CONQUER: quitting nicotine by gradually reducing e-cigarette nicotine with filters and a sensory support device

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.