Healthy Subject Clinical Trial
Official title:
Nicotine Delivery From Novel Non-tobacco Electronic Systems (ENDS)
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.
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.
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