VapingNCT05936099

Adolescent Inpatient Tobacco and ENDS Intervention

A study testing E-cigarette & Tobacco Use Treatment Intervention in people with Vaping and Smoking, run by Children's Mercy Hospital Kansas City at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to develop and evaluate an evidence-based intervention to assist adolescents and young adults with current vaping to quit vaping and smoking. Read more about this study

Who is it for?: Ages 14 to 21 yearsHealthy volunteers can take part
Conditions the study is for: Vaping, Smoking
What is being tested?: E-cigarette & Tobacco Use Treatment Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 144 participants
Where: 1 siteUnited States
Study dates: 1 Aug 2023to 20 Dec 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 14 to 21 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Admitted to the hospital
Screens positive for past 30 day e-cigarette use
Parent/guardian agrees to leave the room

Who cannot join

Age is less than 14 years or over 21 years
Not comfortable speaking/reading English
Too ill to participate
Severe psychiatric illness
Too developmentally delayed/cognitively impaired

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Mercy Hospital
Kansas City, Missouri, 64108

Other trials in United States

About this study

Official title: Development and Implementation of a Tobacco and ENDS Use Intervention for Adolescents and Young Adults in the Pediatric Hospital

The purpose of this study is to develop and evaluate an evidence-based intervention to assist adolescents and young adults with current vaping to quit vaping and smoking.

Read the detailed description

Use of electronic nicotine delivery system (ENDS), which are noncombustible tobacco products (e.g., e-cigarettes), has increased dramatically among youth and is associated with numerous adverse health outcomes as well as use of alcohol and other illicit substances. National guidelines recommend counseling to address tobacco use at every adolescent clinical visit; however, many at-risk adolescents do not routinely attend primary care. Although evidence supports treatment of tobacco use during an adult hospitalization, no interventions have been developed or tested in the pediatric hospital setting. Based on promising theoretically-based evidence from the primary care and hospital settings, we will design, iteratively refine and assess implementation of a novel tobacco and ENDS use intervention for hospitalized adolescents and young adults (AYAs). We do so by conducting a randomized controlled pilot study (n=144) with 3-month follow up to evaluate preliminary efficacy as well as implementation outcomes (i.e., acceptability, feasibility, fidelity).

Conditions: Vaping, Smoking
Being tested: E-cigarette & Tobacco Use Treatment Intervention
Keywords: Vaping, Adolescents, Cessation
Medical subject headings: Vaping, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

E-cigarette & Tobacco Use Treatment InterventionBehavioural
The behavioral intervention includes health education on vaping health risk and outcomes, motivational interviewing, and assisted quit planning from a health educator and counseling and nicotine replacement therapy (if appropriate) provided by a physician.

Study groups in NCT05936099
Study group	Role	What they receive
Control	No intervention	Participants will complete the baseline survey and receive an informational brochure
Intervention	Experimental	Participants will complete the baseline survey, receive a behavioral health intervention supported by computerized decision support, and take an exit survey Receives: Behavioral: E-cigarette & Tobacco Use Treatment Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Self-reported 30-day Abstinence
Self reported cessation, assessed at 3 month follow up survey.
Measured: 3 month follow-up
Biochemically Verification of Past 30 Day Cessation
For participants who self-reported past 30 day cessation, an option was provided to biochemically verify cessation with a mailed saliva sample.
Measured: 3 month follow-up

Secondary outcomes (6)

Acceptability of Intervention - Satisfaction and Likeliness to Recommend Program
Ratings from participants on perceived acceptability (i.e., satisfaction and usefulness) of the intervention
Measured: Study completion (approximately 12 weeks)
Acceptability of Intervention - Utility of Intervention
Acceptability of the intervention assessed by intervention element completion rates (i.e. overall uptake of support resources).
Measured: Study completion (approximately 12 weeks)
Feasibility of Intervention - Duration of Intervention
Assessment of the feasibility of the intervention based on information about delivery gathered from the computerized decision making system (CDS) such as the duration of the intervention.
Measured: Study completion (approximately 12 weeks)
Feasibility of Intervention - Intervention Interruptions
Assessment of the feasibility of the intervention based on information about delivery gathered from the computerized decision making system (CDS) such as the number of interruptions (by clinical staff, parents, or others) that occurred during intervention delivery.
Measured: Study completion (approximately 12 weeks)
Feasibility of Intervention - Health Educator Survey
Feasibility of the intervention as assessed by the health educator who delivered the intervention.
Measured: Study completion (approximately 12 weeks)
Fidelity of Intervention Delivered by a Health Educator
Extent of fidelity achieved in intervention delivery by a health educator. The mean score was calculated from 0 (never/very poor) to 5 (always/very good) for each of the 10 fidelity rating questions, which were summed, with a maximum possible score of 50. The scale utilized was an adapted version of the Motivational Interviewing Treatment Integrity tool (MITI).
Measured: Study completion (approximately 12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202320 Dec 2025

First posted7 Jul 2023
Study start1 Aug 2023
Primary completion20 Dec 2024
Study completion20 Dec 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 (2)Papers the sponsor has linked to this study.
Other trials for VapingStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 144 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05936099
Sponsor's protocol ID: STUDY00002116
Other IDs: K23DA055736
Status last verified: Jan 2026
First submitted: 30 Jun 2023
Last updated: 9 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Masonbrink AR, Wooten S, Yeh HW, Stancil S, Miller MK, Wilson K, Simon TD, Leventhal A, Catley D. Pilot randomised controlled trial of an e-cigarette and tobacco use intervention for hospitalised youth. Tob Control. 2026 Jul 31:tc-2025-060006. doi: 10.1136/tc-2025-060006. Online ahead of print.
PubMed 42538285
Wooten S, Catley D, Miller MK, Wilson K, Richter KP, Masonbrink A. Treatment of e-cigarette use among hospitalised adolescents and young adults: a protocol for intervention development and evaluation of preliminary efficacy and implementation outcomes in a randomised controlled trial. BMJ Open. 2025 Jan 8;15(1):e094323. doi: 10.1136/bmjopen-2024-094323.
PubMed 39779271

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development and Implementation of a Tobacco and ENDS Use Intervention for Adolescents and Young Adults in the Pediatric Hospital
ClinicalTrials.gov ID: NCT05936099
Acronym / sponsor ID: STUDY00002116
Conditions: Vaping, Smoking
Keywords: Vaping, Adolescents, Cessation
Study type: Interventional
Recruitment status: Completed
Enrolment: 144 participants (actual)
Lead sponsor: Children's Mercy Hospital Kansas CityUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
Study start: 1 Aug 2023 (actual)
Primary completion: 20 Dec 2024 (actual)
Study completion: 20 Dec 2025 (actual)
First posted: 7 Jul 2023 (actual)
Results: Posted 9 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to develop and evaluate an evidence-based intervention to assist adolescents and young adults with current vaping to quit vaping and smoking.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Control	No intervention	–Participants will complete the baseline survey and receive an informational brochure
Intervention	Experimental	Behavioral: E-cigarette & Tobacco Use Treatment InterventionParticipants will complete the baseline survey, receive a behavioral health intervention supported by computerized decision support, and take an exit survey

Who may qualify

Ages: 14 to 21 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Admitted to the hospital
Screens positive for past 30 day e-cigarette use
Parent/guardian agrees to leave the room

Key exclusion criteria (5 listed)

Age is less than 14 years or over 21 years
Not comfortable speaking/reading English
Too ill to participate
Severe psychiatric illness
Too developmentally delayed/cognitively impaired

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
E-cigarette & Tobacco Use Treatment InterventionThe behavioral intervention includes health education on vaping health risk and outcomes, motivational interviewing, and assisted quit planning from a health educator and counseling and nicotine replacement therapy (if appropriate) provided by a physician.	Behavioural	Intervention

Primary outcome

Self-reported 30-day Abstinence
Time frame: 3 month follow-up
Self reported cessation, assessed at 3 month follow up survey.
Biochemically Verification of Past 30 Day Cessation
Time frame: 3 month follow-up
For participants who self-reported past 30 day cessation, an option was provided to biochemically verify cessation with a mailed saliva sample.

6 secondary outcomes

Acceptability of Intervention - Satisfaction and Likeliness to Recommend Program
Time frame: Study completion (approximately 12 weeks)
Acceptability of Intervention - Utility of Intervention
Time frame: Study completion (approximately 12 weeks)
Feasibility of Intervention - Duration of Intervention
Time frame: Study completion (approximately 12 weeks)
Feasibility of Intervention - Intervention Interruptions
Time frame: Study completion (approximately 12 weeks)
Feasibility of Intervention - Health Educator Survey
Time frame: Study completion (approximately 12 weeks)
Fidelity of Intervention Delivered by a Health Educator
Time frame: Study completion (approximately 12 weeks)

Results and safety

Results posted to the registry on 9 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	48	38
Intervention	96	58

Primary outcome: Self-reported 30-day Abstinence

Time frame: 3 month follow-up. Count of participants. Unit: Participants

Measure	Control n = 38	Intervention n = 58
Value	16	25

Control vs Intervention: p = 0.91, Fisher Exact
Intervention: Odds Ratio (OR): 0.77 (95% CI 0.27 to 2.19)

Primary outcome: Biochemically Verification of Past 30 Day Cessation

Time frame: 3 month follow-up. Count of participants. Unit: Participants

Measure	Intervention n = 58	Control n = 38
Agreed to do biochemical verification & successfully completed test	1	2
Agreed to do biochemical verification & did not complete test	5	2
Declined offer to complete biochemical verification test	16	10
Ineligible for to complete biochemical verification test due to tobacco use or NRT use	36	24

Population analysed: Only those who indicated they had not used tobacco in any form (traditional cigarettes or electronic cigarettes) and had not taken nicotine replacement therapy (NRT) in the past 30 days were given the option to complete the biochemical verification.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment to the end of 3 month follow up. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 48 (0%)	0 of 48 (0%)	0 of 48
Intervention	0 of 96 (0%)	0 of 96 (0%)	0 of 96

Limitations and caveats (from the sponsor): We enrolled e-cigarette users at any stage of motivation to quit, which may have impacted intervention efficacy. Due to practical limitations participants and the research team were not blinded to study conditions which may have led to bias in the assessment of outcome. We relied on self-report which is susceptible to social desirability bias and had very low biochemical verification completion rates to confirm our primary outcome. As a single site study there is limited generalizability.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42538285Masonbrink AR, Wooten S, Yeh HW, Stancil S, Miller MK, Wilson K, Simon TD, Leventhal A, Catley D. Pilot randomised controlled trial of an e-cigarette and tobacco use intervention for hospitalised youth. Tob Control. 2026 Jul 31:tc-2025-060006. doi: 10.1136/tc-2025-060006. Online ahead of print.
Derived from this study: PubMed 39779271Wooten S, Catley D, Miller MK, Wilson K, Richter KP, Masonbrink A. Treatment of e-cigarette use among hospitalised adolescents and young adults: a protocol for intervention development and evaluation of preliminary efficacy and implementation outcomes in a randomised controlled trial. BMJ Open. 2025 Jan 8;15(1):e094323. doi: 10.1136/bmjopen-2024-094323.
Individual participant dataSharing planned: No

Related trials for Vaping

Not yet recruitingPhase 1
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Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
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Recruiting
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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.

Abbey Masonbrink, MD, MPH principal investigator

Children's Hospital Los Angeles

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing E-cigarette & Tobacco Use Treatment Intervention in people with Vaping and Smoking, run by Children's Mercy Hospital Kansas City 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 3 inclusion and 5 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 9 Feb 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 9 Feb 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?

Self-reported 30-day Abstinence (time frame: 3 month follow-up). 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 NCT05936099, 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 9 Feb 2026.