Smoking Study With Behavioral Therapy for Hypertensive Patients

NCT ID: NCT00879177

Last Updated: 2017-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 203 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2014-11-30

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 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.

Conditions

Cigarette Smoking; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

Study drug (varenicline) for 12 weeks, brief smoking cessation counseling for 5 weeks, and ambulatory blood pressure monitoring at Weeks 6 and 24.

Group Type: ACTIVE_COMPARATOR

Varenicline

Intervention Type: DRUG

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.

Group B

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.

Group Type: EXPERIMENTAL

Varenicline

Intervention Type: DRUG

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

Intervention Type: BEHAVIORAL

confirmed negative smoking status at different time points

Interventions

Varenicline

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.

Intervention Type: DRUG

behavioral therapy

confirmed negative smoking status at different time points

Intervention Type: BEHAVIORAL

Other Intervention Names

CHANTIX

Eligibility Criteria

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

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

UConn Health

OTHER

Sponsor Role: lead

Responsible Party

William B. White

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William B White, M.D.

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

University of Connecticut Health Center

Farmington, Connecticut, United States

Countries

United States

Other Identifiers

R01DA024667

Identifier Type: NIH

Identifier Source: secondary_id

View Link

08-218

Identifier Type: -

Identifier Source: org_study_id