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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
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    July 24, 2022
    Last Updated
    August 11, 2022
    Sponsor
    University of Texas at Austin
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    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
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    TinCat LGBTQ+ Smoking Cessation Via Asynchronous Telehealth

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