E-cigarette UseV2VNCT05140915
Vaper to Vaper: A Multimodal Mobile Peer Driven Intervention to Support Adolescents in Quitting Vaping
A study testing Peer Messaging, Peer Coaching via Text and Gamification in people with E-cigarette Use and Vaping, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The dramatic increase in the use of e-cigarettes among U.S. adolescents has been called a national epidemic, with more adolescents now using e-cigarettes than traditional cigarettes. The high amounts of nicotine in e-cigarettes harm adolescents and put them at greater risk of becoming traditional cigarette smokers. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- E-cigarette Use, Vaping
- What is being tested?
- Peer Messaging, Peer Coaching via Text and Gamification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2022to 30 Aug 2024
- 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 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Enrolled in grade 9-12 at participating high school
- Current e-cigarette user, as defined as a response greater than "0 days" to the question: "During the past 7 days, on how many days did you use e-cigarettes?" This eligibility criterion is modeled on a question in the 2018 National Youth Tobacco Survey (NYTS), a survey of U.S. middle and high school students which used a 30-day timeframe.
- Have a smartphone.
- English- or Spanish-speaking
- Exclusion Criteria: Unable or unwilling to provide informed assent or consent (in the case of those aged 18 years or older).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Chan Medical School
Worcester, Massachusetts, 01605
About this study
The dramatic increase in the use of e-cigarettes among U.S. adolescents has been called a national epidemic, with more adolescents now using e-cigarettes than traditional cigarettes. The high amounts of nicotine in e-cigarettes harm adolescents and put them at greater risk of becoming traditional cigarette smokers. The investigators propose to develop Vaper-to-Vaper (V2V), a suite of mobile peer driven tools including peer texting and coaching based on lessons learned in the investigators' prior tobacco intervention work, to engage and help adolescents use strategies to manage cravings and successfully quit.
Read the detailed description
The FDA and the US Surgeon General call the increasing use of e-cigarettes among U.S. adolescents an epidemic, with e-cigarette use exceeding combustible cigarette use. The high amounts of nicotine in e-cigarettes harm adolescent brain development, impacting learning, memory, and attention. Adolescent e-cigarette users also are at higher risk than non-users of transitioning to traditional cigarettes. While prevention is important, evidence-based interventions to engage and help adolescent e-cigarette users quit are critically needed. Key challenges include adolescents perceiving e-cigarette use to be of low risk resulting in a low intention to quit, and the major influence of peers in e-cigarette use. Given there currently are no evidence-based cessation interventions to assist adolescent e-cigarette users in quitting, as suggested by the American Academy of Pediatrics and FDA, the investigators propose to develop Vaper-to-Vaper (V2V), a multi-modal mobile peer driven intervention, based on lessons learned in our prior tobacco intervention work. Peer-driven interventions have been found to successfully improve smoking outcomes in adolescents, and the investigators have had success in developing peer-driven interventions for low motivated adult smokers. The Investigators therefore will adapt these approaches for adolescent e-cigarette users. V2V's goal will be to engage, educate, motivate, and facilitate the adolescent in using strategies to manage cravings and successfully quit. The V2V components will include: Peer Messaging (tailored messages pushed via texting), Peer Coaching (asynchronous communications with trained coaches via texting), and Gamification (using game design to motivate participation). Adapting these tools to the unique needs of adolescent e-cigarette users will further extend these tools into novel directions. For Aim 1 the investigators will convene a peer advisory panel of 20 adolescent e-cigarette users to participate in a qualitative assessment and further development of V2V components. In Aim 2 the investigators will evaluate the feasibility of the research protocols and the feasibility and acceptability of the V2V intervention in a pilot feasibility study with eighty adolescent e-cigarette users from 4 high schools (schools randomized to either V2V intervention or control) recruited and followed for 6 months. The investigators hypothesize being able to recruit 80 adolescents (20/school, 40 per study condition) and that >85% will be retained in each study condition at 6-month follow-up (Aim 2A). For Aim 2b the investigators will monitor V2V engagement (e.g., number of V2V texting quizzes completed, peer coaching interactions, peer videos viewed) and assess acceptability of and satisfaction with the program. For Aim 2C the investigators hypothesize that the intervention will be associated with greater cotinine-validated 7-day point prevalence vaping abstinence rates, lower time to first quit attempt, and less amount of e-cigarette use compared to control at 6-month follow-up. This Stage I project, adapting an existing intervention and feasibility/pilot testing, will provide the necessary materials and information to proceed to a subsequent large-scale Stage III R01 trial to test the efficacy of the V2V intervention in supporting adolescent e-cigarette users in quitting.
- Conditions
- E-cigarette Use, Vaping
- Being tested
- Peer Messaging, Peer Coaching via Text, Gamification, E-Cigarette Cessation Materials
- Keywords
- Vaping, Adolescents
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer MessagingBehavioural
Peer messages, written by current and former adolescent e-cigarette users and tailored by age and readiness-to-quit.
Peer Coaching via TextBehavioural
Peer coaching, facilitated by texting
GamificationBehavioural
Gamification, designed to motivate participation
E-Cigarette Cessation MaterialsOther
E-cigarette cessation materials by the Research Coordinator at the time of study enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Students in schools randomized to the intervention will receive: (1) peer messages, written by current and former adolescent e-cigarette users and tailored by age and readiness-to-quit; (2) peer coaching, facilitated by texting; and (3) gamification, designed to motivate participation. Receives: Behavioral: Peer Messaging; Behavioral: Peer Coaching via Text; Behavioral: Gamification |
| Control | Active comparator | Students in schools randomized to the control condition will be provided e-cigarette cessation materials by the Research Coordinator at the time of study enrollment. Receives: Other: E-Cigarette Cessation Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Recruitment and Retention
Investigators will assess the number of those screened, eligible, and consented who remain active in the program at 3 months.
Measured: 3 months
Secondary outcomes (8)
Acceptability of and Satisfaction With the Intervention
Investigators will access the acceptability of and satisfaction with the intervention, as measured by Client Satisfaction Questionnaire (CSQ-8).The overall CSQ-8 score is calculated by summing the respondent's rating (item rating) score for each scale item. Scores therefore range from 8 to 32, with higher values indicating higher satisfaction. Similarly, investigators will look for association between summary score and cessation.
Measured: 3 months
Number of Participants With Abstinence From Vaping as Measured by Saliva Samples [Cotinine-validated 7-day Point Prevalence]
Cotinine-validated 7-day point prevalence abstinence, as measured by saliva samples collected from all; analyzed for those reporting 7-day abstinence; cut-off 11.4 ng/ml, cotinine-imputed abstinence when cotinine is missing.
Measured: 3 months
Number of Peer Coaching Interactions
Investigators will assess the system use (for V2V intervention only), as measured by the number of peer coaching interactions completed.
Measured: 3 months
Number of Peer Videos Viewed
Investigators will assess the system use (for V2V intervention only), as measured by the self-reported frequency of viewing peer videos.
Measured: 3 months
Number of Games Engaged In
Investigators will assess the system use (for V2V intervention only), as measured by the self-reported frequency of reading gamification texts.
Measured: 3 months
Change in Self-Efficacy Score
Assessment of change in self-efficacy, as measured by the Self-efficacy Questionnaire (SEQ-12). The SEQ-12 (Self-Efficacy) Score is the mean of 12 items coded 1 (Not at all confident) to 5 (Extremely Confident). The score can range from 1-5, with higher scores indicating better confidence to refrain from vaping.
Measured: Baseline and 3 months
Number of Participants With With Change in Stage of Change
Investigators will also assess the change in stage of change, as measured by Prochaska's Stages of Change model. The stages of change are: Precontemplation, Contemplation, Preparation/Determination, Action/Willpower, Maintenance, and Relapse. Participants will self-report their stage of change at 0 and 3 months.
Measured: Baseline and 3 months
Change in Severity of Nicotine Addiction
Investigators will assess the change in the severity of nicotine addiction, as measured by the Hooked on Nicotine Checklist. The Hooked on Nicotine Checklist Score is the sum of 10 items coded 0 (Not endorsed) or 1 (Endorsed). The possible range is 0-10, with higher scores indicating a higher level of addiction.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start19 Dec 2022
- Primary completion9 Jun 2023
- Study completion30 Aug 2024
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 (2)Papers the sponsor has linked to this study.
- Other trials for E-cigarette UseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Rajani Sadasivam, University of Massachusetts, Worcester
- Investigators
- Rajani Sadasivam, PhD, Principal investigator, University of Massachusetts, WorcesterLori Pbert, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140915
- Sponsor's protocol ID
- H00021082
- Other IDs
- R34DA050992
- Acronym
- V2V
- Status last verified
- Sep 2025
- First submitted
- 18 Nov 2021
- Last updated
- 4 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The final dataset will be available within 12 months of the end of the funded grant period. Due to the nature of our research, we will be collecting identifying information (i.e. names, phone numbers). We will strip the final dataset of identifiers prior to release for sharing. Even though the final dataset will be striped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of study participants with unusual characteristics. Thus, we will make the data and associated documentation available to qualified academic investigators for non-commercial research under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroying or returning the data after analyses are completed.
Publications
Pbert L, Dube CE, Nagawa CS, Simone DP, Wijesundara JG, Sadasivam RS. Vaping cessation support recommendations from adolescents who vape: a qualitative study. BMC Public Health. 2024 Jun 17;24(1):1615. doi: 10.1186/s12889-024-19036-1.
PubMed 38886719Pbert L, Dube CE, Nagawa CS, Simone DP, Wijesundara J, Sadasivam R. Vaping Cessation Support Recommendations from Adolescents Who Vape: A Qualitative Study. Res Sq [Preprint]. 2024 Mar 20:rs.3.rs-4077848. doi: 10.21203/rs.3.rs-4077848/v1.
PubMed 38562810
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaper to Vaper: A Multimodal Mobile Peer Driven Intervention to Support Adolescents in Quitting Vaping
- ClinicalTrials.gov ID
- NCT05140915
- Acronym / sponsor ID
- V2V / H00021082
- Conditions
- E-cigarette Use, Vaping
- Keywords
- Vaping, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 9 Jun 2023 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Posted 23 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The dramatic increase in the use of e-cigarettes among U.S. adolescents has been called a national epidemic, with more adolescents now using e-cigarettes than traditional cigarettes. The high amounts of nicotine in e-cigarettes harm adolescents and put them at greater risk of becoming traditional cigarette smokers. The investigators propose to develop Vaper-to-Vaper (V2V), a suite of mobile peer driven tools including peer texting and coaching based on lessons learned in the investigators' prior tobacco intervention work, to engage and help adolescents use strategies to manage cravings and successfully quit.
Detailed description
The FDA and the US Surgeon General call the increasing use of e-cigarettes among U.S. adolescents an epidemic, with e-cigarette use exceeding combustible cigarette use. The high amounts of nicotine in e-cigarettes harm adolescent brain development, impacting learning, memory, and attention. Adolescent e-cigarette users also are at higher risk than non-users of transitioning to traditional cigarettes. While prevention is important, evidence-based interventions to engage and help adolescent e-cigarette users quit are critically needed. Key challenges include adolescents perceiving e-cigarette use to be of low risk resulting in a low intention to quit, and the major influence of peers in e-cigarette use. Given there currently are no evidence-based cessation interventions to assist adolescent e-cigarette users in quitting, as suggested by the American Academy of Pediatrics and FDA, the investigators propose to develop Vaper-to-Vaper (V2V), a multi-modal mobile peer driven intervention, based on lessons learned in our prior tobacco intervention work. Peer-driven interventions have been found to successfully improve smoking outcomes in adolescents, and the investigators have had success in developing peer-driven interventions for low motivated adult smokers. The Investigators therefore will adapt these approaches for adolescent e-cigarette users. V2V's goal will be to engage, educate, motivate, and facilitate the adolescent in using strategies to manage cravings and successfully quit. The V2V components will include: Peer Messaging (tailored messages pushed via texting), Peer Coaching (asynchronous communications with trained coaches via texting), and Gamification (using game design to motivate participation). Adapting these tools to the unique needs of adolescent e-cigarette users will further extend these tools into novel directions. For Aim 1 the investigators will convene a peer advisory panel of 20 adolescent e-cigarette users to participate in a qualitative assessment and further development of V2V components. In Aim 2 the investigators will evaluate the feasibility of the research protocols and the feasibility and acceptability of the V2V intervention in a pilot feasibility study with eighty adolescent e-cigarette users from 4 high schools (schools randomized to either V2V intervention or control) recruited and followed for 6 months. The investigators hypothesize being able to recruit 80 adolescents (20/school, 40 per study condition) and that >85% will be retained in each study condition at 6-month follow-up (Aim 2A). For Aim 2b the investigators will monitor V2V engagement (e.g., number of V2V texting quizzes completed, peer coaching interactions, peer videos viewed) and assess acceptability of and satisfaction with the program. For Aim 2C the investigators hypothesize that the intervention will be associated with greater cotinine-validated 7-day point prevalence vaping abstinence rates, lower time to first quit attempt, and less amount of e-cigarette use compared to control at 6-month follow-up. This Stage I project, adapting an existing intervention and feasibility/pilot testing, will provide the necessary materials and information to proceed to a subsequent large-scale Stage III R01 trial to test the efficacy of the V2V intervention in supporting adolescent e-cigarette users in quitting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Peer Messaging, Behavioral: Peer Coaching via Text, Behavioral: GamificationStudents in schools randomized to the intervention will receive: (1) peer messages, written by current and former adolescent e-cigarette users and tailored by age and readiness-to-quit; (2) peer coaching, facilitated by texting; and (3) gamification, designed to motivate participation. |
| Control | Active comparator | Other: E-Cigarette Cessation MaterialsStudents in schools randomized to the control condition will be provided e-cigarette cessation materials by the Research Coordinator at the time of study enrollment. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Enrolled in grade 9-12 at participating high school
- Current e-cigarette user, as defined as a response greater than "0 days" to the question: "During the past 7 days, on how many days did you use e-cigarettes?" This eligibility criterion is modeled on a question in the 2018 National Youth Tobacco Survey (NYTS), a survey of U.S. middle and high school students which used a 30-day timeframe.
- Have a smartphone.
- English- or Spanish-speaking
- Exclusion Criteria: Unable or unwilling to provide informed assent or consent (in the case of those aged 18 years or older).
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 |
|---|---|---|
| Peer MessagingPeer messages, written by current and former adolescent e-cigarette users and tailored by age and readiness-to-quit. | Behavioural | Intervention |
| Peer Coaching via TextPeer coaching, facilitated by texting | Behavioural | Intervention |
| GamificationGamification, designed to motivate participation | Behavioural | Intervention |
| E-Cigarette Cessation MaterialsE-cigarette cessation materials by the Research Coordinator at the time of study enrollment. | Other | Control |
Primary outcome
Participant Recruitment and Retention
Time frame: 3 months
Investigators will assess the number of those screened, eligible, and consented who remain active in the program at 3 months.
8 secondary outcomes
Acceptability of and Satisfaction With the Intervention
Time frame: 3 months
Number of Participants With Abstinence From Vaping as Measured by Saliva Samples [Cotinine-validated 7-day Point Prevalence]
Time frame: 3 months
Number of Peer Coaching Interactions
Time frame: 3 months
Number of Peer Videos Viewed
Time frame: 3 months
Number of Games Engaged In
Time frame: 3 months
Change in Self-Efficacy Score
Time frame: Baseline and 3 months
Number of Participants With With Change in Stage of Change
Time frame: Baseline and 3 months
Change in Severity of Nicotine Addiction
Time frame: Baseline and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38886719Pbert L, Dube CE, Nagawa CS, Simone DP, Wijesundara JG, Sadasivam RS. Vaping cessation support recommendations from adolescents who vape: a qualitative study. BMC Public Health. 2024 Jun 17;24(1):1615. doi: 10.1186/s12889-024-19036-1.
- Derived from this study: PubMed 38562810Pbert L, Dube CE, Nagawa CS, Simone DP, Wijesundara J, Sadasivam R. Vaping Cessation Support Recommendations from Adolescents Who Vape: A Qualitative Study. Res Sq [Preprint]. 2024 Mar 20:rs.3.rs-4077848. doi: 10.21203/rs.3.rs-4077848/v1.
- Individual participant dataSharing planned: No. The final dataset will be available within 12 months of the end of the funded grant period. Due to the nature of our research, we will be collecting identifying information (i.e. names, phone numbers). We will strip the final dataset of identifiers prior to release for sharing. Even though the final dataset will be striped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of study participants with unusual characteristics. Thus, we will make the data and associated documentation available to qualified academic investigators for non-commercial research under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroying or returning the data after analyses are completed.
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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.
Rajani Sadasivam, PhD principal investigator
University of Massachusetts, Worcester
Lori Pbert, PhD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Messaging, Peer Coaching via Text and Gamification in people with E-cigarette Use and Vaping, run by University of Massachusetts, Worcester 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 5 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: finished, as of the sponsor's last update on 4 Sep 2025. 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 23 Apr 2025). 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?
Participant Recruitment and Retention (time frame: 3 months). 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 NCT05140915, which also lists 2 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 4 Sep 2025.