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Comparison of Nicotine Plasma Concentrations and Subjective Effects for Three Menthol Electronic Cigarettes vs Combustible Menthol Cigarettes and Nicotine Gum

NCT02664012 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2018-06-04

No results posted yet for this study

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 menthol electronic cigarettes versus combustible menthol cigarettes and nicotine gum.

Conditions

  • Smoking

Interventions

OTHER

Own Brand Menthol Cigarette

combustible menthol cigarette brand style smoked most frequently by subject

OTHER

Electronic Menthol Cigarette #1

VUSE® Digital Vapor Cigarette (menthol flavor, 14 mg nicotine)

OTHER

Electronic Menthol Cigarette #2

VUSE® Digital Vapor Cigarette (menthol flavor, 29 mg nicotine)

OTHER

Electronic Menthol Cigarette #3

VUSE® Digital Vapor Cigarette (menthol flavor, 36 mg 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

  • Charles Tomek, 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
2016-01-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02664012 on ClinicalTrials.gov