Skip to main content
OpenTrials
Completed

NCT Number: NCT00879177

Smoking Study With Behavioral Therapy for Hypertensive Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cigarette Smoking Behavior Cardiovascular Diseases Hypertension Smoking Tobacco Smoking Tobacco Use Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: CHANTIX

Behavioral therapy

Behavioral

confirmed negative smoking status at different time points

Primary outcomes

  1. Short-term and long-term smoking abstinence and improved health benefits

    Time frame: Weeks 5,6,8,12,24,36,52

Secondary outcomes

  1. Decrease in blood pressure and heart rate in hypertensive subjects

    Time frame: Week 6 and Week 24

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Contingency Management for Initiating Smoking Abstinence in Patients With Hypertension

Acronym: VANQUISH

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Apr 9, 2009
Registry last updated
Apr 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.