Tobacco CessationNCT04251273
Text Message Quit Vaping Intervention for Young Adults
A study testing This is Quitting in people with Tobacco Cessation, run by Truth Initiative at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Cessation
- What is being tested?
- This is Quitting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,588 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2019to 12 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Failure to confirm mobile number after initial sign-up
Trial locations and contacts
1 site in 1 country.
United States1 site
Truth Initiative
Washington D.C., District of Columbia, 20001
About this study
Official title: A Randomized Trial of a Text Message Quit Vaping Intervention for Young Adults
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.
Read the 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.
- Conditions
- Tobacco Cessation
- Being tested
- This is Quitting, Assessment only Control
- Keywords
- E-cigarette Cessation, Vaping Cessation, Mobile Intervention, Digital Intervention
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is QuittingOther
Text message-based intervention for quit vaping support.
Assessment only ControlOther
Assessment only
| Study group | Role | What they receive |
|---|---|---|
| This is Quitting | Experimental | 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. Receives: Other: This is Quitting |
| Assessment only Control | Other | 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 Receives: Other: Assessment only Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 months post enrollment
Secondary outcomes (3)
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.
Measured: 7 month post enrollment
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.
Measured: 7 months post enrollment
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.
Measured: 7 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start19 Dec 2019
- Primary completion12 Nov 2020
- Study completion12 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tobacco CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1: Intervention - Text message intervention Arm 2: Control - Assessment only
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,588 participants (actual)
Sponsor and investigators
- Lead sponsor
- Truth Initiative
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda L. Graham, PhD, Truth Initiative
- Investigators
- Amanda L Graham, PhD, Principal investigator, Truth Initiative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251273
- Sponsor's protocol ID
- TruthInitiativeQVS
- Status last verified
- Jun 2024
- First submitted
- 23 Jan 2020
- Last updated
- 10 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD are not available to other researchers. For access to deidentified dataset, please contact study administrator for more information.
Publications
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.
PubMed 32356774Graham 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.
PubMed 35777699Graham 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.
PubMed 33999133Graham AL, Cha S, Do EK, Jacobs MA, Edwards G, Papandonatos GD. Dual abstinence from nicotine vaping and cannabis use among young people: secondary analyses from two U.S.-based randomized controlled trials of vaping cessation. Subst Abuse Treat Prev Policy. 2025 Nov 3;20(1):48. doi: 10.1186/s13011-025-00679-1.
PubMed 41177894
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of a Text Message Quit Vaping Intervention for Young Adults
- ClinicalTrials.gov ID
- NCT04251273
- Acronym / sponsor ID
- TruthInitiativeQVS
- Conditions
- Tobacco Cessation
- Keywords
- E-cigarette Cessation, Vaping Cessation, Mobile Intervention, Digital Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,588 participants (actual)
- Lead sponsor
- Truth InitiativeUniversity, hospital or other
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 12 Nov 2020 (actual)
- Study completion
- 12 Nov 2020 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Posted 14 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Arm 1: Intervention - Text message intervention Arm 2: Control - Assessment only
| Arm | Type | Receives |
|---|---|---|
| This is Quitting | Experimental | Other: This is QuittingParticipants 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. |
| Assessment only Control | Other | Other: Assessment only ControlAfter 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 |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Failure to confirm mobile number after initial sign-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is QuittingText message-based intervention for quit vaping support. | Other | This is Quitting |
| Assessment only ControlAssessment only | Other | Assessment only Control |
Primary outcome
Number of Participants With Self-reported 30-day Point Prevalence Abstinence (ITT)
Time frame: 7 months post enrollment
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.
3 secondary outcomes
Number of Participants With Self-reported 30-day Point Prevalence Abstinence (Responder Only)
Time frame: 7 month post enrollment
Number of Participants With Self-reported 7-day Point Prevalence Abstinence (ITT)
Time frame: 7 months post enrollment
Number of Participants With Self-reported 7-day Point Prevalence Abstinence (Responder Only)
Time frame: 7 months post enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32356774Graham 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.
- Background: PubMed 35777699Graham 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.
- Results publication: PubMed 33999133Graham 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.
- Derived from this study: PubMed 41177894Graham AL, Cha S, Do EK, Jacobs MA, Edwards G, Papandonatos GD. Dual abstinence from nicotine vaping and cannabis use among young people: secondary analyses from two U.S.-based randomized controlled trials of vaping cessation. Subst Abuse Treat Prev Policy. 2025 Nov 3;20(1):48. doi: 10.1186/s13011-025-00679-1.
- Individual participant dataSharing planned: No. IPD are not available to other researchers. For access to deidentified dataset, please contact study administrator for more information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda L Graham, PhD principal investigator
Truth Initiative
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing This is Quitting in people with Tobacco Cessation, run by Truth Initiative at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Self-reported 30-day Point Prevalence Abstinence (ITT) (time frame: 7 months post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04251273, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024; AzTrials last refreshed its copy on 28 Oct 2026.