Overview

This trial is active, not recruiting.

Conditions cigarette smoking, hypertension
Treatments varenicline, behavioral therapy
Phase phase 4
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

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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Study drug (varenicline) for 12 weeks, brief smoking cessation counseling for 5 weeks, and ambulatory blood pressure monitoring at Weeks 6 and 24.
varenicline CHANTIX
Varenicline: 1 tab 0.5mg once a day for 3 days; 1 tab 0.5mg twice a day for 4 days; followed by 1 tab 1mg twice a day for 11 weeks.
(Experimental)
Study drug (varenicline) for 12 weeks, brief smoking cessation counseling for 5 weeks, ambulatory blood pressure monitoring at Weeks 6 and 24, and behavioral therapy for Weeks 2-5.
varenicline CHANTIX
Varenicline: 1 tab 0.5mg once a day for 3 days; 1 tab 0.5mg twice a day for 4 days; followed by 1 tab 1mg twice a day for 11 weeks.
behavioral therapy behavioral therapy
confirmed negative smoking status at different time points

Primary Outcomes

Measure
Short-term and long-term smoking abstinence and improved health benefits
time frame: Weeks 5,6,8,12,24,36,52

Secondary Outcomes

Measure
Decrease in blood pressure and heart rate in hypertensive subjects
time frame: Week 6 and Week 24

Eligibility Criteria

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

Additional Information

Official title Contingency Management for Initiating Smoking Abstinence in Patients With Hypertension
Principal investigator William B White, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by University of Connecticut Health Center.