Nicotine Patch, Blood Flow and Oxidative Stress Study

NCT ID: NCT00954096

Last Updated: 2009-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2006-12-31

Brief Summary

This study will address the hypothesis that nicotine, like cigarette smoking acting as a pro-oxidant may have adverse effects on arterial function.

Detailed Description

Smoking causes >400,000 deaths from cardiovascular disease (CVD) per year. The molecular basis of smoking induced tissue injury remains unclear but considerable evidence supports a role for oxidant stress (OS).

Arterial function has been shown to be impaired in smokers even before the onset of angiographically demonstrable atherosclerosis. Defects in endothelium dependant flow mediated vasodilatation (FMD) are seen in those at risk of or with overt vascular disease.

Cigarette smoking is highly addictive. Spontaneous quit rates approximate 3%. Even those using nicotine replacement therapy (NRT) have high relapse rates (67-75%) on completion of the 8-12 week course of NRT. Thus there is interest in the use of extended NRT as a "safer" alternative to cigarette smoking. However such assumptions may be premature. Nicotine demonstrates proxidant effects in vitro and in small studies has been associated with endothelial dysfunction. Studies simultaneously assessing the effects of nicotine on oxidative stress and arterial function in humans have not been performed.

The current proposal will address the hypothesis that nicotine, like cigarette smoking acting as a pro-oxidant may have adverse effects on arterial function.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: DOUBLE

Study Groups

Transdermal nicotine patch or placebo

A single blood specimen (85ml) will be drawn. They will be asked to empty their bladder. The patch will be applied. Following application of the patch, heart rate and blood pressure will be measured every 15 minutes for the 1st hour, every 30 minutes for the next 3 hours and hourly after that until the end of the study. Urine will be collected in two 4-hour aliquots. FMD will be measured after approximately 6 hours of nicotine exposure. After 8 hours exposure, following the end of the 2nd urine collection, the patch will be removed and the subject discharged. Following a minimum of 2 weeks (maximum 8 weeks) washout, the subject will repeat the study, receiving the other patch.

Group Type: EXPERIMENTAL

transdermal nicotine patch (7mg)

Intervention Type: DRUG

A 7mg transdermal nicotine patch will be applied to the subject's arm for an 8 hour period.

Interventions

transdermal nicotine patch (7mg)

A 7mg transdermal nicotine patch will be applied to the subject's arm for an 8 hour period.

Intervention Type: DRUG

Other Intervention Names

Nicotine patch; Habitrol; Nicoderm CQ; Nicotrol

Eligibility Criteria

Inclusion Criteria

• Healthy individuals
• Nonsmokers who have never smoked
• Normal medical history
• Normal physical examination
• Normal laboratory data
• Negative urinary pregnancy test for females

Exclusion Criteria

• Previous CVD
• Chronic medication use
• History alcoholism
• History of smoking
• Current pregnancy
• Subjects, who have less than or equal to 60% platelet aggregation in response to arachidonic acid will also be excluded.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

University of Pennsylvania

Principal Investigators

Garret A FitzGerald, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania Institute for Translational Medicine and Therapeutics

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Related Links

http://www.itmat.upenn.edu/

Institute for Translational Medicine and Therapeutics, University of Pennsylvania

Other Identifiers

0875

Identifier Type: -

Identifier Source: secondary_id

707275

Identifier Type: -

Identifier Source: org_study_id