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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05897242
Other study ID # RG1122763
Secondary ID NCI-2022-10010UG
Status Completed
Phase N/A
First received
Last updated
Start date January 4, 2024
Est. completion date April 26, 2024

Study information

Verified date May 2024
Source Fred Hutchinson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date April 26, 2024
Est. primary completion date April 26, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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.

Study Design


Intervention

Behavioral:
Smartphone app
Use ACT on Vaping smartphone app
Other:
Text Message
Receive text messages
Survey Administration
Ancillary studies

Locations

Country Name City State
United States Fred Hutch/University of Washington Cancer Consortium Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
Fred Hutchinson Cancer Center National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall treatment satisfaction rating 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). At 3 months
Primary Change in readiness to quit Will evaluate differences of Contemplation Ladder scores. From baseline to 3 months post-randomization
Primary Self-reported 24-hour quit attempt Will evaluate differences descriptively. At 3 months post-randomization
Primary Cotinine-confirmed 30-day point prevalence abstinence from all nicotine and tobacco Will evaluate differences descriptively. At 3 months post-randomization
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