Smoking Study With Behavioral Therapy for Hypertensive Patients

Contingency Management for Initiating Smoking Abstinence in Patients With Hypertension

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00879177

Acronym

VANQUISH

Enrollment

203

Registered

2009-04-09

Start date

2009-04-30

Completion date

2014-11-30

Last updated

2017-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cigarette Smoking, Hypertension

Keywords

smoking, varenicline, behavioral therapy, ABPM, hypertension

Brief 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.

Interventions

DRUGVarenicline

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.

BEHAVIORALbehavioral therapy

confirmed negative smoking status at different time points

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Short-term and long-term smoking abstinence and improved health benefits	Weeks 5,6,8,12,24,36,52

Secondary

Measure	Time frame
Decrease in blood pressure and heart rate in hypertensive subjects	Week 6 and Week 24

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026