Behavioral Intervention for Vaping

(VIA Trial)

Overseen By Julia Jashinski, MSW

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Smoking cessation aids

Disqualifiers: Smoking cessation aids, others

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

Compensation: Varies

Number of Visits: 19

Duration: 12 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well a program called QuitVaping, combined with text message support, helps teens stop vaping nicotine compared to receiving only educational materials and text support. The goal is to determine if the structured program leads to higher quitting rates. Participants will be divided into two groups: one will receive weekly support sessions for 12 weeks, while the other will receive only educational resources. Teens aged 14-18 who have vaped at least weekly for the past three months and wish to quit or reduce vaping are suitable candidates for this study. As an unphased trial, this study offers teens a unique opportunity to contribute to important research that could shape future vaping cessation programs.

Will I have to stop taking my current medications?

If you are using smoking cessation medications like nicotine patches, gum, or certain prescription drugs, you will need to stop using them to participate in this study. The study provides its own support for quitting vaping.

What prior data suggests that this behavioral intervention is safe for adolescents?

Research shows that programs like QuitVaping, which help people stop vaping, are generally safe and manageable. Previous studies on these programs have found that participants often feel more confident about quitting and remaining vape-free over time. Reports of negative side effects are rare or minor.

Although this trial doesn't involve medical treatment, the support and text message programs resemble other successful methods for quitting vaping. These programs focus on providing support and motivation, which carry very low risk. Overall, based on existing research and the nature of these support programs, the QuitVaping intervention is considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the QuitVaping program because it offers a unique approach to help teens quit vaping. Unlike standard options like nicotine replacement therapies or prescription medications, QuitVaping combines weekly behavioral support sessions with the convenience of videoconferencing, making it more accessible for young people. Additionally, the program encourages participation in This is Quitting, a text-based support system tailored specifically for adolescents, providing continuous motivation and guidance. This dual approach of combining personalized support with digital engagement is what sets QuitVaping apart from traditional cessation methods.

What evidence suggests that this trial's treatments could be effective for vaping cessation?

Research has shown that programs designed to help people stop vaping can be very effective. One study demonstrated that a mobile program improved participants' success in quitting, raising their average score from 4.9 to 7.0 out of 10 over 12 weeks. Another study found that nearly half of young adults quit vaping after using a phone support service for three months. Additionally, interactive text message programs have also succeeded in helping people stop vaping. In this trial, participants in the QuitVaping (QV) arm will attend behavioral support sessions and be encouraged to sign up for the This is Quitting (TIQ) text message program. Meanwhile, participants in the Enhanced Usual Care (EUC) arm will be encouraged to sign up for the TIQ program without attending behavioral support sessions. These findings suggest that support methods like the QuitVaping program and text message support can effectively help young people quit vaping. ^{2 3 4 6 7}

Who Is on the Research Team?

Randi M. Schuster, PhD

Principal Investigator

Massachusetts General Hospital

A. Eden Evins, MD, MPH

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for teens who are currently vaping and want to quit. They should be willing to receive text messages as part of the intervention. There's no detailed exclusion criteria provided, but typically participants with certain health issues or those not meeting age requirements might be excluded.

Inclusion Criteria

Have a parent or legal guardian who is able and willing to provide written informed consent (if under age 18)

Self-report of at least weekly nicotine vaping for the prior ≥3 months and semiquantitative saliva screening for cotinine positive for recent nicotine use

Self-report of no regular combusted tobacco use in the 2 months prior to enrollment and exhaled CO <10 ppm

Exclusion Criteria

Unwilling to abstain during the study from using smoking cessation aids other than those provided by the study

Unwilling to provide saliva or urine samples

Any condition or situation that would, in the investigator's opinion, make it unlikely that the participant could adhere safely to the study protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Treatment

Participants receive either the QuitVaping intervention with weekly behavioral support sessions or Enhanced Usual Care with education and advice to quit vaping

12 weeks

12 visits (in-person or virtual)

Follow-up

Participants are monitored for nicotine abstinence with assessments and biochemical verification

24 weeks

6 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• QuitVaping
• This is Quitting (TIQ)

Trial Overview The study is testing if a program called QuitVaping, along with extra texting support, can help teens stop using nicotine better than just getting educational materials and advice (Enhanced Usual Care). Teens will be randomly placed in one of these two groups.

How Is the Trial Designed?

Group I: QuitVaping (QV) Experimental Treatment 2 Interventions

Participants will: * Attend QuitVaping behavioral support sessions, completed via videoconference or in-person, once per week for 12 weeks * Be encouraged to sign up for This is Quitting (TIQ), a text message vaping cessation program for adolescents

Group II: Enhanced Usual Care (EUC) Active Control 1 Intervention

Participants will: * Be encouraged to sign up for This is Quitting (TIQ), a text message vaping cessation program for adolescents * Attend no behavioral support sessions

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A meta-analysis of 18 studies involving 3756 papers found no significant difference in the rates of adverse events (AEs) like cough, oral irritation, and nausea between nicotine electronic cigarettes (ECs) and nicotine replacement therapies (NRTs).

The similar incidence of AEs suggests that the preference for nicotine ECs over NRTs is not driven by differences in adverse effects, indicating a need for further research to explore other factors influencing user choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Common adverse events of electronic cigarettes compared with traditional nicotine replacement therapies: A systematic review and meta-analysis. Anandan, AS., Leung, J., Chan, GCK., et al.[2023]

Participants receiving an 8-week nicotine replacement therapy (NRT) had significantly higher quit rates (42.5%) compared to those receiving a 4-week NRT (33.3%), indicating that longer NRT duration enhances cessation success.

Among participants in a multiple-call program, those who received both 4-week NRT shipments had a quit rate of 51.1%, compared to 31.1% for those who only received one shipment, suggesting that consistent support and extended NRT can improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Temporary NRT Enhancement in a State Quitline and Web-Based Program. Cole, S., Suter, C., Nash, C., et al.[2019]

Citations

1. 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 ...

2. ajpmonline.org ajpmonline.org/article/S0749-3797(24)00371-4/fulltext

Quitline-Based Young Adult Vaping Cessation This quitline-delivered intervention was successful at helping young adults quit vaping, with almost half abstinent after 3 months.

3. truthinitiative.org truthinitiative.org/research-resources/quitting-smoking-vaping/quitting-tobacco-facts-and-stats

Quitting Tobacco: Facts and Stats In 2020, 8.5% of adult current smokers successfully quit smoking in the past year, up from 7.5% in 2018.

4. tobaccocontrol.bmj.com tobaccocontrol.bmj.com/content/early/2025/02/20/tc-2024-058798

Vaping cessation interventions: a systematic review and ... Our findings demonstrate a significant increase in the odds of achieving short-term vaping abstinence and continuous abstinence rates, ...

5. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2779740

Effectiveness of a Vaping Cessation Text Message ... Results of this randomized clinical trial demonstrated that a tailored and interactive text message intervention was effective in promoting vaping cessation ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8576600/

e-Cigarette Cessation: Content Analysis of a Quit Vaping ... This study aims to examine a quit vaping subreddit to understand how e-cigarette users are experiencing and approaching vaping cessation.

7. 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 ( ...