View Clinical Trial (Medical Research Study)
Contingency Management for Initiating Smoking Abstinence in Patients With Hypertension
| City: |
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Farmington |
| State: |
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Connecticut |
| Zip Code: |
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06030 |
| Conditions: |
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Cigarette Smoking - Hypertension |
| Purpose: |
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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.
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| Study Summary: |
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| 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
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| NCT ID: |
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NCT00879177 |
| Primary Contact: |
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Principal Investigator
William B White, M.D.
University of Connecticut Health Center
Karen M Gilliam, M.A.
Phone: 860-372-8418
Email: kgilliam@uchc.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Farmington, Connecticut 06030
United States
Karen M Gilliam, M.A.
Phone: 860-372-8418
Email: kgilliam@uchc.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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