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SuspendedNCT06487806Updated Jul 11, 2025

SmokefreeSGM Español Pilot, Beta Testing a Text-based Smoking Cessation Intervention for Sexual and Gender Minority(SGM) Groups Preferring Spanish Language

An interventional study of SmokefreeSGM in Smoking Cessation, sponsored by The University of Texas Health Science Center, Houston. Suspended at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-11.

Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment

Why this study was suspended
We are hiring staff
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to test the usability, engagement and acceptability of SmokefreeSGM Español, a culturally and linguistically tailored version of SmokefreeSGM, among Spanish-speaking SGM smokers.

02

Conditions studied

  • Smoking Cessation

Keywords

  • lesbian, gay, bisexual, transgender, queer/questioning (one's sexual or gender identity), and intersex(LGBTQI)
03

In context

Smoking Cessation

304 studies on the registry are indexed under Smoking Cessation; 139 are open to participants now.

This study's planned enrollment of 20 is below the median of 154 across 285 interventional studies indexed under Smoking Cessation.

Browse Smoking Cessation studies →

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Currently live in the United States
  • Have smoked at least 100 cigarettes in their lifetime, smoke every day, and smoke ≥ 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
  • Speak fluent Spanish

Exclusion criteria

Exclusion Criteria:

  • 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
  • Current use of tobacco products other than cigarettes or electronic nicotine delivery systems (ENDS) (i.e., (e.g., cigar, cigarillo, little cigar, pipe, Hookah)
  • Enrollment in another smoking cessation study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Beta testing group

    Behavioral: SmokefreeSGM

Interventions

  • BehavioralSmokefreeSGM

    Participants will be asked to set a quit date within the next 15 days before being enrolled in the SmokefreeSGM Español text messaging program. They will be mailed a 6-week supply of nicotine patches. The participants will get daily text messages for 6 weeks that will encourage them to quit smoking.

06

What researchers measure

Primary outcomes

  1. Perceived Usability as Assessed by the System Usability Scale (SUS)

    This is a 10-item questionnaire. Total score ranges from 0 to 100, with a higher score indicating greater usability and a score above 75 indicating better outcome

    Time frame: end of intervention (1month after quit date)

  2. Engagement with the text-messaging program as assessed by number of text messages a participant sends, including replies to the bidirectional texts messages of SmokefreeSGM Español program

    Time frame: end of intervention (1month after quit date)

  3. Acceptability at 1 month as Assessed by the System Usability Scale (SUS)

    This is a 10-item questionnaire. Total score ranges from 0 to 100, with a higher score indicating greater acceptability

    Time frame: end of intervention (1month after quit date)

07

Study locations

1 site
  • The University of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06487806
Lead sponsor
The University of Texas Health Science Center, Houston
Responsible party
Irene Tami-Maury (Assistant Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Jul 5, 2024
Start date
Aug 13, 2024
Primary completion
May 31, 2027 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Jul 11, 2025

Study contacts

Irene Tami-Maury, DMD, MSc, DrPH
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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