Status:
COMPLETED
Smoking Study With Behavioral Therapy for Hypertensive Patients
Lead Sponsor:
UConn Health
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cigarette Smoking
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT00879177
Start Date
April 1 2009
End Date
November 1 2014
Last Update
April 10 2017
Active Locations (1)
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1
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030