Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-03-02 @ 4:08 AM
Study NCT ID:
NCT01923402
Status:
COMPLETED
Last Update Posted:
2016-02-19
First Post:
2013-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of Biomarkers of Effect From Chronic Tobacco Usage
Sponsor:
R.J. Reynolds Tobacco Company
Organization:
Study Overview
Official Title:
Development of Biomarkers of Effect From Chronic Tobacco Usage: A Clinical Study Examining Metabolic Profiling, Inflammation, and Oxidative Stress
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: