Clinical trial NCT04251273: Text Message Quit Vaping Intervention for Young Adults
Official title: A Randomized Trial of a Text Message Quit Vaping Intervention for Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Cessation
Keywords: E-cigarette Cessation
Vaping Cessation
Mobile Intervention
Digital Intervention
Lead sponsor: Truth Initiative
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 2588
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1: Intervention - Text message intervention Arm 2: Control - Assessment only
Primary purpose: TREATMENT

Brief summary: This research study, conducted by Truth Initiative, will help us learn how text messaging can help young adults between 18 and 24 years of age quit vaping.

Detailed description: The Quit Vaping Study (QVS)'s primary aim is to conduct a fully powered comparative effectiveness trial to evaluate the effectiveness of a quit vaping text message program in promoting abstinence from e-cigarettes among young users aged 18-24. This study is a 2-arm randomized controlled trial conducted among young users aged 18-24 recruited through online channels. Participants will be randomized to a quit vaping text message intervention or to an assessment-only control condition and followed for 7 months to roughly correspond to 6-months post-treatment. The secondary aim is to examine potential mediators of program effectiveness, including treatment engagement and changes in self-efficacy and perceived social support for quitting.

Eligibility criteria: Inclusion Criteria:

* Age 18-24
* Past 30-day use of e-cigarettes containing nicotine
* Interest in quitting e-cigarette use in the next 30 days
* US residence

Exclusion Criteria:

* Failure to confirm mobile number after initial sign-up

Primary outcomes:
measure: Number of Participants With Self-reported 30-day Point Prevalence Abstinence (ITT)
timeFrame: 7 months post enrollment
Secondary outcomes:
measure: Number of Participants With Self-reported 30-day Point Prevalence Abstinence (Responder Only)
timeFrame: 7 month post enrollment
measure: Number of Participants With Self-reported 7-day Point Prevalence Abstinence (ITT)
timeFrame: 7 months post enrollment
measure: Number of Participants With Self-reported 7-day Point Prevalence Abstinence (Responder Only)
timeFrame: 7 months post enrollment
Other outcomes:
Locations:
city: Washington
country: United States
facility: Truth Initiative
state: District of Columbia
Study officials:
affiliation: Truth Initiative
name: Amanda L Graham, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Graham AL, Jacobs MA, Amato MS, Cha S, Bottcher MM, Papandonatos GD. Effectiveness of a Quit Vaping Text Message Program in Promoting Abstinence Among Young Adult E-Cigarette Users: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 May 1;9(5):e18327. doi: 10.2196/18327.
citation: Graham AL, Cha S, Papandonatos GD, Amato MS, Jacobs MA, Abroms LC, Berg CJ. E-cigarette and combusted tobacco abstinence among young adults: Secondary analyses from a U.S.-based randomized controlled trial of vaping cessation. Prev Med. 2022 Dec;165(Pt B):107119. doi: 10.1016/j.ypmed.2022.107119. Epub 2022 Jun 28.
citation: Graham AL, Amato MS, Cha S, Jacobs MA, Bottcher MM, Papandonatos GD. Effectiveness of a Vaping Cessation Text Message Program Among Young Adult e-Cigarette Users: A Randomized Clinical Trial. JAMA Intern Med. 2021 Jul 1;181(7):923-930. doi: 10.1001/jamainternmed.2021.1793.