Tobacco Use DisorderNCT05499364
TinCat LGBTQ+ Smoking Cessation Via Asynchronous Telehealth
A study testing TinCat and Quit.gov program in people with Tobacco Use Disorder and Tobacco Use Cessation, run by University of Texas at Austin.
Trial summary
The purpose of this study is to assess the efficacy of a novel telehealth-based intervention to reduce tobacco use among LGBTQ+ people. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder, Tobacco Use Cessation
- What is being tested?
- TinCat and Quit.gov program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 and over
- Live in Greater Austin
- Identify as LGBTQ+
- Current smokers
- High speed internet access
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Tobacco Use Disorder, Tobacco Use Cessation
- Being tested
- TinCat, Quit.gov program
- Medical subject headings
- Tobacco Use Disorder, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TinCatBehavioural
7-10 minute personalized video sessions based in tobacco cessation modules.
Quit.gov programBehavioural
7-10 minute generic videos directing participants through quit.gov program
| Study group | Role | What they receive |
|---|---|---|
| Quit.gov program | Active comparator | Generic intervention based on quit.gov sessions. Receives: Behavioral: Quit.gov program |
| TinCat | Experimental | Individualized asynchronous telehealth including LGBTQ+ affirming components. Receives: Behavioral: TinCat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start1 Jan 2023 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to the control or intervention groups randomly.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Parent, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499364
- Sponsor's protocol ID
- STUDY00003092
- Status last verified
- Aug 2022
- First submitted
- 24 Jul 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34484026
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TinCat Tobacco Cessation Protocol for LGBTQ+ Austinites
- ClinicalTrials.gov ID
- NCT05499364
- Acronym / sponsor ID
- STUDY00003092
- Conditions
- Tobacco Use Disorder, Tobacco Use Cessation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to the control or intervention groups randomly.
| Arm | Type | Receives |
|---|---|---|
| Quit.gov program | Active comparator | Behavioral: Quit.gov programGeneric intervention based on quit.gov sessions. |
| TinCat | Experimental | Behavioral: TinCatIndividualized asynchronous telehealth including LGBTQ+ affirming components. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 and over
- Live in Greater Austin
- Identify as LGBTQ+
- Current smokers
- High speed internet access
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TinCat7-10 minute personalized video sessions based in tobacco cessation modules. | Behavioural | TinCat |
| Quit.gov program7-10 minute generic videos directing participants through quit.gov program | Behavioural | Quit.gov program |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Background: PubMed 34484026Teah 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing TinCat and Quit.gov program in people with Tobacco Use Disorder and Tobacco Use Cessation, run by University of Texas at Austin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mike Parent, PhD (352-642-2404, michael.parent@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tobacco use (time frame: 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05499364, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.