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

NCT00673595 | Terminated Results DMC

• 1 other identifier: 06-007194
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking

Keywords

smoking; varenicline; flow-mediated dilation; blood pressure; baroreflex

Outcome Measures

Primary Outcomes (1)

• Arterial Endothelial Function as Measured by Flow-mediated Dilation

  Flow-mediated dilation of the brachial artery will be measured using high-resolution ultrasound. Arterial diameter will be measured above the small cavity in the elbow joint from ultrasound images at rest in response to an increase in blood flow to the area. This blood flow will be induced by inflation of a blood pressure cuff placed around the forearm to a pressure of at least 50 mm Hg above systolic pressure for 5 min, followed by release. The ultrasound image of the artery will be recorded continuously from 30 sec before until 2 min after cuff release.

  2 weeks after participants quit smoking (study visit 3, day 15)

Secondary Outcomes (1)

• 24-hour Ambulatory Blood Pressure

  2 weeks after participants quit smoking (study visit 3, day 15)

Study Arms (2)

Varenicline

ACTIVE COMPARATOR

Participants on this arm will receive varenicline tablets for 15 days.

Drug: Varenicline

Placebo

PLACEBO COMPARATOR

Participants on this arm will receive placebo tablets for 15 days.

Drug: Placebo

Interventions

Varenicline DRUG

Smoking cessation assistance: study days 1-3: 0.5 mg once daily, study days 4-7: 0.5 mg twice daily, study days 8-15: 1 mg twice daily; study day 16: 1 mg once. The tablets should be taken orally after food intake with 200 ml of water. The treatment phase may be prolonged up to a maximum of 2 weeks under the following conditions: 1) the participant voluntarily agrees to the prolongation of the study, 2) both the participant and investigator are confident that the participant will be able to completely refrain from smoking for at least 10 days until the final study day.

Also known as: Chantix

Varenicline

Placebo DRUG

The pharmacy will prepare tablets that match the varenicline tablets. The tablets should be taken orally after food intake with 200 ml of water.

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Known condition causing endothelial dysfunction except smoking (i.e. diabetes, hyperlipi¬demia, arterial hypertension, obesity)
• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Limitations and Caveats

This study was terminated early due to difficulty with recruiting subjects and with subjects complying with the protocol.

Results Point of Contact

• Title: Dr. John H. Eisenach
• Organization: Mayo Clinic

eisenach.john@mayo.edu

507-266-8715

Study Officials

• John H Eisenach, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 5, 2008
• First Posted: May 7, 2008
• Study Start: March 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2010
• Last Updated: March 16, 2012
• Results First Posted: March 16, 2012

Record last verified: 2012-02

Locations

US (1)