ACT on Vaping App for Nicotine Addiction

Overseen By Jaimee Heffner, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Fred Hutchinson Cancer Center

Disqualifiers: Other cessation treatments, Prison, others

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

Compensation: Varies

Number of Visits: 5

Duration: 4 months

1372 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you can use other tobacco cessation treatments during the trial.

What data supports the effectiveness of the ACT on Vaping App treatment for nicotine addiction?

Research on technology-based interventions for asthma suggests that apps can help manage health conditions by improving education and monitoring. This implies that the ACT on Vaping App might also be effective in helping people manage nicotine addiction by providing similar support. ^{1 2 3 4 5}

How is the ACT on Vaping App treatment different from other treatments for nicotine addiction?

The ACT on Vaping App is unique because it likely uses a digital approach to help manage nicotine addiction, which can be more accessible and engaging for young users compared to traditional methods like nicotine replacement therapy or counseling. This app-based treatment may offer personalized support and real-time tracking of vaping habits, making it a novel tool in addressing nicotine dependence among adolescents and young adults. ^{6 7 8 9 10}

What is the purpose of this trial?

This clinical trial evaluates a smartphone application (app) called Acceptance and Commitment Therapy (ACT) on Vaping for helping young adults quit using electronic cigarettes (e-cigarettes). E-cigarettes pose numerous risks, particularly to youth and young adults. Addressing the high prevalence of e-cigarette use by young adults requires effective and accessible treatments to support current users to quit. Research shows this group prefers and benefits from newer methods of treatment delivery such as digital interventions. ACT on Vaping is a digital therapeutic intended to deliver behavioral therapy to young adults who vape to motivate and support abstinence from all nicotine and tobacco products. The app contains sessions that promote awareness of cues that trigger tobacco use and teach skills for responding to these triggers in a way that is tailored for the participant's readiness to quit. Receiving access to the ACT on Vaping app may be effective in helping young adults quit vaping.

Research Team

Jaimee Heffner, PhD

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

This trial is for young adults who use e-cigarettes and are interested in quitting. Participants should be comfortable using a smartphone app and responding to text messages and surveys as part of the study.

Inclusion Criteria

Current weekly user of e-cigarette product(s) for the last 30 days

Has a smartphone; either an Android (running version 12 or higher) or iPhone (running iOS version 17 or higher, iPhone 11 or more recent)

Experience downloading and using one or more apps on their smartphone

Exclusion Criteria

Google voice number as sole phone number, due to its association with fraudulent study entry attempts

Member of the same household as another research participant

Currently in prison

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the ACT on Vaping app and receive text message interventions and check-ins

4 months

Incentivized text message check-ins at 2 weeks, 2 months, and 4 months

Follow-up

Participants are monitored for changes in vaping behavior and abstinence

6 months

Follow-up assessments at 3 and 6 months

Treatment Details

Interventions

• ACT on Vaping App

Trial Overview The ACT on Vaping app, which delivers behavioral therapy through a smartphone, is being tested. It aims to help users quit vaping by teaching them how to handle triggers related to tobacco use. The effectiveness of this digital intervention will be evaluated.

Participant Groups

Group I: Arm I (ACT on Vaping app (Version A) + incentivized texts + intervention texts) Experimental Treatment 3 Interventions

Participants receive access to the ACT on Vaping app utilizing Acceptance and Commitment Therapy. Participants also receive text message intervention content, as well as incentivized text message check-ins at 2 weeks, 2 months, and 4 months to assess changes in vaping on study.

Group II: Arm II (ACT on Vaping app (Version B) + incentivized texts) Placebo Group 3 Interventions

Participants receive access to the ACT on Vaping app including health education content. Participants receive incentivized text message check-ins at 2 weeks, 2 months, and 4 months to assess changes in vaping on study.

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

A systematic review identified 6 mHealth apps that integrate with inhaler sensors, showing modest improvements in maintenance inhaler adherence and reduced use of rescue inhalers among asthma patients.

Despite these positive effects, the apps did not significantly impact overall asthma control or health outcomes, indicating a need for more comprehensive studies to evaluate their effectiveness in managing asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of mHealth Applications That Interface with Inhaler Sensors in Asthma. Nguyen, E., Miao, B., Pugliese, N., et al.[2021]

Social media recruitment led to a higher number of downloads (87 users), but only 17% continued using the asthma management app for 30 days, indicating a challenge in maintaining long-term engagement.

In contrast, practice-based recruitment resulted in fewer downloads (24 patients), but a higher adherence rate of 54% over 30 days, suggesting that support from healthcare professionals significantly boosts ongoing app usage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mixed method observational study of strategies to promote adoption and usage of an application to support asthma self-management. Hui, CY., McKinstry, B., Walton, R., et al.[2021]

Juul EU delivers significantly less nicotine compared to Juul US and traditional cigarettes, with a maximum nicotine concentration (Cmax) of only 3.8 ng/ml versus 21.1 ng/ml for Juul US, indicating a lower potential for nicotine delivery.

Due to its lower nicotine delivery, Juul EU may have limited effectiveness in helping smokers quit, as users reported it less effective in relieving urges to smoke compared to Juul US.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine delivery and user reactions to Juul EU (20 mg/ml) compared with Juul US (59 mg/ml), cigarettes and other e-cigarette products. Phillips-Waller, A., Przulj, D., Smith, KM., et al.[2021]

References

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

Impact of Technology-Based Interventions on Patient-Reported Outcomes in Asthma: A Systematic Review. [2021]

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

Systematic Review of mHealth Applications That Interface with Inhaler Sensors in Asthma. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Comparability of a provisioned device versus bring your own device for completion of patient-reported outcome measures by participants with chronic obstructive pulmonary disease: qualitative interview findings. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Comparability of a provisioned device versus bring your own device for completion of patient-reported outcome measures by participants with chronic obstructive pulmonary disease: quantitative study findings. [2022]

5. England pubmed.ncbi.nlm.nih.gov

A mixed method observational study of strategies to promote adoption and usage of an application to support asthma self-management. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Measuring E-cigarette dependence: Initial guidance. [2023]

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

Vaping product access and use among 14-17-year-olds in New South Wales: a cross-sectional study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Use of e-cigarettes and smoked tobacco in youth aged 14-15 years in New Zealand: findings from repeated cross-sectional studies (2014-19). [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Nicotine Dependence from Different E-Cigarette Devices and Combustible Cigarettes among US Adolescent and Young Adult Users. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Nicotine delivery and user reactions to Juul EU (20 mg/ml) compared with Juul US (59 mg/ml), cigarettes and other e-cigarette products. [2021]