Endothelial Function and Autonomic Regulation After Short-term Smoking Cessation: Varenicline Versus Placebo
Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Smoking
Intervention: Varenicline (Drug); Placebo (Drug)
Phase: N/A
Status: Terminated
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s): John H Eisenach, M.D., Principal Investigator, Affiliation: Mayo Clinic
Summary
The purpose of this study is to evaluate endothelial function and autonomic regulation (for
example, heart rate and blood pressure) in smokers before and after short-term smoking
cessation. The endothelium is the thin layer of cells that lines the interior surface of
blood vessels. The endothelium releases nitric oxide, which promotes dilation of the blood
vessels and inhibits inflammation. Previous studies have shown that tobacco use is
associated with endothelial dysfunction, and tobacco use increases heart rate and blood
pressure.
We hypothesize that 2 weeks of smoking cessation will improve endothelial function. We will
also determine if endothelial function and autonomic regulation after short-term smoking
cessation differs for patients that achieve abstinence with the smoking cessation agent
varenicline compared to placebo.
Clinical Details
Official title: Endothelial Function and Autonomic Regulation After Short-term Smoking Cessation: Varenicline Versus Placebo
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Primary outcome: Arterial Endothelial Function as Measured by Flow-mediated Dilation
Secondary outcome: 24-hour Ambulatory Blood Pressure
Detailed description:
Smoking is a major cardiovascular risk factor and is associated with arterial endothelial
dysfunction, a key event in atherosclerosis. Previous observations have suggested that
smoking-related endothelial dysfunction is dose-related and potentially reversible after
withdrawal from smoking. To our knowledge, no data are available regarding potential
improvement of arterial endothelial function in the first weeks of smoking cessation. This
time frame is especially important because due to smoke-free policies in healthcare
facilities, all smokers requiring surgery are abstinent from tobacco for at least some
period of time.
Varenicline, a partial agonist at α4β2 neuronal nicotinic acetyl-choline (nAChR) receptors,
received FDA approval as a novel medication for helping cigarette smokers to stop smoking.
Given the anticipated common use of varenicline, it is important to define if the drug
alters endothelial function and/or autonomic effects. Based on the lesser potency of
varenicline (compared to nicotine) at nAChR receptors in peripheral ganglia and on
endothelial cells of blood vessels, it may be hypothesized that varenicline has less or no
influence on autonomic control of blood pressure and heart rate, and less or no influence on
endothelial function.
Therefore, the aims of this study are 1) to determine the effects of short-term smoking
cessation on endothelial function and autonomic regulation, and 2) to determine if these
effects will be altered during treatment with varenicline.
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Regular smokers (currently >10 cigarettes/day; >5 pack years)
- Willing to quit smoking for at least the duration of the study
- Able and willing to give written informed consent
Exclusion Criteria:
- Known condition causing endothelial dysfunction except smoking (i. e. diabetes,
hyperlipi¬demia, arterial hypertension, obesity)
- Regular drug treatment and/or sporadic consumption of drugs within the last 4 weeks
(exclusion has to be decided in each individual)
- Acute or chronic illness
- Participation in clinical trial within 1 month before the study
- Excessive daily intake of alcohol (>2 servings per day) or caffeine (>4 servings/day)
- Drug and/or alcohol abuse.
Locations and Contacts
Mayo Clinic, Rochester, Minnesota 55905, United States
Additional Information
Mayo Clinic Clinical Trials
Starting date: March 2007
Last updated: February 21, 2012
|