Smoking Study With Behavioral Therapy for Hypertensive Patients
Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
Participant gender:
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.