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

Overview

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.

This is a Phase II, single-arm, open-label, multi-center, interventional trial designed to assess the efficacy and safety of the VapeAway system for vaping cessation. The study will enroll approximately 70 adult participants who are daily users of nicotine-containing e-cigarettes and are motivated to quit. All enrolled participants will receive the active VapeAway intervention, which consists of a 42-day (±21 days) core program utilizing progressive nicotine tapering filters, a behavioral substitution device (Fix Bar), and a digital support system. The total study duration per participant will be approximately 90 days. The primary efficacy endpoint, the Continuous Abstinence Rate (CAR) at 30 days post-intervention completion, will be statistically compared to a predefined historical control spontaneous cessation rate of 7%. The study will enroll adult males and females, aged 21 years and older, who are daily or near-daily users of nicotine-containing e-cigarettes for at least 3 months, have a saliva cotinine level ≥10 ng/mL, and score ≥4 on the Penn State Electronic Cigarette Dependence Index (PSECDI). Participants must be highly motivated to quit, as confirmed by standardized assessments (Likert scale, Motivation To Stop Scale, and the Preparation stage of the Transtheoretical Model). The study includes several componenets: 1. Nicotine Tapering Filters: Participants will self-administer by attaching a new, study-supplied filter to their personal e-cigarette device each morning. Filters are used for all vaping sessions throughout the day and discarded after 24 hours. Participants will progress through the three filter levels (25%, 50%, 75% reduction) at scheduled intervals as follows: • Level 1 Filter (Days 1-14 ±7 days): Reduces nicotine delivery by 25% relative to baseline vaping device. • Level 2 Filter (Days 14-28 ±7 days): Reduces nicotine delivery by 50%. • Level 3 Filter (Days 28-42 ±7 days): Reduces nicotine delivery by 75%. Fix Bar: The Fix Bar is a behavioral substitution tool used in conjunction with nicotine tapering to replace the act of vaping. It can be used whenever the participant is vaping less than their baseline level, and it increases in use proportionally across each level. * Each Fix Bar contains three toothpicks and is refilled daily. * There are three distinct Fix Bars, one for each level of the program. * Participants will be assessed for their baseline vaping use calculated as hours per/day and will be instructed to increase Fix Bar usage (as a vaping replacement) for each timeout level, with target time replacements as follows: Level 1 (Days 1-14 ±7 days): * Week 1: Replace 15-20% of vaping time with Fix Bar * Week 2: Replace 30-35% of vaping time with Fix Bar Level 2 (Days 14-28 ±7 days): * Week 3: Replace 45-50% of vaping time with Fix Bar * Week 4: Replace 60--65% of vaping time with Fix Bar Level 3 (Days 28-42 ±7 days): * Week 5: Replace 80-85% of vaping time with Fix Bar * Week 6: Replace 95-100% of vaping time with Fix Bar 2. Use of the Fix Bar to replace vaping as oral fixation is optional however, the timeout periods are mandatory and will be tracked weekly. All participants will receive comprehensive training on the correct use of all system components at the Day 1 visit. Adherence will be monitored through weekly logs and reviewed at each study visit. Biochemical verification (saliva cotinine) will be performed at scheduled timepoints. 3. Digital Support System: Participant Support Messaging Protocol. As part of the intervention strategy for this study, all enrolled participants will receive ongoing motivational and supportive communication throughout the trial period and for a follow-up duration of up to 3 months post-intervention completion. The purpose of these communications is to enhance engagement, provide encouragement, and support participants in their efforts to reduce or cease vaping. 4. Text Message Support: Participants will receive up to five pre-written support text messages per week. These messages will be: * Designed to be motivational, encouraging, and engaging. * Focused on reinforcing positive behavior change, promoting well-being, and addressing common challenges in vaping cessation. * Tailored where possible to the participant's stage in the cessation journey. 5. Daily Text Messages: Separate from the support messages, participants will receive daily text messages reminding them of the number of timeout hours they are required to do for the day. Upon completion of the intervention, participants will be followed for 30 days and a saliva cotinine test will be performed at the end of the follow-up period to confirm cessation.