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Nicotine DependenceNCT06909500

A Digital Intervention (ACT on Vaping App) for Vaping Cessation in Young Adult E-Cigarette Users

A study testing Smartphone app, Text Message and Survey Administration in people with Nicotine Dependence and Tobacco-Related Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
What is being tested?
Smartphone app, Text Message and Survey Administration
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,178 participants
Where
1 siteUnited States
Study dates
20 May 2026to 15 Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age 18-30
  • 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
  • Have a mobile data plan and/or access to WiFi to support the use of the ACT on Vaping app
  • Has access to text messaging
Show all 10Show fewer
  • Has an email address
  • United States (US) resident, with a US mailing address
  • Willing to complete all study procedures
  • Comfortable reading and writing in English

Who cannot join

  • Currently using other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (note: use of these treatment is allowable during trial participation)
  • Member of the same household as another research participant
  • Currently in prison
  • Google voice number as sole phone number, due to its association with fraudulent study entry attempts
  • Is ineligible per fraud prevention protocol
  • Employees/family of investigator or study center

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jaimee Heffner, PhD contact

206-667-7314

jheffner@fredhutch.org

United States1 site, 1 recruiting

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

    Jaimee Heffner, PhD, 206-667-7314, jheffner@fredhutch.org

    Jaimee Heffner, PhD

    Recruiting

Other trials in United States

About this study

Official title: ACT on Vaping: Digital Therapeutic for Young Adult Vaping Cessation

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.

Read the detailed description

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants use the ACT on Vaping app (Version A) and receive a text messaging program to motivate and support quitting. Participants also receive incentivized text message check-ins at 2 weeks, 2 months, and 4 months to assess their vaping status.

ARM II: Participants use the ACT on Vaping app (Version B) and receive incentivized text message check-ins at 2 weeks, 2 months, and 4 months to assess their vaping status.

After completion of study intervention, participants are followed up at 3, 5.5, and 6 months.

Being tested
Smartphone app, Text Message, Survey Administration
Medical subject headings
Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Smartphone appBehavioural

    Also called ACT on Vaping (Version A)

    Receive access to the ACT on Vaping app

  • Smartphone appBehavioural

    Also called ACT on Vaping (Version B)

    Receive access to the ACT on Vaping app

  • Text MessageOther

    Also called SMS Text

    Receive incentivized text messages to access vaping status

  • Text MessageOther

    Also called SMS Text

    Receive intervention text messages

  • Survey AdministrationOther

    Ancillary studies

Study groups in NCT06909500
Study groupRoleWhat they receive
Arm I (ACT on Vaping app (Version A) + incentivized texts + intervention texts)ExperimentalParticipants 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.
Receives: Behavioral: Smartphone app; Other: Text Message; Other: Survey Administration
Arm II (ACT on Vaping app (Version B) + incentivized texts)Sham comparatorParticipants 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.
Receives: Behavioral: Smartphone app; Other: Text Message; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cotinine-confirmed 30-day point prevalence abstinence from all nicotine and tobacco

    Biochemically confirmed 30-day abstinence from all nicotine and tobacco (excluding Food and Drug Administration [FDA]-approved pharmacotherapies). Will be assessed in each individual and summarized within each group as a proportion.

    Measured: At 6 months post-randomization

Secondary outcomes (5)

  1. Self-reported 30-day point prevalence abstinence from vaping

    Proportion of participants self-reporting 30-day abstinence from vaping. Will be assessed in each individual and summarized within each group as a proportion. The proportion of "success" will be compared between groups using logistic regression.

    Measured: At 3 months post-randomization

  2. Self-reported 30-day point prevalence abstinence from vaping

    Proportion of participants self-reporting 30-day abstinence from vaping. Will be assessed in each individual and summarized within each group as a proportion. The proportion of "success" will be compared between groups using logistic regression.

    Measured: At 6 months post-randomization

  3. Cotinine-confirmed 7-day point prevalence abstinence from all nicotine and tobacco

    Biochemically confirmed 7-day abstinence from all nicotine and tobacco (excluding FDA-approved pharmacotherapies). Will be assessed in each individual and summarized within each group as a proportion. The proportion of "success" will be compared between groups using logistic regression.

    Measured: At 3 months post-randomization

  4. Number of 24-hour quit attempts

    Number of times between baseline and 3-month follow-up that participant stopped using all nicotine and tobacco (excluding FDA-approved pharmacotherapies) for 24 hours or longer. Will be assessed in each individual and summarized within each group as a continuous variable and analyzed using linear regression.

    Measured: Baseline to 3 months post-randomization

  5. Change in readiness to quit using electronic cigarettes (e-cigarettes) on the Contemplation Ladder

    Self-reported motivation to quit smoking e-cigarettes (Contemplation Ladder), rated 1-10. Higher scores indicate greater motivation to quit (i.e., high [> 5] versus low [5 or less]). Will be assessed in each individual and summarized within each group as a change score and analyzed using linear regression.

    Measured: Baseline to 3 months post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2025
  2. Study start20 May 2026
  3. Primary completion15 Nov 2027 (estimated)
  4. Study completion15 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
1,178 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06909500
Sponsor's protocol ID
RG1125194
Other IDs
NCI-2025-01611, UH3DA057032, FHIRB0021091
Status last verified
Sep 2026
First submitted
27 Mar 2025
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We plan to preserve \& share the following scientific data: * Survey Data: De-identified individual \& aggregate survey data (including raw and recoded data) necessary to replicate main outcomes will be shared * App utilization data: Individual level, de-identified aggregate data necessary to replicate main outcomes will be shared Documentation made publicly available to the research community will also include PDFs of the following: * Survey instruments with proprietary measures redacted * A description of the data collection methods * Copies of study consent forms \& other relevant documentation of IRB approval \& limitations on data sharing or usage * Survey codebook * Methods used to code or summarize open-text survey responses * Steps taken to remove direct \& indirect identifiers in the data * Description of the software \& analytical methods used in survey data analyses * Code used in data analyses

Questions about this trial

What is this clinical trial studying?

A study testing Smartphone app, Text Message and Survey Administration in people with Nicotine Dependence and Tobacco-Related Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jaimee Heffner, PhD (206-667-7314, jheffner@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cotinine-confirmed 30-day point prevalence abstinence from all nicotine and tobacco (time frame: At 6 months post-randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06909500.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.

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