NCT01923402

Development of Biomarkers of Effect From Chronic Tobacco Usage

Development of Biomarkers of Effect From Chronic Tobacco Usage: A Clinical Study Examining Metabolic Profiling, Inflammation, and Oxidative Stress

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: R.J. Reynolds Tobacco Company · Industry
• Sex: Male
• Age: 35 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study was conducted to develop biomarkers of tobacco effect that would indicate potential harm related to tobacco consumption. To gain a better understanding of chronic effects of tobacco consumption, this cross-sectional clinical study enrolled generally healthy, adult male consumers of cigarettes (SMK), moist snuff (MSC), and no tobacco products (NTC).

Detailed description

This single site, three-group (healthy, adult male smokers (SMK), moist snuff consumers (MSC), and non-tobacco consumers (NTC), single-blind, cross-sectional study, included one overnight confinement of study subjects for Test Visit (Visit #3). No lifestyle changes were required, inclusive of tobacco habits. In addition to the Screening Visit (Visit #1), two other visits (Acceptance Visit \[Visit #2\] and a Test Visit \[Visit #3\]) were conducted at the clinical study site.

Conditions

• Cigarette Smoking

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2013-08-15
• Last updated: 2016-02-19

Locations

1 site across 1 country: United States