NCT05140915

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 2, 2021

Completed
1 year until next milestone

Study Start

First participant enrolled

December 19, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
8 months until next milestone

Results Posted

Study results publicly available

April 23, 2025

Completed
Last Updated

September 4, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

November 18, 2021

Results QC Date

December 6, 2024

Last Update Submit

September 2, 2025

Conditions

Keywords

VapingAdolescents

Outcome Measures

Primary Outcomes (1)

  • Participant Recruitment and Retention

    Investigators will assess the number of those screened, eligible, and consented who remain active in the program at 3 months.

    3 months

Secondary Outcomes (8)

  • Acceptability of and Satisfaction With the Intervention

    3 months

  • Number of Participants With Abstinence From Vaping as Measured by Saliva Samples [Cotinine-validated 7-day Point Prevalence]

    3 months

  • Number of Peer Coaching Interactions

    3 months

  • Number of Peer Videos Viewed

    3 months

  • Number of Games Engaged In

    3 months

  • +3 more secondary outcomes

Study Arms (2)

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.

Behavioral: Peer MessagingBehavioral: Peer Coaching via TextBehavioral: 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.

Other: E-Cigarette Cessation Materials

Interventions

Peer MessagingBEHAVIORAL

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

Intervention

Peer coaching, facilitated by texting

Intervention
GamificationBEHAVIORAL

Gamification, designed to motivate participation

Intervention

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

Control

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMass Chan Medical School

Worcester, Massachusetts, 01605, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

SmokingBehavior

Results Point of Contact

Title
Dr. Rajani Sadasivam
Organization
University of Massachusetts Chan Medical School

Study Officials

  • Rajani Sadasivam, PhD

    University of Massachusetts Chan Medical School

    PRINCIPAL INVESTIGATOR
  • Lori Pbert, PhD

    University of Massachusetts Chan Medical School

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 18, 2021

First Posted

December 2, 2021

Study Start

December 19, 2022

Primary Completion

June 9, 2023

Study Completion

August 30, 2024

Last Updated

September 4, 2025

Results First Posted

April 23, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

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.

Locations