Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Smoking Study With Behavioral Therapy for Hypertensive Patients (VANQUISH)

This study has been completed.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
William B. White, UConn Health Identifier:
First received: March 24, 2009
Last updated: April 6, 2017
Last verified: April 2017
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.

Condition Intervention Phase
Cigarette Smoking
Drug: Varenicline
Behavioral: behavioral therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Contingency Management for Initiating Smoking Abstinence in Patients With Hypertension

Resource links provided by NLM:

Further study details as provided by William B. White, UConn Health:

Primary Outcome Measures:
  • Short-term and long-term smoking abstinence and improved health benefits [ Time Frame: Weeks 5,6,8,12,24,36,52 ]

Secondary Outcome Measures:
  • Decrease in blood pressure and heart rate in hypertensive subjects [ Time Frame: Week 6 and Week 24 ]

Enrollment: 203
Study Start Date: April 2009
Study Completion Date: November 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: 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.
Other Name: CHANTIX
Experimental: 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.
Drug: 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.
Other Name: CHANTIX
Behavioral: behavioral therapy
confirmed negative smoking status at different time points


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00879177

United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
National Institute on Drug Abuse (NIDA)
Principal Investigator: William B White, M.D. UConn Health
  More Information

Responsible Party: William B. White, Professor of Medicine, UConn Health Identifier: NCT00879177     History of Changes
Other Study ID Numbers: 08-218
R01DA024667 ( US NIH Grant/Contract Award Number )
Study First Received: March 24, 2009
Last Updated: April 6, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by William B. White, UConn Health:
behavioral therapy

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 25, 2017