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Effects of Electronic Cigarettes on Nicotine Concentrations (ECIG)

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ClinicalTrials.gov Identifier: NCT01775787
Recruitment Status : Completed
First Posted : January 25, 2013
Results First Posted : November 30, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

This study will examine whether nicotine levels increase with electronic cigarettes. It will also examine whether electronic cigarettes alter lung function tests. The study will obtain preliminary data on the medical effects of electronic cigarettes, with two different nicotine flavors, tobacco and tobacco with menthol, which are available for over the counter purchase.

The electronic cigarettes and juice used in this study is available for purchase through the internet. An investigational new drug application (IND) is not needed for this study.


Condition or disease Intervention/treatment
Health Behavior Drug: Nicotine with Tobacco Flavor and Tobacco & Menthol Flavor

Detailed Description:

This is a randomized two-period cross-over study in which subjects who smoke greater than 10 cigarettes will be instructed to quit smoking and use either Joye (Ego C brand) with an 18 mg cartridge containing either a tobacco or tobacco mentholated flavor for one week. Prior to starting e-cig use we will collect one blood sample for nicotine/cotinine as a measure of overall nicotine exposure. Subjects will use the device for one week and at the end of approximately one week of use, we will assess nicotine/cotinine concentrations (before and 5, 10, 15, 20 and 30 minutes after the onset of ECIG use), pulmonary function tests (before and 5 minutes after ECIG use), and subjective impressions of satisfaction. At the end of one week, subjects will be crossed over to the other condition and assessments will be repeated after another week of E-cigarette use.

A total of 30 smokers will be recruited from the surrounding areas via advertisements in newspapers and radio advertisements and University of Connecticut Health Center (UCHC) broadcast e-mail. Posters will be placed in clinical areas to recruit from physician practices. Current smokers are being proposed for three reasons: 1) we wish to determine whether nicotine levels from e-cigarettes rise to the levels of regular cigarettes when used by regular smokers; 2) we wish to determine if there are any differences seen in pulmonary function when a person switches from regular cigarettes to e-cigarettes; 3) we wish to evaluate the level of satisfaction that regular smokers have with e-cigarettes. All of these questions will have implications for later, more extensive studies of e-cigarettes, particularly in regard to their utility as a smoking cessation modality.

Once a potential study subject calls and expresses interest in the study, preliminary inclusion criteria will be assessed over the phone. Inclusion criteria include 1) at least 18 years of age; 2) current use of at least 10 cigarettes daily; 3) willing to abstain from cigarette smoking, and substitute e-cigs, for approximately 2 weeks; 4) able to read and sign a consent form; Exclusion criteria: 1) unstable medical or psychiatric disorders as determined by the principal investigator; 2) pregnancy; 3) known hypersensitivity to nicotine or propylene glycol or menthol; 4) previous myocardial infarction (M.I.) or stroke; 5) uncontrolled hypertension [Blood pressure (BP) >160/100); 6) insulin dependent diabetes; 7) known chronic obstructive pulmonary disease (COPD) or asthma.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Electronic Cigarettes on Nicotine Concentrations Before and 5, 10, 15, 20 and 30 Minutes After Use
Study Start Date : October 2012
Primary Completion Date : June 2015
Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Tobacco Flavor/ Tobacco & Menthol Flavor

Subjects randomized to Tobacco Flavor group 7-10 days, then crossed over to Tobacco and Menthol Flavor for 7-10 days.

Nicotine with Tobacco Flavor and Tobacco & Menthol Flavor (18mg/mL nicotine)

Drug: Nicotine with Tobacco Flavor and Tobacco & Menthol Flavor
Subjects randomized to either Tobacco Flavor group for 7-10 days than crossed over to Tobacco & Menthol Flavor for 7-10 days or Tobacco & Menthol Flavor group for 7-10 days than crossed over to Tobacco Flavor for 7-10 days
Other Names:
  • Tobacco Flavor
  • Tobacco & Menthol Flavor
  • Electronic Cigarette
  • Nicotine
Tobacco & Menthol Flavor/Tobacco Flavor

Subjects randomized to Tobacco and Menthol Flavor for 7-10 days,then crossed over to Tobacco Flavor for 7-10 days.

Nicotine with Tobacco Flavor and Tobacco & Menthol Flavor (18mg/mL nicotine)

Drug: Nicotine with Tobacco Flavor and Tobacco & Menthol Flavor
Subjects randomized to either Tobacco Flavor group for 7-10 days than crossed over to Tobacco & Menthol Flavor for 7-10 days or Tobacco & Menthol Flavor group for 7-10 days than crossed over to Tobacco Flavor for 7-10 days
Other Names:
  • Tobacco Flavor
  • Tobacco & Menthol Flavor
  • Electronic Cigarette
  • Nicotine


Outcome Measures

Primary Outcome Measures :
  1. Effects E-cig Use on Venous Nicotine Concentrations Before and 5 Minutes After Use [ Time Frame: 7-10 days ]
    To determine the effects of acute E-cig use on venous nicotine concentrations 5 minutes before and 5 minutes after 7-10 days of e-cigarette use.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Smoking 10 cigarettes daily
  • Agree to abstain from smoking and use electronic cigarettes for 2 weeks

Exclusion Criteria:

  • Unstable medical or psychiatric disorders as determined by the principal investigator
  • Pregnancy
  • Known hypersensitivity to nicotine or propylene glycol or menthol
  • Recent M. I. or stroke
  • Uncontrolled hypertension (BP.>160/100)
  • Insulin dependent diabetes
  • Known COPD or asthma
  • Alcohol or other drug abuse or dependence
Contacts and Locations

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): NCT01775787


Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030-3940
Sponsors and Collaborators
UConn Health
Investigators
Principal Investigator: Cheryl Oncken, M.D. UConn Health
More Information

Additional Information:
Publications:
Responsible Party: Cheryl Oncken, Professor, Department of Medicine, UConn Health
ClinicalTrials.gov Identifier: NCT01775787     History of Changes
Other Study ID Numbers: ECIG 13-002-3
First Posted: January 25, 2013    Key Record Dates
Results First Posted: November 30, 2017
Last Update Posted: November 30, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Cheryl Oncken, UConn Health:
smoking

Additional relevant MeSH terms:
Nicotine
Menthol
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
Antipruritics
Dermatologic Agents