NCT07766655招募中3 期
A Randomized, Double-Blind, Placebo and Active-Controlled Trial to Evaluate the Efficacy and Safety of AXS-05 for Smoking Cessation in Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 705
- 试验地点
- 17
- 主要终点
- 4-Week Continuous Smoking Abstinence Rate
研究概览
简要总结
This study is a Phase 3, multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group trial to evaluate the efficacy and safety of AXS-05 compared to placebo and bupropion for smoking cessation in adults.
详细描述
Eligible subjects will be randomized in a 1:1:1 ratio to receive AXS-05, bupropion, or placebo for 12 weeks, followed by an 18-week follow-up period.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18 to 65 (inclusive)
排除标准
- •Unable to comply with study procedures.
- •Medically inappropriate for study participation in the opinion of the investigator.
研究组 & 干预措施
AXS-05
Experimental
Up to 12 weeks
干预措施: AXS-05 (dextromethorphan-bupropion) (Drug)
Placebo
Placebo Comparator
Up to 12 weeks
干预措施: Placebo (Drug)
Bupropion
Experimental
Up to 12 weeks
干预措施: Bupropion (Drug)
结局指标
主要结局
4-Week Continuous Smoking Abstinence Rate
时间窗: Weeks 9 to 12
次要结局
未报告次要终点
研究者
研究点 (17)
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