Cardiovascular Disease Biomarkers in Smokers and Moist Snuff Consumers

Completed

Conditions studied: Cardiovascular Disease, Cigarette Smoking

In brief

This cross-sectional study was primarily a cardiovascular disease (CVD) study designed a) to compare selected CVD biomarker data between subjects who were long-term consumers of cigarettes or moist snuff and non-consumers of tobacco and b) to identify principal endpoints related to CVD risk that differed among the three tobacco-use cohorts. The following assessments provided the primary study endpoints for comparative analyses between the cohorts: 1. CVD-related physiological assessments: Flow-mediated dilation (FMD), carotid intima-media thickness (CIMT), ankle-brachial index (ABI), spirometry and expired carbon monoxide (ECO). 2. CVD-related biomarker assessments in blood and urine (biomarkers of tobacco effect). 3. Biomarkers of tobacco exposure in urine and blood.

Key facts

Study ID: NCT01692353
Run by: R.J. Reynolds Tobacco Company
People needed: 168
Starts: 2008-09-01
Expected to finish: 2009-04-01
Last updated by the study team: 2016-02-17

Who can join

Age: 26 and older, up to 49. Sex: male. Healthy volunteers: accepted.

You may qualify if…

Smokers: exclusive FF (full flavor; > 13.0 mg FTC "tar" ) or FFLT (full flavor, low "tar" [6.0 to 13.0 mg FTC "tar"]) smokers who reported smoking at least 15 cigarettes daily for at least three years prior to Day 1 and whose ECO was 10 to 100 ppm (ranges of 2 to 9 ppm and 101 to 125 ppm were allowed upon joint review by the Sponsor and Investigator).
Moist Snuff Consumers: exclusive oral smokeless tobacco users of any brand (Copenhagen, Skoal, Grizzly, Kodiak, Timber Wolf, Longhorn, Red Man, Levi Garrett, Beech-Nut, Chattanooga Chew, Kayak, etc.), any style (snuff cut, long cut, fine cut, pouch, loose, or plug) and any flavor (natural, straight, mint, wintergreen, etc.) who reported using at least two cans or packages per week for at least three years prior to Day 1 and whose ECO was 0 to 5 ppm (a range of 6 to 10 ppm was allowed upon joint review by the Sponsor and Investigator).
Non-tobacco Consumers: never-smokers/never-ST users whose ECO was 0 to 5 ppm (a range of 6 to 10 ppm was allowed upon joint review by the Sponsor and Investigator).
Male, between 26 and 49 years of age, inclusive (on Day 1 check-in).
Free of clinically significant health problems in the opinion of the Investigator.
Forced expiratory volume exhaled in one second (FEV1) ≥70% of predicted at Screening.
Willing to undergo all study procedures during confinement.
Not taking medication on a daily basis for chronic medical disorders deemed clinically significant by the Investigator.
Willing to suspend usage of daily aspirin or over-the-counter (OTC) medication seven days prior to Day 1.
Not taking any creatine supplements.
Negative tests for selected drugs of abuse and alcohol at Screening and at Day 1 check-in.
Able to read and comprehend questionnaires in English.
Able to comprehend and willing to sign an Informed Consent Form (ICF).

You may not qualify if…

At Screening, a BP that exceeds 140/90.
<70% predicted FEV1 from three acceptable maneuvers.
Unwilling to have the FMD procedure performed two or more times during confinement.
Unwilling to have the ABI procedure performed two times during confinement.
For the FMD determination, poor brachial artery visualization due to extremely deep position or severe artifacts (noise) due to overlying muscle that, in the sonographer(s)' opinion, would result in an inferior, unreadable or unobtainable brachial artery image.
A donation of blood from 30 days prior to Screening through Day 1, inclusive, or of plasma from two weeks prior to Screening through Day 1, inclusive.
Receipt of blood products within two months prior to Day 1 check-in.
Evidence of visible oral cancer, as found in an oral health examination at Screening or based on oral health questions at Day 1 check-in.
Subject who is an employee of the clinical site.
Subject who has participated in any other investigational study drug or product trial in which receipt of an investigational study drug or product occurred within 30 days prior to Day 1 check-in, inclusive.

Where it is running

MDS Pharma Services (US), Inc. (Currently Celerion) — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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