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

Nicotine Dependence Clinical Trial

Official title:

ACT on Vaping: Digital Therapeutic for Young Adult Vaping Cessation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05897242
• Other study ID #: RG1122763
• Secondary ID: NCI-2022-10010UG
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 4, 2024
• Est. completion date: May 17, 2024

Study information

• Verified date: March 2024
• Source: Fred Hutchinson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• 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: Active, not recruiting
• Enrollment: 61
• Est. completion date: May 17, 2024
• Est. primary completion date: May 17, 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.

Related Conditions & MeSH terms

• Nicotine Addiction
• Nicotine Dependence
• Nicotine Use Disorder
• Tobacco Use Disorder
• Vaping

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