Novel Medication as a Potential Smoking Cessation Aid
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Percent of Days of Confirmed Abstinence (Out of 5 Maximum)
研究概览
简要总结
The purpose of this study is to provide preliminary information assessing if levomilnacipran may be effective at increasing smoking cessation rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be between 25 years old and 55 years old
- •Smoke a minimum number of cigarettes per day
- •Indicate motivation to quit smoking
排除标准
- •Current or history of medical or psychiatric conditions that could interfere with measures being studied or that could be affected by the study medication
- •Use of medication that could interfere with measures to be studied or that could be expected to interact with levomilnacipran
- •Are pregnant or breast feeding
- •The investigators will evaluate if there are other reasons why someone may not be eligible to participate
研究组 & 干预措施
Levomilnacipran
In the first three week period levomilnacipran is evaluated whereas in the second three week period placebo is evaluated
干预措施: Levomilnacipran (Drug)
Levomilnacipran
In the first three week period levomilnacipran is evaluated whereas in the second three week period placebo is evaluated
干预措施: Placebo (Drug)
Placebo
In the first three week period placebo is evaluated whereas in the second three week period levomilnacipran is evaluated
干预措施: Levomilnacipran (Drug)
Placebo
In the first three week period placebo is evaluated whereas in the second three week period levomilnacipran is evaluated
干预措施: Placebo (Drug)
结局指标
主要结局
Percent of Days of Confirmed Abstinence (Out of 5 Maximum)
时间窗: 5 days
Subjects will be asked to abstain for five consecutive days during the third week of each intervention period with the percentage of confirmed abstinence days being the primary outcome measure
次要结局
未报告次要终点