The CONQUER Trial - Cessation Of Nicotine, QUitting With E-cigarette Reduction
ConditionAddiction Nicotine
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorVapeAway
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
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)
Disqualifiers
PHQ-2 score ≥ 2 (see appendix)
GAD-2 score ≥ 2 (see appendix)
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
Self-reported or medically diagnosed substance use disorder (excluding nicotine), unless in sustained remission (>12 months).
Trial design
Design model
Single group
Treatments tested in this trial
VapeAway filter system
DeviceA 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.
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: Intervention ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Vaping Cessation
To determine the prevalence of vaping abstinence (quit rates) with the VapeAway system at 30 days after completion of the program (intervention period) verified by self-reporting and biochemical testing
Time frame
up to 90 daysSecondary outcomes
1
Filter Compliance
Percent of time the subject vaped with use of filter
Time frame
Up to 63 days Source ClinicalTrials.gov