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

NCT07322432 | Recruiting Phase 2 FDA Device

• 1 other identifier: 2025-VPA-001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Keywords

Vaping; Vaping Addiction; Vaping Cessation; Vape

Outcome Measures

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

  up to 90 days

Secondary Outcomes (1)

• Filter Compliance

  Up to 63 days

Study Arms (1)

Intervention Arm

EXPERIMENTAL

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

Device: VapeAway filter system

Interventions

VapeAway filter system DEVICE

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.

Intervention Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VapeAway: lead

Study Sites (1)

Prime Infusion

New York, New York, 10128, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use Disorder; Vaping

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Smoking; Behavior

Study Officials

• Mendel Goldfinger, MD

  VapeAway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Clinical Trial Manager, PhD

CONTACT

2017548404; trial.vapeaway@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2026
• First Posted: January 7, 2026
• Study Start: December 24, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)