Nicotine Delivery from Novel Non-tobacco Electronic System in Smokers

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. Assess and compare short-term “functional” nicotine effects of the different products by using subjective measures such as relief of craving and withdrawal symptoms. Assess indoor air quality when various types and brands of ENDS products are used by study participants. (Study 1)

II. Explore the effect of flavorings added to nicotine solution on puffing topography and nicotine delivery, and indoor air quality, 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.

IV. Assess level of particulate contamination when various types of ENDS products are used (study 1) and/or when various flavors are used (study 2) by study participants.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I (Study 1): After overnight tobacco abstinence, participants smoke ad lib a single cigarette of their own brand and receive 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): After overnight tobacco abstinence, participants smoke ad lib a single cigarette of their own brand and receive the eGO ENDS product with one of five random nicotine solution flavors over 3.5-4 hours at least 7 days apart for 6 weeks. Participants are provided with pre-filled tanks of 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.