The CONQUER Trial - Cessation Of Nicotine, QUitting With E-cigarette Reduction (NCT07322432) | Clinical Trial Compass
RecruitingPhase 2
The CONQUER Trial - Cessation Of Nicotine, QUitting With E-cigarette Reduction
United States70 participantsStarted 2025-12-24
Plain-language 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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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
Exclusion Criteria:
* 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).
* Illic…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.