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Nicotine Delivery From Novel Non-Tobacco Electronic System in Smokers

2015-10-16 12:23:23 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Conditions

Cigarette Smoker

Intervention

Electronic Cigarette, Electronic Cigarette, Laboratory Biomarker Analysis, Pharmacological Study, Questionnaire Administration

Location

Roswell Park Cancer Institute
Buffalo
New York
United States
14263

Status

Not yet recruiting

Source

Roswell Park Cancer Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-10-16T12:23:23-0400

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Medical and Biotech [MESH] Definitions

Electronic devices that are designed to provide NICOTINE in the form of an inhaled aerosol. They typically are made in the shape of CIGARETTES in order to simulate the experience of CIGARETTE SMOKING.

Electronic implements worn on the body as an implant or as an accessory. Examples include wearable diagnostic devices, wearable ACTIVITY TRACKERS, wearable INFUSION PUMPS, wearable computing devices, SENSORY AIDS, and electronic pest repellents.

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Discarded electronic devices containing valuable and sometimes hazardous materials such as LEAD, NICKEL, CADMIUM, and MERCURY. (from http://www.epa.gov/osw/conserve/materials/ecycling/faq.htm#impact accessed 4/25/2010)

Controlled operations of analytic or diagnostic processes, or systems by mechanical or electronic devices.

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