NCT05586308

Brief Summary

This study aims to evaluate the feasibility and compare the preliminary effect of vaping cessation program consisting of media literacy education and real-time text messaging support and leverage insights from behavioral economics to enhance social and financial incentives to improve program engagement, and eventually abstinence. Our hypotheses are that 1) the Combined arm is associated with improved vaping abstinence to the Media literacy and Financial incentive arms; and 2) the financial incentive-related arms (either Combined or Financial incentive) enhance engagement compared to the non-incentive related arms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 19, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 7, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
7 months until next milestone

Results Posted

Study results publicly available

January 29, 2026

Completed
Last Updated

January 29, 2026

Status Verified

January 1, 2025

Enrollment Period

11 months

First QC Date

October 14, 2022

Results QC Date

December 9, 2025

Last Update Submit

January 23, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Engagement_remote checkin_3

    Engagement will be assessed by proportions of participants who submitted the remote saliva cotinine sample at remote checkin 3.

    3 months

  • Retention

    The number of participants who completed the end-of-study assessment (Week 12).

    3 months

Secondary Outcomes (2)

  • Biochemically Verified Vaping Abstinence

    3 months

  • Self-reported Vaping Abstinence

    3 months

Study Arms (4)

Active control

OTHER

Participants in this arm will receive an evidence-based text-messaging support.

Behavioral: Text-massaging suport

Media literacy

ACTIVE COMPARATOR

Participants will receive media literacy e-learning lessons and an evidence-based text-messaging support.

Behavioral: Text-massaging suportBehavioral: Media literacy

Financial incentive

ACTIVE COMPARATOR

Participants will receive financial incentive intervention and an evidence-based text-messaging support.

Behavioral: Text-massaging suportBehavioral: Financial incentive

Combined

EXPERIMENTAL

Participants will receive media literacy e-learning lessons, financial incentive, and an evidence-based text-messaging support program.

Behavioral: Text-massaging suportBehavioral: Financial incentiveBehavioral: Media literacy

Interventions

Text-messaging quitting support program (i.e., This is Quitting) is an evidence-based, free mobile program from Truth Initiative designed to help young people quit vaping. The program is fully automated and interactive. To establish or reinforce perceived social norms and social support around quitting, a majority of messages come from other users who have submitted them to the program.

Active controlCombinedFinancial incentiveMedia literacy

1. Participants will earn $3 for each saliva cotinine sample submission regardless of positive or negative results after the quit day (an assessments at Week 6, Week 8, Week 10, and Week 12, during the abstinence phase) 2. Participants will earn additional escalating rewards for each negative sample- $7 for Week 6, $12 for Week 8, $17 for Week 10, and $22 for Week 12 (2 months after the target quit date). The bonus starts at $7 and increase by $5 for each subsequent negative cotinine sample (i.e., $7, $12, $17, and $22). 3. A reset contingency will be used. That is the reward amount will be returned back to original $7 if there is a missing or positive saliva cotinine sample

CombinedFinancial incentive
Media literacyBEHAVIORAL

Media literacy e-learning lessons cover topics regarding what e-cigarettes are and how they work, how nicotine and nicotine addiction affects the brain and behavior, how to prepare to quit vaping, developing a quit plan and how to deal with cravings and relapse. The program focuses on changing knowledge, attitudes and beliefs related to e-cigarette use, as well as emphasizing vaping related media literacy.

CombinedMedia literacy

Eligibility Criteria

Age19 Years - 29 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 19-29
  • Report vaping in the previous 30 days
  • Have access to internet/video chat/SMS text message
  • Are interested in quitting vaping in the next 30 days

You may not qualify if:

  • Self-report as currently pregnant or planning to become pregnant in the next 3 months
  • Already involved in vaping cession programs (either behavioral or medical intervention)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (1)

  • Michaud T, Puga T, Archer R, Theye E, Zagurski C, Estabrooks P, Dai HD. Enhancing Text Message Support With Media Literacy and Financial Incentives for Vaping Cessation in Young Adults: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2025 Feb 21;14:e60527. doi: 10.2196/60527.

MeSH Terms

Conditions

Health Risk BehaviorsVapingSmoking CessationPatient Participation

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSmokingPatient Acceptance of Health CareTreatment Adherence and Compliance

Results Point of Contact

Title
Tzeyu Michaud
Organization
University of Nebraska Medical Center

Study Officials

  • Tzeyu Michaud, PhD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study employs a pilot, 4-arm randomized clinical trial design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2022

First Posted

October 19, 2022

Study Start

December 7, 2023

Primary Completion

November 1, 2024

Study Completion

June 30, 2025

Last Updated

January 29, 2026

Results First Posted

January 29, 2026

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Data obtained through this study may be provided to qualified researchers with academic interest in vaping cessation program targeting youth/young adults. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a data transfer/use agreement) are prerequisites to the sharing of data with the requesting party.

Shared Documents
SAP, ICF, CSR
Time Frame
Data requests can be submitted starting 12 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
Access Criteria
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing/USE Agreement.

Locations