Characterization of Nicotine Exposure and Urge-to-Smoke Following Use of Electronic and Conventional Cigarettes

Summary

This trial was the initial characterization of the blu™ products being studied, with the purpose of gaining an understanding of the exposure to nicotine and craving reduction attained following use of blu™ e-cigarettes by adult smokers. Two types of exposures were utilized: a single controlled administration and a short-term ad lib use. As smoking behaviors vary from smoker to smoker, a controlled administration allows for some standardization of nicotine "dose" for each of the study products to better understand their uptake characteristics as well as urge reduction achieved under controlled conditions. Further evaluation under ad lib product use conditions provides insight into product self-administration behaviors that will allow subjects to achieve acceptable levels of urge reduction. Comparisons were made to evaluate differences between blu™ formulations as well as to the market-leading conventional cigarette, Marlboro Gold King Size ("Marlboro cigarette').

Conditions

• Smoking

Interventions

OTHER

blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin vehicle)

electronic cigarettes

OTHER

blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin/PG vehicle)

electronic cigarettes

OTHER

blu™ Magnificent Menthol rechargeable (2.4% nicotine, glycerin vehicle)

electronic cigarettes

OTHER

blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin vehicle)

electronic cigarettes

OTHER

blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin/PG vehicle)

electronic cigarettes

OTHER

Marlboro Cigarette

cigarettes

Sponsors & Collaborators

• Lorillard Tobacco Company

  lead INDUSTRY

Principal Investigators

• Michael R. Gartner, MD · Celerion

Study Design

Allocation

RANDOMIZED

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-03-31

Primary Completion

2014-05-31

Completion

2014-07-31

Countries

• United States

Study Locations