E-Cigarettes: Dynamic Patterns of Use and Health Effects
Condition: Smoking; Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Observational

Summary: 
      The proposed research will provide in-depth, longitudinal data, based on real-time reports,
      which will address key priorities for the FDA including, increased understanding of the
      relations between electronic cigarette (e-cig) use and 1) nicotine dependence, 2) reductions
      in combustible cigarette (CC) use, 3) attempts to quit CC use and the success of those
      attempts, and 4) health-related outcomes such as biomarkers of exposure and carcinogenicity.
    

Detailed description: 
      Primary Aim: Characterize e-cig use patterns both acutely and over 2 years and relate them to
      patterns of CC use (including reduced CC use), nicotine dependence and related variables
      (e.g., withdrawal suppression), and attempts and success in quitting CC use. Investigators
      will use ecological momentary assessment (EMA) to obtain fine grained, real-time data on
      e-cig and CC use. These data will be used to test the hypotheses that increasing and higher
      levels of e-cig use, measured in real-time, will be negatively related to CC use, nicotine
      dependence, and CC withdrawal severity and positively related to CC quit attempts and CC
      cessation success.

      Secondary Aim 1: Determine how the use of e-cigs is related to biomarkers of tobacco exposure
      and cancer risk, and to acute and chronic pulmonary health outcomes. Investigators will
      examine the relation between e-cig use and cancer biomarkers, exposure biomarkers, and
      pulmonary function.

      Secondary Aim 2: Identify person factors, contextual variables, and patterns of behaviors and
      symp-toms that predict e-cig and CC use patterns and key outcomes (e.g., CC cessation,
      health-related outcomes), and identify variables that moderate relations between e-cig use
      and such outcomes. Investigators will attempt to identify contextual variables and person
      factors that predict increased e-cig use, decreased CC use (including cessation), reduced
      nicotine dependence, and significant changes in biomarkers and health outcomes. Further,
      investigators will identify variables that moderate such relations, revealing factors and
      events that make changes in e-cig and CC use, and associated outcomes, especially likely.
    

Intervention name(s): No intervention: observation only
Intervention type(s): Other
Intervention description(s): For all participants: We will conduct a 2-year longitudinal cohort study comprising participants who smoke exclusively CCs (n=175) and dual users of e-cigs and CCs (n=275). We will use state-of-the-art ecological momentary assessments to determine: 1) dynamic patterns of e-cig and CC use and related outcomes (e.g., dependence, withdrawal symptoms, CC quit attempts and quitting success); 2) episodic (affective, contextual, social) and stable person-factor (lifestyle factors, demographics) variables that covary meaningfully with e-cig and CC use and related outcomes; and 3) biomarkers of tobacco and carcinogen exposure as well as other health-related outcomes (e.g., reduced pulmonary function.
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        2 groups: regular users of electronic cigarettes and commercial cigarettes and regular
        exclusive users of commercial cigarettes
      
Biospecimen description: 
      urine samples retained for additional analyses
    
Keywords: electronic cigarettes; nicotine dependence; smoking; tobacco use