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Nicotine Patch, Blood Flow and Oxidative Stress Study

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00954096
First received: July 29, 2009
Last updated: October 23, 2009
Last verified: October 2009
History of Changes
  Purpose

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


Condition Intervention
Healthy
 Drug: transdermal nicotine patch (7mg)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: The Effect Of Nicotine On Indices Of Arterial Function And Oxidative Stress

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Assess the dose-related effects of nicotine in humans, on novel indices of lipid peroxidation, protein oxidation and DNA modification by lipid adducts. [ Time Frame: 1 - 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the dose-related effects of nicotine in humans on COX activation. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Assess the dose-related effects of nicotine in humans on blood flow mediated arterial function. [ Time Frame: 3 - 6 months ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: October 2002
Study Completion Date: December 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Drug: transdermal nicotine patch (7mg)
A 7mg transdermal nicotine patch will be applied to the subject's arm for an 8 hour period.
Other Names:
  • Nicotine patch
  • Habitrol
  • Nicoderm CQ
  • Nicotrol

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00954096

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institutes of Health (NIH)
Investigators
Principal Investigator: Garret A FitzGerald, MD University of Pennsylvania Institute for Translational Medicine and Therapeutics
  More Information

Additional Information:
Institute for Translational Medicine and Therapeutics, University of Pennsylvania  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Garret A. FitzGerald M.D Chair, Department of Pharmacology- Director, Institute for Translational Medicine and Therapeutics, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00954096     History of Changes
Other Study ID Numbers: 707275, 0875
Study First Received: July 29, 2009
Last Updated: October 23, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
 Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013