TinCat LGBTQ+ Smoking Cessation Via Asynchronous Telehealth

August 11, 2022 updated by: Michael Parent, University of Texas at Austin

TinCat Tobacco Cessation Protocol for LGBTQ+ Austinites

The purpose of this study is to assess the efficacy of a novel telehealth-based intervention to reduce tobacco use among LGBTQ+ people.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
11 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

April 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

July 24, 2022

First Submitted That Met QC Criteria

August 10, 2022

First Posted (Actual)

August 12, 2022

Study Record Updates

Last Update Posted (Actual)

August 16, 2022

Last Update Submitted That Met QC Criteria

August 11, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003092

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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