Comparison of Nicotine Plasma Concentrations and Subjective Effects for Three Electronic Cigarettes vs Combustible Cigarettes and Nicotine Gum
NCT02269514 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2018-06-04
Summary
The purpose of this study is to measure plasma nicotine uptake parameters, physiological measures, and subjective effect measures in smokers during and following a single ad libitum use of three electronic cigarettes versus combustible cigarettes and nicotine gum.
Conditions
- Smoking
Interventions
- OTHER
-
Own Brand Cigarette
combustible cigarette brand style smoked most frequently by subject
- OTHER
-
Electronic Cigarette #1
VUSE® Digital Vapor Cigarette (original flavor, 14mg nicotine)
- OTHER
-
Electronic Cigarette #2
VUSE® Digital Vapor Cigarette (original flavor, 29mg nicotine)
- OTHER
-
Electronic Cigarette #3
VUSE® Digital Vapor Cigarette (original flavor, 36mg nicotine)
- OTHER
-
Leading U.S. Nicotine Gum
4 mg nicotine polacrilex gum
Sponsors & Collaborators
-
Celerion
collaborator INDUSTRY -
RAI Services Company
collaborator INDUSTRY -
R.J. Reynolds Vapor Company
lead INDUSTRY
Principal Investigators
-
Michael Gartner, MD · Celerion
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 21 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-05-31
- Primary Completion
- 2015-01-31
- Completion
- 2015-01-31
Countries
- United States
Study Locations
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