VapeAway for Nicotine Addiction from Vaping

(CONQUER Trial)

Overseen By Sarah Clinical Trial Manager, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: VapeAway

Disqualifiers: Mental health, Substance use, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 42 days

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Mendel Goldfinger, MD

Principal Investigator

VapeAway

Are You a Good Fit for This Trial?

The CONQUER Trial is for adults over 21 who vape nicotine daily or nearly every day, have a strong dependence on e-cigarettes, and are motivated to quit. They must not use other nicotine products during the study and be willing to follow all requirements, including attending visits.

Inclusion Criteria

I use nicotine e-cigarettes almost every day for the last 3 months.

I am ready to take action to change my behavior within the next month.

I score 4 or higher on the e-cigarette dependence test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow the VapeAway system, including nicotine tapering filters, Fix Bar, and digital support, for vaping cessation

42 days

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a saliva cotinine test

30 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• VapeAway system

Trial Overview

This trial tests the VapeAway system's ability to help people stop vaping. It includes filters that reduce nicotine gradually, a sensory device called Fix Bar, and digital support. The goal is to see if participants can stay off e-cigarettes for at least 30 days after completing the program.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

VapeAway

Lead Sponsor