Smoking Study With Behavioral Therapy for Hypertensive Patients

UConn Health203 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

203

Conditions

Cigarette Smoking Hypertension

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Short-term and long-term smoking abstinence and improved health benefits

Time frame: Weeks 5,6,8,12,24,36,52

Secondary Outcomes

Decrease in blood pressure and heart rate in hypertensive subjects

Time frame: Week 6 and Week 24