Health TrialsbyHealthPanel

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

ConditionsNicotine DependenceTobacco-Related Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorFred Hutchinson Cancer Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Smartphone app

    Behavioral

    Receive access to the ACT on Vaping app

  • Smartphone app

    Behavioral

    Receive access to the ACT on Vaping app

  • Text Message

    Other intervention

    Receive incentivized text messages to access vaping status

  • Text Message

    Other intervention

    Receive intervention text messages

  • Survey Administration

    Other intervention

    Ancillary studies

Treatment groups

1,178 Participants
are divided into 2 treatment groups
Group A: Arm I (ACT on Vaping app (Version A) + incentivized texts + intervention texts)Experimental treatment 3 interventions
Group B: Arm II (ACT on Vaping app (Version B) + incentivized texts)Sham comparator 3 interventions

Trial outcomes

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.

Time frame
At 6 months post-randomization

Secondary outcomes

1

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.

Time frame
At 3 months post-randomization
2

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.

Time frame
At 6 months post-randomization
3

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.

Time frame
At 3 months post-randomization
4

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.

Time frame
Baseline to 3 months post-randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fred Hutchinson Cancer Center

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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