Nicotine VapingPhase 1NCT05994209
Testing the Feasibility and Acceptability of Social Media and Digital Therapeutics to Decrease Vaping Behaviors
A Phase 1 study testing quitSTART Mobile Application and Chatbot Feature in quitSTART Mobile Application in people with Nicotine Vaping and Nicotine Use Disorder, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Use of vaping products (e.g., electronic nicotine delivery systems, e-cigarettes) has been increasing rapidly, particularly among teens and young adults. With limited information on the long-term effects of vaping products, health information about vaping has been somewhat unclear in regards to associated health… Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Nicotine Vaping, Nicotine Use Disorder
- What is being tested?
- quitSTART Mobile Application and Chatbot Feature in quitSTART Mobile Application
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2025to 30 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- US Resident
- English Speaking
- Have daily access to a smartphone
- Current vaping product user (P30D)
- Identified as socially networking about a desire to quit vaping and/or experiencing negative health outcomes due to vaping
- Vaping product user only (i.e., not using vaping as a means to support combustible smoking cessation)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis, School of Medicine
St Louis, Missouri, 63110
About this study
Use of vaping products (e.g., electronic nicotine delivery systems, e-cigarettes) has been increasing rapidly, particularly among teens and young adults. With limited information on the long-term effects of vaping products, health information about vaping has been somewhat unclear in regards to associated health risks. Teens and young adults may be reluctant to disclose their use of vaping products to parents or health providers and instead turn to social media to share and seek out information regarding vaping risks and cessation supports. Thus, our current proposal outlines the use of social media to identify teens and young adults socially networking about vaping, the use of an online chatbot screen to evaluate individual cessation support needs, and the use of a digital intervention system to support vaping cessation. The mobile intervention used in this study is based on a widely-used evidence-based mobile intervention for combustible smoking (i.e., quitSTART) and has been adapted for vaping and young adults to include an in-app chatbot to guide users to tailored content and to motivate and encourage their cessation efforts. We aim to integrate our social media recruitment and online screening approach to connect individuals with this mobile app intervention, and will conduct a randomized controlled trial to evaluate user engagement with and preliminary efficacy of the digital intervention on reducing vaping behaviors among teens and young adults.
- Conditions
- Nicotine Vaping, Nicotine Use Disorder
- Being tested
- quitSTART Mobile Application, Chatbot Feature in quitSTART Mobile Application
- Keywords
- vaping, mobile app intervention, youth, young adults, chatbot, nicotine, social media
- Medical subject headings
- Vaping, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quitSTART Mobile ApplicationDevice
Mobile application with educational content, motivational messages, self-monitoring, and tips for managing cravings to support vaping cessation among young adults.
Chatbot Feature in quitSTART Mobile ApplicationBehavioural
In-App chatbot feature emedded into quitSTART mobile application to motivate vaping cessation and support app navigation.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Nationwide resource referral and intervention waitlist |
| Experimental Group A: Mobile App Intervention | Experimental | quitSTART Mobile Application Adapted for Vaping Cessation Among Young Adults Receives: Device: quitSTART Mobile Application |
| Experimental Group B: Mobile App Intervention with Embedded Chatbot Feature | Experimental | quitSTART Mobile Application Adapted for Vaping Cessation Among Young Adults Including Embedded Chatbot Feature Receives: Device: quitSTART Mobile Application; Behavioral: Chatbot Feature in quitSTART Mobile Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaping cessation
Vaping cessation as assessed by 7 day self-reported vaping abstinence at follow-up. Timeline follow back procedures will be used to establish abstinence or if participants lapsed (their first instance of vaping post quit) or relapsed (vaped on 7 consecutive days) at each follow up time point.
Measured: Baseline, 6 weeks, 3 months
Secondary outcomes (3)
Nicotine dependence
Nicotine dependence will be assessed using the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS).
Measured: Baseline, 6 weeks, 3 months
Risk perception related to vaping
Perceived risks of vaping, both general and conditional, will be assessed with two items adapted from Wackowski et al., 2020. "How harmful, if at all, do you think vaping/using an e-cigarette is to a user's health?" (general) and "Imagine you vaped/used e-cigarettes daily for the next 10 years and used no other tobacco product. How harmful do you think this vaping would be to your health?" (conditional), both using a five-point response scale (not at all-extremely harmful).
Measured: Baseline, 6 weeks, 3 months
Intervention engagement
Data automatically captured within the chatbot, and app platform will be used to calculate a composite measure of engagement for those randomized to each of these intervention components and will be examined as a predictor of outcomes. We will use a modified version of an app Engagement Index (EI).
Measured: Baseline, 6 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start4 Jun 2025
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Why it stopped: Due to low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine VapingStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston, University of South Carolina, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994209
- Sponsor's protocol ID
- 1R34DA054725-01A1
- Other IDs
- R34DA054725
- Status last verified
- Oct 2026
- First submitted
- 8 Aug 2023
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Feasibility and Acceptability of Social Media and Digital Therapeutics to Decrease Vaping Behaviors
- ClinicalTrials.gov ID
- NCT05994209
- Acronym / sponsor ID
- 1R34DA054725-01A1
- Conditions
- Nicotine Vaping, Nicotine Use Disorder
- Keywords
- vaping, mobile app intervention, youth, young adults, chatbot, nicotine, social media
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to low recruitment
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston, University of South Carolina, National Institute on Drug Abuse (NIDA)
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Use of vaping products (e.g., electronic nicotine delivery systems, e-cigarettes) has been increasing rapidly, particularly among teens and young adults. With limited information on the long-term effects of vaping products, health information about vaping has been somewhat unclear in regards to associated health risks. Teens and young adults may be reluctant to disclose their use of vaping products to parents or health providers and instead turn to social media to share and seek out information regarding vaping risks and cessation supports. Thus, our current proposal outlines the use of social media to identify teens and young adults socially networking about vaping, the use of an online chatbot screen to evaluate individual cessation support needs, and the use of a digital intervention system to support vaping cessation. The mobile intervention used in this study is based on a widely-used evidence-based mobile intervention for combustible smoking (i.e., quitSTART) and has been adapted for vaping and young adults to include an in-app chatbot to guide users to tailored content and to motivate and encourage their cessation efforts. We aim to integrate our social media recruitment and online screening approach to connect individuals with this mobile app intervention, and will conduct a randomized controlled trial to evaluate user engagement with and preliminary efficacy of the digital intervention on reducing vaping behaviors among teens and young adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Nationwide resource referral and intervention waitlist |
| Experimental Group A: Mobile App Intervention | Experimental | Device: quitSTART Mobile ApplicationquitSTART Mobile Application Adapted for Vaping Cessation Among Young Adults |
| Experimental Group B: Mobile App Intervention with Embedded Chatbot Feature | Experimental | Device: quitSTART Mobile Application, Behavioral: Chatbot Feature in quitSTART Mobile ApplicationquitSTART Mobile Application Adapted for Vaping Cessation Among Young Adults Including Embedded Chatbot Feature |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- US Resident
- English Speaking
- Have daily access to a smartphone
- Current vaping product user (P30D)
- Identified as socially networking about a desire to quit vaping and/or experiencing negative health outcomes due to vaping
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| quitSTART Mobile ApplicationMobile application with educational content, motivational messages, self-monitoring, and tips for managing cravings to support vaping cessation among young adults. | Device | Experimental Group A: Mobile App Intervention, Experimental Group B: Mobile App Intervention with Embedded Chatbot Feature |
| Chatbot Feature in quitSTART Mobile ApplicationIn-App chatbot feature emedded into quitSTART mobile application to motivate vaping cessation and support app navigation. | Behavioural | Experimental Group B: Mobile App Intervention with Embedded Chatbot Feature |
Primary outcome
Vaping cessation
Time frame: Baseline, 6 weeks, 3 months
Vaping cessation as assessed by 7 day self-reported vaping abstinence at follow-up. Timeline follow back procedures will be used to establish abstinence or if participants lapsed (their first instance of vaping post quit) or relapsed (vaped on 7 consecutive days) at each follow up time point.
3 secondary outcomes
Nicotine dependence
Time frame: Baseline, 6 weeks, 3 months
Risk perception related to vaping
Time frame: Baseline, 6 weeks, 3 months
Intervention engagement
Time frame: Baseline, 6 weeks, 3 months
Results and safety
The study was stopped early (reason given: Due to low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing quitSTART Mobile Application and Chatbot Feature in quitSTART Mobile Application in people with Nicotine Vaping and Nicotine Use Disorder, run by Washington University School of Medicine 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 6 inclusion and 0 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: stopped early, as of the sponsor's last update on 26 Oct 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to low recruitment). Results are not available in the source record.
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?
Vaping cessation (time frame: Baseline, 6 weeks, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2026.