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Switching to Reduced Oxidant or Nicotine Content Cigarettes in Smokers

NCT02415270 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2018-07-27

No results posted yet for this study

Summary

The overall objectives of this clinical study are to determine in smokers the short term effects of switching to tobacco products that deliver low levels of nicotine or reactive oxygen/nitrogen species (ROS/RNS) on smoking behavior and biomarkers of tobacco smoke exposure and oxidative stress.

Conditions

  • Tobacco Smoking Behavior

Interventions

OTHER

Reduced Nicotine Cigarettes

Human topography data will show if smokers smoke their cigarettes differently from baseline following randomization. Select biosamples of participants will be used to analyze how biomarkers differ among groups

OTHER

Reduced ROS/RNS

Human topography data will show if smokers smoke their cigarettes differently from baseline following randomization. Select biosamples of participants will be used to analyze how biomarkers differ among groups

OTHER

Control

Human topography data will show if smokers change the way they smoke due to being in a research study. Select biosamples of participants will be used to analyze how biomarkers differ among groups

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    collaborator FED

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • John Richie, Ph.D · Milton S. Hershey Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-01-31
Completion
2017-01-01

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 NCT02415270 on ClinicalTrials.gov