Effects of Electronic Cigarettes on Nicotine Concentrations (ECIG)
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.
|Health Behavior||Other: Nicotine with Tobacco Flavor Other: Nicotine with Tobacco and Menthol Flavor|
|Study Design:||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|
- Effects E-cig use on venous nicotine concentrations before and 5, 10, 15,20 and 30 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, 10, 15, 20 and 30 minutes after 7-10 days of e-cigarette use.
- Effects of E-cig use on measures of pulmonary resistance before and 5 minutes after use [ Time Frame: 7-10 days ]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.
- Comparing smoking vs. e-cigarette use [ Time Frame: 14-20 days ]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..
|Study Start Date:||October 2012|
|Study Completion Date:||June 2015|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01775787
|United States, Connecticut|
|University of Connecticut Health Center|
|Farmington, Connecticut, United States, 06030-3940|
|Principal Investigator:||Cheryl Oncken, M.D.||UConn Health|