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Nicotine Patch, Blood Flow and Oxidative Stress Study

The Effect Of Nicotine On Indices Of Arterial Function And Oxidative Stress

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00954096
Enrollment
55
Registered
2009-08-06
Start date
2002-10-31
Completion date
2006-12-31
Last updated
2009-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGtransdermal nicotine patch (7mg)

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

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Assess the dose-related effects of nicotine in humans, on novel indices of lipid peroxidation, protein oxidation and DNA modification by lipid adducts.1 - 3 years

Secondary

MeasureTime frame
Assess the dose-related effects of nicotine in humans on COX activation.1 year
Assess the dose-related effects of nicotine in humans on blood flow mediated arterial function.3 - 6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026