The CONQUER Trial - Cessation Of Nicotine, QUitting With E-cigarette Reduction

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

Qualifiers

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

Treatments tested in this trial

  • VapeAway filter system

Treatment groups

70 Participants
are divided into 1 treatment group

Sponsors and collaborators