MedTrace Logo

Assess Biomarkers of Tobacco Exposure and Nicotine Pharmacokinetics in Smokers After a 5-Day In-Clinic Confinement Switch to an Electronic Cigarette or Nicotine Gum

NCT02323438 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2018-06-01

No results posted yet for this study

Summary

A single-center, randomized, controlled, switching, open-label, parallel cohort study. Smoking subjects will be confined to a clinic for 9 days. During their stay, baseline assessments during ad libitum smoking will occur for the first 3 days. Following baseline, subjects will be switched to either an Electronic Cigarette or Nicotine Gum, and post-product switch assessments will occur for 6 days.

Conditions

  • Smoking

Interventions

OTHER

Usual Brand Cigarette

Combustible cigarette brand style smoked most frequently by subject

OTHER

Electronic Cigarette #1

Electronic cigarette

OTHER

Electronic Cigarette #2

Electronic cigarette

OTHER

Leading U.S. Nicotine Gum

4 mg nicotine polacrilex gum

Sponsors & Collaborators

  • Davita Clinical Research

    collaborator INDUSTRY

  • RAI Services Company

    collaborator INDUSTRY

  • R.J. Reynolds Vapor Company

    lead INDUSTRY

Principal Investigators

  • Harry Alcorn, Jr., PharmD · Davita Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT02323438 on ClinicalTrials.gov