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Nicotine Patch, Blood Flow and Oxidative Stress Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00954096
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : October 27, 2009
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE July 29, 2009
First Posted Date  ICMJE August 6, 2009
Last Update Posted Date October 27, 2009
Study Start Date  ICMJE October 2002
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2009)
  • Assess the dose-related effects of nicotine in humans on COX activation. [ Time Frame: 1 year ]
  • Assess the dose-related effects of nicotine in humans on blood flow mediated arterial function. [ Time Frame: 3 - 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nicotine Patch, Blood Flow and Oxidative Stress Study
Official Title  ICMJE The Effect Of Nicotine On Indices Of Arterial Function And Oxidative Stress
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Healthy
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: transdermal nicotine patch (7mg)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 5, 2009)
55
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2006
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00954096
Other Study ID Numbers  ICMJE 707275
0875
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Garret A. FitzGerald M.D Chair, Department of Pharmacology- Director, Institute for Translational Medicine and Therapeutics, University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Garret A FitzGerald, MD University of Pennsylvania Institute for Translational Medicine and Therapeutics
PRS Account University of Pennsylvania
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP