Clincosm LogoSign in Get a demo

A Smartphone Application (ACT on Vaping) for Vaping Cessation in Young Adults

Sponsor
Fred Hutchinson Cancer Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05897242
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
60
Enrollment
1
Location
2
Arms
10
Anticipated Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Smartphone app
  • Other: Text Message
  • Other: Survey Administration
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Any outcome evaluator who has direct contact with participants will be blinded to treatment assignment.
Primary Purpose:
Prevention
Official Title:
ACT on Vaping: Digital Therapeutic for Young Adult Vaping Cessation
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: Smartphone app
Use ACT on Vaping smartphone app
Other Names:
  • ACT on Vaping

    • Other: Text Message
    Receive text messages
    Other Names:
  • SMS Text

    • Other: Survey Administration
    Ancillary studies
    Active Comparator: Arm II (Incentivized text message check-ins)

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

    Other: Text Message
    Receive text messages
    Other Names:
  • SMS Text

    • Other: Survey Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Overall treatment satisfaction rating [At 3 months]

      Will calculate descriptive statistics (e.g., means, proportions) for the ACT on Vaping treatment group to assess treatment satisfaction (i.e., mean level of overall satisfaction with ACT on Vaping, with 3.5 on a 5-point scale being the "go" criterion).

    2. Change in readiness to quit [From baseline to 3 months post-randomization]

      Will evaluate differences of Contemplation Ladder scores.

    3. Self-reported 24-hour quit attempt [At 3 months post-randomization]

      Will evaluate differences descriptively.

    4. Cotinine-confirmed 30-day point prevalence abstinence from all nicotine and tobacco [At 3 months post-randomization]

      Will evaluate differences descriptively.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fred Hutch/University of Washington Cancer Consortium Seattle Washington United States 98109

    Sponsors and Collaborators

    • Fred Hutchinson Cancer Center
    • National Institute on Drug Abuse (NIDA)

    Investigators

    • Principal Investigator: Jaimee Heffner, Fred Hutch/University of Washington Cancer Consortium

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fred Hutchinson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05897242
    Other Study ID Numbers:
    • RG1122763
    • NCI-2022-10010
    • UG3DA057032
    First Posted:
    Jun 9, 2023
    Last Update Posted:
    Jun 9, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Tobacco Use Disorder

    Study Results

    No Results Posted as of Jun 9, 2023