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Smoking Study With Behavioral Therapy for Hypertensive Patients (VANQUISH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00879177
First Posted: April 9, 2009
Last Update Posted: April 10, 2017
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.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
William B. White, UConn Health
  Purpose
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 Hypertension Drug: Varenicline Behavioral: behavioral therapy Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879177


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

Responsible Party: William B. White, Professor of Medicine, UConn Health
ClinicalTrials.gov Identifier: NCT00879177     History of Changes
Other Study ID Numbers: 08-218
R01DA024667 ( U.S. NIH Grant/Contract )
First Submitted: March 24, 2009
First Posted: April 9, 2009
Last Update Posted: April 10, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
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:
smoking
varenicline
behavioral therapy
ABPM
hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs