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Clinical Trials/NCT05897242
NCT05897242
Completed
Not Applicable

ACT on Vaping: Digital Therapeutic for Young Adult Vaping Cessation

Fred Hutchinson Cancer Center1 site in 1 country61 target enrollmentJanuary 4, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nicotine Dependence
Sponsor
Fred Hutchinson Cancer Center
Enrollment
61
Locations
1
Primary Endpoint
Overall Treatment Satisfaction Rating
Status
Completed
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 4, 2024
End Date
April 26, 2024
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jaimee Heffner

Associate Professor

Fred Hutchinson Cancer Center

Eligibility Criteria

Inclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Overall Treatment Satisfaction Rating

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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