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Trial record 1 of 1 for:    NCT04251273
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Text Message Quit Vaping Intervention for Young Adults

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ClinicalTrials.gov Identifier: NCT04251273
Recruitment Status : Completed
First Posted : January 31, 2020
Last Update Posted : February 5, 2021
Sponsor:
Information provided by (Responsible Party):
Amanda L. Graham, PhD, Truth Initiative

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.

Condition or disease Intervention/treatment Phase
Tobacco Cessation Other: This is Quitting Other: Assessment only Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Arm 1: Intervention - Text message intervention Arm 2: Control - Assessment only
Masking: Single (Participant)
Masking Description: Participants are not explicitly told they are in the control group, although they may deduce their assignment from presence or lack of regular text message intervention.
Primary Purpose: Treatment
Official Title: A Randomized Trial of a Text Message Quit Vaping Intervention for Young Adults
Actual Study Start Date : December 19, 2019
Actual Primary Completion Date : November 12, 2020
Actual Study Completion Date : November 12, 2020

Arm Intervention/treatment
Experimental: This is Quitting

Participants will be enrolled to receive messages from This is Quitting.

Users receive one age-appropriate message per day tailored to their enrollment date or quit date, which can be set and reset via text message. Those not ready to quit receive 4 weeks of messages focused on building skills and confidence. Users who set a quit date receive messages for a week preceding it and 8 weeks afterward that include encouragement and support, skill- and self-efficacy building exercises, coping strategies, and information about the risks of vaping, benefits of quitting, and cutting down to quit. Keywords COPE, STRESS, SLIP, and MORE provide on-demand support.

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

Assessment only Control
After an initial enrollment message, participants will be contacted periodically to assess e-cigarette use. At the end of the intervention period, they will receive information on how to sign up for This is Quitting if they are interested in the program
Other: Assessment only Control
Assessment only




Primary Outcome Measures :
  1. Self-reported 30-day point prevalence abstinence [ Time Frame: 7 months post enrollment ]
    In the past 30 days, did you vape at all, even a puff of someone else's?


Secondary Outcome Measures :
  1. 30-day point prevalence abstinence [ Time Frame: 1 month post enrollment ]
    In the past 30 days, did you vape at all, even a puff of someone else's?

  2. Number of quit attempts [ Time Frame: 1 month and 7 months post enrollment ]
    Since you joined the study a month ago/In the last 6 months, how many times have you stopped vaping - not even a puff - for one day or longer because you were trying to quit for good?

  3. Changes in e-cigarette use [ Time Frame: 1 month and 7 months post enrollment ]
    How many days per week do you vape? On average, how many puffs/hits on your vape do you take on a typical day?

  4. Changes in confidence in quitting e-cigarettes [ Time Frame: 1 month and 7 months post enrollment ]
    How confident are you that you can quit vaping? Response on a scale of 1-10



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 24 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251273


Locations
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United States, District of Columbia
Truth Initiative
Washington, District of Columbia, United States, 20001
Sponsors and Collaborators
Truth Initiative
Investigators
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Principal Investigator: Amanda L Graham, PhD Truth Initiative
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amanda L. Graham, PhD, Chief of Innovations, Truth Initiative
ClinicalTrials.gov Identifier: NCT04251273    
Other Study ID Numbers: TruthInitiativeQVS
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: February 5, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD are not available to other researchers. For access to deidentified dataset, please contact study administrator for more information.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amanda L. Graham, PhD, Truth Initiative:
E-cigarette Cessation
Vaping Cessation
Mobile Intervention
Digital Intervention