The CONQUER Trial - Cessation Of Nicotine, QUitting With E-cigarette Reduction
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
70 participants
Dec 24, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria11
- 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 Criteria14
- 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
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07322432