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

Fred Hutchinson Cancer Center (FHCC)

Status: Begins enrollment this month

Conditions: Nicotine Dependence; Tobacco-Related Carcinoma

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06909500

UH3DA057032 (U.S. NIH Grant/Contract)

NCI-2025-01611 (Registry Identifier)

RG1125194

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,372 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,372 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Other: Text Message

Behavioral: Smartphone app

Behavioral: Smartphone app

Other: Survey Administration

Other: Text Message

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

Sham Comparator group

Description:

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.

Treatment:

Other: Text Message

Behavioral: Smartphone app

Behavioral: Smartphone app

Other: Survey Administration

Other: Text Message