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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-10010 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| UG3DA057032 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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Almost one in ten young adults report current e-cigarette use, putting them at risk of developing nicotine addiction and long-term health effects of exposure to inhaled toxicants. Despite the need for effective treatments to help these young users quit, very few treatments targeting any type of tobacco use among young adults have been evaluated, particularly for young adults who vape and have unique treatment needs. To address these needs, this trial will evaluate a digital program for young adult e-cigarette users at all stages of readiness to quit called ACT on Vaping.
OUTLINE:
Participants are randomized to 1 of 2 arms.
ARM I: Participants use the ACT on Vaping smartphone app and text messaging program and receive incentivized text messages assessing their vaping status.
ARM II: Participants receive incentivized text messages check-ins assessing their vaping status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (Act on Vaping app) | Experimental | Participants receive supportive messages and use the ACT on Vaping smartphone app. They also receive incentivized text message check-ins assessing their vaping status. |
|
| Arm II (Incentivized text message check-ins) | Active Comparator | Participants receive incentivized text messages check-ins assessing their vaping status. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartphone app | Behavioral | Use ACT on Vaping smartphone app |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Treatment Satisfaction Rating | We calculated descriptive statistics (mean, standard deviation) for the primary acceptability benchmark of overall satisfaction averaging at least 3.5 on a 1-5 Likert-type scale within the ACT on Vaping arm only. Overall satisfaction was assessed with a 5-point Likert-type item on the 3-month follow-up survey, with response options ranging from (1) "not at all" to (5) "very much." The ACT on Vaping benchmark average of 3.5 falls between ratings of 3="somewhat" and 4="mostly." Higher values are associated with a higher level of satisfaction. | At 3 months post-randomization |
| Change in Readiness to Quit | Will evaluate differences of Contemplation Ladder scores. The 1-item Contemplation Ladder, scores range from 0-10, was used to assess readiness to quit using e-cigarettes. The higher the score, the more ready the person is to make a change. The anchor for the cut-off score of 5, indicating high vs. low quit readiness, is "Think I should quit but not quite ready." | From baseline to 3 months post-randomization |
| Percentage of Participants With a 24-hour Quit Attempt | Making a 24-hour quit attempt between baseline and 3-month follow-up was assessed via self-report at the 3-month follow-up survey. The percentage of participants with self-reported 24-hour quit attempts is evaluated descriptively. | At 3 months post-randomization |
| Cotinine-confirmed 30-day Point Prevalence Abstinence From All Nicotine and Tobacco | Complete case, self-reported 30-day abstinence from all nicotine and tobacco products at 3 months, confirmed via saliva cotinine testing. Differences were evaluated descriptively. | At 3 months post-randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaimee Heffner | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40411791 | Derived | Heffner JL, Baker K, Georgiou K, Graham AL, Kelly MM, Konstantinou P, Lamprou E, Lele C, Lok KZ, Orzechowski M, Ruiz RA, Serfozo E, Karekla M. ACT on Vaping: Pilot Randomized Controlled Trial of a Novel Digital Health App With Text Messaging for Young Adult Vaping Cessation. Nicotine Tob Res. 2026 Apr 22;28(5):720-730. doi: 10.1093/ntr/ntaf112. |
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Participants were recruited via the Facebook/Instagram advertising platform. Two hundred individuals were eligible. The final sample comprised 61 participants who were randomized in January 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Act on Vaping App) | Participants receive supportive messages and use the ACT on Vaping smartphone app. They also receive incentivized text message check-ins assessing their vaping status. Smartphone app: Use ACT on Vaping smartphone app Text Message: Receive text messages Survey Administration: Ancillary studies |
| FG001 | Arm II (Incentivized Text Message Check-ins) | Participants receive incentivized text messages check-ins assessing their vaping status. Text Message: Receive text messages Survey Administration: Ancillary studies |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Act on Vaping App) | Participants receive supportive messages and use the ACT on Vaping smartphone app. They also receive incentivized text message check-ins assessing their vaping status. Smartphone app: Use ACT on Vaping smartphone app Text Message: Receive text messages Survey Administration: Ancillary studies |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Treatment Satisfaction Rating | We calculated descriptive statistics (mean, standard deviation) for the primary acceptability benchmark of overall satisfaction averaging at least 3.5 on a 1-5 Likert-type scale within the ACT on Vaping arm only. Overall satisfaction was assessed with a 5-point Likert-type item on the 3-month follow-up survey, with response options ranging from (1) "not at all" to (5) "very much." The ACT on Vaping benchmark average of 3.5 falls between ratings of 3="somewhat" and 4="mostly." Higher values are associated with a higher level of satisfaction. | We calculated descriptive statistics (e.g., means, proportions) for the ACT on Vaping treatment group to evaluate the go/no-go criteria and to compare the two arms on other indicators of treatment acceptability and efficacy. Given that pilot and feasibility trials are not appropriate designs for testing hypotheses regarding the efficacy of interventions, we focused on descriptive differences as an alternative to hypothesis testing. | Posted | Mean | Standard Deviation | units on a scale | At 3 months post-randomization |
|
Adverse events were collected by a web-based survey (on Day 21, 42, 63, and at the 3-month follow-up time point).
Adverse events were collected by a web-based survey, and their relationship to the intervention was adjudicated by an independent medical monitor.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Act on Vaping App) | Participants receive supportive messages and use the ACT on Vaping smartphone app. They also receive incentivized text message check-ins assessing their vaping status. Smartphone app: Use ACT on Vaping smartphone app Text Message: Receive text messages Survey Administration: Ancillary studies |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | The lingering symptoms of COVID- 19 may be influenced by the trial. |
A limitation of this study is the small sample size, which, while appropriate for a pilot study, does not allow for a definitive evaluation of acceptability or efficacy and limits the generalizability of the findings. Additionally, the cotinine testing for biochemical verification of abstinence was not directly observed, leaving open the possibility that the test could have been completed by someone other than the participant.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jaimee Heffner, Associate Professor | Fred Hutchinson Cancer Center | 2066677314 | jheffner@fredhutch.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 10, 2024 | Apr 14, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 20, 2023 | Mar 21, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D012907 | Smoking |
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Any outcome evaluator who has direct contact with participants will be blinded to treatment assignment.
| Text Message | Other | Receive text messages |
|
|
| Survey Administration | Other | Ancillary studies |
|
| Withdrawal by Subject |
|
| Arm II (Incentivized Text Message Check-ins) |
Participants receive incentivized text messages check-ins assessing their vaping status. Text Message: Receive text messages Survey Administration: Ancillary studies |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Vaping frequency (past 30 days) | Count of Participants | Participants |
|
| Vaping intensity (past 30 days) | Count of Participants | Participants |
|
| Other tobacco product use (past 30 days) | Count of Participants | Participants |
|
| 24-hour quit attempts (past 12 months) | Count of Participants | Participants |
|
| Contemplation Ladder Score | Count of Participants | Participants |
|
| e-cigarette Fagerström Test for Nicotine Dependence (e-FTND) | Range of scores is 0-10. Higher values represent greater severity of dependence. | Mean | Standard Deviation | units on a scale |
|
| OG000 | Arm I (Act on Vaping App) | Participants receive supportive messages and use the ACT on Vaping smartphone app. They also receive incentivized text message check-ins assessing their vaping status. Smartphone app: Use ACT on Vaping smartphone app Text Message: Receive text messages Survey Administration: Ancillary studies |
|
|
| Primary | Change in Readiness to Quit | Will evaluate differences of Contemplation Ladder scores. The 1-item Contemplation Ladder, scores range from 0-10, was used to assess readiness to quit using e-cigarettes. The higher the score, the more ready the person is to make a change. The anchor for the cut-off score of 5, indicating high vs. low quit readiness, is "Think I should quit but not quite ready." | We calculated descriptive statistics (e.g., means, proportions) for the ACT on Vaping treatment group to evaluate the go/no-go criteria and to compare the two arms on other indicators of treatment acceptability and efficacy. | Posted | Mean | Standard Deviation | units on a scale | From baseline to 3 months post-randomization |
|
|
|
| Primary | Percentage of Participants With a 24-hour Quit Attempt | Making a 24-hour quit attempt between baseline and 3-month follow-up was assessed via self-report at the 3-month follow-up survey. The percentage of participants with self-reported 24-hour quit attempts is evaluated descriptively. | Posted | Count of Participants | Participants | At 3 months post-randomization |
|
|
|
| Primary | Cotinine-confirmed 30-day Point Prevalence Abstinence From All Nicotine and Tobacco | Complete case, self-reported 30-day abstinence from all nicotine and tobacco products at 3 months, confirmed via saliva cotinine testing. Differences were evaluated descriptively. | Posted | Count of Participants | Participants | At 3 months post-randomization |
|
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|
| 0 |
| 31 |
| 0 |
| 31 |
| 1 |
| 31 |
| EG001 | Arm II (Incentivized Text Message Check-ins) | Participants receive incentivized text messages check-ins assessing their vaping status. Text Message: Receive text messages Survey Administration: Ancillary studies | 0 | 30 | 0 | 30 | 3 | 30 |
|
| Worsening of pre-existing mental health condition | Psychiatric disorders | Systematic Assessment | Worsening of a pre-existing mental health condition. |
|
| Lowered resting heart rate | Cardiac disorders | Systematic Assessment | The participant reported an extremely lowered resting heart rate of 45 BPM after quitting smoking a few days prior. |
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| Burn on inner thigh. | Skin and subcutaneous tissue disorders | Systematic Assessment | Burn to inner thigh from laptop battery. |
|
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| D001519 |
| Behavior |