Recruiting
Phase 2

VapeAway

Sponsor:

VapeAway

Code:

NCT07322432

Conditions

Addiction Nicotine

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

VapeAway filter system

Study Details

Brief summary:

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

Addiction Nicotine

Study ID

NCT07322432

Start date

Dec 24, 2025

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • 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 ≥ 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 ≥ 2 (see appendix)
  • GAD-2 score ≥ 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

Study Design

Enrollment

70 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Intervention Arm

Participants with a vaping addiction that use the VapeAway system to help vaping cessation

Interventions

VapeAway filter system

A 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.

Primary outcome measure

  • Vaping Cessation [ Time Frame: up to 90 days ]

Central Contacts and Locations

Central contacts

Sarah Aminov, PhD - Clinical Trial Manager

2017548404trial.vapeaway@gmail.com

Locations

Prime Infusion

Recruiting

New York, New York, United States, 10128

More Information

Sponsor

VapeAway

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Keywords

  • Vaping
  • Vaping Addiction
  • Vaping Cessation
  • Vape

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by VapeAway on 2026-01-07.