Effects of Electronic Cigarettes on Nicotine Concentrations (ECIG)

This study is currently recruiting participants.
Verified January 2013 by University of Connecticut Health Center
Sponsor:
Information provided by (Responsible Party):
Cheryl Oncken, University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT01775787
First received: October 12, 2012
Last updated: January 16, 2014
Last verified: January 2013
  Purpose

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, tabacco and tabacco with menthol, which are available for over the counter purchase.

The elctronic 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 Intervention
Health Behavior
Other: Nicotine with Tobacco Flavor
Other: Nicotine with Tobacco and Menthol Flavor

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • Effects E-cig use on venous nicotine concentrations before and 5, 10, 15,20 and 30 minutes after use [ Time Frame: 7-10 days ] [ Designated as safety issue: No ]
    To determine the effects of acute E-cig use on venous nicotine concentrations 5 minutes before and 5, 10, 15, 20 and 30 minutes after 7-10 days of e-cigarette use.


Secondary Outcome Measures:
  • Effects of E-cig use on measures of pulmonary resistance before and 5 minutes after use [ Time Frame: 7-10 days ] [ Designated as safety issue: No ]
    To determine the acute effects of E-cig use before and 5 minutes after use on measures of pulmonary resistance after 7-10 days of product use.


Other Outcome Measures:
  • Comparing smoking vs. e-cigarette use [ Time Frame: 14-20 days ] [ Designated as safety issue: No ]
    To obtain preliminary data comparing smoking vs. e-cigarette use on 1) overall nicotine exposure as measured by cotinine; 2) nicotine cravings and on expectancies; 3) resting pulmonary function tests as measured by body plethysmography; 4) effects on pulmonary function testing with tobacco with and without menthol flavoring..


Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Nicotine with Tobacco Flavor
Electronic cigarette liquid 18mg of nicotine in a tobacco flavor solution.
Other: Nicotine with Tobacco and Menthol Flavor
Randomly assigned to 18mg of nicotine with tobacco and menthol flavor for 7 to 10 days and then switched to other flavor for an additional 7 to 10 days.
Other Names:
  • Tobacco with Menthol Flavor
  • Electronic Cigarette
  • Nicotine
Nicotine with Tobacco and Menthol Flavor
Electronic cigarette liquid 18mg of nicotine in a tobacco and menthol flavor solution.
Other: Nicotine with Tobacco Flavor
Randomly assigned to 18mg of nicotine with tobacco flavor for 7 to 10 days and then switched to other flavor for an additional 7 to 10 days.
Other Names:
  • Tobacco flavor
  • Electronic Cigarette
  • Nicotine

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 expsoure. Subjects will use the devise for one week and at the end of approximately one week of use, we will assess nicotine/cotinine concentrations (before and 5, 1015,20 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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01775787

Contacts
Contact: Lynn McLaughlin, R.N. 860-679-4647 lmclaughlin@uchc.edu

Locations
United States, Connecticut
University of Connecticut Health Center Recruiting
Farmington, Connecticut, United States, 06030-3940
Contact: Lynn McLaughlin, R.N.    860-679-4647    lmclaughlin@uchc.edu   
Principal Investigator: Cheryl Oncken, M.D.         
Sub-Investigator: Mark Litt, Ph.D.         
Sub-Investigator: Nausherwan K Burki, M.D.         
Sponsors and Collaborators
University of Connecticut Health Center
Investigators
Principal Investigator: Cheryl Oncken, M.D. University of Connecticut Health Center
  More Information

No publications provided

Responsible Party: Cheryl Oncken, Professor, Department of Medicine, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT01775787     History of Changes
Other Study ID Numbers: ECIG 13-002-3
Study First Received: October 12, 2012
Last Updated: January 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:
smoking

Additional relevant MeSH terms:
Menthol
Nicotine
Nicotine polacrilex
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
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
Central Nervous System Stimulants
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014