Clinical trial NCT06909500: A Digital Intervention (ACT on Vaping App) for Vaping Cessation in Young Adult E-Cigarette Users
Official title: ACT on Vaping: Digital Therapeutic for Young Adult Vaping Cessation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nicotine Dependence
Tobacco-Related Carcinoma
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-04-03
Enrollment: 1372
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cotinine-confirmed 7-day point prevalence abstinence from all nicotine and tobacco
timeFrame: At 6 months post-randomization
Secondary outcomes:
measure: Self-reported 7-day point prevalence abstinence from all nicotine and tobacco
timeFrame: At 6 months post-randomization
measure: Self-reported 7-day point prevalence abstinence from all nicotine and tobacco
timeFrame: At 3 months post-randomization
measure: Cotinine-confirmed 7-day point prevalence abstinence from all nicotine and tobacco
timeFrame: 3 At 3 months post-randomization
measure: Self-reported 30-day point prevalence abstinence from all nicotine and tobacco
timeFrame: At 3 months post-randomization
measure: Self-reported 30-day point prevalence abstinence from all nicotine and tobacco
timeFrame: At 6 months post-randomization
measure: Self-reported 7-day point prevalence abstinence from vaping
timeFrame: At 3 months post-randomization
measure: Self-reported 30-day point prevalence abstinence from vaping
timeFrame: At 3 months post-randomization
measure: Self-reported 7-day point prevalence abstinence from vaping
timeFrame: At 6 months post-randomization
measure: Self-reported 30-day point prevalence abstinence from vaping
timeFrame: At 6 months post-randomization
measure: Number of 24-hour quit attempts
timeFrame: Baseline to 3 months post-randomization
measure: Prolonged self-reported abstinence from all nicotine and tobacco for 90 days
timeFrame: At 6 months post-randomization
measure: Change in readiness to quit using electronic cigarettes (e-cigarettes) on the Contemplation Ladder
timeFrame: Baseline to 3 months post-randomization
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Jaimee Heffner, PhD
role: PRINCIPAL_INVESTIGATOR
References: