	Device: E-Cig 24mg Nicotine; E-Cig 24mg Nicotine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Biomarker Concentrations: Nicotine Equivalents	Change in concentration of nicotine equivalents in units of mmol/mg creatinine.	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.	Baseline, Week 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Anne Joseph, MD, University of Minnesota

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2016
• Primary Completion (Actual): March 8, 2019
• Study Completion (Actual): March 8, 2019

Study Registration Dates

• First Submitted: March 13, 2017
• First Submitted That Met QC Criteria: March 13, 2017
• First Posted (Actual): March 20, 2017

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: smoking; nicotine; electronic cigarettes
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2015NTLS139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No