Investigating Efficacious E-Cigarette Interventions and Cessation Effects on Cancer-Related Biomarkers: A Randomized Trial of Varenicline in Adults
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 326
- 试验地点
- 2
- 主要终点
- Number of Participants Abstinent From E-cigarette Use at Week 12
研究概览
简要总结
This is randomized, placebo-controlled clinical trial in treatment-seeking adults who report regular e-cigarette use to test the hypothesis that varenicline is efficacious for quitting e-cigarettes.
详细描述
Participants will randomly be assigned to 12-weeks of varenicline (titrated to 2mg daily) or matching placebo plus brief cessation advice from a counselor and self-management resources. All participants will also complete research assessments every 3 weeks during treatment and a final follow-up visit at week 26.
The primary objective is to test the efficacy of varenicline vs. placebo on e-cigarette quit rates. We will also evaluate predictors and moderators of outcomes and explore changes in health biomarkers following e-cigarette cessation treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •report daily use of an e-cigarette containing nicotine
- •live in Connecticut or South Carolina
排除标准
- •regular use of other tobacco products besides e-cigarettes
- •medical contraindications for varenicline use
- •current treatment for tobacco cessation
- •lack proficiency in English
研究组 & 干预措施
Varenicline
Participants will randomly be assigned to 12-weeks of varenicline (titrated to 2mg daily) plus brief cessation advice with a counselor and self-management resources.
干预措施: Varenicline 1mg BID (Drug)
Placebo
Participants will randomly be assigned to 12-weeks of matching placebo plus brief cessation advice with a counselor and self-management resources.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Abstinent From E-cigarette Use at Week 12
时间窗: Week 12
7-day point-prevalence e-cigarette abstinence (PPA) at Week 12 defined as no ecigarette use \[and no use of any combusted tobacco product\], not even a puff, biochemically verified by saliva cotinine
次要结局
- Number of Participants Abstinent From E-cigarette Use at Week 26(Week 26)