Clinical trial NCT00879177: Smoking Study With Behavioral Therapy for Hypertensive Patients
Official title: Contingency Management for Initiating Smoking Abstinence in Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cigarette Smoking
Hypertension
Keywords: smoking
varenicline
behavioral therapy
ABPM
hypertension
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2009-04-09
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Short-term and long-term smoking abstinence and improved health benefits
timeFrame: Weeks 5,6,8,12,24,36,52
Secondary outcomes:
measure: Decrease in blood pressure and heart rate in hypertensive subjects
timeFrame: Week 6 and Week 24
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: William B White, M.D.
role: PRINCIPAL_INVESTIGATOR
References: