Adolescent Inpatient Tobacco and ENDS Intervention

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05936099
• Other study ID #: STUDY00002116
• Secondary ID: 5K23DA055736-02
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: July 10, 2025

Study information

• Verified date: January 2024
• Source: Children's Mercy Hospital Kansas City
• Contact: Abbey Masonbrink, MD, MPH
• Phone: 816-802-3236
• Email: armasonbrink[@]cmh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: July 10, 2025
• Est. primary completion date: July 10, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 21 Years

Eligibility

Inclusion Criteria:

• Admitted to the hospital

• Screens positive for past 30 day e-cigarette use

• Parent/guardian agrees to leave the room

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Smoking
• Vaping

Intervention

Behavioral:
• E-cigarette & Tobacco Use Treatment Intervention
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.

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City	National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported 30-day abstinence	Cessation verified with biochemical verification of a saliva sample	3 month follow up
Secondary	Acceptability of intervention in pediatric inpatient hospital setting	Ratings from participants, participants' parent, and providers on perceived acceptability (i.e., satisfaction) of the intervention	End of study (enrollment completion)
Secondary	Feasibility of intervention	Ratings from participants, participants' parent, and providers on perceived feasibility (i.e., utility or practicability) of the intervention	End of study (enrollment completion)
Secondary	Fidelity of intervention delivered by a health educator	Extent of fidelity achieved in intervention delivery	End of study (enrollment completion)