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

NCT06909500 | Not Yet Recruiting

• 3 other identifiers: RG1125194NCI-2025-01611UH3DA057032
• Study Type: interventional
• Target: 1,178
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Tobacco-Related Carcinoma; Nicotine Dependence

Outcome Measures

Primary Outcomes (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.

  At 6 months post-randomization

Secondary Outcomes (5)

• Self-reported 30-day point prevalence abstinence from vaping

  At 3 months post-randomization

• Self-reported 30-day point prevalence abstinence from vaping

  At 6 months post-randomization

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

  At 3 months post-randomization

• Number of 24-hour quit attempts

  Baseline to 3 months post-randomization

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

  Baseline to 3 months post-randomization

Study Arms (2)

Arm I (ACT on Vaping app (Version A) + incentivized texts + intervention texts)

EXPERIMENTAL

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.

Behavioral: Smartphone app; Other: Text Message; Other: Survey Administration

Arm II (ACT on Vaping app (Version B) + incentivized texts)

SHAM COMPARATOR

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.

Behavioral: Smartphone app; Other: Text Message; Other: Survey Administration

Interventions

Smartphone app BEHAVIORAL

Receive access to the ACT on Vaping app

Also known as: ACT on Vaping (Version A)

Arm I (ACT on Vaping app (Version A) + incentivized texts + intervention texts)

Text Message OTHER

Receive incentivized text messages to access vaping status

Also known as: SMS Text

Arm I (ACT on Vaping app (Version A) + incentivized texts + intervention texts); Arm II (ACT on Vaping app (Version B) + incentivized texts)

Survey Administration OTHER

Ancillary studies

Arm I (ACT on Vaping app (Version A) + incentivized texts + intervention texts); Arm II (ACT on Vaping app (Version B) + incentivized texts)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Jaimee Heffner, PhD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaimee Heffner, PhD

CONTACT

206-667-7314; jheffner@fredhutch.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The control app will also be called ACT on Vaping in participant-facing materials, for blinding purposes; Any outcome evaluator who has direct contact with participants will remain blinded to treatment group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: May 7, 2026
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): November 15, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• 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.
• 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.

Locations

US (1)