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Changes in Biomarkers Associated With Use of Electronic Cigarettes

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ClinicalTrials.gov Identifier: NCT03084315
Recruitment Status : Active, not recruiting
First Posted : March 20, 2017
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
To determine changes in biomarkers associated with the use of electronic cigarettes among African American menthol and nonmenthol smokers.

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

Detailed Description:

Primary Aim: To determine changes in biomarkers associated with the use of electronic cigarettes among African American menthol and nonmenthol smokers.

Primary Hypothesis: At 8 weeks and 24 weeks post-enrollment, there will be a significant association between use of electronic cigarettes and biomarkers of smoking exposure such that changes in biomarkers from baseline to follow-up will be higher among participants randomized to the active e-cigarette condition.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Stratified (i.e., stratification by menthol status) blocked randomization
Masking: Single (Participant)
Masking Description: All participants are blinded to intervention group
Primary Purpose: Basic Science
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 1, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

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




Primary Outcome Measures :
  1. Changes in biomarkers [ Time Frame: Baseline, Week 4, Week 8, Week 24 ]
    Changes in urinary biomarkers of nicotine



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03084315


Locations
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United States, Minnesota
DCRU
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
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Principal Investigator: Anne Joseph, MD University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03084315     History of Changes
Other Study ID Numbers: 1509M78241
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
smoking
electronic cigarettes
nicotine
Additional relevant MeSH terms:
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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