Smoking Study With Behavioral Therapy for Hypertensive Patients (VANQUISH)
This study is currently recruiting participants.
Verified January 2013 by University of Connecticut Health Center
Sponsor:
University of Connecticut Health Center
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: January 16, 2013
Last verified: January 2013
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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: | September 2014 |
| Estimated Primary Completion Date: | September 2013 (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
Contacts
| Contact: Karen M Gilliam, M.A. | 860-372-8418 | kgilliam@uchc.edu |
Locations
| United States, Connecticut | |
| University of Connecticut Health Center | Recruiting |
| Farmington, Connecticut, United States, 06030 | |
| Contact: Karen M Gilliam, M.A. 860-372-8418 kgilliam@uchc.edu | |
| Principal Investigator: William B White, M.D. | |
| Sub-Investigator: Sheila Alessi, Ph.D. | |
| Sub-Investigator: Nancy M Petry, Ph.D. | |
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: | January 16, 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 May 16, 2013