drugset / Trial / NCT00879177

Smoking Study With Behavioral Therapy for Hypertensive Patients

NCT00879177

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2009-04
Primary completion
2014-08
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Varenicline Small molecule 1 mg

Indications