Nicotine Addiction, Nicotine Dependence, Nicotine Use Disorder, Nicotine Vaping, Vaping
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSmartphone app
Use ACT on Vaping smartphone app
OTHERText Message
Receive text messages
OTHERSurvey Administration
Ancillary studies
Sponsors
National Institute on Drug Abuse (NIDA)
Fred Hutchinson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Any outcome evaluator who has direct contact with participants will be blinded to treatment 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). * Owns an Android phone or iPhone. * Has an email address. * United States (US) resident, with a US mailing address. * Willing to complete all study procedures.
Exclusion criteria
* Currently using other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (note: use of these treatments is allowable during trial participation). * Member of the same household as another research participant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Treatment Satisfaction Rating | At 3 months post-randomization | 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. |
| Change in Readiness to Quit | From baseline to 3 months post-randomization | 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. |
| Percentage of Participants With a 24-hour Quit Attempt | At 3 months post-randomization | 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. |
| Cotinine-confirmed 30-day Point Prevalence Abstinence From All Nicotine and Tobacco | At 3 months post-randomization | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 31 |
| 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 | 30 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Incomplete | 1 | 0 |
| Overall Study | Lost to Follow-up | 6 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Arm I (Act on Vaping App) | Arm II (Incentivized Text Message Check-ins) | Total |
|---|---|---|---|
| 24-hour quit attempts (past 12 months) At least 1 attempt | 26 Participants | 21 Participants | 47 Participants |
| 24-hour quit attempts (past 12 months) No attempts | 5 Participants | 9 Participants | 14 Participants |
| Age, Continuous | 21.5 years STANDARD_DEVIATION 3.2 | 22 years STANDARD_DEVIATION 3.6 | 21.8 years STANDARD_DEVIATION 3.4 |
| Contemplation Ladder Score High quit readiness (>5) | 24 Participants | 24 Participants | 48 Participants |
| Contemplation Ladder Score Low quit readiness (≤ 5) | 7 Participants | 6 Participants | 13 Participants |
| e-cigarette Fagerström Test for Nicotine Dependence (e-FTND) | 5 units on a scale STANDARD_DEVIATION 2.2 | 5.4 units on a scale STANDARD_DEVIATION 2.5 | 5.2 units on a scale STANDARD_DEVIATION 2.3 |
| Other tobacco product use (past 30 days) At least daily | 3 Participants | 4 Participants | 7 Participants |
| Other tobacco product use (past 30 days) Less than once a month | 5 Participants | 8 Participants | 13 Participants |
| Other tobacco product use (past 30 days) Not at all | 15 Participants | 13 Participants | 28 Participants |
| Other tobacco product use (past 30 days) Once a month or more, but less than once a week | 4 Participants | 3 Participants | 7 Participants |
| Other tobacco product use (past 30 days) Once a week or more, but not daily | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 27 Participants | 49 Participants |
| Region of Enrollment United States | 31 participants | 30 participants | 61 participants |
| Sex: Female, Male Female | 22 Participants | 13 Participants | 35 Participants |
| Sex: Female, Male Male | 9 Participants | 17 Participants | 26 Participants |
| Vaping frequency (past 30 days) At least daily | 25 Participants | 30 Participants | 55 Participants |
| Vaping frequency (past 30 days) Once a week or more but not daily | 6 Participants | 0 Participants | 6 Participants |
| Vaping intensity (past 30 days) 0-4 times/day | 6 Participants | 1 Participants | 7 Participants |
| Vaping intensity (past 30 days) 10-14 times/day | 4 Participants | 6 Participants | 10 Participants |
| Vaping intensity (past 30 days) 15-19 times/day | 5 Participants | 5 Participants | 10 Participants |
| Vaping intensity (past 30 days) 20-29 times/day | 3 Participants | 5 Participants | 8 Participants |
| Vaping intensity (past 30 days) 30+ times/day | 3 Participants | 6 Participants | 9 Participants |
| Vaping intensity (past 30 days) 5-9 times/day | 10 Participants | 7 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 30 |
| other Total, other adverse events | 1 / 31 | 3 / 30 |
| serious Total, serious adverse events | 0 / 31 | 0 / 30 |
Outcome results
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.
Time frame: From baseline to 3 months post-randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Act on Vaping App) | Change in Readiness to Quit | 0.96 units on a scale | Standard Deviation 2 |
| Arm II (Incentivized Text Message Check-ins) | Change in Readiness to Quit | 0.72 units on a scale | Standard Deviation 1.7 |
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.
Time frame: At 3 months post-randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm I (Act on Vaping App) | Cotinine-confirmed 30-day Point Prevalence Abstinence From All Nicotine and Tobacco | 1 Participants |
| Arm II (Incentivized Text Message Check-ins) | Cotinine-confirmed 30-day Point Prevalence Abstinence From All Nicotine and Tobacco | 0 Participants |
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.
Time frame: At 3 months post-randomization
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Act on Vaping App) | Overall Treatment Satisfaction Rating | 3.8 units on a scale | Standard Deviation 1.3 |
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.
Time frame: At 3 months post-randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm I (Act on Vaping App) | Percentage of Participants With a 24-hour Quit Attempt | 21 Participants |
| Arm II (Incentivized Text Message Check-ins) | Percentage of Participants With a 24-hour Quit Attempt | 22 Participants |