Characterization of Biomarkers of Tobacco Exposure, Urge-to-Smoke Following Exclusive and Dual Ad Lib Use of Electronic Cigarettes

Summary

This is a randomized, open-label, forced-switch, parallel, proof-of-concept study to assess exposure to biomarkers of tobacco exposure following short-term ad lib use of three blu e-cigarette products. The primary objectives of this study are to:

1. Compare changes in selected urine and blood biomarkers of tobacco exposure within cohorts following a 5-day forced-switch from usual brand conventional combustible cigarettes to exclusive use of blu e-cigarettes, dual use of blu e cigarettes and the subject's usual brand combustible cigarette, or smoking cessation.
2. Compare changes in selected urine and blood biomarkers of tobacco exposure among cohorts following a 5-day forced-switch from usual brand conventional combustible cigarettes to exclusive use of a blu e cigarette, dual use of a blu e-cigarette and the subject's usual brand combustible cigarette, or smoking cessation.

The secondary objectives of this study are to:

1. Compare changes in selected physiological endpoints affected by tobacco exposure within cohorts during a 5-day forced-switch from usual brand conventional combustible cigarettes to exclusive use of blu e cigarettes, dual use of blu e cigarettes and the subject's usual brand combustible cigarette, or smoking cessation.
2. Compare changes in selected physiological endpoints affected by tobacco exposure among cohorts following a forced-switch to exclusive use of a blu e cigarette, dual use of a blu e-cigarette and the subject's usual brand combustible cigarette, or smoking cessation.
3. Determine daily nicotine consumption from blu e-cigarettes following exclusive use of blu e cigarettes or dual use of blu e-cigarettes and the subject's usual brand combustible cigarette over a 5-day period.
4. Assess the effectiveness of exclusive use of blu e-cigarettes or dual use of blu e-cigarettes and the subject's usual brand combustible cigarette to reduce the urge to smoke.
5. Assess subject opinions of various characteristics of blu e-cigarettes.
6. Assess the safety and tolerability of short-term use of blu e-cigarettes.

Conditions

• Cigarette Smoking

Interventions

OTHER

Exclusive blu™ e-cigarette A1

Classic Tobacco rechargeable e cigarette

OTHER

Exclusive blu™ e-cigarette A2

Magnificent Menthol rechargeable e cigarette

OTHER

Exclusive blu™ e-cigarette A3

Cherry Crush rechargeable e cigarette

OTHER

Dual blu™ e-cigarette and usual brand B1

Classic Tobacco rechargeable e cigarette and a usual brand combustible cigarette

OTHER

Dual blu™ e-cigarette and usual brand B2

Magnificent Menthol rechargeable e cigarette and a usual brand combustible cigarette

OTHER

Dual blu™ e-cigarette and usual brand B3

Cherry Crush rechargeable e cigarette and a usual brand combustible cigarette

OTHER

Nicotine product cessation C

Nicotine cessation

Sponsors & Collaborators

• Celerion

  collaborator INDUSTRY

• Lorillard Tobacco Company

  lead INDUSTRY

Principal Investigators

• Michael R. Gartner, M.D. · Celerion

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-09-30

Primary Completion

2014-12-31

Completion

2014-12-31

Countries

• United States

Study Locations