NCT07322432 The CONQUER Trial - Cessation Of Nicotine, QUitting With E-cigarette Reduction
| NCT ID | NCT07322432 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | VapeAway |
| Condition | Addiction Nicotine |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-12-24 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 70 participants in total. It began in 2025-12-24 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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). * 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
Contact & Investigator
Mendel Goldfinger, MD
PRINCIPAL INVESTIGATOR
VapeAway
Frequently Asked Questions
Who can join the NCT07322432 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Addiction Nicotine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07322432 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07322432 currently recruiting?
Yes, NCT07322432 is actively recruiting participants. Contact the research team at trial.vapeaway@gmail.com for enrollment information.
Where is the NCT07322432 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07322432 clinical trial?
NCT07322432 is sponsored by VapeAway. The principal investigator is Mendel Goldfinger, MD at VapeAway. The trial plans to enroll 70 participants.
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