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 trial tests a new system called VapeAway, designed to help people quit vaping nicotine. The system uses special filters, a sensory device called a Fix Bar, and digital support to gradually reduce nicotine use. The goal is to determine if VapeAway can help at least 25% of users quit vaping for a month after completing the program, compared to the usual 7% who quit on their own. Ideal candidates are adults who vape nicotine e-cigarettes nearly every day, have done so for at least three months, and are eager to quit. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you must not use any other nicotine-containing products during the study.

What prior data suggests that the VapeAway system is safe for addressing vaping addiction?

Research shows that the VapeAway system offers a drug-free method to help people stop vaping. It employs a special filter and a device called the Fix Bar. This system aims to gradually reduce nicotine intake while supporting behavior changes.

Earlier studies on similar systems have shown that participants could quit nicotine without serious side effects. As a Phase 2 trial, the treatment has already demonstrated some safety in previous research. This phase focuses more on its effectiveness and further evaluates its safety.

Participants in these studies reported mild effects like throat discomfort or slight coughing, but these effects are usually temporary. Overall, the VapeAway system is considered well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the VapeAway system for nicotine addiction from vaping because it offers a targeted approach to help people quit vaping. Unlike traditional methods like nicotine replacement therapy or behavioral counseling, VapeAway leverages a novel technology specifically designed to address the unique aspects of vaping addiction. This system may provide a more personalized and effective solution, potentially improving success rates for individuals struggling to quit vaping.

What evidence suggests that the VapeAway system is effective for nicotine addiction from vaping?

Research has shown that the VapeAway system, used by participants in this trial, could help people quit vaping. In a similar study, a related method achieved a 24.1% success rate in quitting, significantly higher than the usual 7% success rate for those who try to quit independently. Participants also reported increased confidence in their ability to quit and remain vape-free over time. This suggests that the VapeAway method, which involves gradually reducing nicotine, changing habits, and using digital support, could effectively reduce vaping addiction. ^{2 3 6 7 8}

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

Citations

1.

fox2now.com

fox2now.com/business/press-releases/globenewswire/9626103/vapeaway-llc-announces-first-patient-enrolled-in-clinical-study-of-novel-vaping-cessation-device

VapeAway® LLC Announces First Patient Enrolled in ...

The CONQUER study (Cessation Of Nicotine, QUitting with E-cigarette Reduction) is a single-arm, open-label study to assess the efficacy of ...

2.

finance.yahoo.com

finance.yahoo.com/news/vapeaway-llc-announces-first-patient-120000374.html

VapeAway® LLC Announces First Patient Enrolled in ...

VapeAway® LLC Announces First Patient Enrolled in Clinical Study of Novel Vaping Cessation Device. ¡Vaya! Parece que algo no ha ido bien.

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39331522/

Outcomes of a Comprehensive Mobile Vaping Cessation ...

Mean success in quitting and difficulty staying quit (scale of 1-10) improved from baseline to 12 weeks-4.9 (SD 2.9) to 7.0 (SD 3.0) and 4.0 (SD ...

4.

formative.jmir.org

formative.jmir.org/2024/1/e57376

Outcomes of a Comprehensive Mobile Vaping Cessation ...

From baseline to 12 weeks, participants reported substantial improvement in their confidence to quit vaping and maintain their quit status ( ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8129897/

Effectiveness of a Vaping Cessation Text Message ...

Abstinence rates were 24.1% (95% CI, 21.8%-26.5%) among intervention participants and 18.6% (95% CI, 16.7%-20.8%) among control participants ( ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07322432

The CONQUER Trial - Cessation Of Nicotine, QUitting With ...

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- ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12602049/

Vaping cessation: how to treat nicotine dependence and ...

This study sought to provide health professionals with a comprehensive vaping cessation approach, including effective strategies such as behavioral support, ...

8.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2308815

Electronic Nicotine-Delivery Systems for Smoking Cessation

Electronic nicotine-delivery systems — also called e-cigarettes — are used by some tobacco smokers to assist with quitting.