Smoking Study With Behavioral Therapy for Hypertensive Patients

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UConn Health
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Varenicline

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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