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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04251273
Other study ID # TruthInitiativeQVS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 19, 2019
Est. completion date November 12, 2020

Study information

Verified date May 2022
Source Truth Initiative
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2588
Est. completion date November 12, 2020
Est. primary completion date November 12, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 24 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
This is Quitting
Text message-based intervention for quit vaping support.
Assessment only Control
Assessment only

Locations

Country Name City State
United States Truth Initiative Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Truth Initiative

Country where clinical trial is conducted

United States, 

References & Publications (2)

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/jamain — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Self-reported 30-day Point Prevalence Abstinence (ITT) Number of participant who responded "No" to the question "In the past 30 days, did you vape at all, even a puff of someone else's?" Denominator is all randomized participants. 7 months post enrollment
Secondary Number of Participants With Self-reported 30-day Point Prevalence Abstinence (Responder Only) Number of participants with who responded 'No" to the question "In the past 30 days, did you vape at all, even a puff of someone else's?" Denominator is participants with responses only. 7 month post enrollment
Secondary Number of Participants With Self-reported 7-day Point Prevalence Abstinence (ITT) Number of participants who responded "No" to the question "Have you used any vape, even one puff, in the past 7 days?" Denominator is all randomized participants. 7 months post enrollment
Secondary Number of Participants With Self-reported 7-day Point Prevalence Abstinence (Responder Only) Number of participants who responded "No" to the question "Have you used any vape, even one puff, in the past 7 days?" Denominator is those who responded to the question only. 7 months post enrollment
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