Nicotine Dependence, Tobacco-Related Carcinoma
Conditions
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, 5.5, and 6 months.
Interventions
BEHAVIORALSmartphone app
Receive access to the ACT on Vaping app
OTHERText Message
Receive incentivized text messages to access vaping status
OTHERSurvey Administration
Ancillary studies
Sponsors
Fred Hutchinson Cancer Center
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cotinine-confirmed 30-day point prevalence abstinence from all nicotine and tobacco | At 6 months post-randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported 30-day point prevalence abstinence from vaping | At 3 months post-randomization | 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. |
| Cotinine-confirmed 7-day point prevalence abstinence from all nicotine and tobacco | At 3 months post-randomization | 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. |
| 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. Will be assessed in each individual and summarized within each group as a continuous variable and analyzed using linear regression. |
| 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 \[\> 5\] versus low \[5 or less\]). Will be assessed in each individual and summarized within each group as a change score and analyzed using linear regression. |
Countries
United States
Contacts
CONTACTJaimee Heffner, PhD
PRINCIPAL_INVESTIGATORJaimee Heffner, PhD
Fred Hutch/University of Washington Cancer Consortium
Outcome results
None listed