Endothelial Function and Autonomic Regulation After Short-term Smoking Cessation: Varenicline Versus Placebo

• Status: Terminated
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Varenicline

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.