Nicotine Patch, Blood Flow and Oxidative Stress Study
|ClinicalTrials.gov Identifier: NCT00954096|
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : October 27, 2009
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: transdermal nicotine patch (7mg)||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effect Of Nicotine On Indices Of Arterial Function And Oxidative Stress|
|Study Start Date :||October 2002|
|Actual Primary Completion Date :||November 2006|
|Actual Study Completion Date :||December 2006|
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.
- 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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00954096
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Garret A FitzGerald, MD||University of Pennsylvania Institute for Translational Medicine and Therapeutics|