Smoking Study With Behavioral Therapy for Hypertensive Patients (VANQUISH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00879177
Recruitment Status : Completed
First Posted : April 9, 2009
Last Update Posted : April 10, 2017
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
William B. White, UConn Health

March 24, 2009
April 9, 2009
April 10, 2017
April 2009
August 2014   (Final data collection date for primary outcome measure)
Short-term and long-term smoking abstinence and improved health benefits [ Time Frame: Weeks 5,6,8,12,24,36,52 ]
Same as current
Complete list of historical versions of study NCT00879177 on Archive Site
Decrease in blood pressure and heart rate in hypertensive subjects [ Time Frame: Week 6 and Week 24 ]
Same as current
Not Provided
Not Provided
Smoking Study With Behavioral Therapy for Hypertensive Patients
Contingency Management for Initiating Smoking Abstinence in Patients With Hypertension
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.
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Cigarette Smoking
  • Hypertension
  • 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
  • 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.
    Intervention: Drug: Varenicline
  • 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
    • Behavioral: behavioral therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2014
August 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
R01DA024667 ( U.S. NIH Grant/Contract )
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
William B. White, UConn Health
UConn Health
National Institute on Drug Abuse (NIDA)
Principal Investigator: William B White, M.D. UConn Health
UConn Health
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP