Smoking Study With Behavioral Therapy for Hypertensive Patients
This trial is active, not recruiting.
|Conditions||cigarette smoking, hypertension|
|Treatments||varenicline, behavioral therapy|
|Sponsor||University of Connecticut Health Center|
|Collaborator||National Institute on Drug Abuse (NIDA)|
|Start date||April 2009|
|End date||July 2014|
|Trial size||260 participants|
|Trial identifier||NCT00879177, 08-218, R01DA024667|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Short-term and long-term smoking abstinence and improved health benefits
time frame: Weeks 5,6,8,12,24,36,52
Decrease in blood pressure and heart rate in hypertensive subjects
time frame: Week 6 and Week 24
Male or female participants at least 18 years old.
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
|Official title||Contingency Management for Initiating Smoking Abstinence in Patients With Hypertension|
|Principal investigator||William B White, M.D.|
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