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TinCat LGBTQ+ Smoking Cessation Via Asynchronous Telehealth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05499364
Recruitment Status : Not yet recruiting
First Posted : August 12, 2022
Last Update Posted : August 16, 2022
Sponsor:
Information provided by (Responsible Party):
Michael Parent, University of Texas at Austin

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Tobacco Use Cessation Behavioral: TinCat Behavioral: Quit.gov program Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be assigned to the control or intervention groups randomly.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TinCat Tobacco Cessation Protocol for LGBTQ+ Austinites
Estimated Study Start Date : January 1, 2023
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : June 30, 2023
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Quit.gov program
Generic intervention based on quit.gov sessions.
 Behavioral: Quit.gov program
7-10 minute generic videos directing participants through quit.gov program
Experimental: TinCat
Individualized asynchronous telehealth including LGBTQ+ affirming components.
 Behavioral: TinCat
7-10 minute personalized video sessions based in tobacco cessation modules.


Outcome Measures
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Primary Outcome Measures :
  1. Tobacco use [ Time Frame: 11 weeks ]

    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).



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05499364


Contacts
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Contact: Mike Parent, PhD 352-642-2404 michael.parent@austin.utexas.edu

Sponsors and Collaborators
University of Texas at Austin
More Information
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Publications:

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Responsible Party: Michael Parent, Associate professor, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT05499364    
Other Study ID Numbers: STUDY00003092
First Posted: August 12, 2022    Key Record Dates
Last Update Posted: August 16, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders