Hypertension Clinical Trial
— VANQUISHOfficial title:
Contingency Management for Initiating Smoking Abstinence in Patients With Hypertension
Verified date | April 2017 |
Source | UConn Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 203 |
Est. completion date | November 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Connecticut Health Center | Farmington | Connecticut |
Lead Sponsor | Collaborator |
---|---|
UConn Health | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Short-term and long-term smoking abstinence and improved health benefits | Weeks 5,6,8,12,24,36,52 | ||
Secondary | Decrease in blood pressure and heart rate in hypertensive subjects | Week 6 and Week 24 |
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