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โ† Trials
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The CONQUER Trial - Cessation Of Nicotine, QUitting With E-cigarette Reduction

RecruitingPhase 2Ages 21 Years - anyAllVapeAway
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In plain words

What the trial is, and whether it could suit you

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 b

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age: Adults aged 21 years and older * Current Vaping Behavior: Daily or near-daily use (โ‰ฅ5 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 โ‰ฅ 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 โ‰ฅ 2 (see appendix) * GAD-2 score โ‰ฅ 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
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What it tests

  • VapeAway filter system
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Where

1 site
Prime Infusion
New York, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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