Does Doxazosin Attenuate Stress-induced Smoking and Improve Clinical Outcomes?
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Latency (Min) to Initiate Ad-lib Smoking Session
研究概览
简要总结
The purpose of this study is to examine whether doxazosin will attenuate the ability of stress to precipitate smoking lapse behavior in treatment seeking daily smokers. Participants will participate in a smoking cessation attempt after the laboratory sessions.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 18-60
- •Able to read and write English
- •Motivated to Quit Smoking
排除标准
- •Any significant current medical conditions that would contraindicate smoking
- •Current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) abuse or dependence of other substances, other than nicotine dependence or alcohol abuse
- •Positive test results at intake appointment on urine drug screens for illicit drugs
- •Past 30 day use of psychoactive drugs including anxiolytics and antidepressants
- •Women who are pregnant or nursing
- •Suicidal, homicidal or evidence of current severe mental illness such as schizophrenia, bipolar disorder or major depression, or anxiety disorders
- •Participants who have donated blood within the past 6 weeks
- •Individuals who are currently taking other medications prescribed for smoking cessation
- •Specific exclusions for administration of doxazosin or any alpha blocker
研究组 & 干预措施
Doxazosin 4mg/day
doxazosin 4mg/day
干预措施: Doxazosin 4mg/day (Drug)
Placebo
placebo control
干预措施: Placebo (Drug)
Doxazosin 8mg/day
doxazosin 8mg/day
干预措施: Doxazosin 8mg/day (Drug)
结局指标
主要结局
Latency (Min) to Initiate Ad-lib Smoking Session
时间窗: 0 up to 50 minutes (Delay Period)
Latency to start smoking in the stress and neutral ad-lib smoking lab sessions. Subjects had the opportunity to delay smoking for 50 minutes (delay period). Once the subject decides to smoke, the 1 hour ad-lib smoking session begins. They can chose to smoke as little or as much as they wish.
次要结局
- Number of Cigarettes Smoked During Ad-lib Session(60 minutes (ad-lib smoking period))
研究者
Sherry McKee
Associate Professor of Psychiatry
Yale University