Smoking Study With Behavioral Therapy for Hypertensive Patients (VANQUISH)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
William B. White, University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00879177
First received: March 24, 2009
Last updated: December 9, 2013
Last verified: December 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of Connecticut Health Center:

Primary Outcome Measures:
  • Short-term and long-term smoking abstinence and improved health benefits [ Time Frame: Weeks 5,6,8,12,24,36,52 ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 260
Study Start Date: April 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 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
Other Name: behavioral therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00879177

Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
University of Connecticut Health Center
Investigators
Principal Investigator: William B White, M.D. University of Connecticut Health Center
  More Information

No publications provided

Responsible Party: William B. White, Professor of Medicine, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT00879177     History of Changes
Other Study ID Numbers: 08-218, R01DA024667
Study First Received: March 24, 2009
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:
smoking
varenicline
behavioral therapy
ABPM
hypertension

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

ClinicalTrials.gov processed this record on April 14, 2014