Smoking Study With Behavioral Therapy for Hypertensive Patients

NCT00879177 | Completed Phase 4

• 2 other identifiers: 08-218R01DA024667
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

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

Keywords

smoking; varenicline; behavioral therapy; ABPM; hypertension

Outcome Measures

Primary Outcomes (1)

• Short-term and long-term smoking abstinence and improved health benefits

  Weeks 5,6,8,12,24,36,52

Secondary Outcomes (1)

• Decrease in blood pressure and heart rate in hypertensive subjects

  Week 6 and Week 24

Study Arms (2)

Group A

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.

Drug: Varenicline

Group B

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.

Drug: Varenicline; Behavioral: behavioral therapy

Interventions

Varenicline 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.

Also known as: CHANTIX

Group A; Group B

behavioral therapy BEHAVIORAL

confirmed negative smoking status at different time points

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UConn Health: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

Cigarette Smoking; Hypertension; Smoking

Interventions

Varenicline; Behavior Therapy

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Tobacco Use; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• William B White, M.D.

  UConn Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: March 24, 2009
• First Posted: April 9, 2009
• Study Start: April 1, 2009
• Primary Completion: August 1, 2014
• Study Completion: November 1, 2014
• Last Updated: April 10, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)