Behavior, Health RiskNCT05586308
Incentive-based and Media Literacy Informed Approaches to Improve Vaping Cessation
A study testing Text-massaging suport, Financial incentive and Media literacy in people with Behavior, Health Risk and Implementation Science, run by University of Nebraska at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 29 years
- Conditions the study is for
- Behavior, Health Risk, Implementation Science, E Cigarette Use
- What is being tested?
- Text-massaging suport, Financial incentive and Media literacy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2023to 30 Jun 2025
- 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 19 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Must meet all the inclusion criteria
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Unversity of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Pilot Study of Incentive-based and Media Literacy-informed Approaches to Improve Vaping Cessation Among Young Adults
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.
Read the detailed description
The objective of this pilot study is to evaluate the feasibility and compare the potential effect of different vaping cessation intervention components in addition to evidence-based text-messaging support, including 1) media literacy interactive e-learning lessons, 2) financial incentives, and 3) combined (media literacy + financial incentive) on vaping abstinence among current young adult vapers over a three-month timeframe with the following specific aims: Aim 1. To assess the feasibility of a multi-component vaping cessation program; and Aim 2 To evaluate the preliminary effect of a multicomponent vaping cessation program. Eligible participants are young adults aged 19-29 and are current vapers (i.e., has vaped in the previous 30 days).We will employ a 4-arm, feasibility randomized trial design to determine the preliminary effect of different vaping intervention components on vaping abstinence over a 3-month timeframe, consisting of a 1-month quitting preparation phase and 2-month abstinence phase. Eligible participants (n=80) will be randomized (in a 1:1:1:1 ratio), using a computer-generated algorithm, to to one of four vaping cessation interventions: 1) Active control: text-messaging support, 2) Media literacy: media literacy + text-messaging support, 3) Financial incentive: financial incentive + text-messaging support, and 4) Combined: media literacy e-learning lessons + financial incentive + text-messaging support, at the baseline visit. Regardless of intervention arms, all enrolled participants will receive receive an evidence-base text-messaging support program for quitting vaping (This is Quitting). Participants will be followed through a 3-month study period including a 1-month quitting preparation phase and a 2-month abstinence phase. All participants will be asked to provide the 5 saliva cotinine samples- at baseline and end-of-study visits and 3 at video calls (remote submissions). Participants who assigned to the financial incentive Combined groups will be provided monetary rewards for submitting saliva cotinine samples during the abstinence period. To examine the feasibility of biomarker testing for toxic exposures, for a subsample of 20 participants, a panel of biomarkers of toxic exposures will be measured at baseline and at the end of study.
- Conditions
- Behavior, Health Risk, Implementation Science, E Cigarette Use, Cessation, Smoking, Incentives, Engagement, Patient
- Being tested
- Text-massaging suport, Financial incentive, Media literacy
- Medical subject headings
- Health Risk Behaviors, Vaping, Smoking Cessation, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text-massaging suportBehavioural
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.
Financial incentiveBehavioural
- 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)
- 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).
- 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
Media literacyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Active control | Other | Participants in this arm will receive an evidence-based text-messaging support. Receives: Behavioral: Text-massaging suport |
| Media literacy | Active comparator | Participants will receive media literacy e-learning lessons and an evidence-based text-messaging support. Receives: Behavioral: Text-massaging suport; Behavioral: Media literacy |
| Financial incentive | Active comparator | Participants will receive financial incentive intervention and an evidence-based text-messaging support. Receives: Behavioral: Text-massaging suport; Behavioral: Financial incentive |
| Combined | Experimental | Participants will receive media literacy e-learning lessons, financial incentive, and an evidence-based text-messaging support program. Receives: Behavioral: Text-massaging suport; Behavioral: Financial incentive; Behavioral: Media literacy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement_remote checkin_3
Engagement will be assessed by proportions of participants who submitted the remote saliva cotinine sample at remote checkin 3.
Measured: 3 months
Retention
The number of participants who completed the end-of-study assessment (Week 12).
Measured: 3 months
Secondary outcomes (2)
Biochemically Verified Vaping Abstinence
Biochemically verified vaping abstinence (negative results- < 30 ng/mL) will be measured by saliva cotinine samples at end of study (Week 12).
Measured: 3 months
Self-reported Vaping Abstinence
Self-reported vaping abstinence will be assessed by the question "In the past 30 days, did you vape at all, even a puff of someone else?" at the end-of-study visit.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start7 Dec 2023
- Primary completion1 Nov 2024
- Study completion30 Jun 2025
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 (1)Papers the sponsor has linked to this study.
- Other trials for Behavior, Health RiskStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study employs a pilot, 4-arm randomized clinical trial design.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Tzeyu Michaud, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586308
- Sponsor's protocol ID
- 0596-22-EP
- Other IDs
- U54GM115458
- Status last verified
- Jan 2025
- First submitted
- 14 Oct 2022
- Last updated
- 29 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39983103
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Incentive-based and Media Literacy-informed Approaches to Improve Vaping Cessation Among Young Adults
- ClinicalTrials.gov ID
- NCT05586308
- Acronym / sponsor ID
- 0596-22-EP
- Conditions
- Behavior, Health Risk, Implementation Science, E Cigarette Use, Cessation, Smoking, Incentives, Engagement, Patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 19 Oct 2022 (actual)
- Results
- Posted 29 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of this pilot study is to evaluate the feasibility and compare the potential effect of different vaping cessation intervention components in addition to evidence-based text-messaging support, including 1) media literacy interactive e-learning lessons, 2) financial incentives, and 3) combined (media literacy + financial incentive) on vaping abstinence among current young adult vapers over a three-month timeframe with the following specific aims: Aim 1. To assess the feasibility of a multi-component vaping cessation program; and Aim 2 To evaluate the preliminary effect of a multicomponent vaping cessation program. Eligible participants are young adults aged 19-29 and are current vapers (i.e., has vaped in the previous 30 days).We will employ a 4-arm, feasibility randomized trial design to determine the preliminary effect of different vaping intervention components on vaping abstinence over a 3-month timeframe, consisting of a 1-month quitting preparation phase and 2-month abstinence phase. Eligible participants (n=80) will be randomized (in a 1:1:1:1 ratio), using a computer-generated algorithm, to to one of four vaping cessation interventions: 1) Active control: text-messaging support, 2) Media literacy: media literacy + text-messaging support, 3) Financial incentive: financial incentive + text-messaging support, and 4) Combined: media literacy e-learning lessons + financial incentive + text-messaging support, at the baseline visit. Regardless of intervention arms, all enrolled participants will receive receive an evidence-base text-messaging support program for quitting vaping (This is Quitting). Participants will be followed through a 3-month study period including a 1-month quitting preparation phase and a 2-month abstinence phase. All participants will be asked to provide the 5 saliva cotinine samples- at baseline and end-of-study visits and 3 at video calls (remote submissions). Participants who assigned to the financial incentive Combined groups will be provided monetary rewards for submitting saliva cotinine samples during the abstinence period. To examine the feasibility of biomarker testing for toxic exposures, for a subsample of 20 participants, a panel of biomarkers of toxic exposures will be measured at baseline and at the end of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This study employs a pilot, 4-arm randomized clinical trial design.
| Arm | Type | Receives |
|---|---|---|
| Active control | Other | Behavioral: Text-massaging suportParticipants in this arm will receive an evidence-based text-messaging support. |
| Media literacy | Active comparator | Behavioral: Text-massaging suport, Behavioral: Media literacyParticipants will receive media literacy e-learning lessons and an evidence-based text-messaging support. |
| Financial incentive | Active comparator | Behavioral: Text-massaging suport, Behavioral: Financial incentiveParticipants will receive financial incentive intervention and an evidence-based text-messaging support. |
| Combined | Experimental | Behavioral: Text-massaging suport, Behavioral: Financial incentive, Behavioral: Media literacyParticipants will receive media literacy e-learning lessons, financial incentive, and an evidence-based text-messaging support program. |
Who may qualify
- Ages
- 19 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Must meet all the inclusion criteria
- 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)
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 |
|---|---|---|
| Text-massaging suportText-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. | Behavioural | Active control, Combined, Financial incentive, Media literacy |
| Financial incentive1. 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 | Behavioural | Combined, Financial incentive |
| Media literacyMedia 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. | Behavioural | Combined, Media literacy |
Primary outcome
Engagement_remote checkin_3
Time frame: 3 months
Engagement will be assessed by proportions of participants who submitted the remote saliva cotinine sample at remote checkin 3.
Retention
Time frame: 3 months
The number of participants who completed the end-of-study assessment (Week 12).
2 secondary outcomes
Biochemically Verified Vaping Abstinence
Time frame: 3 months
Self-reported Vaping Abstinence
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39983103Michaud 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Behavior, Health Risk
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruitingObservational study
A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Cross-Sectional Bhutanese Community of Central Ohio Health Study to Understand Acculturation as Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating ...
Cardiometabolic Risk Factors, Mental Health
Recruiting
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Obesity, Smoking Cessation
Not yet recruiting
Deaf CBT-TS to Reduce Suicide Risk
Depression - Major Depressive Disorder, Anxiety
Recruiting
Communicating About Nicotine Reduction in Cigarettes
Tobacco Products, Smoking Behavior
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.
Tzeyu Michaud, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text-massaging suport, Financial incentive and Media literacy in people with Behavior, Health Risk and Implementation Science, run by University of Nebraska 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 4 inclusion and 3 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 29 Jan 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2026). 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?
Engagement_remote checkin_3 (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT05586308, which also lists 1 linked publication.
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 29 Jan 2026.