Smoking Study With Behavioral Therapy for Hypertensive Patients

Study Overview
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Brief Summary
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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.

Official Title
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Contingency Management for Initiating Smoking Abstinence in Patients With Hypertension

Conditions
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Cigarette Smoking, Hypertension

Intervention / Treatment
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* Drug: Varenicline
* Behavioral: behavioral therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Study drug (varenicline) for 12 weeks, brief smoking cessation counseling for 5 weeks, and ambulatory blood pressure monitoring at Weeks 6 and 24. | Drug: Varenicline<br>* 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.<br>* Other names: CHANTIX;|
| Experimental: Group B<br>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. | Drug: Varenicline<br>* 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.<br>* Other names: CHANTIX;Behavioral: behavioral therapy<br>* confirmed negative smoking status at different time points<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term and long-term smoking abstinence and improved health benefits |  | Weeks 5,6,8,12,24,36,52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in blood pressure and heart rate in hypertensive subjects |  | Week 6 and Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking, varenicline, behavioral therapy, ABPM, hypertension