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

Not Applicable

Not yet recruiting

• Conditions: Nicotine Dependence; Tobacco-Related Carcinoma

• Registration Number: NCT06909500
• Lead Sponsor: Fred Hutchinson Cancer Center

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.

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 and 6 months.

Study Timeline

• Study First Submitted: 2025-03-27
• Study First Submitted QC: 2025-03-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Study First Posted: 2025-04-03
• Last Update Posted: 2025-04-04
• Study Start: 2025-09-01
• Primary Completion: 2027-05-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1372

Inclusion Criteria

• Age 18-30
• Age of majority (to provide informed consent) in current state/territory of residence
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cotinine-confirmed 7-day point prevalence abstinence from all nicotine and tobacco	At 6 months post-randomization	Biochemically confirmed 7-day abstinence from all nicotine and tobacco (excluding FDA-approved pharmacotherapies).

Secondary Outcome Measures

Name	Time	Method
Self-reported 7-day point prevalence abstinence from all nicotine and tobacco	At 3 months post-randomization	Proportion of participants self-reporting 7-day abstinence from all nicotine and tobacco (excluding FDA-approved pharmacotherapies).
Cotinine-confirmed 7-day point prevalence abstinence from all nicotine and tobacco	3 At 3 months post-randomization	Biochemically-confirmed 7-day abstinence from all nicotine and tobacco (excluding FDA-approved pharmacotherapies).
Self-reported 30-day point prevalence abstinence from all nicotine and tobacco	At 6 months post-randomization	Proportion of participants self-reporting 30-day abstinence from all nicotine and tobacco (including FDA-approved pharmacotherapies).
Self-reported 7-day point prevalence abstinence from vaping	At 6 months post-randomization	Proportion of participants self-reporting 7-day abstinence from vaping.
Self-reported 30-day point prevalence abstinence from vaping	At 6 months post-randomization	Proportion of participants self-reporting 30-day abstinence from vaping.
Number of 24-hour quit attempts	Baseline to 3 months post-randomization	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.
Prolonged self-reported abstinence from all nicotine and tobacco for 90 days	At 6 months post-randomization	Proportion of participants self-reporting no nicotine or tobacco use (excluding FDA-approved pharmacotherapies) for 90 days prior to 6-month follow-up.
Change in readiness to quit using electronic cigarettes (e-cigarettes) on the Contemplation Ladder	Baseline to 3 months post-randomization	Self-reported motivation to quit smoking e-cigarettes (Contemplation Ladder), rated 1-10. Higher scores indicate greater motivation to quit \[i.e., high (\>5) vs. low (5 or less)\].

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States