NCT00879177

Smoking Study With Behavioral Therapy for Hypertensive Patients

Contingency Management for Initiating Smoking Abstinence in Patients With Hypertension

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: UConn Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cigarette Smoking
• Hypertension

Interventions

Type	Name	Description
DRUG	Varenicline	Varenicline: 1 tab 0.5mg once a day for 3 days; 1 tab 0.5mg twice a day for 4 days; followed by 1 tab 1mg twice a day for 11 weeks.
BEHAVIORAL	behavioral therapy	confirmed negative smoking status at different time points

Timeline

• Start date: 2009-04-01
• Primary completion: 2014-08-01
• Completion: 2014-11-01
• First posted: 2009-04-09
• Last updated: 2017-04-10

Locations

1 site across 1 country: United States