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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app designed to help young adults quit using e-cigarettes. The app, called the ACT on Vaping App, employs a type of behavioral therapy to increase awareness of triggers that lead to vaping and teaches skills to manage these triggers. It provides a flexible and accessible way for users to quit vaping and all nicotine products. Ideal participants are U.S. residents aged 18-30 who have used e-cigarettes weekly for the past month and have a smartphone with internet access. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could help others quit vaping.

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 prior data suggests that this app is safe for young adults?

Research shows that people generally like the ACT on Vaping app. In a previous study, users rated their satisfaction with the app at an average of 3.8 out of 5, exceeding the standard for acceptability. This indicates that users found the app easy to use and helpful.

As a digital tool, the app avoids the physical risks associated with medication. Instead, it employs behavioral therapy to assist young adults in quitting vaping. In the study, participants using the app reported attempts to quit, indicating its potential effectiveness.

Overall, based on the available data, the ACT on Vaping app appears to be a safe option for those wanting to quit e-cigarettes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ACT on Vaping app because it offers a fresh approach to tackling nicotine addiction, especially among those who vape. Unlike traditional treatments like nicotine replacement therapy or prescription medications, this app uses Acceptance and Commitment Therapy (ACT), which focuses on helping users develop psychological flexibility and commitment to change. The app is also enhanced with incentivized and intervention text messages, providing personalized support and motivation over time. This combination of digital therapy and real-time support could make quitting vaping more accessible and engaging for users, offering a new way to address this growing health concern.

What evidence suggests that the ACT on Vaping app could be effective for nicotine addiction?

Research has shown that the ACT on Vaping app might help young adults quit vaping. An initial study found users considered the app helpful and promising for quitting nicotine, with participants rating their satisfaction at least 3.5 out of 5. This trial will compare two versions of the app. Arm I participants will use the ACT on Vaping app (Version A), which utilizes Acceptance and Commitment Therapy (ACT) and includes intervention texts. Arm II participants will use the ACT on Vaping app (Version B) with health education content. Both groups will receive incentivized text message check-ins. This digital approach aims to encourage users to stop using e-cigarettes and other tobacco products. Although still early, these findings suggest the app could be an effective tool for quitting vaping. ^{1 2 4 5 6}

Who Is on the Research Team?

Jaimee Heffner, PhD

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. academic.oup.com academic.oup.com/ntr/advance-article/doi/10.1093/ntr/ntaf112/8145603

ACT on Vaping: Pilot Randomized Controlled Trial of a Novel ... Overall, the results of this study suggest that the ACT on Vaping program was acceptable and shows promise as a digital health intervention for ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06909500

NCT06909500 | A Digital Intervention (ACT on Vaping App ... 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 ...

3. reporter.nih.gov reporter.nih.gov/project-details/10694913

Digital Therapeutic for Young Adult Vaping Cessation (c) Completed pilot trial (n=60) showing satisfaction with ACT on Vaping averaging at least 3.5 out of 5; and (d) relative to control, evidence of better ...

4. formative.jmir.org formative.jmir.org/2024/1/e57376

Outcomes of a Comprehensive Mobile Vaping Cessation ... This exploratory, prospective, single-arm, remote cohort study of the Pivot vaping cessation program assessed enrollment and questionnaire completion rates.

5. withpower.com withpower.com/trial/act-on-vaping-app-for-nicotine-addiction-19938

ACT on Vaping App for Nicotine Addiction This clinical trial evaluates a smartphone application (app) called Acceptance and Commitment Therapy (ACT) on Vaping for helping young adults quit using ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40411791/

ACT on Vaping: Pilot Randomized Controlled Trial of a ... A higher proportion of participants in the ACT on Vaping arm reported a 24-hour quit attempt (87.5% vs. 75.9%), exceeding the efficacy benchmark ...