CONQUER: quitting nicotine by gradually reducing e-cigarette nicotine with filters and a sensory support device
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
This project tests whether the VapeAway system—progressive nicotine-tapering filters, a Fix Bar sensory device, and digital support—can help motivated adult daily e-cigarette users quit nicotine.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | VapeAway Industry-sponsored |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07322432 on ClinicalTrials.gov |
What this trial studies
CONQUER is a Phase II, single-arm, open-label, multi-center trial planned to enroll about 70 adults who vape nicotine daily and are motivated to quit. Participants complete a roughly 42-day core VapeAway program (±21 days) using progressive nicotine-tapering filters, a behavioral Fix Bar substitution device, and structured digital support, with total follow-up of about 90 days. The primary endpoint is Continuous Abstinence Rate (CAR) at 30 days post-intervention compared to a historical spontaneous cessation rate of ~7%; secondary outcomes include saliva cotinine, vaping frequency, withdrawal symptoms, and dependence scores. Eligibility requires biochemical confirmation of nicotine use, a minimum dependence score, and high readiness to quit, and all participants receive the active intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older who vape nicotine daily or near-daily, have saliva cotinine ≥10 ng/mL, a PSECDI score ≥4, and demonstrate strong motivation and readiness to quit.
Not a fit: People who are not motivated to quit, who use only non-nicotine e-cigarettes, who cannot attend required visits, or who meet exclusionary mental health or concurrent-product criteria are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If effective, the VapeAway system could substantially raise short-term quit rates for adults who vape by combining gradual nicotine reduction with behavioral support.
How similar studies have performed: Related methods—gradual nicotine reduction and behavioral substitution combined with digital support—have shown modest success in tobacco cessation, but the specific VapeAway filter-based tapering approach is novel and not yet widely tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Prime Infusion — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Mendel Goldfinger, MD — VapeAway
- Study coordinator: Sarah Clinical Trial Manager, PhD
- Email: trial.vapeaway@gmail.com
- Phone: 2017548404
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.