Actively Recruiting
The CONQUER Trial - Cessation Of Nicotine, QUitting With E-cigarette Reduction
Led by VapeAway · Updated on 2026-01-07
70
Participants Needed
1
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The CONQUER Trial - Cessation Of Nicotine, QUitting With E-cigarette Reduction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 21 years and older
- Daily or near-daily use (5 or more days per week or at least 20 days per month) of nicotine-containing e-cigarettes for at least 3 months
- Motivation and desire to quit as shown by scores of 4 or 5 on all 5-point Likert-type scale questions
- Score of 6 or 7 on Motivation To Stop Scale (MTSS)
- Classified in the Preparation stage of the Transtheoretical Model of behavior change
- Saliva cotinine level of 10 ng/ml or higher
- Penn State Electronic Cigarette Dependence Index (PSECDI) score of 4 or above
- Willingness to participate in the study and follow all requirements
- Willingness to avoid using other nicotine products during the study
- Ability to attend visits and provide informed consent
You will not qualify if you...
- PHQ-2 score of 2 or higher indicating mental health concerns
- GAD-2 score of 2 or higher indicating anxiety concerns
- Use of any nicotine products other than vaping (e.g., cigarettes) within the past 30 days
- Current or recent substance use disorder (excluding nicotine), unless in remission for over 12 months
- Illicit drug use in the past 60 days
- Positive screening for alcohol use disorder in the past year
- Any serious medical condition or medication that contraindicates participation as determined by the study physician
- Pregnancy or breastfeeding
- Symptomatic cardiovascular disease
- Participation in another smoking or vaping cessation trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Prime Infusion
New York, New York, United States, 10128
Actively Recruiting
Research Team
S
Sarah Clinical Trial Manager, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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