Smoking Study With Behavioral Therapy for Hypertensive Patients (VANQUISH)

UConn Health

Status and phase: Completed; Phase 4

Conditions: Hypertension; Cigarette Smoking

Treatments: Behavioral: behavioral therapy; Drug: Varenicline

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00879177

08-218

R01DA024667 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 203 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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203 participants in 2 patient groups

Group A

Active Comparator group

Description:

Study drug (varenicline) for 12 weeks, brief smoking cessation counseling for 5 weeks, and ambulatory blood pressure monitoring at Weeks 6 and 24.

Treatment:

Drug: Varenicline

Group B

Experimental group

Description:

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.

Treatment:

Drug: Varenicline

Behavioral: behavioral therapy