Does CERC-501 Attenuate Stress-precipitated Smoking Lapse?
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Number of Cigarettes Smoked
研究概览
简要总结
A Randomized, Double-Blind, Placebo-Controlled, Crossover Design Study of CERC-501 in a Human Laboratory Model of Stress-precipitated Smoking Behavior.
详细描述
The study will be performed in subjects who are heavy cigarette smokers currently not seeking treatment for tobacco use disorder.
The study is a crossover design study (within-subject analysis), which allows for subjects to be their own control.
Each period of the crossover consists of a 7-day out-patient treatment period followed by a single out-patient testing day on Day 8. Subjects will participate in a laboratory session following the McKee Stress-Smoking Lapse Test. Upon completion, subjects will undergo a 7 day washout period followed by the second period of the crossover design and a 7-day follow-up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
CERC-501
Administered orally once daily, 10mg daily, 8 days
干预措施: CERC-501 (Drug)
Placebo
Administered orally daily, 8 days
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Cigarettes Smoked
时间窗: 60 min
Number of cigarettes smoked during the self administration period
Latency
时间窗: 50 min
Latency (in minutes and seconds) to time of first cigarette smoking during the delay period
次要结局
未报告次要终点