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

Trial Summary

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 data supports the effectiveness of the treatment QuitVaping, This is Quitting (TIQ) for vaping cessation?

A pilot study found that participants who received behavioral support and a vape-taper plan were more likely to be vape-free and nicotine-free at 6 months, suggesting that behavioral interventions can be effective in helping people quit vaping. ^{1 2 3 4 5}

Is the behavioral intervention for vaping safe for humans?

The research does not provide specific safety data for the behavioral intervention for vaping, but it does mention that e-cigarette users often report mild adverse events (unwanted effects) and some health improvements. This suggests that while there may be some minor side effects, many users also experience positive health changes. ^{6 7 8 9 10}

How is the QuitVaping treatment different from other vaping cessation treatments?

QuitVaping is unique because it uses a behavioral intervention called contingency management (CM), which is delivered via telehealth to help young adults quit vaping. This approach is novel as it adapts an established method for smoking cessation to specifically target vaping, offering a structured and supportive way to quit through remote access. ^{5 11 12 13 14}

What is the purpose of this trial?

This study will test the hypothesis that the QuitVaping (QV) intervention and additional texting support will improve nicotine abstinence rates in adolescents as compared to Enhanced Usual Care (EUC: education about nicotine, vaping and addiction, advice to quit vaping, referral to TIQ texting support). Approximately 400 adolescents will be randomly assigned to one of two arms (1) QuitVaping intervention plus texting support to quit vaping and (2) EUC only.

Research Team

A. Eden Evins, MD, MPH

Principal Investigator

Massachusetts General Hospital

Randi M. Schuster, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Impact of a Temporary NRT Enhancement in a State Quitline and Web-Based Program. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Tobacco dependence diagnosis and treatment in Veterans Health Administration residential substance use disorder treatment programs. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Pilot Study of Electronic Nicotine Delivery Systems (ENDS) Cessation Methods. [2021]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Nicotine replacement therapies: patient safety and persistence. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a smoking cessation self-help intervention for dual users of tobacco cigarettes and E-cigarettes: Intervention development and research design. [2018]

6. Australia pubmed.ncbi.nlm.nih.gov

Common adverse events of electronic cigarettes compared with traditional nicotine replacement therapies: A systematic review and meta-analysis. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Vaping-Related Adverse Events and Perceived Health Improvements: A Cross-Sectional Survey among Daily E-Cigarette Users. [2021]

8. Greece pubmed.ncbi.nlm.nih.gov

Characteristics and correlates of electronic cigarette product attributes and undesirable events during e-cigarette use in six countries of the EUREST-PLUS ITC Europe Surveys. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Impact of E-cigarettes on Smoking and Related Outcomes in Veteran Smokers With Psychiatric Comorbidity. [2020]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Placing Health Warnings on E-Cigarettes: A Standardized Protocol. [2019]

11. Ireland pubmed.ncbi.nlm.nih.gov

A pilot feasibility study of a behavioral intervention for nicotine vaping cessation among young adults delivered via telehealth. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Smoking cessation 2: behavioral treatments. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

Youth e-cigarette use: Assessing for, and halting, the hidden habit. [2021]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Assessing the Testability of the Multi-Theory Model (MTM) in Predicting Vaping Quitting Behavior among Young Adults in the United States: A Cross-Sectional Survey. [2023]