Nicotine Delivery From Novel Non-Tobacco Electronic System in Smokers
Condition: Cigarette Smoker; Current Smoker; Healthy Subject
Study type: Interventional

Summary: 
      This randomized pilot clinical trial studies nicotine delivery from novel non-tobacco
      electronic system (ENDS) in smokers. Studying the levels of nicotine delivered by various
      types and brands of ENDS to the bloodstream, and comparing this to the levels delivered from
      conventional cigarettes (the participant's own brand) may help provide information about the
      use of nicotine-containing products that may help inform/reform current tobacco policy,
      practice, and harm reduction approaches.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Determine the levels of nicotine effectively delivered by various types and brands of ENDS
      to the bloodstream and compare them to levels delivered from conventional cigarettes. (Study
      1)

      II. Explore the effect of flavorings added to nicotine solution on puffing topography and
      nicotine delivery and, assess and compare short-term "functional" nicotine effects of the
      different products by using subjective measures such as relief of craving and withdrawal
      symptoms. (Study 2)

      SECONDARY OBJECTIVES:

      I. Determine the amounts of nicotine present in various brands and types of ENDS. (Study 3)

      II. Determine nicotine yields in vapors from various types of ENDS under laboratory
      conditions. (Study 4)

      TERTIARY OBJECTIVES:

      I. Develop a standardized testing protocol for ENDS that will reflect users' puffing behavior
      and product characteristics.

      II. Develop and validate the analytical method for analysis of nicotine content in the vapor.

      III. Propose a standardized puffing regimen for generating vapors for analytical purposes:
      Such a testing protocol will reflect the puffing behavior observed among ENDS users and
      should be specific to ENDS type.

      OUTLINE: Participants are randomized to 1 of 2 arms.

      ARM I (Study 1): Participants are asked to smoke ad lib a single cigarette of their own brand
      and provided with a different type of ENDS product at each visit (e-cigarette, disposable
      e-cigarette, eGo, personal vaporizer, e-cigar, and e-pipe) over 3.5-4 hours at least 7 days
      apart for 7 weeks. Participants are provided with cartridges of the same amounts of nicotine
      with regular (tobacco) or menthol flavor according to smoker's preference, instructed on how
      to use the product, asked to practice using it for 7 days, and return to the study center for
      their next visit.

      ARM II (Study 2): Participants are asked to smoke ad lib a single cigarette of their own
      brand and provided with the BLU e-cigarette ENDS product with nicotine solution of one of
      five flavors over 3.5-4 hours at least 7 days apart for 6 weeks. Participants are provided
      with cartridges of maximum available amounts of nicotine and different flavors at each visit,
      instructed on how to use the product, asked to practice using it for 7 days, and return to
      the study center for their next visit.
    

Intervention name(s): Electronic Cigarette; Electronic Cigarette; Laboratory Biomarker Analysis; Pharmacological Study; Questionnaire Administration
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Receive different type of ENDS product at each visit; Receive BLU e-cigarette ENDS product; Correlative studies; Correlative studies; Ancillary studies
Other intervention name(s): e-Cigarette; Electronic Nicotine Delivery System; e-Cigarette; Electronic Nicotine Delivery System
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention