Nicotine Patch, Blood Flow and Oxidative Stress Study
The Effect Of Nicotine On Indices Of Arterial Function And Oxidative Stress
2 other identifiers
interventional
55
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy
Started Oct 2002
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 29, 2009
CompletedFirst Posted
Study publicly available on registry
August 6, 2009
CompletedOctober 27, 2009
October 1, 2009
4.1 years
July 29, 2009
October 23, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (1)
Transdermal nicotine patch or placebo
EXPERIMENTALA 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.
Interventions
A 7mg transdermal nicotine patch will be applied to the subject's arm for an 8 hour period.
Eligibility Criteria
You may qualify if:
- Healthy individuals
- Nonsmokers who have never smoked
- Normal medical history
- Normal physical examination
- Normal laboratory data
- Negative urinary pregnancy test for females
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- National Institutes of Health (NIH)collaborator
Study Sites (1)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Garret A FitzGerald, MD
University of Pennsylvania Institute for Translational Medicine and Therapeutics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 29, 2009
First Posted
August 6, 2009
Study Start
October 1, 2002
Primary Completion
November 1, 2006
Study Completion
December 1, 2006
Last Updated
October 27, 2009
Record last verified: 2009-10