Vaper to Vaper: A Multimodal Mobile Peer Driven Intervention to Support Adolescents in Quitting Vaping

NCT ID: NCT05140915

Last Updated: 2025-09-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-19

Study Completion Date

2024-08-30

Brief Summary

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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

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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

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E-cigarette Use Vaping

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

Peer Messaging

Intervention Type BEHAVIORAL

Peer messages, written by current and former adolescent e-cigarette users and tailored by age and readiness-to-quit.

Peer Coaching via Text

Intervention Type BEHAVIORAL

Peer coaching, facilitated by texting

Gamification

Intervention Type BEHAVIORAL

Gamification, designed to motivate participation

Control

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.

Group Type ACTIVE_COMPARATOR

E-Cigarette Cessation Materials

Intervention Type OTHER

E-cigarette cessation materials by the Research Coordinator at the time of study enrollment.

Interventions

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Peer Messaging

Peer messages, written by current and former adolescent e-cigarette users and tailored by age and readiness-to-quit.

Intervention Type BEHAVIORAL

Peer Coaching via Text

Peer coaching, facilitated by texting

Intervention Type BEHAVIORAL

Gamification

Gamification, designed to motivate participation

Intervention Type BEHAVIORAL

E-Cigarette Cessation Materials

E-cigarette cessation materials by the Research Coordinator at the time of study enrollment.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

13 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role lead

Responsible Party

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Rajani Sadasivam

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rajani Sadasivam, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts Chan Medical School

Lori Pbert, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts Chan Medical School

Locations

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UMass Chan Medical School

Worcester, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38886719 (View on PubMed)

Pbert 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.

Reference Type DERIVED
PMID: 38562810 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R34DA050992

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H00021082

Identifier Type: -

Identifier Source: org_study_id

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