NCT00773357已完成2 期
Modeling Stress-precipitated Smoking Behavior for Medication Development
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Latency to Initiate Ad-lib Smoking Session
研究概览
简要总结
The purpose of this study is to examine whether guanfacine will attenuate the ability of stress to precipitate smoking lapse behavior in treatment seeking and non-treatment seeking daily smokers.
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
- 否
入选标准
- •ages 18-60
- •able to read and write in English
排除标准
- •any significant current medical conditions that would contraindicate smoking
- •current Diagnostic and Statistical Manual IV (DSM-IV) abuse or dependence of other substances, other than nicotine (or caffeine) dependence
- •positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
- •women who are pregnant or nursing
- •suicidal, homicidal or evidence of severe mental illness
- •participants prescribed any psychotropic drug in the 30 days prior to study enrollment
- •blood donation within the past 6 weeks
- •participants who have engaged in a quit attempt in the past 3 months
- •specific exclusions for administration of guanfacine not already specified include: Hypotensive individuals with sitting blood pressure below 90/50 mmHG; EKG evidence at baseline screening of any clinically significant conduction abnormalities, including a Bazett's corrected QT interval (QTc) >450 msec for men and QTc>470 msec for women; known intolerance for guanfacine
研究组 & 干预措施
Guanfacine
Experimental
guanfacine 3mg/day
干预措施: guanfacine (Drug)
Placebo
Placebo Comparator
placebo control
干预措施: placebo (Drug)
结局指标
主要结局
Latency to Initiate Ad-lib Smoking Session
时间窗: 50 minutes
latency to initiate smoking (in minutes) during a 50-minute period.
次要结局
未报告次要终点
研究者
Sherry McKee
Professor of Psychiatry
Yale University
研究点 (1)
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