Smoking Study With Behavioral Therapy for Hypertensive Patients
- Conditions
- Cigarette SmokingHypertension
- Interventions
- Behavioral: behavioral therapy
- Registration Number
- NCT00879177
- Lead Sponsor
- UConn Health
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 203
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group B behavioral therapy Study drug (varenicline) for 12 weeks, brief smoking cessation counseling for 5 weeks, ambulatory blood pressure monitoring at Weeks 6 and 24, and behavioral therapy for Weeks 2-5. Group B Varenicline Study drug (varenicline) for 12 weeks, brief smoking cessation counseling for 5 weeks, ambulatory blood pressure monitoring at Weeks 6 and 24, and behavioral therapy for Weeks 2-5. Group A Varenicline Study drug (varenicline) for 12 weeks, brief smoking cessation counseling for 5 weeks, and ambulatory blood pressure monitoring at Weeks 6 and 24.
- Primary Outcome Measures
Name Time Method Short-term and long-term smoking abstinence and improved health benefits Weeks 5,6,8,12,24,36,52
- Secondary Outcome Measures
Name Time Method Decrease in blood pressure and heart rate in hypertensive subjects Week 6 and Week 24
Trial Locations
- Locations (1)
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States