Lab to Real World Assessment of E-cigarette Abuse Liability and Appeal
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Observational

Summary: 
      The proposed research is a longitudinal human lab study to examine how measures of abuse
      liability and product appeal vary by e-cigarette device type, and how these lab assessments
      may predict subsequent e-cigarette and other tobacco use behavior at 1,3, and 6 months. An
      additional aim is to evaluate e-cigarette safety and tolerability among smokers by device
      type.
    

Detailed description: 
      The proposed research is a longitudinal human lab study to involving 6 lab visits and 3
      follow-up surveys at 1, 3, and 6 months after participants' last lab visit. Investigators
      will enroll 30 smokers (≥10 cig/day) who have not used e-cigarettes in the past 30 days and
      have never used e-cigarettes "fairly regularly." After a telephone screening to confirm
      eligibility, participants will attend Virginia Commonwealth University's (VCU) Clinical
      Behavioral Pharmacology Laboratory for all lab visits. The specific aims are to:

      Aim 1. Examine how measures of abuse liability and product appeal vary by ECIG device type
      (Markten vs. e-Go).

      Aim 2. Compare differences in abuse liability and product appeal between participants' usual
      brand of tobacco cigarette, Markten, and e-Go.

      Aim 3. As an exploratory aim, examine the extent to which measures of abuse liability and
      product appeal as measured in the lab (including TPPT) predict participants' real-world ECIG
      use at the 1-, 3-, and 6-month follow-up surveys.

      Aim 4. To monitor safety and tolerability the MarkTen and e-Go among smokers.
    

Intervention name(s): MarkTen and e-Go e-cigarettes
Intervention type(s): Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 30 community volunteers who currently use 10 or more cigarettes per day and have
        no immediate plans to quit smoking will be enrolled. Investigators will attempt to recruit
        an equal number of men and women of diverse racial/ethnic backgrounds. This preliminary
        study is not intended to address gender or race/ethnic differences.
      
Biospecimen description: 
      Plasma nicotine: Investigators will examine change in plasma nicotine concentration before
      and after 5 minutes of directed product use (10 total puffs). At the start of the session, a
      phlebotomist will draw 7mL of blood via venipuncture (no catheter). Participants will then be
      directed to take a puff of their own brand/assigned e-cigarette device every 30 seconds for 5
      minutes. At the end of the directed use session, the phlebotomist will draw another 7mL of
      blood via venipuncture. Blood samples will be processed at the Center for Study of Tobacco
      Products lab, frozen, and walked across the street to the Bioanalytical Mass Spectrometry
      Core Laboratory at VCU for cotinine/3-OH analysis using previously developed assays. Blood
      samples will not be retained for additional analyses.