Contingency Management and Pharmacotherapy for Smoking Cessation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Smoking abstinence based on expired carbon monoxide tests, urinary cotinine tests and self-report.
研究概览
简要总结
In total, 70 smokers will be randomized to: standard of care smoking cessation medication varenicline alone (an FDA-approved smoking cessation medication) or varenicline plus contingency management (CM) (a behavioral procedure with rewards for target behaviors, like smoking abstinence). Patients in both conditions will receive varenicline for 12 weeks with standard smoking cessation therapy and regular breath and urine sample monitoring for smoking. Patients assigned to CM will earn chances to win prizes for each breath sample that tests negative for smoking, and urine samples that test negative for smoking will result in even greater chances for prizes. More CM patients are expected to achieve and maintain abstinence than patients receiving varenicline alone.
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
- •smoke >10 cigarettes/day, with no abstinent period exceeding 3 months in past year
- •expired CO of >8 ppm
- •self-reported desire to stop smoking
- •>18 years of age
- •resting systolic BP<160 mmHg and diastolic BP<100 mmHg and otherwise in good health
- •if on antihypertensive medication, have not changed medications in the past month and do not intend to change in next 3 months
- •English speaking
排除标准
- •receipt of smoking cessation treatment (behavioral or pharmacological) in past month
- •serious or unstable medical disease in past 6 months, including myocardial infarction, cancer, congestive heart failure, kidney failure, stroke, or seizures
- •evidence or history of allergic reactions contraindicating varenicline 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
- •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, due to potential similarity with prize CM, although no increases in gambling have been noted
研究组 & 干预措施
Standard of Care
Medication (varenicline) for 12 weeks (Day 1 through 84) and brief counseling based on public health service guidelines for 5 weeks (Day 1 through 35).
干预措施: Standard of Care (Other)
Standard of Care plus Contingency Management
Medication (varenicline) for 12 weeks (Day 1 through 84), brief counseling based on public health service guidelines for 5 weeks (Day 1 through 35), plus prize-based contingency management for carbon monoxide samples and urinary cotinine samples that meet smoking abstinence criteria.
干预措施: contingency management (Behavioral)
Standard of Care plus Contingency Management
Medication (varenicline) for 12 weeks (Day 1 through 84), brief counseling based on public health service guidelines for 5 weeks (Day 1 through 35), plus prize-based contingency management for carbon monoxide samples and urinary cotinine samples that meet smoking abstinence criteria.
干预措施: Standard of Care (Other)
结局指标
主要结局
Smoking abstinence based on expired carbon monoxide tests, urinary cotinine tests and self-report.
时间窗: weeks 5, 12 & 24
次要结局
- Changes from baseline in ambulatory 24-hour systolic blood pressure.(6 and 24 weeks following the initiation of medication)