The CONQUER Trial: Cessation Of Nicotine, QUitting With E-cigarette Reduction - A Single-Arm, Open-Label Clinical Trial to Assess the Efficacy of VapeAway in Promoting Vaping Cessation Compared to Historical Rates of Vaping Cessation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Vaping Cessation
研究概览
简要总结
This clinical trial evaluates the VapeAway system, a novel, multi-modal intervention designed to address the multifaceted nature of vaping addiction. VapeAway combines progressive nicotine tapering via proprietary filters, behavioral substitution with a sensory device (Fix Bar), and structured digital support. The purpose of this research is to evaluate the efficacy and safety of the investigational VapeAway system, a multi-component behavioral and nicotine-reduction intervention, for promoting cessation of nicotine-containing e-cigarette use in motivated adults. The primary objective is to determine if the VapeAway program can achieve a Continuous Abstinence Rate (CAR) of at least 25% at 30 days post-intervention completion, a rate which will be statistically compared to the historical spontaneous cessation rate of approximately 7%. Secondary objectives include assessing reductions in biochemical nicotine exposure (cotinine), vaping frequency, withdrawal symptoms, and electronic cigarette dependence, as well as characterizing the safety and tolerability profile of the intervention.
Participants will be asked to follow the VapeAway system (filters, Fix Bar and timeout periods) as prescribed by the protocol for about 42 days. During this time, participants should keep track of vaping sessions throughout the trial.
详细描述
This is a Phase II, single-arm, open-label, multi-center, interventional trial designed to assess the efficacy and safety of the VapeAway system for vaping cessation.
The study will enroll approximately 70 adult participants who are daily users of nicotine-containing e-cigarettes and are motivated to quit.
All enrolled participants will receive the active VapeAway intervention, which consists of a 42-day (±21 days) core program utilizing progressive nicotine tapering filters, a behavioral substitution device (Fix Bar), and a digital support system. The total study duration per participant will be approximately 90 days. The primary efficacy endpoint, the Continuous Abstinence Rate (CAR) at 30 days post-intervention completion, will be statistically compared to a predefined historical control spontaneous cessation rate of 7%.
The study will enroll adult males and females, aged 21 years and older, who are daily or near-daily users of nicotine-containing e-cigarettes for at least 3 months, have a saliva cotinine level ≥10 ng/mL, and score ≥4 on the Penn State Electronic Cigarette Dependence Index (PSECDI). Participants must be highly motivated to quit, as confirmed by standardized assessments (Likert scale, Motivation To Stop Scale, and the Preparation stage of the Transtheoretical Model).
The study includes several componenets:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: Adults aged 21 years and older
- •Current Vaping Behavior: Daily or near-daily use (≥5 days/week or at least 20 days per month) of nicotine-containing e-cigarettes for at least the past 3 months.
- •Motivation and desire to quit as determined by all of the following three assessment tools:
- •Score of 4 or 5 on all 5-point Likert-type scale questions (see appendix)
- •Score of 6 or 7 on Motivation To Stop Scale (MTSS) (see appendix)
- •Participants must be classified in the Preparation stage of the Transtheoretical Model of behavior change (see appendix)
- •Saliva Cotinine level ≥ 10 ng/ml
- •Penn State Electronic Cigarette Dependence Index (PSECDI) of at least 4 and above
- •Willingness to participate in the study and all study requirements
- •Willingness to not use any other nicotine-containing products for the duration of the study
- •Ability to attend visits and provide informed consent
排除标准
- •Mental Health Concerns with a score above the following thresholds:
- •PHQ-2 score ≥ 2 (see appendix)
- •GAD-2 score ≥ 2 (see appendix)
- •Use of Other Tobacco or Nicotine Products:
- •Use of any nicotine products except for vaping, including combustible tobacco (e.g., cigarettes) or other non-e-cigarette nicotine delivery systems within the past 30-days
- •Current Substance or alcohol Use Disorder:
- •Self-reported or medically diagnosed substance use disorder (excluding nicotine), unless in sustained remission (>12 months).
- •Illicit drug use in the past 60 days
- •Screening positive for alcohol use disorder in past year
- •Medical Contraindications:
- •Any serious medical condition or medication that would contraindicate participation in a behavioral cessation trial (to be defined and assessed by study physician or PI).
- •Pregnant or breastfeeding
- •Symptomatic cardiovascular disease
- •Participation in another smoking/vaping cessation trial
研究组 & 干预措施
Intervention Arm
Participants with a vaping addiction that use the VapeAway system to help vaping cessation
干预措施: VapeAway filter system (Device)
结局指标
主要结局
Vaping Cessation
时间窗: up to 90 days
To determine the prevalence of vaping abstinence (quit rates) with the VapeAway system at 30 days after completion of the program (intervention period) verified by self-reporting and biochemical testing
次要结局
- Filter Compliance(Up to 63 days)