Smoking CessationNCT05645354
SmokefreeSGM, A Text-based Smoking Cessation Feasibility Trial for Sexual and Gender Minority Groups
A study testing SmokefreeSGM and SmokefreeTXT in people with Smoking Cessation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to test the feasibility and acceptability of Smokefree Sexual and Gender Minority (SGM), an SGM-tailored version of the SmokefreeTXT text messaging program Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- SmokefreeSGM and SmokefreeTXT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2022to 9 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identify as an LGBTQ+ individual
- Currently live in the United States
- Have smoked at least 100 cigarettes in their lifetime, smoke every day, and smoke greater than or equal to 5 cigarettes a day
- Are willing to quit smoking in the next 15 days
- Have a cell phone number with an unlimited short message service (SMS) plan
- Have a positive cotinine saliva test to indicate their smoking status
Who cannot join
- Have a prepaid cell phone plan (pay-as-you-go plan)
- Have a cell phone number that does not work and/or is registered to someone else
- Have inadequate equipment/devices (i.e., webcam, speakers, mic) for participating in telehealth sessions via Microsoft Teams, Webex, or Zoom AND cannot meet in-person
- Pregnant or breastfeeding persons (nicotine patches are not generally recommended to this groups since nicotine can affect fetal and neonatal brain development)
- Contraindication for nicotine patches. Absolute contraindications include: severe eczema or serious skin conditions, allergy to nicotine patches, pregnancy, breastfeeding, heart attack in the past 2 months, ongoing angina, peptic ulcer disease, arrhythmia, or uncontrolled blood pressure. Potential contraindications include: stroke in the past 6 months, insulin therapy, and a current diagnosis of liver, kidney, or heart disease. Study participants reporting a potential contraindication will require approval from their primary care provider and/or other treating physician (e.g., psychiatrist) to use nicotine patches. If the request is denied or not returned in 2 weeks, potential study participants will be excluded from the study.
- Current use of tobacco cessation medications
- Enrollment in another smoking cessation study
- Non-English speakers
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of this study is to test the feasibility and acceptability of Smokefree Sexual and Gender Minority (SGM), an SGM-tailored version of the SmokefreeTXT text messaging program
- Conditions
- Smoking Cessation
- Being tested
- SmokefreeSGM, SmokefreeTXT
- Keywords
- lesbian, gay, bisexual, transgender, queer (LGBTQ)
- Medical subject headings
- Smoking Cessation, Homosexuality, Female, Homosexuality, Bisexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmokefreeSGMBehavioural
Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of LGBTQ+ smokers.
SmokefreeTXTBehavioural
Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of the general population
| Study group | Role | What they receive |
|---|---|---|
| SmokefreeSGM | Experimental | Not described Receives: Behavioral: SmokefreeSGM |
| SmokefreeTXT | Active comparator | Not described Receives: Behavioral: SmokefreeTXT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as Assessed by Number of Participants Recruited for the Study
Measured: Baseline
Feasibility as Assessed by Number of Participants That Completed Month 1 Visit
Measured: end of month 1
Feasibility as Assessed by Number of Participants That Completed Month 3 Visit
Measured: end of month 3
Feasibility as Assessed by Number of Participants That Completed Month 6 Visit
Measured: end of month 6
Acceptability as Assessed by Number of Participants Who Completed Qualitative Interviews
Measured: 6 months follow up
Secondary outcomes (3)
Number of Participants That Quit Smoking
Measured: 1 month follow up
Number of Participants That Quit Smoking
Measured: 3 month follow up
Number of Participants That Quit Smoking
Measured: 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start10 Nov 2022
- Primary completion9 Jul 2024
- Study completion9 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Irene Tami-Maury, The University of Texas Health Science Center, Houston
- Investigators
- Irene Tami-Maury, DMD, DrPH, MSc, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645354
- Sponsor's protocol ID
- HSC-SPH-22-0717
- Other IDs
- K22CA237639
- Status last verified
- Jul 2025
- First submitted
- 1 Dec 2022
- Last updated
- 17 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tundealao S, Oubda MC, Klaff R, Reininger B, McNeill L, Tami-Maury I. Pragmatic recruitment strategies for a text-based smoking cessation intervention for sexual and gender minority groups. Discov Public Health. 2025;22(1):743. doi: 10.1186/s12982-025-01117-0. Epub 2025 Nov 24.
PubMed 41306822
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SmokefreeSGM, A Text-based Smoking Cessation Feasibility Trial for Sexual and Gender Minority Groups
- ClinicalTrials.gov ID
- NCT05645354
- Acronym / sponsor ID
- HSC-SPH-22-0717
- Conditions
- Smoking Cessation
- Keywords
- lesbian, gay, bisexual, transgender, queer (LGBTQ)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 9 Jul 2024 (actual)
- First posted
- 9 Dec 2022 (actual)
- Results
- Posted 17 Aug 2025
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 test the feasibility and acceptability of Smokefree Sexual and Gender Minority (SGM), an SGM-tailored version of the SmokefreeTXT text messaging program
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SmokefreeSGM | Experimental | Behavioral: SmokefreeSGM |
| SmokefreeTXT | Active comparator | Behavioral: SmokefreeTXT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Self-identify as an LGBTQ+ individual
- Currently live in the United States
- Have smoked at least 100 cigarettes in their lifetime, smoke every day, and smoke greater than or equal to 5 cigarettes a day
- Are willing to quit smoking in the next 15 days
- Have a cell phone number with an unlimited short message service (SMS) plan
Key exclusion criteria (8 listed)
- Have a prepaid cell phone plan (pay-as-you-go plan)
- Have a cell phone number that does not work and/or is registered to someone else
- Have inadequate equipment/devices (i.e., webcam, speakers, mic) for participating in telehealth sessions via Microsoft Teams, Webex, or Zoom AND cannot meet in-person
- Pregnant or breastfeeding persons (nicotine patches are not generally recommended to this groups since nicotine can affect fetal and neonatal brain development)
- Contraindication for nicotine patches. Absolute contraindications include: severe eczema or serious skin conditions, allergy to nicotine patches, pregnancy, breastfeeding, heart attack in the past 2 months, ongoing angina, peptic ulcer disease, arrhythmia, or uncontrolled blood pressure. Potential contraindications include: stroke in the past 6 months, insulin therapy, and a current diagnosis of liver, kidney, or heart disease. Study participants reporting a potential contraindication will require approval from their primary care provider and/or other treating physician (e.g., psychiatrist) to use nicotine patches. If the request is denied or not returned in 2 weeks, potential study participants will be excluded from the study.
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 |
|---|---|---|
| SmokefreeSGMParticipants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of LGBTQ+ smokers. | Behavioural | SmokefreeSGM |
| SmokefreeTXTParticipants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of the general population | Behavioural | SmokefreeTXT |
Primary outcome
Feasibility as Assessed by Number of Participants Recruited for the Study
Time frame: Baseline
Feasibility as Assessed by Number of Participants That Completed Month 1 Visit
Time frame: end of month 1
Feasibility as Assessed by Number of Participants That Completed Month 3 Visit
Time frame: end of month 3
Feasibility as Assessed by Number of Participants That Completed Month 6 Visit
Time frame: end of month 6
Acceptability as Assessed by Number of Participants Who Completed Qualitative Interviews
Time frame: 6 months follow up
3 secondary outcomes
Number of Participants That Quit Smoking
Time frame: 1 month follow up
Number of Participants That Quit Smoking
Time frame: 3 month follow up
Number of Participants That Quit Smoking
Time frame: 6 month follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41306822Tundealao S, Oubda MC, Klaff R, Reininger B, McNeill L, Tami-Maury I. Pragmatic recruitment strategies for a text-based smoking cessation intervention for sexual and gender minority groups. Discov Public Health. 2025;22(1):743. doi: 10.1186/s12982-025-01117-0. Epub 2025 Nov 24.
- 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.
Irene Tami-Maury, DMD, DrPH, MSc principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmokefreeSGM and SmokefreeTXT in people with Smoking Cessation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 17 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as Assessed by Number of Participants Recruited for the Study (time frame: Baseline). The study lists 5 primary outcomes in all. 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 NCT05645354, 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 17 Aug 2025.