Smoking Study With Behavioral Therapy for Hypertensive Patients

Completed · Phase 4

Conditions studied: Cigarette Smoking, Hypertension

In brief

In total, 260 patients with pre- and stage I hypertension, who are regular smokers, will be randomized to: varenicline alone or varenicline plus behavioral therapy. Patients in both conditions will receive varenicline (titrated to a maximal dose of 1.0 mg twice daily) for 12 weeks along with standard smoking cessation therapy and regular carbon monoxide (CO) and cotinine monitoring. A significantly higher proportion of behavioral therapy patients are expected to achieve and maintain long durations of abstinence than patients receiving varenicline alone. Clinic and 24-hour blood pressure (BP) and heart rate (HR) will be primary clinical outcomes. The investigators expect that BP and HR will decrease more among behavioral therapy than non-behavioral therapy patients and reductions in smoking may mediate decreases in these indices.

Key facts

Study ID

NCT00879177

Run by

UConn Health

People needed

203

Starts

2009-04-01

Expected to finish

2014-11-01

Last updated by the study team

2017-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• regular smokers, with no period of abstinence exceeding 3 months in past year
• expired CO of at least 8 ppm
• self-reported desire to stop smoking
• at least 18 years of age
• resting systolic BP of 120-160 mmHg and/or diastolic BP of 80-100 mmHg but otherwise in good health (see exclusion criteria)
• if on antihypertensive medication, have not changed medications during the previous month and do not intend to change in the next 3 months
• English speaking

You may not qualify if…

• receipt of smoking cessation treatment (behavioral or pharmacological) in the past month
• serious or unstable medical disease within the past 6 months, including myocardial infarction, cancer, congestive heart failure, kidney failure, stroke, or seizures
• evidence or history of allergic reactions contraindicating varenicline use or clinically significant laboratory or electrocardiographic (ECG) abnormalities
• breastfeeding, pregnant or not using effective contraception if a woman of childbearing potential
• arm circumference of >42 cm, which precludes accurate BP monitoring
• serious psychiatric illness in past 6 months (e.g., schizophrenia, psychosis, suicide risk, drug or alcohol dependence other than nicotine)
• use of tobacco containing products other than cigarettes in past month and do not agree to abstain from use of these products during study participation
• ongoing use of any of the following medications: nicotine replacement therapies, monoamine oxidase inhibitors, antipsychotics, mood stabilizers, or naltrexone
• in recovery for pathological gambling

Where it is running

• University of Connecticut Health Center — Farmington, Connecticut, United States

Full record on ClinicalTrials.gov

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