NCT05645354

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

Completed NA Results posted Last updated 17 August 2025

What this trial tests

NA trial testing SmokefreeSGM in Smoking Cessation in 100 participants. Completed in 9 July 2024.

Timeline

10 November 2022

Primary endpoint
9 July 2024

9 July 2024

Quick facts

Lead sponsor	The University of Texas Health Science Center, Houston
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	100
Start date	10 November 2022
Primary completion	9 July 2024
Estimated completion	9 July 2024
Sites	1 location across United States

Drugs / interventions tested

• SmokefreeSGM
• SmokefreeTXT

Conditions studied

• Smoking Cessation — all drugs for Smoking Cessation →

Sponsor

The University of Texas Health Science Center, Houston

Who can join

18 and older, any sex, with Smoking Cessation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility as Assessed by Number of Participants Recruited for the Study Primary · Baseline

Group	Value	95% CI
All Participants Screened	100

Feasibility as Assessed by Number of Participants That Completed Month 1 Visit Primary · end of month 1

Group	Value	95% CI
SmokefreeSGM	35
SmokefreeTXT	34

Feasibility as Assessed by Number of Participants That Completed Month 3 Visit Primary · end of month 3

Group	Value	95% CI
SmokefreeSGM	22
SmokefreeTXT	20

Feasibility as Assessed by Number of Participants That Completed Month 6 Visit Primary · end of month 6

Group	Value	95% CI
SmokefreeSGM	19
SmokefreeTXT	16

Acceptability as Assessed by Number of Participants Who Completed Qualitative Interviews Primary · 6 months follow up

Group	Value	95% CI
SmokefreeSGM	16
SmokefreeTXT	9

Number of Participants That Quit Smoking Secondary · 1 month follow up

Group	Value	95% CI
SmokefreeTXT	18
SmokefreeSGM	15

Number of Participants That Quit Smoking Secondary · 3 month follow up

Group	Value	95% CI
SmokefreeTXT	7
SmokefreeSGM	8

Number of Participants That Quit Smoking Secondary · 6 month follow up

Group	Value	95% CI
SmokefreeTXT	3
SmokefreeSGM	7

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SmokefreeSGM

Serious: 0/50 (0%)

Deaths: 0/50

SmokefreeTXT

Serious: 0/50 (0%)

Deaths: 0/50

Other adverse events (2 terms — click to expand)

Reaction	System	SmokefreeSGM	SmokefreeTXT
Nausea	General disorders	—	—
Palpitations	General disorders	—	—

Data from ClinicalTrials.gov NCT05645354 adverse events section.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pragmatic recruitment strategies for a text-based smoking cessation intervention for sexual and gender minority groups.
   Tundealao S, Oubda MC, Klaff R, Reininger B, et al · · 2025 · PMID 41306822 · DOI 10.1186/s12982-025-01117-0