Smoking Study With Behavioral Therapy for Hypertensive Patients
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Smoking Cessation |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/30/2013 |
| Start Date: | April 2009 |
| End Date: | September 2014 |
| Contact: | Karen M Gilliam, M.A. |
| Email: | kgilliam@uchc.edu |
| Phone: | 860-372-8418 |
Contingency Management for Initiating Smoking Abstinence in Patients With Hypertension
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.
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
We found this trial at
1
site
263 Farmington Ave
Farmington, Connecticut 06030
Farmington, Connecticut 06030
(860) 679-2000
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