NCT05897242

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

January 4, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 6, 2025

Completed
Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

May 31, 2023

Results QC Date

April 22, 2025

Last Update Submit

June 16, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

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.

Behavioral: Smartphone appOther: Text MessageOther: Survey Administration

Arm II (Incentivized text message check-ins)

ACTIVE COMPARATOR

Participants receive incentivized text messages check-ins assessing their vaping status.

Other: Text MessageOther: Survey Administration

Interventions

Smartphone appBEHAVIORAL

Use ACT on Vaping smartphone app

Also known as: ACT on Vaping
Arm I (Act on Vaping app)

Receive text messages

Also known as: SMS Text
Arm I (Act on Vaping app)Arm II (Incentivized text message check-ins)

Ancillary studies

Arm I (Act on Vaping app)Arm II (Incentivized text message check-ins)

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Tobacco Use DisorderVaping

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersSmokingBehavior

Limitations and Caveats

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.

Results Point of Contact

Title
Jaimee Heffner, Associate Professor
Organization
Fred Hutchinson Cancer Center

Study Officials

  • Jaimee Heffner

    Fred Hutch/University of Washington Cancer Consortium

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Any outcome evaluator who has direct contact with participants will be blinded to treatment assignment.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 31, 2023

First Posted

June 9, 2023

Study Start

January 4, 2024

Primary Completion

April 26, 2024

Study Completion

April 26, 2024

Last Updated

June 24, 2025

Results First Posted

June 6, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations