Smoking Study With Behavioral Therapy for Hypertensive Patients

Hypertension Clinical Trial

— VANQUISH  

Official title:

Contingency Management for Initiating Smoking Abstinence in Patients With Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00879177
• Other study ID #: 08-218
• Secondary ID: R01DA024667
• Status: Completed
• Phase: Phase 4
• First received: March 24, 2009
• Last updated: April 6, 2017
• Start date: April 2009
• Est. completion date: November 2014

Study information

• Verified date: April 2017
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: November 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking
• Hypertension

Intervention

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.

Behavioral:
• behavioral therapy
confirmed negative smoking status at different time points

Locations

Country	Name	City	State
United States	University of Connecticut Health Center	Farmington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
UConn Health	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-term and long-term smoking abstinence and improved health benefits		Weeks 5,6,8,12,24,36,52
Secondary	Decrease in blood pressure and heart rate in hypertensive subjects		Week 6 and Week 24