The Role of Nicotine and Non-Nicotine Alkaloids in E-Cigarette Use and Dependence
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The advent of electronic cigarette (e-cigarette) technologies represents one of the most
      significant developments in the last several decades, and provides a novel and promising
      strategy for substantially reducing the morbidity and mortality associated with smoking.
      However, serious concerns have been raised regarding the possibility that e-cigarettes will
      sustain a dependency on nicotine and that they may lead to continued use of conventional
      cigarettes known to be extremely harmful to health. Cigarette addiction critically involves a
      dependence on nicotine, but it is likely that other tobacco constituents contribute to
      dependence as well. Recent evidence suggests that non-nicotine tobacco alkaloids, or NNTAs
      (including anabasine, anatabine, nornicotine, and myosmine) may play a role in tobacco
      dependence. These alkaloids have been shown to augment the reinforcing effects of nicotine in
      animal models and to affect cravings in human smokers. E-cigarettes contain variable
      quantities of nicotine and NNTAs, but there is virtually no information available concerning
      the role of e-cigarette nicotine or NNTA content in influencing the concurrent use of
      cigarettes and e-cigarettes, when smokers attempt to switch from conventional combustible
      cigarettes to e-cigarettes. Additionally, it is not known whether the presence of nicotine
      and NNTAs in e- cigarettes may sustain dependence, making it difficult to relinquish these
      products. The proposed project will assess the acceptability, extent of switching behavior,
      and degree of dependence maintained when smokers are provided with e-cigarettes containing
      nicotine and NNTAs.
    

Detailed description: 
      A single group of thirty smokers will be recruited for the study to provide initial data to
      inform follow-up randomized controlled trials.

      Dependence and concurrent use of e-cigarettes and cigarettes will be assessed by a battery of
      self-report, biochemical, and behavioral indices. This is not a tobacco cessation study and
      there is no intent to use e-cigarettes as a smoking cessation treatment. Smokers will be
      asked to use the e-cigarettes instead of their regular cigarettes during the study.
      E-cigarettes will not be used for the purpose of reducing urges, withdrawal or nicotine
      dependence; and e-cigarettes will not be described or used as a medical device or therapy.

      Specific Aim 1: To assess the extent of switching from combustible cigarettes to e-cigarettes
      delivering nicotine along with NNTAs.

      Switching will be assessed by self-report diaries and by reductions in expired air carbon
      monoxide, an index of combustible cigarette use.

      Specific Aim 2: To assess the acceptability of e-cigarettes delivering nicotine along with
      NNTAs.

      Ratings of user satisfaction and other subjective effects will be collected from
      participants, for both their customary brand of cigarettes and the e-cigarette to be used.

      Specific Aim 3: To determine the extent of dependence maintained during use of e-cigarettes
      delivering nicotine with NNTAs, as well as the relationship between dependence and
      self-reported use of cigarettes and e-cigarettes.
    

Intervention name(s): E-cigarettes
Intervention type(s): Combination Product
Intervention description(s): Participants will be asked to switch from cigarette use to use of e-cigarettes for eight weeks.
Other intervention name(s): Electronic Nicotine Delivery System (ENDS); e-cigs; electronic cigarettes
Intervention MeSH terms: Nicotine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Nicotine addiction; Cigarette smoking; E-cigarettes