Contingency Management for Initiating Smoking Abstinence in Patients With Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Short-term and long-term smoking abstinence and improved health benefits
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Varenicline (Drug)
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.
干预措施: Varenicline (Drug)
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.
干预措施: behavioral therapy (Behavioral)
结局指标
主要结局
Short-term and long-term smoking abstinence and improved health benefits
时间窗: Weeks 5,6,8,12,24,36,52
次要结局
- Decrease in blood pressure and heart rate in hypertensive subjects(Week 6 and Week 24)
研究者
William B. White
Professor of Medicine
UConn Health