Changes in Biomarkers Associated With Use of Electronic Cigarettes

• ClinicalTrials.gov Identifier: NCT03084315
• Recruitment Status: Completed
• First Posted: March 20, 2017
• Results First Posted: March 20, 2020
• Last Update Posted: August 26, 2021
• Sponsor: University of Minnesota
• Information provided by (Responsible Party): University of Minnesota

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Biomarkers	Device: E-Cig Zero Nicotine; Device: E-Cig 24mg Nicotine	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 234 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Blocked randomization, block size unknown to staff or investigators
• Masking: Single (Participant)
• Masking Description: All participants are blinded to intervention group
• Primary Purpose: Prevention
• Official Title: Changes in Biomarkers Associated With Use of Electronic Cigarettes Among African American Menthol and Nonmenthol Smokers
• Actual Study Start Date: November 15, 2016
• Actual Primary Completion Date: March 8, 2019
• Actual Study Completion Date: March 8, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures:

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.

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, Minnesota

DCRU

Minneapolis, Minnesota, United States, 55414

Sponsors and Collaborators

University of Minnesota

Investigators

• Principal Investigator: Anne Joseph, MD; University of Minnesota

  Study Documents (Full-Text)

Documents provided by University of Minnesota:

Study Protocol and Statistical Analysis Plan  [PDF] July 26, 2019

Informed Consent Form  [PDF] September 8, 2017

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT03084315
• Other Study ID Numbers: 2015NTLS139
• First Posted: March 20, 2017
• Results First Posted: March 20, 2020
• Last Update Posted: August 26, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by University of Minnesota:

smoking; electronic cigarettes; nicotine

Additional relevant MeSH terms:

Nicotine; Ganglionic Stimulants; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action