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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-01611 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| UH3DA057032 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (ACT on Vaping app (Version A) + incentivized texts + intervention texts) | Experimental | 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. |
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| Arm II (ACT on Vaping app (Version B) + incentivized texts) | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartphone app | Behavioral | Receive access to the ACT on Vaping app |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 6 months post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 3 months post-randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jaimee Heffner, PhD | Contact | 206-667-7314 | jheffner@fredhutch.org |
| Name | Affiliation | Role |
|---|---|---|
| Jaimee Heffner, PhD | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Recruiting | Seattle | Washington | 98109 | United States |
We plan to preserve & share the following scientific data:
Documentation made publicly available to the research community will also include PDFs of the following:
Final data submission and release of data used in publications will occur at the time of publication. Other shared data will be made available at or before the end of the project period. We will follow the data retention plan of the final selected repository, but at a minimum, we intend to ensure that data is available for a period of not less than 5 years after the end of this trial.
All data sharing will be done in compliance with NIH data sharing policies, applicable laws and regulations, and in accordance with guidance from journal publishers. At this time, we plan to share scientific data and meta-data in NCI's Cancer Data Service (CDS). CDS allows open and controlled access to data to ensure access is provided to qualified researchers, data access is tracked, and users understand how to cite and credit use of the data. Data will only be shared for non-profit, non-commercial and non-proprietary purposes to qualified researchers or as allowed by CDS. Based on the nature of the data, which is not sensitive, we anticipate making it publicly available (as opposed to controlled access) but will follow final recommendations from the IRB as to whether access should be controlled.
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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.
| Smartphone app | Behavioral | Receive access to the ACT on Vaping app |
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| Text Message | Other | Receive incentivized text messages to access vaping status |
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| Text Message | Other | Receive intervention text messages |
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| Survey Administration | Other | Ancillary studies |
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| 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. |
| At 6 months post-randomization |
| 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. | At 3 months post-randomization |
| 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. | Baseline to 3 months post-randomization |
| Change in readiness to quit using electronic cigarettes (e-cigarettes) on the Contemplation Ladder | 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. | Baseline to 3 months post-randomization |