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

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.

Study Overview

• Status: Recruiting
• Conditions: Nicotine Dependence; Tobacco-Related Carcinoma
• Intervention / Treatment: Other: Survey Administration; Behavioral: Smartphone app; Other: Text Message; Other: Text Message

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.

• Study Type: Interventional
• Enrollment (Estimated): 1178
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jaimee Heffner, PhD; Phone Number: 206-667-7314; Email: jheffner@fredhutch.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutch/University of Washington Cancer Consortium
      • Contact: Jaimee Heffner, PhD; Phone Number: 206-667-7314; Email: jheffner@fredhutch.org
      • Principal Investigator: Jaimee Heffner, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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
• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (ACT on Vaping app (Version A) + incentivized texts + intervention texts); 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.	Other: Survey Administration; Ancillary studies; Behavioral: Smartphone app; Receive access to the ACT on Vaping app; Other Names: ACT on Vaping (Version B); Other: Text Message; Receive incentivized text messages to access vaping status; Other Names: SMS Text; Other: Text Message; Receive intervention text messages; Other Names: SMS Text
Sham Comparator: Arm II (ACT on Vaping app (Version B) + incentivized texts); 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.	Other: Survey Administration; Ancillary studies; Behavioral: Smartphone app; Receive access to the ACT on Vaping app; Other Names: ACT on Vaping (Version B); Other: Text Message; Receive incentivized text messages to access vaping status; Other Names: SMS Text; Other: Text Message; Receive intervention text messages; Other Names: SMS Text

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 6 months post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 3 months post-randomization
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.	At 6 months post-randomization
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.	At 3 months post-randomization
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.	Baseline to 3 months post-randomization
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.	Baseline to 3 months post-randomization

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Jaimee Heffner, PhD, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2026
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): November 15, 2027

Study Registration Dates

• First Submitted: March 27, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): April 3, 2025

Study Record Updates

• Last Update Posted (Actual): September 8, 2026
• Last Update Submitted That Met QC Criteria: September 3, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Tobacco Use Disorder
• Other Study ID Numbers: RG1125194; NCI-2025-01611 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); UH3DA057032 (U.S. NIH Grant/Contract); FHIRB0021091 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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

• IPD Sharing Time Frame: Final data submission and release of data used in publications will occur at the time of publication. Other shared data will be made available at or before the end of the project period. We will follow the data retention plan of the final selected repository, but at a minimum, we intend to ensure that data is available for a period of not less than 5 years after the end of this trial.
• IPD Sharing Access Criteria: All data sharing will be done in compliance with NIH data sharing policies, applicable laws and regulations, and in accordance with guidance from journal publishers. At this time, we plan to share scientific data and meta-data in NCI's Cancer Data Service (CDS). CDS allows open and controlled access to data to ensure access is provided to qualified researchers, data access is tracked, and users understand how to cite and credit use of the data. Data will only be shared for non-profit, non-commercial and non-proprietary purposes to qualified researchers or as allowed by CDS. Based on the nature of the data, which is not sensitive, we anticipate making it publicly available (as opposed to controlled access) but will follow final recommendations from the IRB as to whether access should be controlled.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No