SmokefreeSGM, A Text-based Smoking Cessation Feasibility Trial for Sexual and Gender Minority Groups

NCT ID: NCT05645354

Last Updated: 2025-08-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-10

Study Completion Date

2024-07-09

Brief Summary

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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

Detailed Description

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Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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SmokefreeSGM

Group Type EXPERIMENTAL

SmokefreeSGM

Intervention Type BEHAVIORAL

Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of LGBTQ+ smokers.

SmokefreeTXT

Group Type ACTIVE_COMPARATOR

SmokefreeTXT

Intervention Type BEHAVIORAL

Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of the general population

Interventions

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SmokefreeSGM

Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of LGBTQ+ smokers.

Intervention Type BEHAVIORAL

SmokefreeTXT

Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of the general population

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

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
* Enrollment in another smoking cessation study
* Non-English speakers
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Irene Tami-Maury

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Irene Tami-Maury, DMD, DrPH, MSc

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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K22CA237639

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC-SPH-22-0717

Identifier Type: -

Identifier Source: org_study_id

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