The Feasibility of Treatment for Vaping Cessation
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- Rate of e-cigarette abstinence after 12 weeks of treatment with varenicline plus brief behavioral therapy as an aid to stop vaping
研究概览
简要总结
Researchers are gathering information on the feasibility of treating e-cigarette users with 12-weeks of varenicline (Chantix®) in assisting with stopping the use of e-cigarettes.
详细描述
Because the process of developing nicotine dependence and the reinforcing mechanisms of nicotine delivered in high concentrations are similar between tobacco cigarettes and newer generation electronic cigarettes, the investigators hypothesize that evidence based treatment approaches used in treating tobacco dependence should be effective in treating dependence on electronic cigarettes. Since there is no existing evidence base for treatment of electronic cigarette dependence, preliminary evidence is needed from feasibility and open label studies to guide in the development of future randomized clinical trials. In this study, vaping participants will be treated with a 12 week course of varenicline as well as have nicotine dependence counseling through a certified tobacco treatment specialist followed up 12 weeks post end of medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 是
入选标准
- •≥18 years and ≤65 years of age;
- •No use of tobacco in any form (except E-cigarettes) in the past 3 months;
- •currently using e-cigarettes
排除标准
- •Current moderate or severe depression
- •Use of any treatments for tobacco dependence within the past 30 days;
- •Recent history (past 3 months) of abuse of, or dependence on, a substance other than nicotine;
- •Women who are pregnant or lactating, or who are of childbearing potential and are likely to become pregnant during the medication phase, or a male who is able to father a child, and are not willing to use a reliable form of contraception,
- •Subject describes having a medical history of: a) unstable angina; b) myocardial infarction within the past 3 months; c) coronary angioplasty; or d) an untreated cardiac dysrhythmia;
- •Subject currently has cancer [excluding non-melanoma skin cancer] not in remission;
- •Known allergy to varenicline;
- •Subject has a medical condition deemed by the investigators to be exclusionary to the study.
研究组 & 干预措施
E-cigarette users
Participants who are regular users of e-cigarettes will be treated with a 12 week course of varenicline for stopping vaping.
干预措施: Varenicline (Drug)
E-cigarette users
Participants who are regular users of e-cigarettes will be treated with a 12 week course of varenicline for stopping vaping.
干预措施: brief behavioral therapy (Other)
结局指标
主要结局
Rate of e-cigarette abstinence after 12 weeks of treatment with varenicline plus brief behavioral therapy as an aid to stop vaping
时间窗: 12 weeks
The rate of self reported e-cigarette abstinence verified biochemically with nicotine and nicotine metabolites in urine will be assessed at the end of a 12-week course of varenicline plus brief behavioral therapy.
次要结局
未报告次要终点