Effects of Electronic Cigarettes on Nicotine Concentrations
Condition: Health Behavior
Study type: Interventional

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.
    

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.
    

Intervention name(s): Nicotine with Tobacco Flavor and Tobacco & Menthol Flavor
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): Tobacco Flavor; Tobacco & Menthol Flavor; Electronic Cigarette; Nicotine
Intervention MeSH terms: Menthol; Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: smoking