NCT06745154

Brief Summary

This clinical trial evaluates the impact of Quitting Using Executive Function Strategy Training (QUEST) on quitting smoking (cessation) in homeless young adult smokers with an acquired brain injury (ABI). Over 70% of youth and young adults experiencing homelessness (YYEH) smoke tobacco. More than half of YYEH who smoke have made at least one attempt to quit smoking but few use evidence-based methods to increase success. In addition, 9 out of 10 of these have an acquired brain injury which may have a negative impact on successful smoking cessation. QUEST may help homeless young adult smokers with an ABI quit smoking.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

June 26, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2024

Completed
Last Updated

December 20, 2024

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

December 17, 2024

Last Update Submit

December 17, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Rate of executive function difficulties

    The number of times participants experience executive function difficulties with adhering to the Quit Line protocol will be recorded via survey questionnaires.

    Up to 8 weeks

  • Factors impacting access to evidence-based treatment

    All factors reported by participants via survey questionnaires that impacted their ability to access Quit Line treatment will be recorded.

    Up to 8 weeks

  • Contact with Quitline

    The number of contacts each participant had with the Quit Line throughout the study will be recorded via survey questionnaires.

    Up to 8 weeks

  • Use of nicotine replacement therapy

    The number of times participants made use of nicotine replacement therapies throughout the length of the study will be recorded via survey questionnaires.

    Up to 8 weeks

Study Arms (1)

Prevention (QUEST)

EXPERIMENTAL

Patients receive access to the Ohio Tobacco Quitline, receive nicotine patches, gum, or lozenges for up to 8 weeks. Patients also participate in tobacco cessation counseling sessions for 5 sessions over 8 weeks. Patients additionally undergo cognitive assessment and nasal swab collection on study.

Procedure: Biospecimen CollectionProcedure: Cognitive AssessmentOther: InterviewDrug: Nicotine ReplacementBehavioral: Smoking Cessation InterventionOther: Survey AdministrationOther: Tobacco Cessation Counseling

Interventions

Undergo nasal swab collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Prevention (QUEST)

Undergo cognitive assessment

Prevention (QUEST)

Ancillary studies

Prevention (QUEST)

Given nicotine patches, gum, or lozenges

Also known as: Nicotine Replacement Therapy, NRT
Prevention (QUEST)

Receive access to the Ohio Tobacco Quit Line

Also known as: Smoking and Tobacco Use Cessation Interventions
Prevention (QUEST)

Ancillary studies

Prevention (QUEST)

Participate in counseling sessions

Prevention (QUEST)

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • Utilizing STAR House ( a drop-in center for youth and young adults experiencing homelessness) services
  • Use of combustible tobacco product in the last week
  • Willing to quit smoking in the next 30 days
  • Acquired Brain Injury (ABI) (15 youth with and 15 without)
  • CHATS will be used to determine ABI. Ask "C", "H" and "A" of the CHATS tool. If yes to C OR H and yes to A, that will be considered positive for ABI
  • Have access to a phone
  • Willing to use phone for QuitLine (QL) services
  • Willing to enroll in Ohio Tobacco Quit Line
  • Willing to share Ohio Tobacco Quit Line portal data with researchers
  • Willing to provide biospecimens (exhaled air and nasal samples)
  • Conversational English skills

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

MeSH Terms

Interventions

Specimen HandlingMental Status and Dementia TestsInterviews as TopicNicotine Replacement TherapySmoking Devices

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesNeuropsychological TestsPsychological TestsBehavioral Disciplines and ActivitiesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthDrug TherapyTherapeuticsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Julianna Nemeth, PhD

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2024

First Posted

December 20, 2024

Study Start

June 26, 2023

Primary Completion

August 30, 2023

Study Completion

August 30, 2023

Last Updated

December 20, 2024

Record last verified: 2024-12

Locations