TinCat LGBTQ+ Smoking Cessation Via Asynchronous Telehealth
Primary Purpose
Tobacco Use Disorder, Tobacco Use Cessation
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TinCat
Quit.gov program
Sponsored by
About this trial
This is an interventional treatment trial for Tobacco Use Disorder
Eligibility Criteria
Inclusion Criteria:
- Age 18 and over
- Live in Greater Austin
- Identify as LGBTQ+
- Current smokers
- High speed internet access
Exclusion Criteria:
- Exceed screener cutoff for suicide risk
- Exceed screener cutoff for borderline personality disorder
- Report current active substance use other than tobacco that interferes with functioning
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Quit.gov program
TinCat
Arm Description
Generic intervention based on quit.gov sessions.
Individualized asynchronous telehealth including LGBTQ+ affirming components.
Outcomes
Primary Outcome Measures
Tobacco use
Cigarette and vape assessments based on prior research on vaping/smoking:
Cigarette: Today, did you have at least one puff on a cigarette (yes/no) IF YES, THEN How many cigarettes did you smoked (at least one puff) (1-"more than 60").
Vaping: Today, did you use an electronic nicotine delivery system (i.e., a vape containing nicotine), even just one puff? (yes/no) IF YES, THEN How many times they had at least one puff (1 time, 2-5 times, 6-10 times, 11-15 times, 16-20 times, 21-25 times, 26-30 times, 31 or more times).
Secondary Outcome Measures
Full Information
NCT ID
NCT05499364
First Posted
July 24, 2022
Last Updated
August 11, 2022
Sponsor
University of Texas at Austin
1. Study Identification
Unique Protocol Identification Number
NCT05499364
Brief Title
TinCat LGBTQ+ Smoking Cessation Via Asynchronous Telehealth
Official Title
TinCat Tobacco Cessation Protocol for LGBTQ+ Austinites
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the efficacy of a novel telehealth-based intervention to reduce tobacco use among LGBTQ+ people.
Detailed Description
After being informed about potential risks and screened into the study, patients will be randomized into the treatment or control group. Control group participants will complete 7 sessions based on quit.gov smoking cessation planning. Intervention participants will complete 7 sessions of individualized asynchronous telehealth sessions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder, Tobacco Use Cessation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned to the control or intervention groups randomly.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Quit.gov program
Arm Type
Active Comparator
Arm Description
Generic intervention based on quit.gov sessions.
Arm Title
TinCat
Arm Type
Experimental
Arm Description
Individualized asynchronous telehealth including LGBTQ+ affirming components.
Intervention Type
Behavioral
Intervention Name(s)
TinCat
Intervention Description
7-10 minute personalized video sessions based in tobacco cessation modules.
Intervention Type
Behavioral
Intervention Name(s)
Quit.gov program
Intervention Description
7-10 minute generic videos directing participants through quit.gov program
Primary Outcome Measure Information:
Title
Tobacco use
Description
Cigarette and vape assessments based on prior research on vaping/smoking:
Cigarette: Today, did you have at least one puff on a cigarette (yes/no) IF YES, THEN How many cigarettes did you smoked (at least one puff) (1-"more than 60").
Vaping: Today, did you use an electronic nicotine delivery system (i.e., a vape containing nicotine), even just one puff? (yes/no) IF YES, THEN How many times they had at least one puff (1 time, 2-5 times, 6-10 times, 11-15 times, 16-20 times, 21-25 times, 26-30 times, 31 or more times).
Time Frame
11 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18 and over
Live in Greater Austin
Identify as LGBTQ+
Current smokers
High speed internet access
Exclusion Criteria:
Exceed screener cutoff for suicide risk
Exceed screener cutoff for borderline personality disorder
Report current active substance use other than tobacco that interferes with functioning
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mike Parent, PhD
Phone
352-642-2404
Email
michael.parent@austin.utexas.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34484026
Citation
Teah GE, Conner TS. Psychological and Demographic Predictors of Vaping and Vaping Susceptibility in Young Adults. Front Psychol. 2021 Aug 17;12:659206. doi: 10.3389/fpsyg.2021.659206. eCollection 2021. Erratum In: Front Psychol. 2022 Apr 22;13:871241.
Results Reference
background
Learn more about this trial
TinCat LGBTQ+ Smoking Cessation Via Asynchronous Telehealth
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