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
VapeAway
Summary
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.
Description
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 wi…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- DeviceVapeAway filter system
A multi-component, drug-free program for vaping cessation. The system integrates three core elements: nicotine tapering filters, fix bar behavioral substitution tool, digital support system.
Location
- Prime InfusionNew York, New York